66--VISN 2 Downstate Requirements Contract for Methicillin Resistant Staphylococcus Aureus-Polymerase Chain Reaction Testing

1 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, and the VA Medical Centers in New York and New Jersey require a Polymerase Chain Reaction (PCR) Molecular Diagnostics Testing Platform that enables a comprehensive menu of tests inlusive of tests depicted in the Workload Data table. A single analyzer platform is preferred, space availability and cost savings. The sensitivity and specificity of each assay should yield at least a 95% confidence interval. The selected analyzer will be used for PCR testing in: New York Harbor Healthcare System at Manhattan New York Harbor Healthcare System at Brooklyn New Jersey Healthcare System at East Orange Northport VAMC Bronx VAMC(James J. Peters VAMC) See the list of requirements The NAICS Code is 325413 In-Vitro Diagnostic Substance Manufacturing 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.): 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 Monday February 26, 2018 to Tina Cavalieri, Contract Specialist, at contact@example.gov, referencing the following 36C24218Q0250-PCR Molecular Diagnostics. DO NOT SEND QUOTES AT THIS TIME STATEMENT OF WORK PCR Molecular Diagnostics Introduction and Scope of Work Molecular Diagnostics laboratories, Veterans Affairs Medical Centers VISN 2 Down State, require a Polymerase Chain Reaction (PCR) Molecular Diagnostics Testing Platform that enables a comprehensive menu of tests inclusive of tests depicted in the Workload Data table. A single analyzer platform is preferred due to staffing deficits, space availability, and cost savings/avoidance. A Backup analyzer is required to ensure continuity of care. The sensitivity and specificity of each assay should yield at least a 95% confidence interval. The selected analyzers will be used for PCR testing in Bronx, Brooklyn, Manhattan, East Orange, and Northport VA Medical Centers. Each site may elect to perform all assays or a desired number of assays. This contract will be used for one base year and four option years. The contractor shall provide a primary and secondary analyzer (depending on the need of the facility), service, and all supplies to the Medical Centers as cost per reportable 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 (specimen collection kits), 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 reportable 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 7 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 reportable 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 FY2017. 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. 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 Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile with identification of 027 strain, Influenza A, B, RSV, H1N1, Chlamydia trachomatis/Neisseria gonorrhea, Mycobacterium tuberculosis complex, Streptococcus pyogenes, Trichomonas Vaginalis, and Carbapenemase producing organism identification with differentiation among the major families of resistant genes. Also, if additional testing (new or reformulated) is available, those tests may be added to the testing menu. The analyzer possess Ease of Use. User friendly and walk-away capability (where applicable) that is not labor intensive and avoids unsafe aerosol producing steps including maintenance requirements. Ease of use includes minimum set up time, automated sample barcoding and minimal amount of time to perform daily, weekly and monthly 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 24 hours a day 7 days a week with a call back within 1 hour. 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: Clearly define turn-around time for each test proposed. 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. 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. Contractor must provide a continuous, on site hands-on training for users on the instrument and software as needed. Latest software must be user friendly and updated as soon as a new version is released at no cost to VISN 2 South. Ability to interface with VISTA. 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 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. Contractor provides PM (preventative maintenance) according to manufacturer s specifications at contractor cost. If instrument is down for >72 hours contractor must replace instrument at no cost to VA. Contractor will provide the names and location of users in the area for site visits. Contractor will supply the same lot number for each quarter to each facility, to reduce cost of quality control. Contractor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and SDS s (also available in CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Additional Requirements Ability to provide functions that are required by the specifications. The equipment should be able to perform FDA approved tests such as Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile with identification of 027 strain, Influenza A, B, RSV, H1N1, Chlamydia trachomatis/Neisseria gonorrhea, Mycobacterium tuberculosis complex, Streptococcus pyogenes, Trichomonas Vaginalis, and Carbapenemase producing organism identification with differentiation among the major families of resistant genes. Also, if additional testing (new or reformulated) is available, those tests may be added to the testing menu. The hardware architecture of the offered system with open, modular redundant and scalable architecture. The software architecture of the offered system with flexible, open, standard based and operationally redundant software are preferred. The workflow management of the offered system. This includes the operational and management reporting, provision of alerts by the system. The ability to detect and confirm the presence of Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile with identification of 027 strain, Influenza A, B, RSV, H1N1, Chlamydia trachomatis/Neisseria gonorrhea, Mycobacterium tuberculosis complex, Streptococcus pyogenes, Trichomonas Vaginalis, and Carbapenemase producing organism identification with differentiation among the major families of resistant genes. Also, if additional testing is available (new or reformulated), those tests may be added to the testing menu. Technical support resource pool (knowledge base, availability, proximity) Training offering & depth of training teams Application support resource pool (knowledge base, availability, proximity) Contractor presentation followed by site visits Ease of Use. User friendly and walk-away capability (where applicable) that is not labor intensive and avoids unsafe aerosol producing steps Added Value Enhancements & new upgrades Preparation of Project Implementation plan and project management offering. Online help for applications software Capabilities and ease of Quality Assurance offering Security and Privacy Support Equipment must be bi-directionally interfaced with VISTA Ability to test on demand PAST PERF. - Provide 3 recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information). Workload Data: Volume per Site FY 2017 Below is the estimated number of tests ordered during fiscal year 2017. The Government does not guarantee the workload will be the same for the proposed new period of performance. Each VA Medical Center, through the Network Contracting Office, will place an order when required. TEST NAME Bronx Northport NYHCS NJHCS TOTAL TEST VOLUME MRSA 3,421 2,049 8,479 5160 19,109 C. difficile 505 325 905 450 2,185 Flu screening (XPRESSFLU/RSV) 395 273 376 550 1,594 CT/NG 1,486 664 2,161 1280 5591 Carbapenemase resistance 450 100 0 0 550 MTB/RIF 300 0 0 180 480 Strep A 120 0 100 0 220 T. Vaginalis 120 0 2,161 0 2281 Delivery The awarded contractor must provide an implementation plan for delivery, installation, set-up, training and connectivity with VA systems to each VISN 2 facility by December 31, 2018 for the following VA Medical Centers: New Jersey Healthcare System East Orange Campus 385 Tremont Avenue East Orange, NJ 07018 James J Peters VA Medical Center 130 W Kingsbridge Rd Bronx, NY. 10468 Northport VA Medical Center 79 Middleville Rd Northport, NY 11768 VA NY Harbor Healthcare System Manhattan Campus 423 E 23rd St. New York, NY. 10010 VA NY Harbor Healthcare System Brooklyn Campus 800 Poly Pl. Brooklyn, NY. 11209 Period of Performance: Base Year: December 31, 2018 to September 30, 2019. Option One: October 1, 2019 to September 30, 2020. Option Two: October 1, 2020 to September 30, 2021. Option three: October 1, 2021 to September 30, 2022 Option four: October 1, 2022 to September 30, 2023. Type of Contract: IDIQ Requirements Contract. The minimum order is $1,000.00 when the Government requires supplies or services covered by this contract. Security Requirements: The selected contractor will be required to complete Business Associate Agreement (BAA)