SOLICITATION NOTICE
66 -- Laboratory Equipment - SBA Subcontracting Plan
- Notice Date
- 7/16/2009
- 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
- FDA1056500
- Archive Date
- 8/15/2009
- Point of Contact
- David - Kordel,
- E-Mail Address
-
david.kordel@fda.hhs.gov
(david.kordel@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Subcontracting Plan Classification Code: 66 Subject: Laboratory Equipment & service agreement Solicitation Number: FDA1056500 Response Date: 31 July 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN 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; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 for full and open competition. The FDA intends to issue a firm fixed-price purchase order for, brand-name or equal for the following laboratory equipment: Two requirements for Systems 1 & 2: CLIN0001IBIS T6000 Biosensor system, which consists of integrated robotics for sample cleanup, sample introduction fluidics, a mass spectrometer for measurement of the DNA Amplicons, and a computer system to control the T6000 and handle the database for identification of the bacteria. System comes with a one-year manufacturer’s warranty known here as “base year”. Quantity 2 each. CLIN0002A liquid handling system to transfer samples of extracted DNA to 96-well plates for PCR amplification (Tecan system), quantity 2 each. CLIN003Thermal cycler units and controller to perform PCR amplification (Eppendorf Master Cycler Systems), quantity 2 each. CLIN004Centrifuge, quantity 2 each. CLIN005Thermo Fisher, King Fisher Flex System with 96 deep-well head with accessories, Tip comb KF96 F/DW Magnet CS100 (#97002534), Plaste PP 96 Deep V-BTM 2 ML CS50 (95040450) and Plates 96 well KF 200UL PK48 (97002540), quantity 2 each. CLIN006Installation and training One requirement for System 3: CLIN007Upgrade of existing T5000 system to T6000 system, with trade-in, quantity 1 each. CLIN008A liquid handling system to transfer samples of extracted DNA to 96-well plates for PCR amplification (Tecan system), quantity 1 each. CLIN009Thermo Fisher, King Fisher Flex System with 96 deep-well head with accessories, Tip comb KF96 F/DW Magnet CS100 (#97002534), Plaste PP 96 Deep V-BTM 2 ML CS50 (95040450) and Plates 96 well KF 200UL PK48 (97002540), quantity 1 each. CLIN010Installation and training CLIN011Option year 1, service and maintenance agreement for all three (3) systems. Requirements and specifications that shall be met by the purchase: A. General Requirements: The systems that FDA requires shall use an integrated sample preparation and measurement approach. It shall use robotics to extract and isolate DNA from samples, followed by transfer to a PCR thermal cycler to amplify the DNA after introduction of particular, and specifically chosen, primers. Once the amplification has been completed, the sample will be robotically handled and cleaned up, followed by analysis using electrospray mass spectrometry. A mass spectrometry measurement of the PCR amplicons gives a detailed organism fingerprint, which provides much more information than a simple yes/no answer provided by probes in real-time PCR; detection is not limited to previously known organisms. The approach can rapidly identify organisms in a mixture without additional sample preparation steps. By adjusting the primer selection, the method can be made general or specific and can rapidly identify mutations (within the amplified region). The approach can handle many different types of samples including: air, soil, water, mucosal swabs and washes, sterile fluids (blood, CSF, urine), hair, teeth, and bone, making it very amenable to food matrices. The approach is also high throughput, allowing for the analysis of 600-1200 samples per 24 hour period. Specific Requirements: 1. Robotic system for handling liquid extracts from KingFisher plates and transferring them to IBIS kits for PCR amplification (Based on Tecan EVO75system). a. One arm-2 pipettor system b. Positioning precision i. X-axis ± 0.15 mm ii. Y-axis ± 0.15 mm iii. Z-axis ± 0.3 mm c. Robotic finger gripper range 58-140 mm 2. 3 thermal cyclers and controller for PCR amplification of samples in IBIS kits (Eppendorf Thermocyclers). a. Sample capacity: 1 microtiter plate 8 x 12 b. Temperature-control range4-99°C c. Temperature distribution across the block: i. 20°C to 72°C±0.6°C ii. 95°C±1.0°C d. Regulation accuracy per well±0.2°C e. Temperature-control speed i. approx. 3°C/s (heating), ii. approx. 2°C/s (cooling) f. Max. no. of cycles99 g. Power consumption500 W 3. Centrifuge a. Max. rcf: 30,130 x g b. Max. rpm: 17,500 1/min c. Max. capacity: 30 x 1.5 / 2.0 ml d. Rotor: holds 2 microplates e. Acceleration time to max. speed: <25 s f. Braking time from max. speed: <25 s 4. Biosensor requirements a. PCR-based amplification of DNA from samples to produce amplicons of 100-120 base pair length, using carefully selected primers that can classify organisms generally or specifically. i. PCR Assay and clean-up kit: This kit contains ten 96-well plates with pre-selected PCR primers that amplify carefully selected regions of DNA to produce products in the size range compatible with the mass range and resolving power of the mass spectrometer. These PCR primers are selected based on the target study and can provide general or specific information about the nature of the organisms in question. The primers are specifically designed by IBIS. Internal standards are also included in the kits. b. Robotic cleanup of PCR amplicons. i. Automated desalting and cleanup module: This component consists of a robotic heat sealer which seals the 96-well plates so that they cannot be contaminated, followed by robotic desalting and clean-up of the PCR amplicons. Desalting is done on magnetic beads. This system is designed to minimize the possibility of sample contamination. ii. Robotics handles up to 15 plates at one time, and contains reagents to handle all 15 plates iii. Processing rate: 30 seconds per well c. Sample injection fluidics module: A custom fluidics module is designed to sample each purified mixture with minimal cross contamination and introduce it into a liquid stream at a carefully controlled flow rate for subsequent ESI-MS analysis. The system alternates between high flow rates (for cleaning between samples) and lower flow rates (200 microliters per minute) for the analytical steps. The module precisely controls injection volumes as well. The injection system controls the voltages on the electrospray source so that the system is not electrospraying while higher cleaning flow rates are being used between samples. d. Electrospray TOF-MS analysis of amplicons at high mass accuracy (<20 ppm). i. Mass spectrometer system for DNA detection: This component consists of an electrospray time-of-flight mass spectrometer (ESI-TOF) for analysis of PCR products introduced by the sample injection fluidics module. This instrument consists of an orthogonal injection time-of-flight mass spectrometer with an off-axis sprayer. The orthogonal injection source allows for ion accumulation prior to MS analysis to improve sensitivity. The TOF contains a reflectron to insure high mass resolution. The mass spectrometer is controlled software that is integrated into IBIS Control software. The instrument has the following specifications: 1. Standard mass range 500 – 2,000 m/z 2. Mass resolution 10,000 FWHM or greater in standard configuration at m/z 1034 3. Mass accuracy of 3 ppm (RMS) error with internal calibration in negative polarity 4. Mass accuracy of 20 ppm or less (RMS) error with external calibration 5. ESI orthogonal electrospray source (1µl –1 ml/min) 6. Instrument control software e. High throughput analysis capability of over 1500 PCR products per day. f. Control and Analysis Software 1. Robotics Software: controls and coordinates the sample handling and sample injection processes by controlling the robotic components of the system. This includes the cleanup and injection portion of the analysis. 2. Control software: This component manages the liquid flow system and the mass spectrometer (by interfacing with the mass spectrometer software), as well as integrates the total operation of the system 3. Sample tracking software 4. Relational database: Curated database of genomics information that contains base counts (composition) for primer pairs for microorganisms. This database contains sequences generated by known primers for a large number of microorganisms. The information is maintained for primers that are designed to differentiate at the family level (e.g. enterobacter) and at the species and strain level. This database is a unique and indispensable part of the system, since base compositions stored in this database will be compared with those generated experimentally. This component is critical for rapid detection and proper identification of bacteria. 5. Analysis of the masses of complementary DNA strands to identify unique composition (based on DNA strand complements) of bases in strand. 6. Comparison of base composition to library of known base compositions (for given primers) for known organisms 7. Data Processor: Analyzes mass spectrometry data from both forward and reverse strands of amplified DNA to generate the unique base composition for the sequence in question. It function is to then compare the generated base composition to a database of known base compositions that would be generated from sequences produced for a given set of primers. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 4:30 pm (1630) EST on 23 July 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," and 2) Price. Technical Capability is significantly more important than price. The Government will evaluate offers for award purposes by adding the base price plus all options to arrive to the total price for the 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 an option line item. Evaluation of Technical Capability shall be based on the requirements provided in the quotation. Offerors shall include the manufacturer, make and model of the product, manufacturer sales literature or other product literature which CLEARLY DOCUMENTS that the offered product meets or exceeds the specifications stated herein. Offerors are required to submit a subcontracting plan. See attachment in the Fedbizopps posting. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.217-8, Option to Extend Services 52.217-9, Option to Extend the Term of the Contract 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. 52.243-1 Changes-Fixed Price 52.244-6 Subcontracts for Commercial Items. This is a Combined Synopsis/Solicitation for laboratory equipment and service maintenance as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 334516; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to three locations: College Park, MD and two yet to be determined. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 31 July 2009 to the attention of David Kordel, david.kordel@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
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