66--INTENT TO SOLE SOURCE ABBOTT LABS HEPATITIS C VIRUS (HCV) GENOTYPING

Solicitation 36C24618Q9834 Notice of Intent to Sole Source reference FAR 6.302-1. The Hampton VA Contracting Office NC06 is procuring a fully automated FDA approved System for Hepatitis C Virus (HCV) Genotyping for the Durham VAMC located 508 Fulton Street Durham North Carolina. The Hampton VA Contracting Office NC06 intends to award on a sole source basis, IAW 10 USC 2304(c)(1), FAR 6.302-1, and Public Law (PL) 109-461, a contract to Abbott Labs Inc. 2000 Regency Parkway, Suite 405 Cary NC 27511 as a responsible source to provide the above-mentioned items. The total award amount is estimated to be $112,246.00. The statutory authority for other than full and open competition is 10USC 2304(c)(1), only one responsible source and no other supplies or services will satisfy agency requirement. Public Law (PL) 109-461 requires VA to increase contracting and subcontracting opportunities for SDVOSBs and VOSBs. The applicable NAICS Code is 325413 and the size standard is 1,250 employees. Interested persons may identify their interest and capability to respond to the requirement or submit quotes. This notice of intent is not a request for quotation or a solicitation of offers. However, all quotes received by September 21th, 2018 at 1:00PM EST of the publication of this synopsis will be considered by the Government. A determination by the Government not to compete this requirement upon receipt of response to this notice is solely within the discretion of the Government. There will be no solicitation available. All Responses shall be emailed to: contact@example.gov. Fully automated FDA approved System for Hepatitis C Virus (HCV) Genotyping Period of Performance 10/1/2018 9/30/2019. 1. INTENT: The Durham VA requires an FDA approved instrument to perform HCV Genotyping using an fully automated method that will detect HCV genotype 1, 2, 3, 4, 5 and subtypes 1a and 1b. HCV genotyping is an essential assay for providers to guide therapy for HCV. A timely, accurate and reproducible test is important for determining course and duration of treatment for HCV. The instrument must be capable of performing HCV GT accurately and reproducibly with minimal hands on time and manual interpretation. 2. PRICING SCHEDULE: A schedule of items offered and per item cost should be included in the proposal. ITEM DESCRIPTION QT UNIT 08L21-090 REALTIME HCV GENOTYPE II AMPLIFICATION REAGENT KIT 52 PER MO 08L21-080 REALTIME HCV GENOTYPE II CONTROL KIT 15 PER MO 04J70-024 mSAMPLE Preparation ENA Extraction Kit 15 PER MO 08L21-001 ABBOTT REALTIME HCV GT II APPLICATION CD-ROM 1 PER MO 04J71-010 DISPOSABLE TIPS(DiTi) 1ml 12 PER MO 04J71-017 DISPOSABLE TIPS(DiTi) 200Ul 2 PER MO 04J71-0452 OPTICAL CALIBRATION KIT 2 PER MO 04J71-020 5ml REACTION VESSELS 2 PER MO 04J71-60 200ml REAGENT VESSELS 8 PER MO 04J71-030 96 DEEP WELL PLATES 3 PER MO 04J71-070 WELL OPTICAL REACTION PLATES 5 PER MO 04J71-075 OPTICAL ADHESIVE COVERS 1 PER MO 04J71-080 MASTER MIX TUBES/CAPS 1 PER MO 4971-093 BIOHAZARD BAGS 2 PER MO Equipment m2000 System (SP & RT) 3. SYSTEM REQUIREMENTS: i. The vendor shall provide an instrument that performs an FDA approved automated HCV genotyping ii. Software, hardware, reagents, consumables and instrument maintenance will be provided iii. The system shall perform patient HCV genotyping within 6 hours without the need for additional specimen preparation. iv. The system is a closed system and removes amplicon exposure v. The system shall be user-friendly requiring minimal hands-on time with walk-away capability and present clear visible results without the need for manual interpretation and eliminates subjective visual strip analysis. vi. The system shall include batch testing with a minimum of 22 tests with 2 controls. vii. The system shall include a quality control program that meets College of American Pathologists (CAP) and regulatory guidelines and ensures proper test performance. 4. INSTRUMENTATION AND SOFTWARE: i. The vendor shall supply all equipment (including reagents and disposable) as required for HCV genotype testing and quality results. ii. Requests for additional instrumentation, upgrades or replacements, due to workload increase, excessive instrumentation/test kit failures/malfunctions, breakdowns, or service call shall be evaluated as needed and annually by the facility laboratory with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/test kits supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement equipment/test kits that can produce the required criteria of this contract satisfactorily to the user. iii. Vendor to provide upgrades to equipment hardware at no additional charge to the Government. These shall be provided as they become available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered. iv. Vendor to provide the user with utility requirements (electrical, guidelines for disposal of waste and hazardous reagents, etc.). v. Any special fees, special shipping and handling fees or other usage fees must be clearly indicated in the price quote. vi. Vendor must indicate reagent storage requirements for freezer, refrigeration etc. 5. OWNERSHIP OF EQUIPMENT: i. Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. ii. In adherence with VA handbook electronic media sanitization, prior to termination or completion of this contract, the hard drive will be removed from the instrument before returning to the vendor. This must be completed within 3o days of termination or completion of the contract or disposal or return of the IT equipment whichever is earlier. 6. INSTALLATION AND VALIDATION: i. Start up the vendor shall provide all reagents, calibrators, controls, consumables/disposable items, parts, accessories and any other items included in the list of supplies required to establish instrument for operation for performance of accepted testing. ii. At installation of new equipment, the vendor will provide technical support specialist/s to assist in equipment installation/set-up. iii. Training the vendor shall provide an instrument training program that is coordinated with and timely to the equipment installation. The initial training should include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the vendor shall provide on-site refresher instrument training, advanced troubleshooting or any appropriate training in renewal option years of the contract if so exercised at no cost to the facility. iv. Method performance/comparison shall be performed at the expense of the Contractor, shall include accuracy, reproducibility, limit of detection material and reagents and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. A minimum of 20 samples spanning the reportable genotypes shall be run by the present and proposed method. v. Vendor shall analyze results and provide statistical studies of the new method. vi. Vendor shall provide required statistical analysis in a binder for on-site staff approval. The process must be completed, the data reviewed and Director approval received before leaving the site following installation of the system on site. 7. SUPPORT SYSTEMS(SERVICE, PREVENTIVE MAINTENANCE AND SHIPPING OF SUPPLIES): i. Emergency needs and preventive maintenance: Vendor shall provide service sufficient to meet the needs of the hospital Monday through Friday 8am 4.30pm. Field engineer service support must be available within twenty four (24) hours of notification, Monday through Friday. All repairs on instrument/equipment must be complete within 24 hours from the time the field engineer arrives. All replacement instrument/equipment must be received within 24 hours from the time the field engineer arrives. ii. A malfunction incident report shall be furnished to the laboratory following a repair call. The report should include, date and time notified, date and time of arrival, serial number, type and model number of equipment, time spent for repair and proof of instrument repair that includes documentation of a sample run of quality control verifying acceptable performance. iii. Preventive maintenance shall be performed as frequently as published in the manufacturers operators manual and within 2 weeks of the scheduled due date. iv. The vendor shall provide at no charge parts necessary for the operation of the system. v. Service is to include all travel, parts for repair or replacement, and labor. Vendor shall provide alternative testing if the equipment requiring repair is down in excess of one (1) week at no additional cost to the government. Costs to be reimbursed by vendor for these costs incurred during downtime to include but not limited to, reagents, labor, and reference laboratory services. vi. Service agreement shall include replacement or repair of all ancillary equipment (i.e. processors). vii. Vendor shall provide all necessary MSDS records. viii. Frequency of shipments: Vendor shall provide initial inventory based on expected use, then establish a standing weekly/monthly/quarterly shipment based on current use, with the capacity to fill emergency requests on-demand. ix. Vendor shall pay all routine shipping fees for all supplies, consumables, and equipment to perform testing and will pay for shipping for volume adjustments should additional testing supplies be required. 8. GOVERNMENT RESPONSIBILITY: The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. 9. TRAINING AND PROCEDURES: i. Vendor shall provide all education/training on-site during installations or update to the equipment. Training to include all relevant testing staff. Training to include basic operation, quality control, interpretation and reporting of results, required user performed maintenance, and troubleshooting. Vendor shall provide a documented record of training (training checklist) completed for all trained staff before leaving laboratory following installation at the laboratory. ii. Vendor shall provide all necessary troubleshooting and operator manuals. Procedures shall be in the CLSI format. Vendor shall provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility. 10. INTERFACE REQUIREMENTS i. The vendor should provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. ii. If there are any software upgrades in the instrument during its life, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. 11. IMPLEMENTATION/TRANSITION TIMEFRAME i. The implementation of the services/requirements described in this solicitation should be completed no later than 90 days after the award of the contract. The vendor shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the vendor and is a result of delays due to the Government. ii. The vendor shall provide with its quotation an implementation plan for installation of new equipment. The plan shall not exceed 90 days for the transition of all services under the awarded contract, including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the vendor to conform to the transition period shall be considered as sufficient cause to terminate the contract for cause. At the end of 90 days from award of the contract, the awarded vendor shall have full and sole responsibility for services under the awarded contract . 12. STANDARD AND QUALITY OF PERFORMANCE: i. This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the vendor s technical specification or as quoted in any contract at an effectiveness level of 90% or more. ii. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. iii. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled termination for cause . (The vendor shall receive revenue for tests reported during the 90-day acceptance period.) iv. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the Government makes a bona fide attempt to contact the vendor designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in the proper operating condition.