MALDI TOF/TOF Mass Spectrometry System for Automation and software solution and tissue imaging capabilities

Added: Mar 16, 2018 3:01 pm (i) 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; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is NIHDA201800088 and the solicitation is issued as a Request for Quotation (RFQ) on a Full and Open competitive basis.

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold of $150,000.00. A Fixed-Price type of contract is contemplated for any resulting contract entered into as a result of this solicitation.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) Number/Effective Date: 2005-97 January 24, 2018.

(iv) The North American Industry Classification System (NAICS) code for this procurement is 334516 Analytical Laboratory Instrument Manufacturing with size standard 1,000 employees.

(v) Background
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) was officially established in fiscal year 2012 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. The Chemical Genomics Center (NCGC) at NCATS requires a Mass Spectrometry Main TOF/TOF System with Automation and MALDI software solution and tissue imaging capabilities. Several programs within NCATS require a next generation automated instrumentation system that allows for the rapid measurement of chemical and biological samples ranging from small molecules to large proteins. The most direct and rapid means to do so is by measuring samples based upon their molecular weight making a mass spectrometer an ideal solution.

For the analytical chemistry group, this will allow the rapid identification of small molecules for quality control purposes, which is critical to ensure that compound libraries used in NCATS screening operations are accurate.

For the biology and assay development group within NCATS, this will allow the rapid measurement of the effect of small molecules on biological systems without the need for traditional labeling techniques such as the use of fluorescence probes of antibodies while also reducing the total sample volume, greatly reducing the cost required to run a HTS screen.

Finally, for the tissue printing group the requirement can be modified to allow for mass spectrometry based imaging which can be used to identify biological markers within bio-printed samples to validate the physiological relevance of tissues produced in this fashion. This requirement must achieve all three of these functions within one instrument.

Various programs and labs within NCATS have been given the directive to perform different types of high throughput screens to evaluate some biological activity and to potentially develop new therapeutics or therapeutic combinations in some cases or in others to determine the relative toxicity of chemical compounds under test.

To do this, a biological experiment is performed in the presence of hundreds of thousands of chemical compounds at various concentrations, requiring that millions of samples be tested for each experiment. This requires that these experiments be run in a high density well plate, to both minimize the total reagent volume used per experiment and to facilitate less total plates to be used to perform an entire assay. Typically, one experiment might consist of screening 500,000 compounds at 5 different total concentrations for a total of 2.5M samples. If this experiment is run using a 1536 well plate, meaning 1536 samples can be tested at a time, this requires nearly 1650 plates. The only way to accomplish handling this many well plates for an experiment is high throughput screening (HTS), which requires a high degree of robotic automation and a means of rapidly measuring samples.

Advances in mass spectrometry instruments have enabled them to do rapid measurement of samples with a broad range of molecular weights, and as NCATS starts to move beyond only small molecules many of the legacy plate readers in use that use fluorescence or luminescent based imaging techniques have limitations in that they require more total assay volume in addition to the requirement of fluorescence labeling of biological samples or the use of antibodies to perform a measurement. The use of a mass based readout eliminates the need for the labeling of samples and reduces assay volumes, thereby reducing costs.

Purpose and Objective: The purpose of this requirement is to obtain a Matrix Assisted Laser Desorption/Ionization (MALDI) TOF/TOF Mass Spectrometry System for Automation and software solution and tissue imaging capabilities in accordance with the specifications described in this notice. The subject supply shall be warrantied in accordance with the Offeror's standard commercial warranty practices.

Product Description: Products offered must include those salient physical, functional, or other characteristics that are deemed essential in meeting the government's needs. Specifically, the following are considered the salient characteristics for this requirement:

MALDI ion source with Smartbeam 3D technology
Gridless MALDI source for maximum ion transmission and sensitivity.

Suitable for large area MALDI targets (up to 1536 positions) in a standard microtiter plate format.

Scanning laser beam with 10 kHz repetition rate and modulated laser beam profile for best sensitivity

Laser beam diameter of 5 µm for versatile applications with different sample preparation techniques; including variable power attenuator allowing fast, routine MALDI imaging applications with pixel sizes of 20 µm

Different Laser focus patterns adapt for optimal sensitivity using different image resolution requirements for full pixel coverage from small to larger pixel size

True pixels at precise quadratic shape, adaptable to different resolution requirements

Solid state laser with laser pulse energy ≥ 100 uJ.

Laser shots ≥ 10 billion (laser technology).

Two-dimensional sample movement by synchronizing a scanning laser beam with a moving sample target - increased stage lifetime and acquisition speed

Data acquisition of up to 50 true square pixel / second

24/7 operation: Convenient ion source cleaning procedure without the use of any tools: direct access to removable, self-aligning lens stack for easy ion source cleaning with minimal downtime. Access through extra vacuum door without touching the rest of the ion source.

Pulsed ion extraction technology for high mass accuracy and unmatched resolution spectra across an extended mass range

Target technology incorporating hydrophilic anchors on a hydrophobic surface for a) on-target pre-concentration leading to increased sensitivity and acquisition speed, b) precisely defined sample spots provide for robust automated sample analysis in arrays of up to 1536 samples per MTP.

Performance Specifications
Linear mass range at least up to 300 kDa.

High mass resolution over a wide mass range. In reflectron mode, resolution of 15,000 - 40,000 FWHM simultaneously across a wide m/z range 900 - 4500 in a seamless mass spectrum.

MS resolution › 50,000 FWHM achieved in MS mode for m/z 3,147 and ≥ 25,000 FWHM for Cytochrome C (m/z 12361)

Reflectron mass accuracy ≤ 1.0 ppm with internal calibration

Isolation resolution prior to MS/MS of 1000

MS/MS sensitivity ≤ 250 amol [Glu1]-Fibrinopeptide B fragment 1,056 Da at S/N ≥ 30:1

MS/MS Fragment Resolution ≥ 10,000 for m/z 1,441

10-bit digitizer for high resolution and dynamic range

Mass Analyzer
TOF/TOF technology with two stage acceleration and precursor ion selector betweenTOF1 and TOF2.

Gridless linear and triple stage reflectron ion optics for detection in linear and reflectron mode, respectively.

Ion optics adapts to analysis mode for best resolution and sensitivity: the MS/MS ion optics moves out the ion path for best MS sensitivity, the reflector is automatically adapted to MS vs MS/MS experiments for best resolution.

CID (Collision-Induced Dissociation) Capability (e.g., Leu/Ile differentiation)

In source decay (ISD) for the direct fragmentation of intact proteins without the need for enzymatic digestion.

In reflectron mode the effective flight path is ≥ 300 cm.

General Specifications
Vertical system with benefits for lab space. Foot print less than 80 cm × 95 cm only, weight maximum 375 kg

Advanced vacuum system with only one turbomolecular pump and one low-maintenance oil-free prevacuum pump.

Software Specifications
SCiLS-Lab image analysis software for mining large MALDI imaging data, statistical analysis and correlation to histological scans, SCiLS Lab Core with basic functionalities and yearly licenses for SCiLS Lab Pro and SCiLS Lab Premium 3D

MALDi software for assay development and sample analysis of large sample cohorts using MPT format plate maps

Method development mode allows for simple testing and evaluation of dozens / hundreds of sample / preparation properties (buffers, matrices, dilutions etc.) to refine the ideal conditions for an assay. Resulting Signal and S/N is evaluated and scored automatically.

Screening mode allows sample batches to be analyzed in terms of data collection and data analysis and export to LIMS as appropriate.

Delivery, Inspection and Acceptance: Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or factory warranty schedules in accordance with standard commercial practice, as applicable. Inspection and acceptance will be performed at a Government facility located at 9800 Medical Center Drive, Rockville, MD 20850. The Government expected build time and delivery is eight (8) weeks days after contractor receipt of any contract resulting from this solicitation.

(vi) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The following is provided as an addendum to FAR clause 52.212-1, Instructions to Offerors: Installation and any onsite training should be quoted on separate line items. Shipping and handling cost must be included in any quotation submitted in response to this solicitation. Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty schedules applicable. Offerors must indicate if any applicable extended warranty coverage (EWC) is only offered at time of purchase in accordance with the Offeror's standard commercial practice, and the length of time of such warranty.

SMALL BUSINESS SUB CONTRACTING PLAN: Offerors must submit a Small Business Sub-Contracting Plan with their initial offer in accordance with the NIH Small Business Sub-Contracting Plan guidance located at the following web address:
https://www.hhs.gov/grants/contracts/contract-policies-regulations/subcontractplan/index.html

Pursuant to NIH's priority of Small Business participation, Offerors shall be required to submit a subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," at FAR Clause No. 52.219-9.

The Small Business subcontracting goal of this acquisition is 33% small business. Offerors are expected to include a subcontracting plan for the performance period stated in their proposal. Offeror's shall submit a completed plan as it pertains to fully achieving the small business goal in the contract.

HHS expects each procuring activity to establish minimum subcontracting goals for all procurements. The anticipated minimum goals for this RFP are as follows:

33% for Small Business;
5% for Small Disadvantaged Business;
5% for Women-Owned Small Business;
3% for HUBZone Small Business; and
3% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.

FAR 52.219-9, Small Business Subcontracting Plan (Jan 2017), Alternate II (Nov 2016), will be applicable to any resultant contract.

(vii) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The following is an addendum to 52.212-2. Responses received to this RFQ will be evaluated on the basis of Lowest Price Technically Acceptable (LPTA). Offeror's submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including shipping cost and estimated time of delivery after receipt of order, and warranty and training considerations. Responses will be evaluated based on contractor's ability to meet the government's SALIENT CHARACTERISTICS stated in this notice and on ability to deliver required supplies. Responses to this solicitation must include clear and convincing evidence of the Offeror's capability of fulfilling the requirement as it relates to the essential government requirements stated in this solicitation. Under the lowest-price technically acceptable (LPTA) process, Offerors' will be determined to be "technically acceptable" or "technically unacceptable" based on an evaluation of responses against the following factors to determine if, as submitted, the proposal is technically acceptable.

(1) Technical Capability: Offerors shall clearly indicate possessing the capability to achieve the essential salient characteristic features of this requirement. The Offeror must indicate in its quotation the ability to provide all of the requirements. The Offeror must indicate in its quotation the ability to meet the delivery requirements. Offerors submitting a response with documented technical specifications and evidence of possessing the technical knowledge, qualifications and capability and management structure needed in successfully achieving this requirement will be determined to be technically acceptable.

(2) Corporate Experience: Demonstrated capability to accomplish contract requirements and extent of relevant experience in the areas covered by the Purchase Description. The Government shall evaluate quotations based on projects that are similar in size, scope, and complexity to the requirements contained in this solicitation.

Respondents that believe that they are manufacturers or authorized resellers of any BRAND-NAME product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.

(viii) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition.

(ix) The provision at FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. An addendum to FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, Offeror Representations and Certifications Commercial Items, applies to this acquisition. The addendum includes the following FAR Clauses, provisions, terms and conditions: (a) 52.217-6 Option for Increased Quantity (Mar 1989).

(x) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition and 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 (Nov 2007) (41 U.S.C. 351, et seq.) applies to this acquisition. See attached for the appendix to 52.212-5.

(xi) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The PRICE QUOTE shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria and a price proposal. Offerors MUST submit historical pricing information ESSENTIALLY EQUAL to a commercial item price list or redacted contract or invoice containing the price offered to a commercial or public entity for the same or similar subject unit of supply.

Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror's cover sheet.

In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."

All responses must be received no later than the date specified in this announcement. Late responses will not be accepted. All responses must reference solicitation number NIHDA201800088. Responses must be submitted electronically to hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at 301-827-5304.