65--Supply: Pulmonary Function Test Equipment Vyntus ONE and Vyntus BODY

36C24819Q1403 Page 2 of 2 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. Solicitation number 36C24819Q1403 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC Number: 2019-05, Effective Date: August 13, 2019. This solicitation is for brand name product and uses Tiered Evaluations (Cascading) to include Large Business. The associated North American Industry Classification System (NAICS) Code for this acquisition is 334510, with a small business size standard of 1250 employees. All interested companies shall provide quotations using the below Price/Cost Schedule format for the following brand name or equal items. PRICE/COST SCHEDULE ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 2.00 EA __________________ __________________ VYNTUS BODY DIFFUSION SYSTEM MODEL/PRODUCT NUMBER: 31802-001 0002 4.00 EA __________________ __________________ GAS .3% CO .3% CH4 21% O2 BAL N2 (ED) MODEL NUMBER: 768093 0003 2.00 EA __________________ __________________ GAS 99.00% OXYGEN (USP) MODEL NUMBER: 761819 0004 2.00 EA __________________ __________________ GAS 16% O2 5% CO2 0.3% CO/CH4/BAL N2 E CYL MODEL NUMBER: V-892590-13 0005 2.00 EA __________________ __________________ ADDITIONAL BREATHING CIRCUIT FOR VYNTUS ONE MODEL NUMBER: 32925-001 0006 2.00 EA __________________ __________________ VYNTUS ONE PFT SYSTEM MODEL NUMBER: 31788-001 0007 5.00 EA __________________ __________________ MS PNEUMO SES HEATED WITH PC 1PR4P MODEL NUMBER: 27265-001 0008 2.00 EA __________________ __________________ ADD APS PRO SES ADD-ON PNEUMO/IOS SP APS MODEL NUMBER: 27267-001 0009 1.00 EA __________________ __________________ MS IOS SES WITH PC 1PR4P MODEL NUMBER: 27270-001 0010 2.00 EA __________________ __________________ PULMONARY OR EXERCISE ONSITE TRAINING 4 DAYS 97075-PM4-OS 0011 1.00 EA __________________ __________________ WEB BASED MOBILE REVIEW APPLICATION FOR PHYSICIAN INTERPRETATION AND REPORTING WORKFLOW MANAGEMENT. INCLUDESS MAIN LICENSE AND 5 CONCURRENT USERS. MODEL NUMBER: V-577090 0012 1.00 EA __________________ __________________ ALLOWS FOR AN ADDITIONAL 25 CONCURRENT USERS (30 TOTAL) FOR THE MOBILE REVIEW APPLICATION. MUST BE COMBINED WITH V-577090. MODEL NUMBER: V-577092 0013 1.00 EA __________________ __________________ IMPLEMENTATION SVCS - PFT W/WORKFLOW MODEL NUMBER: 97060-101 0014 1.00 EA __________________ __________________ SENTRYSUITE SERVER SOFTWARE WIN 10 MODEL NUMBER: V-577400-13 0015 11.00 EA __________________ __________________ SENTRYCONNECT SEAT LICENSE FOR SES MODEL NUMBER: V-577201-100 0016 2.00 EA __________________ __________________ SENTRYCONNECT SEAT LICENSE FOR VMAX MODEL NUMBER: V-577201-102 0017 4.00 EA __________________ __________________ SENTRYCONNECT SEAT LICENSE FOR SOMNOSTAR MODEL NUMBER: V-577201-103 0018 4.00 EA __________________ __________________ SENTRYCONNECT SEAT LICENSE FOR NOXTURNAL MODEL NUMBER: 27217-001 0019 1.00 EA __________________ __________________ SENTRYSUITE TEST LICENSE MODEL NUMBER: 28404-001 0020 1.00 EA __________________ __________________ VMAX PREMIUM TEST LICENSE MODEL NUMBER: 28405-001 0021 1.00 EA __________________ __________________ SOMNOSTAR TEST LICENSE MODEL NUMBER: 28408-001 0022 1.00 EA __________________ __________________ NOX TEST LICENSE MODEL NUMBER: 28409-001 0023 2.00 __________________ __________________ STANDARD CART WITH SHELVES, TOP HALF-CART IS ADJUSTABLE UP/DOWN HEIGHT MODEL NUMBER: V-859140-13 0024 2.00 EA __________________ __________________ ADDITIONAL BREATHING CIRCUIT FOR VYNTUS ONE MODEL NUMBER: 32924-001 GRAND TOTAL __________________ DELIVERY SCHEDULE ITEM NUMBER QUANTITY DELIVERY DATE 0001-0024 SHIP TO: JAMES A. HALEY VA HOSPITAL 13000 BRUCE B. DOWNS TAMPA, FL 33612 USA ALL 30 DAYS ARO ALL ITEMS SHALL BE DELIVERED AND INSTALLED WITHIN 30 DAYS AFTER RECEIPT OF ORDER (ARO) PROCESSING AND ORDER PLACEMENT. STATEMENT OF NEED Pulmonary Function Testing System Equipment GENERAL: The Pulmonary Diagnostics/Respiratory Care Department of the Medical Service at the James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has a requirement for new and updated Vyntus Pulmonary Function Testing (PFT) equipment. The upgrades are needed to ensure the security of the patient database as the current operating system (Windows XP) will soon be obsolete and not supported. Current testing equipment is over two years its replacement date and current database is not compatible with new therapeutic modality required to support the Mission Act. Currently James A. Haley VA Hospital owns medical device equipment with Sentry Suite software installed and the hospital s Bio-Medical Department has built server for Sentry Connect software which will interface into the Computerized Patient Record System (CPRS) which is our electronic medical record (EMR) database. The Vyntus ONE PFT system and the Vyntus BODY system are required to connect to the CPRS server. New iOS testing technology/equipment and new Methacholine Challenge testing equipment is needed as current testing equipment is obsolete and not supported. This new technology is designed to improve quality of patient care and increase productivity and efficiency of clinician staff. New technology and equipment will also allow secure test data transfer from offsite clinics into the main hospital s CPRS and the Veterans Information Systems and Technology Architecture (VISTA) database. BACKGROUND: Pulmonary function tests are valuable investigations in the management of patients with suspected or previously diagnosed respiratory disease. They aid diagnosis, help monitor response to treatment and can guide decisions regarding further treatment and intervention. The interpretation of pulmonary functions tests requires knowledge of respiratory physiology. In this review we describe investigations routinely used and discuss their clinical implications. Pulmonary function tests are a valuable tool to aid Physicians in the investigation, diagnosis and monitoring of patients with respiratory disease. They are also helpful in monitoring patients response to treatment and can guide decisions regarding further treatment and/or intervention. Pulmonary functions tests are frequently ordered as a preoperative evaluation tool to identify suitable surgical candidates. SCOPE: James A. Haley is requesting contractors provide brand name equipment that meets or exceed the physical, functional, and performance of the listed salient characteristics in this section. The equipment features, and technical requirements are essential to meet the need of the Government. PHYSICAL CHARACTERISTICS: Equipment must have the physical characteristics to enable the Government to perform the capabilities: PFT System Features should include: Comprehensive PFT and respiratory mechanics Multiple Platform Testing in One Device CPET and PFT Spirometry testing Real Time BTPS Correction with Pneumotach Transmural Pressure Body Box Software that will interface with currently used Sentry Suite that will enable transfer of current stored patient data from VA outside clinics to the main hospital s EMR and VISTA database. Needs to be able to build out the systems capabilities with new clinical adjuncts that integrate into the systems over its lifecycle such as Aerosol Provocation System (APS) and Impulse Oscilimetry (IOS) which allows to expand services based on need. Energy expenditure data Highly accurate and stable testing data, including flow sensing real-time BTPS correction Efficient testing procedures and new Sentry Suite software reporting and workflow Enhanced automatic data interpretation Automated quality assurance, including real-time monitoring/alerts, an automated sensor stability check, measured CO2 cross-sensitivity and a data manager to view error codes FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide the following functional and performance capability to prevent false readings or results from the equipment during prevention test: Vyntus ONE PFT System. Includes analyzer module (O2, CO2, Multigas), breathing circuit (including Ultrasonic sensor, Flow Path Valve, and Demand Valve), SentrySuite software, standard cart and arm with adjustable height and left/right mousepad, validated WIN 10 PC with sanitizable medical keyboard/mouse, 27 flat panel infinityedge monitor, Office Jet printer, 3-L manual syringe, O2, DLCO and calibration gas regulators, 6 cylinder gas stand, 1 box of MicroGard IIB and IIC (80 each) filters. Tests performed: Spirometry (FVC, SVC, MVV), Lung subdivisions (VTG, FRC-N2, RV, TLC), Real-time DLCO (both Single Breath and (No Suggestions)), MIP/MEP, pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates.1 year warranty plus 4 additional years premium contract included. Vyntus BODY Diffusion System. Includes 1110L body plethysmograph with 551 pound patient bench and 25 inch telescoping arm, breathing circuit (including Ultrasonic sensor, Flow Path Valve, and Demand Valve), SentrySuite software, validated WIN 10 PC with sanitizable medical keyboard/mouse, 27 inch flat panel monitor, Office Jet printer, 3-L manual syringe, DLCO 7bar pressure regulator, 6 cylinder gas stand, box of 80 MicroGard IIB filters. Tests performed: Spirometry (FVC, SVC, MVV), Lung subdivisions (VTG, FRCpl, RV, TLC, Raw, Conductance and specific resistance and Resistance Volume Loops), Realtime DLCO (both Single Breath and Intrabreath), MIP/MEP, and pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, preformatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates. 1 year warranty plus 4 additional years of premium contract included. MS PNEUMO SES HEATED WITH PC 1PR4P. Master Screen Pneumo with Desktop PC and Printer. Heated pneumotach spirometry system. Validated Windows 10 Desktop PC with 22-inch monitor, sound bar, and color deskjet printer included. Master Screen Pneuomo performs all the essential spirometry tests; FVC with Flow Volume Loop, Slow Vital Capacity (SVC), Maximum Voluntary Ventilation (MVV). Pre and Post Bronchodilator testing levels and Bronchial Challenge Testing software also included. Sentry Suite software provides user guidance and feedback regarding test quality according to ATS/ERS or other author's standards. Other software features included; powerful report designer, 10 parameter-linked animated incentives, interactive guided calibration, customizable reference modules, and offline data entry. Device can be used as standalone or can take advantage of our growing family of Sentry Suite solutions for workflow and connectivity such as Sentry.Net and Sentry Connect. APS PRO SES ADD-ON PNEUMO/IOS 5P. APS (Aerosol Provocation System) add on option for MS Pneumo and IOS devices. Computer controlled nebulization device delivering measurable and repeatable drug dosages for bronchial challenge testing. Includes SeS bronchial challenge program. MS IOS SES WITH PC 1PR4P. Master Screen IOS system, Sentry Suite software, validated WIN 10 PC, 22-inch monitor, sound bar, color deskjet printer included. Tests performed- quiet breathing Airways Resistance, Forced Vital Capacity, Slow Vital Capacity and Maximum Voluntary Ventilation, pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates, Patient Data management, multiformat output, SeS SQL DB interface for queries. Device can be used as standalone or can take advantage of our growing family of Sentry Suite solutions for workflow and connectivity such as Sentry.Net and Sentry Connect. SOFTWARE: Contractor must be responsible for the complete software system integration and installation to the current VA CPRS/VISTA system to include all fees, permits, and work required to accomplish the installation. Requirements include: Sentry Suite Workflow Sentry Connect EMR Interface over multiple platforms (Vyntus PFT, Vyntus CPX, Vyntus Spiro, SomnoStar, and Nox) Mobile Connect Review Web based Mobile Review application for Physician Interpretation and reporting workflow management. Includes Main license and 5 Concurrent Users. Allows for an additional 25 concurrent users (30 total) for the Mobile Review application. IMPLEMENTATION SVCS - PFT W/ WORKFLOW Services include Workflow Consultation, Design, Documentation and Training. In addition, IT consultation and assistance in configuring SQL database, historical data migration planning and execution, data security and Sentry.net if purchased are provided. Full description of services to be provided as part of project documentation. SENTRYSUITE SERVER SOFTWARE WIN 10 SENTRYCONNECT SEAT LICENSE FOR SES Single Seat license to connect to SentryConnect gateway- SentrySuite instrument, SentrySuite reading station, Sentry.NET remote access. SENTRYCONNECT SEAT LICENSE FOR VMAX Single Seat license to connect to SentryConnect gateway for Vmax instruments and reading stations. SENTRYCONNECT SEAT LICENSE FOR SOMNOSTAR Single Seat license to connect to SentryConnect gateway for SomnoStar instruments and reading stations. SENTRYCONNECT SEAT LICENSE FOR NOXTURNAL Single Seat license to connect to SentryConnect gateway for Noxturnal instruments and reading stations. SENTRYSUITE TEST LICENSE VMAX ENCORE TEST LICENSE Vmax Encore software license for use in network test environment. SOMNOSTAR TEST LICENSE SomnoStar software license for use in network test environment. NOX TEST LICENSE Noxturnal software license for use in network test environment. SPECIFIC NEED/SALIENT CHARACTERISTICS: Comprehensive pulmonary function testing (PFT) and respiratory mechanics Multiple Platform Testing in One Device CPET and PFT Spirometry testing Real Time BTPS Correction with Pneumotach Transmural Pressure Body Box Sentry Suite that will Interface with EMR Needs to be able to build out the systems capabilities with new clinical adjuncts that integrate into the systems over its lifecycle such as Aerosol Provocation System (APS) and Impulse Oscilimetry (IOS) which allows to expand services based on need. Energy expenditure data Highly accurate and stable testing data, including flow sensing real-time BTPS correction Efficient testing procedures and new Sentry Suite software reporting and workflow Enhanced automatic data interpretation Automated quality assurance, including real-time monitoring/alerts, an automated sensor stability check, measured CO2 cross-sensitivity and a data manager to view error codes QUANTATIES: - 2 Vyntus ONE Pulmonary Function Testing (PFT) Systems and 2 Vyntus BODY Diffusion Systems with associated software and accessories to meet the hereby listed physical, functional and performance characteristics, as well as, listed salient characteristics. Manufacturer: CARE FUSION Model/Product #: Vyntus ONE PFT System and Vyntus BODY Diffusion System. Refer to Cost Schedule for itemized listing of requirements with specific model numbers. PLACE OF PERFORMANCE: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612. Contractor shall provide installation and training on procured items. DELIVERY SCHEDULE: All items to be delivered and installed within 30 days after receipt of order (ARO) processing and order placement. FOB: DESTINATION pricing. WARRANTY OF EQUIPMENT: Contractor will provide manufacturer s warranty on all procured items. Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and no additional addenda to the clause included. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition. 52.204 10 52.209-6 52.219-27 52.222-19 52.222.21 52.222 26 52.222-36 52.222-40 52.222-50 52.223-18 52.225-13 52.232-33 The clause at VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016) (DEVIATION) The clause at VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016) (DEVIATION) The clause at VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) The clause at VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) The clause at VAAR 852.246-71 REJECTED GOODS (OCT 2018) The clause at VAAR 852.273-70 LATE OFFERS (JAN 2003) The following Provisions applies to this acquisition: The provision at 52.204-7, SYSTEM FOR AWARD MANAGEMENT (OCT 2016) The provision at 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS. The provision at 52.212-2 EVALUATION COMMERCIAL ITEMS (OCT 2014) Award shall be made to the quoter whose quotaton offers the best value to the Government. The government will evaluate information based on the following evaluation criteria: TIERED EVALUATION INCLUDING LARGE BUSINESS CONCERNS This procurement is set-aside based on an order of priority as established in 38 U.S.C. 8127. This solicitation is being issued as a tiered evaluation with the following tiers for (1) Service-Disabled Veteran-Owned Small Business concerns, (2) Veteran-Owned Small Business concerns, (3) small business concerns with HUBZone small business concerns and 8(a) participants having priority and (4) large business concerns. If award cannot be made, the solicitation will be cancelled, and the requirement resolicited. Upon completion of the tiered evaluation the comparative evaluation procedures will be used in accordance with FAR 13.106-2(b)(3). COMPARATIVE EVALUATION The Government will award a Firm-Fixed Price contract to the responsible quoter using a comparative evaluation. The comparative evaluation will be performed in accordance with FAR 13.106-2(b)(3). The government reserves the right to select a quotation that provides benefit to the government that exceeds the minimum but is not required to do so. Quoters are advised that quotation may exceed the requirements, but the government is not requesting or accepting alternate quotes; each response must respond to the solicitation requirement, stated in the RFQ. The government will apply the following comparative evaluation process as the basis for award: Assess the direct comparison of one quote with another in a uniform and fair manner to determine which quote provides the government what it needs, where and when in accordance with the Statement of Need (SON) and this Request for Quote. It is an assessment of which response is best as a whole. Once one quotation is found acceptable, it is compared side-by-side to the remaining ones, and the best one is chosen for the best value to the government. The following comparative evaluation factors shall be used: - Technical: Each offeror s quote shall be evaluated based on equipment and services specifications, to determine if the offeror provides a sound, compliant approach that meets the requirements of the Statement of Need and demonstrates a thorough knowledge and understanding of those requirements and their associated risk. In addition, the offeror must submit for evaluation (1) evidence of warranties, (2) specification of brand name products as detailed in the Price/Cost Schedule and Statement of Need. - Delivery Date: The purpose of the delivery factor is to assess the offeror s shipment information and after receipt of order (ARO) delivery days to meet the Government s delivery timeframe of 30 days ARO. - Past Performance: The Government may rely on internal documentation including the Contract Performance Assessment Reporting System (CPARS) and contracting officer s knowledge of and previous experience with supply or service being acquired for determining Past Performance. If no record of past performance is found in CPARS, the contract shall not receive a favorable or unfavorable rating but shall receive a rating of neutral. - Price: Award will be made to the offeror whose price represents the best overall value. Complete Price/Cost schedule. Information not contained in a vendor s quote will not be considered during the evaluation. The Government intends to make award selection without clarification but may determine after evaluating submitted quotes that the elements stated in FAR 13.106-2(b)(3) for evaluation procedures are necessary and conduct them as appropriate. The Government reserves the right to make no award if no quotes meet the requirements of this solicitation. The provision at 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS. All vendors must have an active registration in the System for Award Management (SAM) portal: https://www.sam.gov prior to award. All quoters certified as a Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB) must be verified as SDVOSB/VOSB in the VetBiz/VIP portal: https://www.vip.vetbiz.gov/ prior to award. The provision at 52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (NOV 2011) End of Provisions All quotes shall be submitted to Raimundo Rivera at contact@example.gov and Leslie Hawkins at contact@example.gov by 3:00pm EST on September 19, 2019.