Curian Analyzer

NOTICE OF INTENT TO SOLE SOURCE

The Department of Veterans Affairs, Network Contracting Office (NCO) 22, located at 4811 De[arAirport Plaza Drive, Long Beach, CA 90815 is issuing this Notice of Intent (NOI) to inform industry contractors of the Government's intent to execute a firm fixed price, Sole Source Award.

The intended Contractor is a small vendor MERIDIAN BIOSCIENCE INC located at 3471, River Hills Drive, Cincinnati, OH, 45244.

The Department of Veterans Affairs (VA) San Diego Medical Center requires the acquisition HpSA assays, analyzer, peripherals, supplies and services. Supplies will be used to analyze and interprets HpSA for the VA San Diego Healthcare System which will be for an on-going basis. The CPT pricing shall be inclusive of all relevant supplies and services needed for the Curian HpSA Assays.

The HsPA system comprises assays, analyzer, peripherals, reagents, standards, controls, supplies, parts, accessories, service maintenance, including network support training, installation, shipping, and any other items required. These variable form a tightly coupled ecosystems capable of reading H. pylori stool antigen (HpSA) test and providing an automated analyzer readout throughout cost per test (CPT) services.

This CPT system is a critical, for balancing patient care with financial prudence. The procurement provides reliable and cost-effective pathway for ensuring accurate diagnosis of H. Pylori active infections. At present, Curian HPSA Assay is the only fluorescent immunoassay on the market used to accurately diagnose H. Pylori active infections. Meridian Bioscience manufacturers and supplies the FDA approved Curian instrument and Curian HpSA assay. Their analyzers read the Curian cards and provides results via USB, printer, or LIS connection. Therefore, reducing transcription errors and eliminating subjectivity of the read. Meridian Bioscience is the sole manufacturer of the this product.

These immunoassay test are owned and exclusively supported by Meridian Bioscience. No other procurement avenues exist due to the proprietary nature of the immunoassays test and the systems required to support them.

Place of Performance

Department of Veteran Affairs

VA San Diego Healthcare System

3350 La Jolla Village Blvd

San Diego, CA 92161

DRAFT STATEMENT OF WORK

SECTION A

1. INTRODUCTION, DESCRIPTION, AND SCOPE OF THE CONTRACT
   1. It is the intent of the Department of Veterans Affairs, San Diego Healthcare System to establish a Blanket Purchase Agreement (BPA) for Heliobacter pylori Stool Antigen (HpSA) reagent cartridges. The BPA shall be procured as Cost Per Test (CPT).
   2. The Contractor shall provide all equipment, reagents, standards, controls supplies, parts, accessories, service maintenance, including network support, training, installation, shipping, and any other item required for the proper operation of all equipment and supplies necessary for reading H. pylori stool antigen (HpSA) test and providing an automated analyzer readout throughout cost per test (CPT) services on behalf of VA San Diego Healthcare System.
   3. Place of Delivery: All supplies and services in support of this requirement shall be delivered to and performed at the location listed below. Additional Facilities may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor. Line items within the schedule reflect the overall volume and take into consideration the potential of additional quantities for all line items needed to support future locations.
      1. San Diego VA Healthcare System

3350 La Jolla Village Drive San Diego, CA 92161

1. 1. VA San Diego Healthcare System has provided estimated requirements below. Additional quantities for analyzers, barcode scanner, keyboard, and printer may be added.

San Diego VA Healthcare System

Curian Analyzers 2 with additional units as needed

Barcode Scanner 2 with additional units as needed

Keyboard 2 with additional units as needed

Printer 2 with additional units as needed

1. PERIOD OF PERFORMANCE:
   1. Base Period: (To Be Determined (TBD) upon award)
   2. Overall, with Options: (TBD upon award)
2. DEFINITIONS/ACRONYMS
   1. Cost Per Test (CPT): The loaded cost charged to the VA by the contractor per each test that can be performed on its proposed equipment. The loaded cost shall be all inclusive and incorporate, as a minimum, the following:
      1. equipment uses,
      2. all reagents, supplies, consumables, parts, accessories, and any other item required for the proper operation of the contractor's equipment.
      3. all necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs).
      4. training for Government personnel
      5. delivery, installation and removal of equipment.
   2. QC Quality Controls
3. Business Associate Agreement (BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receive, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule (see Attachment D Business Associate Agreement Template).

SECTION B

1. MINIMUM TECHNICAL REQUIREMENTS
   1. The analyzer must be capable of reading H. pylori stool antigen (HpSA) test and providing an automated analyzer readout.
   2. The analyzer must be capable of transmitting results into VISTA using existing Data Innovation Instruments Manager middleware.
   3. The analyzer must be FDA-Cleared.
   4. Verification samples must have > 90% agreement with all test results.
   5. QC and calibration for all equipment must have a 100% pass rate.
   6. The methodology must be a fluorescent immunoassay.
2. STATEMENT OF WORK
   1. In addition to the general requirements for the Cost-Per-Test stated above, the contractor shall meet the following requirements for instrumentation and consumables pertaining to all H. pylori Stool Antigen testing.
   2. The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide technical support for the software programs required for data management and interfacing results into VISTA. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance.
   3. The contractor shall provide access to digital operator's manual for all instruments supplied under the awarded BPA, for the entire duration of this BPA, including all option years.
   4. The system shall be easily able to accommodate standard infection control practices such as isolation protocols and cleaning in-between patients with most common hospital approved disinfectants and/or wipes.
   5. All instruments, controls, calibrators, and reagents shall be included in the CPT.
   6. Additional supplies purchased through this BPA shall be covered for all necessary, training, installation, service, and maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs) stated in the SOW and RFQ.
   7. The contractor shall be responsible for supporting all aspects of the installation of the analyzer and all accessories, as needed.
   8. The contractor shall provide training in all aspects of the analyzer operation during the initial installation and implementation phase.
   9. The contractor shall provide service on all equipment for the life of the lease.
   10. The contractor shall replace the analyzer, barcode scanner, keyboard, and printer should they become irreparable and be responsible for all costs associated with their placement.
3. MAINTENANCE REQUIREMENTS
   1. Emergency repairs shall be performed after initial telephone notification that the equipment fails in any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangement to enable the maintenance representative to receive such notification.
   2. The contractor shall repair or replace (replace defined as in place and functioning in the facility), at any/all locations specified in the Statement of Work, any malfunctioning equipment within forty-eight (48) hours after receipt of initial telephone notification of a malfunction. The contractor shall provide maintenance coverage twenty-four hours per day, five days per week including all Federal holidays. The contractor shall provide technical support service to assist with troubleshooting twenty-four hours per day, seven days per week including Federal holidays.
   3. Contractor shall provide written report/email of notification of corrective action.
   4. Should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% of greater than the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the operating facility to replace the equipment requiring repair(s) with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer's instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.
   5. Training: All shifts shall be provided with operator training and end-user training resources required to fully train 100% of end-users working on the 1st shift.
4. TRANSITION PERIOD:
   1. Upon award, the transition period for the awardee will have all required analyzer's, peripherals, consumables, training, correlation studies, reagents, controls, interfaces, etc., installed and fully operational shall be within 2 months of award. Offerors shall provide with their proposal a plan for transitioning services from the incumbent contractor to the newly awarded contractor. Contractor's submitted transition plan shall not exceed the required 30-day period contained herein. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. The VA shall have sole discretion in the decision to terminate for failure to comply.
5. DELIVERY: The Contractor shall deliver all supplies and services to the destination determined between the VA and the contractor after the contract is awarded.
   1. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The facility Person of Contact (Hereafter referenced as facility POC) shall be required to notify the Contractor when delivery locations have been changed.
   2. Deliveries shall be made during normal working hours from 8:00am to 4:00pm and a copy of the packing list/slip shall be provided on the day of delivery. The packages packing list/slip shall contain the complete purchase order number, contract number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped. Orders for equipment shall be delivered within no more than 30 working days after receipt of or placement of order. Orders for all consumables shall be delivered within no more than 3 working days.
   3. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.
6. HOURS OF WORK
   1. The contract shall include a full-service agreement to include all necessary calls at a minimum equal to five (5) days a week, nine (9) hours a day. The contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. After hours and weekends in person service are chargeable as per line items within Attachment A.
   2. Any service performed during other than normal work hours must be approved in advance by the facility POC or CO.
   3. When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

This procurement is being conducted using commercial item procedures pursuant to FAR Part 12.

The North American Industry Classification System (NAICS) for this requirement is, 334516 - Analytical Laboratory Instrument Manufacturing. Product of Service Code for this requirement is 6640 Laboratory Equipment and Supplies. The Small Business Administration (SBA) size standard for this sector is 1000 Employees.

If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:

(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of DRAFT SOW requirements. For instances where your company cannot meet the DRAFT SOW requirement(s), please explain. For instances where your company can meet the DRAFT SOW requirement(s), please show how your company meets/exceeds each requirement.

(2) Please review the list of DRAFT SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A.

1. In the VA's efforts to procure domestic end products, are you able to provide a domestic product or a domestic alternative product?

(4) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.

(5) Is your company considered small under the NAICS code identified in this RFI?

(6) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of DRAFT SOW?

(7) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available).

(8) If you're a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified.

(9) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR 125.6?

(10) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?

(11) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?

(12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate.

(13) What is estimated life span of your solution? What support/services does that entail?

(14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained.

(15) Does your organization offer a leasing solution? Please elaborate.

(16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).

(17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.

(18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

(19) Please provide your SAM.gov Unique Entity ID/Cage Code number.

Buy America Compliance

Respondents shall provide sufficient detail to determine compliance with the Buy American Act, including country of origin, domestic content, and availability of domestic alternatives. Responses should be complete and supported with verifiable information.

1. Please identify the country of origin for the end product(s) being offered. Include the location of final assembly/manufacture.
2. Please provide the percentage of domestic content (by cost) for each product(s). Describe the origin of the major components.
3. Does your product qualify as a domestic end product in accordance with the Buy American Act?
4. Please identify the manufacturer's name and location for the product(s). Confirm whether the manufacturer is U.S.-based.
5. Identify the country of origin of each product and indicate whether the product qualifies as a U.S.-made or designated-country end product in accordance with the Trade Agreements Act

This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available, and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government.

All inquiries and concerns must be addressed in writing via e-mail to Kal Carabon at Kahlfanie.Carabon@va.gov with the following information referenced in the subject line, PR for 664-26-3-198-0450 Curian Analyzer . A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All interested parties who are responsible, certified, and capable may identify their interest and may submit capability statement which shall be considered by the agency no later than 3:00 PM Pacific Time (PDT) on Friday, July 10th, 2026 to Kahlfanie Carabon at Kahlfanie.Carabon@va.gov. The interested parties bear full responsibility to ensure complete transmission and timely receipt.

SDVOSB/VOSB respondents.

If respondent is an SDVOSB or VOSB, respondent is encouraged to provide proof of sba.gov certification. In addition, SDVOSB/VOSB Contractors are asked to acknowledge that they understand the limitations on sub-contracting pursuant to FAR 52.219-14, Limitations on Sub-Contracting, which will be included in the impending solicitation. Further SDVOSB/VOSB contractors are asked to respond that they are capable of providing the requested services keeping within the parameters of this clause.

Please provide the information below:

Company Name:

DUNS Number:

Address:

Point of Contact Name:

Phone No:

Email:

Business size information

Select all that applies:

o Small Business

o Emerging Small Business

o Small Disadvantaged Business

o Certified under Section 8(a) of the Small Business Act

o HubZone

o Woman Owned

o Certified Service-Disabled Veteran Owned Small Business (registered in VetBiz.gov)

o Veteran Owned Small Business (registered in VetBiz.gov)

FSS/ GSA Contract Holder

Yes No

FSS/ GSA Contract Number

Effective Date / Expiration Date

NASA SEWP Contract Holder

Yes No

NASA SEWP Contract Number

Effective Date / Expiration Date