This is a combined synopsis/solicitation for commercial items/services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E18Q9538 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92. This requirement will be made using a cascading set-aside under the associated NAICS code 334516 with a small business size standard of 1,000 employees. The full solicitation document is included as an attachment to this notice; to include: a list of contract line items, a Description of requirements for the items to be acquired, SOW/PWS, Date(s) and place(s) of delivery, and applicable clauses and provisions. Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of lowest price technically acceptable. The requirement is for 1 EA Implantable Large Animal Telemetry System. The proposed system shall acquire and analyze physiological data from conscious, freely moving non-human primate models of spinal cord injury and include the following capabilities: Implantable telemetry monitoring probes that can provide the most reliable and efficient method of measuring physiologic parameters, to include blood pressure, glucose, EEG, ECG, respiration, temperature and activity. Sufficient miniaturization of these products to enable easy surgical implantation into large animal models. Implantable telemetry implants designed for acquiring data from conscious, freely moving laboratory animals, providing stress-free data collection while enhancing animal welfare. The implants shall be offered in various sizes to support a range of research models, including mice, rats, dogs and non-human primates. Physiologic signals measured shall include: Pressures: arterial, left ventricular, ocular, bladder, intra-cranial. Biopotentials: ECG, EMG, EEG, EOG. Blood glucose, Respiration. Temperature: core and localized with thermistor, Activity and Sympathetic nerve activity. Implants shall have a minimum battery life of 105 days, allowing long-term monitoring. They shall be compact and lightweight, weighing 56g or less with a volume of 29cc. Transmission range shall be a minimum of 5m, allowing social housing of non-human primate during monitoring. The implants with software shall allow monitoring of Pressures: arterial, left ventricular, ocular, bladder, intra-cranial. Biopotentials: ECG, EMG, EEG, EOG. Blood glucose, Respiration. Temperature: core and localized with thermistor, Animal activity and sympathetic nerve activity. The telemetry system shall use implantable probes, so animals can be chronically instrumented and used sequentially as their own control or in multiple studies to reduce the number of animals. Stress artifact induced by handling is avoided. In addition, the implants and data analysis systems, long-term physiologic measurements shall be obtained around the clock with no lab personnel present. Software and analysis systems shall collate, analyze and manage large datasets containing physiologic signals collected from telemetry from freely behaving non-human primates that are fully compliant with the FDA s Good Laboratory Practice regulations and other federal regulations. The software system shall be a robust, flexible solution for data acquisition and analysis offering acquisition solutions for implantable and external telemetry, traditional hardwired, and other third-party hardware and analysis solutions for cardiovascular/hemodynamic and respiratory endpoints. The system shall be a complete physiologic data acquisition and analysis software platform for researchers to confidently collect, accurately analyze, and quickly summarize study data. The software shall be modular, consisting of multiple acquisition interfaces, as well as a library of pre-programmed, validated software analysis modules providing flexible configurations to meet all experimental needs and easy expansion options for evolving needs. The system shall integrate multiple acquisition interfaces to provide a flexible, scalable solution for acquiring physiologic signals. The system shall allow researchers to collect data from regular, HD and Tel digital implantable telemetry, as well as Jacketed External Telemetry (JET). The signal conditioners and amplifiers shall provide robust acquisition from traditional hardwired signals and third-party analog out telemetry solutions. All of the hardware, software, date collection, analysis, data management and reporting systems shall be fully compliant with FDA 21 CFR Part 11, OECD, CSA/CE/UL, ACURO and IACUC regulations. A Data Security Option (DSO) shall be available to allow the system to operate within FDA 21 CFR Part 11 regulations. The DSO shall use a Smart Card technology and electronic signatures to provide a high level of system security and data control. The DSO system shall provide: Secure Program Login: A System Administrator shall have the capability to initialize User Smart Cards and define access levels unique to each system. Each user shall be assigned a unique Smartcard that defines a PIN required for system access. The user must insert their card into the card reader and enter their PIN to gain access to the system. Electronic Signatures: Each acquisition shall automatically create an encrypted Signature file used as a unique finger print for future verification of the files. Additional data stored on the user s Smartcard shall support Electronic Signatures. A user may attach their electronic signature and any notes related to the signing. Controlled User Privileges: A minimum of ten unique access levels shall be defined on each system. The access level shall determine the privileges granted to users of the application. Every available user function shall be independently assigned or reserved. File Integrity Validation: A verify function which allows saved data sets to be quickly checked for evidence of corruption or tampering shall be included. Multiple User Profiles: Each system user shall be assigned a specific Access Level. In the case of multiple systems at a facility, a user may have different privileges on individual systems. If a user is not assigned on a system, their Smartcard shall not be accepted as a valid login. Hundreds of users may be assigned to each system. Audit Trail: During operation the user shall be able to lock the program by removing their card. Card removal will not alter the current operational state of the system but will prevent unauthorized manipulation if the operator leaves the system unattended. Each insertion and removal of Smart Cards and all changes to operational settings will be recorded in a Log file. Log files provide an Audit Trail, documenting all system activity from application start to end. Telemetry Platform Digital Overview The Telemetry Platform shall be a large animal platform designed to simplify study execution, enhance animal welfare, and improve data accuracy. The system shall be fully-digital, eliminating data corruption from ambient noise or a neighboring animal. Additionally, the animal ID shall be encoded in the telemetry signal to ensure data traceability from the implant to the computer database. The digital implants shall allow for a variety of physiologic signals to be collected from a single animal. The platform shall offer two distinct series of devices: Both series shall leverage identical hardware. One series implants shall be designed for use in chronic physiology monitoring in colony animals. Implants are typically used in safety pharmacology studies to address core battery requirements in cardiovascular (CV), neuroscience, and respiratory applications. Core CV measurements include systemic pressure and ECG, with LV pressure as a secondary measurement. The other implants shall also feature enhanced animal welfare, improved personnel safety and lab efficiency. Remote programming of the system shall enable researchers to start and stop data collection of the implants without entering an animal room; minimized human-animal interaction results in animals that are less stressed, providing a safer environment for technicians. The system shall be designed to support social housing studies and is capable of monitoring up to 16 animals on a single system and up to 48 animals in the same room. Delivery FOB Destination to: VA Hospital San Diego 3350 La Jolla Village Dr. San Diego, CA 92161 Freight, installation and training shall be included in the final price. The following provisions apply to this acquisition: 52.212-1, Instructions to Offerors Commercial, (ix) A statement regarding the applicability of Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with its offer. 52.212-4, Contract Terms and Conditions Commercial Items, 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders Commercial Items, 852.246-70, Guarantee Additional contract requirement(s) or terms and conditions determined by the contracting officer: Set Aside Cascading set-aside procedures. Any award resulting from this solicitation will be made using a cascading set-aside order of precedence as follows: 1. In accordance with FAR Subpart 19.1405 and VAAR Subpart 819.7005, any award under this solicitation will be made on a competitive basis first to an eligible Service Disabled Veteran Owned small business [SDVOSB] concern provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 2. If there is inadequate competition for award to an SDVOSB concern, the SDVOSB set-aside shall be withdrawn and cascaded to the next contracting order of priority in accordance with VAAR 819.7004, which is Veteran Owned Small Businesses (VOSB) and conducted in accordance with the procedures set forth in VAAR 819.7006 provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 3. If there continues to be inadequate competition between SDVOSB and VOSB concerns, the cascading will continue through the contracting order of priority in accordance with VAAR 819.7004 and FAR 19.203. If the contracting officer determines that offers from small business concerns do not meet the solicitation requirements in terms of technical acceptability, past performance, and fair market price, the small business set-aside[s] will be withdrawn and award will be made on the basis of full and open competition. Adequate competition: Adequate competition shall be deemed to exist if At least two competitive offers are received from qualified, responsible business concerns at the set-aside tier under consideration; and Award could be made at fair market price as determined in accordance with FAR 19.202-6. The VA contracting officer reserves the right to consider competitive proposals submitted from all responsible offerors (including large businesses) in determining the fair market price. Due date and submission of quotes: The quotes are due on 8/27/2018 at 10:00 AM and shall be directed electronically to
[email protected]. Quotes shall be marked with the solicitation number. Information regarding the solicitation can be addressed to the Contracting Officer, Michael Haydo,
[email protected]