Sources Sought Notice.docx

This is a Sources Sought Notice announcement; market survey for information only, to be used for preliminary planning purposes. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. Any requests for a solicitation in response to this notice will not be honored. Medical Readiness Contracting Office-West, Fort Cavazos, TX, has an upcoming requirement to solicit for and award a contract to provide for two fully automated leased waterless analyzers as follows: (2) Immunoassay Waterless Analyzers and a reagents test menu of VZV IgG, Measles IgG, Mumps IgG, and Treponema Total testing in accordance with Federal Food and Drug Administration ( FDA) regulatory requirements for the Department of Pathology, Laboratory Department, Martin Army Community Hospital, Fort Benning, GA. This request is anticipated to result in a Firm Fixed-Priced contract. The type of solicitation to issue will be based upon the responses to this synopsis. Contact with Government Personnel, other than the Contract Specialist identified at the bottom of this notice, by any potential offeror, or their employees’, regarding this requirement is strictly prohibited and will not be honored.

The purpose of this synopsis is to gain knowledge of interest, capabilities and qualifications of various members of the Small Business Community to include Section 8(a), Historically Underutilized Business Zones (HUB-Zone), Women-Owned Small Business, and Service-Disabled Veteran-Owned Small Business (SDVOSB), as well as the interest, capabilities and qualifications of various members of the Large Business community, to compete and perform a Firm Fixed Price Contract for these supplies. The type of solicitation to issue will depend upon the responses to this sources sought synopsis. The Government must ensure there is adequate competition among the potential pool of responsive contractors.

The North American Classification System (NAICS) code for this requirement is 325413 “In-Vitro Diagnostic Substance Manufacturing” The Small Business Size Standard in 1,250 size standards in number of employees.

Responses to this Sources Sought Notice should demonstrate the firm’s ability, capability, and responsibility to provide and deliver the products listed below. In response to this notice, interested parties shall submit a written Statement of Capability limited up to 5 pages and shall include the following information:

•Offeror’s name, address, point of contact, phone number, and e-mail address.

•Offeror’s interest in providing a proposal/quote on the solicitation when it is issued.

•Offeror’s capability to provide the products being requested.

•For reference the proposed offeror must be able to provide (2) Immunoassay Analyzers (waterless) and a reagents test menu that encompasses all of the following: VZV IgG, Measles IgG, Mumps IgG, and Treponema Total testing.

•Offeror must be able to ensure that all testing will be performed in accordance with the Food and Drug Administration regulations.

•Offeror must be able to adhere to the requirements of the statement of work.

•The analyzer must be self-contained and not require any additional plumbing for operation.

•The analyzer must interface with the government's system (CERNER, MHS Genesis), recognize MHS-Genesis-generated barcode labels on primary sample tubes, and support automated/semi-automated pre and/or post-analytical specimen processing. These systems should be platform-based and offer full, walk-away automation (i.e., an automation/robotic line).

• The Immunoassay analyzers must have an approved Authorization to Operate (ATO) on the government network. Must be able to meet DOD Risk Management Framework (RMF) IT certification requirements for analyzer cybersecurity standards as set forth in the statement of work.

• Must provide waterless analyzers that are FDA approved, 100-240V, and use FDA approved software for FDA approved testing reagents.

•Must provide high-capacity analyzer to result a least 180 test per hour.

• Analyzer must use Chemiluminescent technology with at least two-week storage of calibration curve and at least 4-week on-board reagent stability.

• Analyzer must have random access, continuous operation, remote access and STAT test capability

• Analyzer must have barcode Reader and disk drive with read and write and USB port for loading and downloading data and on-board operator's/ troubleshooting manuals.

• Analyzer must interface with Laboratory Information System (LIS) Cerner for 2-way communication with broadcast download and host.

• Analyzer Operating system must be Windows 10 or higher.

• Analyzer must provide capability for data and information storage and data management.

• Must provide equipment repairs scheduled and unscheduled as well as preventive maintenance. Vendor will not provide alternate testing or validation for downtime. Provide on-site technical support for installation of analyzers to bring to and maintain a fully operational status including required reagents and supplies.

•Must provide training at their facility for two personnel and on-site training as needed.

• Must ensure proper packaging of reagents, supplies, and equipment and that they are shipped at proper refrigerated or frozen temperatures according to manufacturer specifications.

•Must provide FDA approved reagents for use in clinical testing with expiration dates no less than 6 months of delivery date that function properly and pass lot to lot testing.

•Reagents must be ready to use and do not have to be prepared.

•Must ensure all shipments arrive Monday through Friday between the hours of 8:00am and 3:00pm Eastern Standard Time, excluding holidays and weekends.

• Respond to phone calls regarding shipment discrepancies the same day of notification and discrepancy will be corrected within 24 hours.

• Provide customer notification of updates on any reagents in writing within 5 business days and ensure continuity of services and availability of reagents during reagent revision when required.

•Provide all software and part upgrades at no additional cost.

•Provide analyzer that has user defined capability.

•Analyzer must be able to provide VZV IgG, Measles IgG, Mumps IgG and Treponema Total testing capabilities.

Offeror’s capability to perform a contract of this magnitude and complexity (include offeror’s capability to provide Immunoassay Analyzers and a reagents test menu of VZV IgG, Measles IgG, Mumps IgG, and Treponema Total testing in accordance with Federal FDA regulatory requirements for the Department of Pathology, Laboratory Department, Martin Army Community Hospital, Fort Benning, GA provide at least three (3) examples. This request is anticipated to result in a Firm Fixed-Priced contract.

Documentation of appropriate products must be presented in sufficient detail for the government to determine that your company possesses the necessary means to compete for this acquisition.

Offeror’s type of small business and Business Size (Whether 8(a), HUB Zone, Women-Owned Small Business, Service-Disabled Veteran Owned Small Business, etc.), or Large Business Status, should be documented in the Statement of Capability.

Interested parties are responsible for marking information that is proprietary in nature. No reimbursement will be made for any costs associated with providing information in response to this notice or any follow up information requests. The government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the government to issue a solicitation or ultimately award a contract, nor does it restrict the government to a particular acquisition approach. The government will in no way be bound to this information if any solicitation is issued. No subcontracting opportunity is anticipated. A determination by the government to not compete this proposed contract action based on the responses to this notice is solely within the discretion of the government.

Interested Offeror shall respond to this Sources Sought Notice no later than 10 June 2025 at 10:00 A.M Central Standard Time. All interested businesses must be registered in the System for Award Management (SAM) at www.sam.gov to be eligible for award of government contracts. Fax or email your response to Karan E. Quiles, Contract Specialist email: karan.e.quiles.civ@health.mil. Telephonic inquiries will NOT be honored. EMAIL IS THE ONLY COMMUNICATION METHOD.