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 INTRODUCTION, DESCRIPTION, AND SCOPE OF THE CONTRACT 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). 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. 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. San Diego VA Healthcare System 3350 La Jolla Village Drive San Diego, CA 92161 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 PERIOD OF PERFORMANCE: Base Period: (To Be Determined (TBD) upon award) Overall, with Options: (TBD upon award) DEFINITIONS/ACRONYMS 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: equipment uses, all reagents, supplies, consumables, parts, accessories, and any other item required for the proper operation of the contractor s equipment. all necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs). training for Government personnel delivery, installation and removal of equipment. QC Quality Controls 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 MINIMUM TECHNICAL REQUIREMENTS The analyzer must be capable of reading H. pylori stool antigen (HpSA) test and providing an automated analyzer readout. The analyzer must be capable of transmitting results into VISTA using existing Data Innovation Instruments Manager middleware. The analyzer must be FDA-Cleared. Verification samples must have > 90% agreement with all test results. QC and calibration for all equipment must have a 100% pass rate. The methodology must be a fluorescent immunoassay. STATEMENT OF WORK 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. 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. 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. 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. All instruments, controls, calibrators, and reagents shall be included in the CPT. 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. The contractor shall be responsible for supporting all aspects of the installation of the analyzer and all accessories, as needed. The contractor shall provide training in all aspects of the analyzer operation during the initial installation and implementation phase. The contractor shall provide service on all equipment for the life of the lease. 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. MAINTENANCE REQUIREMENTS 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. 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. Contractor shall provide written report/email of notification of corrective action. Should the repair record of any individual piece of…