Automated Liquid Handler for Molecular Operations
Automated Liquid Handler For Molecular Operations
Sources Sought
Solicitation # FA860119RA2AR
The Government is conducting market research and identifying, as potential sources, companies that may possess the expertise, capabilities, and experience to meet the requirements as specified in the Program Description below.
CAUTION: This Sources Sought is issued solely for information and planning purposes. In accordance with Part 10 of the Federal Acquisition Regulation, the U.S. Government is conducting market research. The intended purpose is to identify potential sources that may possess the expertise, capabilities, and experience to meet USAFSAM/PHE requirements. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Further, USAFSAM/PHE is not at this time seeking proposals, and will not accept unsolicited proposals. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this sources sought. Please be advised that all submissions become Government property and will not be returned. All costs associated with responding to this sources sought will be solely at the responding party's expense. Not responding to this sources sought does not preclude participation in any future RFP, if any is issued. In accordance with Federal Acquisition Regulation 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is the responsibility of the interested parties to monitor this FedBizOpps website for additional information pertaining to this source sought.
INSTRUCTIONS:
•1. Below is a document containing a description of the requirement and a Contractor Capability Survey, which allows you to provide your company's capabilities.
•2. If, after reviewing these documents, you desire to participate in the market research, you should provide documentation that supports your company's capability in meeting these requirements. Failure to provide documentation may result in the government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/ capabilities in order to perform that portion of the requirement (i.e., teaming, subcontracting, etc.).
•3. Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged.
•4. Questions relative to this market survey should be addressed via email to Amy Rosier (AFLCMC/PZIBC), amy.rosier@us.af.mil. Verbal questions will NOT be accepted.
PROGRAM DESCRIPTION
The Epidemiology Laboratory Service at the United States Air Force School of Aerospace Medicine (USAFSAM/PHE) is requesting an automated liquid handling system to increase the efficiency and accuracy of molecular operations which include but are not limited to specimen preparation for Next Generation Sequencing (NGS) methods in a clinical laboratory.
REQUIREMENTS
The requirement is for an automated liquid handling/specimen preparation system, and should include the shipping, delivery, installation, and training needed to operate the device for USAFSAM/PHE at the Wright-Patterson Air Force Base in Ohio. System must allow for operation without operator intervention after necessary reagents, specimens, and any required consumables are loaded onto the system.
Essential Characteristics: Minimum Requirements
•1) Requirements needed in specimen preparation for NGS operations
•a. The system shall be compatible with sample tubes of various brands and sizes (at minimum 0.2 mL to 50 mL), 96-well flat bottomed and conical plates, and other specimen container formats required by other elements of the system.
•b. System must be able to accurately and precisely pipette volumes from 0.1 µL to 5000 µL based on available modular options for the system. The system must maintain this accuracy and precision regardless of the modular pipetting option in addition to the characteristics of the liquid (e.g. conductive/non-conductive, polar/non-polar, organic/inorganic, volatile solvents, viscous solutions).
•c. Must be able to detect liquid levels in wells regardless of characteristics of the liquid mentioned in 1.b. In addition, must be able to detect foam or bubbles on liquid surfaces in order to sufficiently remove the need to manually program liquid levels and to prevent the introduction of air. The System must include all hardware and software necessary to verify the accuracy and precision of liquid detection operations.
•d. Stage/hold and possess the potential to process batches of 96-384 specimens for subsequent preparation in molecular assays and support pre-programming of multiple protocols.
•e. Must be equipped with an 8-channel pipetting head with independent movement along the x and z axis. The pipetting unit must utilize a technique that eliminates aerosol formation during pipetting and tip ejection. In addition, each individual channel must be able to monitor the amount of displaced air when pipetting in order to confirm successful transfer of liquids regardless of consistency (e.g. clots) and/or empty wells. This monitoring must be verifiable in traceable digital audit trails.
•f. Each independent channel must have the ability to compensate for pressure changes in real time caused by characteristics of the liquid (e.g. volatile organics) to eliminate droplet formation.
•g. Capable of piercing aluminum cover sheets using disposable tips for 96 well formats.
•h. Capable of transporting variable sized sample tubes around system landscape.
•i. System must be capable of stacking multiple 96 well plates and must be able to stack and access stacked pipette boxes to maximize hands-off time of the operator.
•j. Must offer optional automated capping and de-capping mechanisms.
•k. System must come with a temperature controlled modular option for assays that require either heating or cooling steps.
•l. System must have a vortex/shaking block that may optionally allow for temperature control as well.
•m. System must have optional modular design offering an onboard thermal cycling (i.e. PCR) capability on board.
•n. System must have the ability to seal 96 well plates to avoid evaporation and contamination.
•o. A minimum requirement is to operate in accordance with the normalization, dilution, library preparation setup, and magnetic bead based nucleic acid purification steps associated with Illumina© (San Diego, CA) NGS reagents, specifically Nextera XT kits. For laboratory protocol additions, expansions, or changes, adaptability of the system is also required.
•p. The system shall include a barcode reader to ensure positive specimen identification and tracking. The system shall allow for barcode read failures to be corrected, if misread or failed to read.
•2) Additional requirements for System
•a. The system must be capable of running Illumina© (San Diego, CA) qualified methods and must be able to generate documentation of proven performance characteristics in association with Illumina©.
•b. System must be less than or equal to the following dimensions: 45 in x 36 in x 32 in (W x H x D).
•c. The system must include the necessary workstation computer with associated software and licenses necessary to run all operations. In addition, system must be capable of loading and running custom designed procedures transferable to or from colleagues with similar systems.
•d. The system shall be capable of interfacing with laboratory information management systems (LIMS) and laboratory IT infrastructure.
•e. In addition, software must be capable of generating custom reports for detailing laboratory operations to include accuracy and precision reporting of specific runs. The software shall be capable of generating system diagnostic reports that include traceability mapping and other sampling faults.
•f. The system shall be capable of generating mapping files to associate initial sample tube identity to 96-well plate positions or vial positions.
•g. The system shall include the option to attach an uninterruptible power supply (UPS) with a backup battery that is compatible with all system components and is capable of conditioning the power to the system.
•h. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the Original Equipment Manager (OEM) terms and conditions.
•i. The power requirement must be between 120-240V and at 60Hz.
•j. The system shall be installed in compliance with Occupational Health and Safety Administration (OSHA) requirements.
•k. The system shall be within manufacturer(s) service life (i.e., repair parts, maintenance, etc.) for a minimum of 5 years from the date of installation.
•l. All components of the system shall be distributed and serviced by one vendor to ensure component compatibility.
•m. The system, including all contractor and subcontractor-provided hardware and software, shall be capable of undergoing Information Assurance (IA) Certification and Accreditation (C&A) for operation on Wright-Patterson AFB IT networks. If the C&A process identifies issues which would lead to denial of Approval to Operate (ATO), contractor shall remedy the issues to the satisfaction of the government within six (6) months of notification. The vendor shall meet with the government to provide a plan to address the issues identified. The vendor shall provide a monthly status report on the progress addressing the issues.
•3) Training Requirements
•a. The Contractor shall provide operator training at USAFSAM/PHE laboratory site in association with system installation and operation requirements for the number of required individuals per lab (no more than five (5) individuals). After training, personnel shall be capable of carrying out normal system operation. This training should include the transfer of existing methods and development of custom designed procedures with trainer.
•b. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America.
•c. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.
•d. Upon delivery, the vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor shall make arrangements for the storage.
CONTRACTOR CAPABILITY SURVEY
Part I. Business Information
Please provide the following business information for your company/institution and for any teaming or joint venture partners:
•· Company/Institute Name:
•· Address:
•· Point of Contact:
•· CAGE Code:
•· Phone Number:
•· E-mail Address:
•· Web Page URL:
•· Size of business pursuant to North American Industry Classification System (NAICS) Code: 334516-ANALYTICAL LABORATORY INSTRUMENT MANUFACTURING, STD Size 1000 employees.
•· Based on the above NAICS Code, state whether your company is:
•o Small Business (Yes / No)
•o Small Disadvantaged Business (Yes / No)
•o Woman Owned Small Business (Yes / No)
•o Economically Disadvantaged Woman Owned Small Business (Yes / No)
•o 8(a) Certified (Yes / No)
•o HUBZone Certified (Yes / No)
•o Veteran Owned Small Business (Yes / No)
•o Service Disabled Veteran Small Business (Yes / No)
*All interested contractors must be registered in SAM in order to be eligible for award of Government contracts. The government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action.
•· A statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership).
•· Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data.
•· Please provide a statement to acceptability of the following proposed non-commercial provisions and clauses, as they are determined to be consistent with customary commercial practice.
•o FAR 52.203-6, Alt I, Restrictions on Subcontractor Sales to the Government (Sep 2006)
•o FAR 52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)
•o FAR 52.209-7, Information Regarding Responsibility Matters (Jul 2013)
•o FAR 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013)
•o FAR 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)
•o FAR 52.215-20, Requirement for Certified Cost or Pricing Data and Other Than Certified Cost or Pricing Data (Oct 2010) FAR 52.229-3, Federal, State, and Local Taxes (Feb 2013) FAR 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013)
•o FAR 52.233-2, Service of Protest (Sep 2006)
•o FAR 52.242-13, Bankruptcy (Jul 1995)
•o FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998)
•o FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998)
•o FAR 52.252-5, Authorized Deviations in Provisions (Apr 1984)
•o FAR 52.252-6, Authorized Deviations in Clauses (Apr 1984)
•o DFARS 252.209-7004, Subcontracting with Firms That Are Owned or Controlled by the Government of a Terrorist Country (Oct 2015)
•o DFARS 252.225-7002, Qualifying Country Sources as Subcontractors (Aug 2016)
•o DFARS 252.232-7007, Limitation of Government's Obligation (APR 2014)
•o AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances (ODS) (Nov 2012)
•o FAR 52.204-7, System for Award Management (Jul 2013
•o FAR 52.204-13, System for Award Management Maintenance (Jul 2013) FAR 52.209-7, Information Regarding Responsibility Matters (Jul 2013)
•o FAR 52.247-34, F.o.b. Destination (Nov 1991)
•o DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights (Sept 2013)
•o DFARS 252.204-7003, Control of Government Personnel Work Product (Apr 1992)
•o DFARS 252.225-7048, Export-Controlled Items (Jun 2013)
•o DFARS 252.243-7001, Pricing of Contract Modifications (Dec 1991)
•o AFFARS 5352.201-9101, Ombudsman (Jun 2016)
•o AFFARS 5352.223-9001, Health and Safety on Government Installations (Nov 2012)
•o SPS STMNT NBR 12: LEVEL I ANTITERRORISM (AT) AWARENESS TRAINING
ATTENTION small business respondents who are interested in submitting a proposal as the prime contractor for this effort:
No set aside decision has been made; however, the Air Force is contemplating setting this acquisition aside for Small Businesses if there is sufficient demonstrated interest and capability. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that two or more small business prime contractors must be capable of performing at least 50% of the entire scope of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, Limitations on Subcontracting. The clause reads, in part, as follows: "Limitations on Subcontracting (Nov 2011) ... (c) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that in performance of the contract in the case of a contract for - (1) Services (except construction). At least 50 percent of the cost of contract Performance incurred for personnel shall be expended for employees of the concern... ". Provide specific details and rationale as to how compliance with FAR clause 52.219-14 would be achieved, including specific details regarding teaming arrangements, etc.
If subcontracts are to be used, provide anticipated percentage of effort to be subcontracted and whether small or large businesses will be used. Teaming and/or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided.
ATTENTION all potential respondents:
The acquisition strategy for this program has not been finalized. If this acquisition is not set aside for small business, it is anticipated that the contract may contain a small business utilization requirement. Please provide feedback on the requirement and what areas are likely candidates for SB subcontracting.
Part II. Capability Survey Questions
•1. Is your firm registered in the System for Award Management (SAM), formally known as Central Contractor Registration (CCR)? In accordance with federal regulations, all contractors doing business with the federal government must be registered in the SAM database.
•2. Describe briefly the capabilities of the nature of the services you provide.
•3. Describe your company's past experience on previous with similar services. Include contract numbers, a brief description of the work performed, period of performance, agency/organization supported, and individual point of contact (Contracting Officer or Program Manager).
•4. Are there specific requirements in the documentation that we provide that would currently preclude your product/service from being a viable solution to our requirement?
•5. Are there established market prices for our requirement? If you offer this product and/or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public? Is our requirement offered to both under similar terms and conditions? Briefly describe any differences.
If your company is interested, e-mail your responses to amy.rosier@us.af.mil. E-mail responses should be received no later than 15 days after the issuance of this notice. Direct and succinct responses are preferred. Marketing materials are considered an insufficient response. As an alternative to electronic submissions you may mail two original signed copies of your response, on or before the same date to:
AFLCMC/PZIBC, Bldg. 1, Room 109
Attn: Amy Rosier
1940 Allbrook Dr.
Wright-Patterson AFB OH 45433-5344
(937) 522-4540
RESPONSE FORMAT INSTRUCTIONS:
Be advised that all correspondence sent via e-mail shall contain a subject line that reads "Automated Liquid Handler For Molecular Operations # FA860119RA2AR". If this subject line is not included, the e-mail may not get through e-mail filters at Wright-Patterson AFB. Filters are designed to delete emails without subject lines or with suspicious subject lines or contents. Attachments with files ending in.zip or .exe are not allowable and will be deleted. Ensure only .pdf, .doc, or .xls documents are attached to email.
Responses are limited to ten (10) pages and may be submitted electronically to the following email address: amy.rosier@us.af.mil.
RESPONSE DUE DATE:
Responses are due no later than 1:00 pm, EST. Friday, 1 March 2019 and should be sent to amy.rosier@us.af.mil.
Primary Point of Contact: Amy Rosier Contract Specialist amy.rosier@us.af.mil
Phone: (937) 522-4540
Contracting Office Address:
1940 ALLBROOK DRIVE
WRIGHT-PATTERSON AFB, Ohio 45433-5309
United States
Place of Contract Performance:
Wright Patterson AFB, Ohio
Dayton, Ohio 45433
United States
Amy M Rosier, Contracting Specialist, Phone 9375224540, Email amy.rosier@us.af.mil
