SOURCES SOUGHT
65 -- Sources Sought-Viral Load Tester
- Notice Date
- 3/26/2019
- Notice Type
- Synopsis
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
- ZIP Code
- 10468-3904
- Solicitation Number
- 36C24219Q0513
- Response Due
- 4/15/2019
- Archive Date
- 5/15/2019
- Point of Contact
- Tina.Cavalieri@va.gov
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought Notice only. This is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified Contractors who are able to meet the requirements listed. This is not a solicitation. A solicitation will be issued at a later date. This notice does not restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary. The Government will not pay for information requested nor will it compensate any Contractor for any cost incurred in developing information provided to the Government. The U.S. Department of Veterans Affairs, Network Contracting Office 2, James J. Peters VAMC requires a Viral Load Tester that enables a comprehensive menu of tests inclusive of tests depicted in the Workload Data table. A single analyzer platform is REQUIRED, due to staffing deficits, space availability and cost savings. The sensitivity and specificity of each assay should yield at least a 95% confidence interval. Please See the list of requirements. The NAICS Code is 334516, with a Small Business Set size standard of 1,000 Employees. Interested Contractors are reminded that in accordance with FAR 4.12, prospective Contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. Your response needs to address how you will meet the Government's requirements. All Contractors that are interested, regardless of their business type, and qualified to meet these requirements are asked to submit the following information: 1) Company Name: 2) Company Address: 3) DUNS Number: 4) Company POC Name: 5) Company POC Phone Number: 6) Company POC Email Address: 7) Company Website: 8) Business type: (Large, Small, Woman-Owned, VOSB/SDVOSB, etc.): 9) You MUST be able to provide a SINGE ANALYZER PLATFORM and be able to confirm how and using what equipment. You must also be able to provide ALL required testing, and list which tests you cannot provide (if applicable). Please identify your company's small business size standard and applicable NAICS code. For more information refer to http://www.sba.gov/content/table-small-business-size-standards. Note: If claiming SDVOSB or VOSB, the firm must be registered and CVE verified in VetBiz Registry http://www.vetbiz.gov/; also include VetBiz certification. Please send your responses by email (no phone calls) no later than 8AM on April 15, 2019 to Tina Cavalieri, Contract Specialist, at Tina.Cavalieri@va.gov, referencing the following 36C242190513-Viral Load Tester. DO NOT SEND QUOTES AT THIS TIME STATEMENT OF WORK Molecular Diagnostics Introduction and Scope of Work The VA Bronx Pathology and Laboratory Services VISN 2 Bronx New York, require a Molecular Diagnostics Testing Platform that enables a comprehensive menu of tests inclusive of test depicted capable of meeting our testing volumes. A single analyzer platform is required due to staffing deficits, space availability, and cost saving / avoidance. The selected analyzer will be used for testing of HCV Viral load, HBV Viral load, CMV Viral load, HIV Viral load, qualitative detection of Chlamydia trachomatis, and Neisseria gonorrhea, testing in the Bronx VA Medical Center. This contract will be for five years (one base year and four option years). The contractor shall provide the analyzer, service, and all supplies to the Medical Center as cost per test. The contractor shall perform to the standards in this contract Description of Services The Contractor shall provide all labor, equipment, uninterruptable power supply units, maintenance, material, reagents, consumables tools, supervision, operational/maintenance manuals, upgrades, training, and parts necessary or incidental to furnish the equipment reagents and consumables for PCR Molecular Diagnostics, as further defined herein. We require the cost per/test to include sufficient reagents and materials to perform all patient testing, required monthly external quality control, lot to lot studies, proficiency testing challenges, and Calibration. We require a Service Contract for the equipment proposed. We require business hours 5 days per week, at a minimum. We require a set cutoff time for same day service, no later than 3:00 pm for same day service. We require the inclusion of all consumables in the cost per/test. This includes, but is not limited to patient collection kits required by the contractor to perform each assay. The VA agrees that it will not alter and/or modify any product loaned under this agreement in any manner without the express written permission of the Contractor. The VA agrees to operate the equipment in accordance with the applicable Operator s Manual provided by the Contractor. VA agrees not to misuse the equipment in any manner. Mandatory/FDA directed upgrades will be provided to the VA. In the event the Contractor develops other technological upgrades for the equipment the Contractor will supply the VA with the upgrades to replace the existing equipment. The VA COR (Contracting Officer Representative) will be notified in advance of such upgrade and a determination will be made by the facility if it is in the best interest of the government to accept the upgrade. If agreed to between the Contractor and the VA, then the existing equipment replaced by the upgrades shall be returned by the VA to the Contractor at the Contractor s expense within 30 days of the replacement. Instructions on the return shall be provided by the Contractor. This upgrade agreement will be effective for the complete period of performance of the contract. The Contractor agrees to repair and/or replace defective equipment as necessary at no expense to the Government. We will not accept remanufactured or used models. The contractor shall provide weight and dimensions of proposed analyzer. The footprint of the system should fit on a typical laboratory countertop otherwise an appropriate cart/table will be provided by the contractor at no charge. A list of the estimated yearly quantity by the participating facility will be provided under this agreement. It is not a guaranteed minimum. Quantities listed in the Performance Work Statement are estimates based on the projected and historical usage during FY2018. If necessary, alter the quantity of testing required as patient needs. Requirements The equipment must be Bi-Directionally Interfaced with the Veterans Affairs VISTA system, Cerner or other VA compatible software. Must show capability of single platform. The analyzer must be at least 95% accurate and reliable in performing PCR testing. Value added enhancements and/or upgrades without additional cost. The analyzer possess the ability to test for HCV Viral load, HBV Viral load, CMV Viral load, HIV Viral load, Chlamydia trachomatis, and Neisseria gonorrhea. The analyzer must contain walk-away capability and avoid unsafe aerosol producing steps during operations or maintenance procedures. The system must have pre-made reagents that can be stored in an onboard refrigerator. The system must have automated sample barcoding The system shall not require daily maintenance. The software program must detect epidemic strains and is able to guide in problem solving. Barcode features should be associated with the equipment. Technical support by telephone must be offered 5 days a week with a call back within 1 hour. Emergency repairs shall be performed within 24 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Representative (COR). JJPVH normal business hours are 8:00 am - 4:30 p.m., excluding weekends and holidays. Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall decide to enable his maintenance representative to receive such notification. The contractor will provide all parts and labor needed to repair the malfunction. The travel, per diem and other expenses associated with the repair will be borne by the contractor Onsite technical field service representative must be provided same day if instrument is non-functional after trouble shooting fails and resolution is not achieved before the call-time cutoff (for example 3:00 pm for same-day service). If after defined cut-off time, we require onsite technical field service representative the following morning. Service Contract is to include, all labor, travel, and parts necessary to make repairs included in the cost per reportable test, with no additional charge for parts or labor. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. Analytical/Measurement Aspects: The vendor must clearly define the turn-around time for each test. The contractor is to define the actual hands on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. At installation of new equipment, contractor will provide technical support to assist in equipment installation/set-up, and validation studies of data sufficient to meet CAP standards, CLSI and Federal Regulations. Instrument Performance/Comparison shall include but is not limited to: Accuracy studies for the assay, Precision studies, Specificity studies, Sensitivity studies, and Carryover studies, if applicable. The vendor shall provide example standard operating procedures (SOPs) and if applicable an Individualized Quality Control Plan (IQCP) for each assay. Post Analytical/Reporting Requirements User Friendly Interface Instrument must have a VA approved interface meaning the interface has already been successfully implemented and is fully operational in a VA facility. The contractor, without additional charge to the government, shall provide training at the government location for two (2) operating personnel at the time of installation of the contractor s equipment. In addition, the contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. Latest software must be user friendly and updated as soon as a new version is released at no cost to VISN 2 South. The vendor must support the set-up for bidirectional interfacing with VISTA; note that preference will be given for the ability to autovalidate through VISTA or Data Innovations (DI). Analyzer shall have the capability of providing printouts for all patient results and controls. Contractor Support Requirements Provides CLSI procedure on CD and on-line. Provides Uninterruptable Power Supply unit for each instrument and maintain it during the contract period. Provide FDA approved analyzer/equipment, reagents, controls, disposables, and any consumable part necessary for analyzing/testing. Contractor shall list the consumable parts provided. The contractor shall provide the validation kits and other necessary supplies to perform the validation of new tests/instrument at no cost to the participating facility. There shall be no cost incurred to any site for validation of any new assay or re-formulated assay during the contract period. Provide Technical Support at each site to perform/assist in method validation (correlation and precision studies) at each site. Provide a Training Plan (on site) defining the number of key operators that will be trained and the number of Training Specialists assigned to each site for training. Training must include but is not limited to the operation of the analyzer, quality control, interpretation and reporting of results, maintenance and trouble-shooting. We require on-site training for new and/or revised assays during the contract period. If training is available off-site, the contractor is to include all costs (transportation, room and board, etc.) for off-site training for the primary operator. Off-site training is preferred but not required. Instrument upgrade - If any upgraded equipment/software is produced during the term of the contract, the contractor will upgrade all equipment/software without an additional charge to the facility. Instrument and assays must be FDA approved. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (26-MAR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
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Link To Document
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/36C24219Q0513/listing.html)
- Record
- SN05260642-F 20190328/190326230023 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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