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Contract Opportunity Modification to a Previous Notice * * * * * * * CLASSIFICATION CODE SUBJECT CONTRACTING OFFICE'S ZIP-CODE SOLICITATION NUMBER BASE NOTICE TYPE RESPONSE DATE (MM-DD-YYYY) ARCHIVE D... Contract Opportunity Modification to a Previous Notice * * * * * * * CLASSIFICATION CODE SUBJECT CONTRACTING OFFICE'S ZIP-CODE SOLICITATION NUMBER BASE NOTICE TYPE RESPONSE DATE (MM-DD-YYYY) ARCHIVE DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS SET-ASIDE NAICS CODE CONTRACTING OFFICE ADDRESS POINT OF CONTACT (POC Information Automatically Filled from User Profile Unless Entered) DESCRIPTION * See Attachment AGENCY'S URL URL DESCRIPTION AGENCY CONTACT'S EMAIL ADDRESS EMAIL DESCRIPTION ADDRESS POSTAL CODE COUNTRY ADDITIONAL INFORMATION GENERAL INFORMATION PLACE OF PERFORMANCE * = Required Field Contract Opportunity Modification to a Previous Notice 66 POC PT INR (VA-18-00117727) Total Test Volume has been corrected Dude 14227 36C24219Q0824 01-17-2020 3 N 334516 Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227 Idalia Algarin idalia.algarin@va.gov 716-862-7461 x 22395 VISN 2 South (Manhattan, Bronx, Brooklyn) USA Page 7 of 7 STATEMENT OF WORK Waived Prothrombin Time/International Normalized Ratio Testing Introduction and Scope of Work Ancillary Testing laboratories, Veterans Affairs Medical Centers VISN 2 South, require a portable point of care testing analyzer that enables waived or non-waived prothrombin time testing which is an assessment of the extrinsic and final common pathways of the coagulation cascade. A single portable Point of Care analyzer is required due to space availability and cost savings/avoidance. The waived or non-waived PT INR analyzer must be an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and international normalized ratio (INR) units. The sensitivity and specificity of the assay should yield at least a 95% confidence interval. The selected portable analyzer will be used for waived prothrombin time testing in the Bronx, Brooklyn and, Manhattan VA Medical Centers. This contract will be for one base year and four option years. The contractor shall provide the analyzer, service, and all supplies to the Medical Centers as cost per test. The contractor shall perform to the standards in this contract. Description of Services The Contractor shall provide all labor, equipment, maintenance, material, consumables, operational/maintenance manuals, upgrades, training, and parts necessary or incidental to furnish the equipment and consumables for PT INR testing, as further defined herein. We require cost per test kit to include sufficient materials to perform all patient testing, required monthly external quality control, lot to lot studies, proficiency testing challenges, and Calibration. We require a service for the equipment proposed during 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 test/KIT. 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 device should be able to fit on a typical laboratory countertop. 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 device should have operator lock out capability to prevent access by unauthorized. The device should have the option of user override to continue testing in case of emergency (i.e. interface failure or any related downtime. The device must have built in on-board quality controls and automatic liquid QC lock-out for failures. The equipment must be Interfaced with the Veterans Affairs VISTA system, CPRS or other VA compatible software. The analyzer must be at least 95% accurate and reliable in performing PT INR testing. Value added enhancements and/or upgrades without additional cost. The analyzer possess the ability to test for PT INR. 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 barcode scanning capability, minimum set up time, and minimal amount of time to perform daily, weekly and monthly maintenance. 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. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. Analytical/Measurement Aspects: The contractor should 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 connect to RALS and interfaced with VISTA and CPRS 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 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. Onsite training is 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 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. Provide technical assistance with analyzer interface until it is operational. Proposal Evaluation Factors All proposals will be evaluated on the following factors: Ability to provide functions that are required by the specifications. The equipment should be able to perform FDA approved tests such as PT INR. Also, if additional testing (new or reformulated) is available, those tests may be added to the testing menu. The workflow management of the offered system. This includes the operational and management reporting, provision of alerts by the system. The ability to test for PT INR. 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. Site visits to be schedule upon submission of proposals. 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 Online help for applications software Capabilities and ease of Quality Assurance offering Security and Privacy Support Equipment must be able to connect to RALS as middleware and interfaced with VISTA and CPRS PAST REFERENCES. - Provide 3 recent and relevant contracts for the same or similar items and other references (including points of contact with telephone numbers and other relevant information). OTHER Assessment of testing needs/menus shall be evaluated as needed by the laboratory with communication to the vendor to receive pricing. There shall be easy assimilation for new tests into the pricing test lists without the need for line item additions to the agreement. The vendor shall remove all equipment within 90 days after notification of the terms of this agreement but not until the completion of new vendor s equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. In the event that any consumable, reagent, or other necessary items are found to be defective and unsuitable for use with the vendor s equipment or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner passible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. Workload Data: Volume per Site FY 2018 TEST NAME Bronx Manhattan Brooklyn TOTAL TEST VOLUME PT INT 4,855 4,800 1,455 11,110 Number of Device 4 8 8 Total Devices 20 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 within 30 days of award. Equipment and testing should be fully functional at all VISN 2 South facilities within 6 months of date of award.