Inactive Total Small Business Set-Aside (FAR 19.5)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will no... This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, identified as REQ 1243248 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This is a firm fixed price requirement. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. This procurement will be for small business set aside. Vendors must be registered in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the beta.sam.gov website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. Introduction: The Winchester Engineering and Analytical Center (WEAC) requires equipment capable of simulating vibrational stresses similar to what would be generated through regular use, transportation, and mishandling. This vibration system is necessary to develop test methods and conduct research that will broaden the scope of analysis that can be performed by WEAC Engineers. The capabilities of this mechanical testing will allow for the evaluation of the safety and performance standards of various devices regulated by the FDA. It will also improve the abilities of the FDA to regulate medical devices by confirming whether devices are following manufacturing specifications, consensus standards and agency compliance. Background: Hypertension is a major risk factor for heart disease that can be monitored by consistent maintenance of an individual’s cardiovascular health through regular blood pressure screenings. With the prevalence of these health factors medical equipment such as non-invasive blood pressure (NIBP) monitors are becoming increasingly utilized in the home healthcare environment. Routine use, transportation and mishandling of these devices can cause critical mechanical stresses that may influence normal functioning capabilities. Due to the environment these home use medical instruments and their accessories are used in, they are required to be durable enough to withstand misuse encountered through routine usage. The Engineering Lab at WEAC does not currently have a vibration test system or any other equipment capable of producing mechanical stresses required to follow ANSI standards of vibration testing on medical devices or lithium batteries. Objectives: The objectives of the requirement are for the Contractor to: Provide a vibration test system capable of documenting conditions and NIST-traceable measurements of home use medical devices and lithium batteries. Perform on-site installation of acquired test system and required components. Upon installation, demonstrate system functionalities and acceptable performance standards per manufacturer’s specifications. Provide on-site training on basic operation, routine maintenance, system troubleshooting and annual calibration procedures. Scope: The requested vibration test system shall be an off-the-shelf product with all required hardware, software, and accessories necessary to properly evaluate home use medical devices and batteries. The vibration test system must be able to accommodate instruments of varying sizes and allow for three-axis sequential analysis through re-orientation of the system fixture. Technical Requirements: At a minimum, the Vibration Test System shall meet the minimum technical requirements identified below: Stand-alone device including: Electrodynamic Shaker 2” displacement for shock testing Internal load support of 600 lbs. Accommodate Room Dimensions: Room Length: 10 ft 11 ¾ in ; Room Width: 3 ft 2 ? in External Cooling Blower Power Amplifier Vibration Controller Hardware Software Pre-programmed Sine, Random, and shock controller test conditions Programmable test parameters (including acceleration, duration, number of cycles, and frequency) and test creation capabilities Compatible with Windows 10 operating system Data interface: USB / RS232 / TCP/IP Multi-user password protection NIST Traceable Calibration Calibration Kit for Vibration Controller Horizontal Slip Table Assembly Sequential multi-axis analysis – (vertical and horizontal) Allow for combined environment testing – (temperature, humidity and vibration) Dimensions: 20 by 20-inch Slip Plate Capable of testing diverse types of handheld or home-use medical devices and varying sized batteries Capable of performing testing on multiple batteries at one time At a minimum, the Vibration Test System shall be capable of completing the following testing conditions: Medical Device Vibration Testing (IEC 60601-1-11) At a minimum, all equipment must withstand: Peak acceleration: 15 g (150 m/s2) Duration: 11 ms Number of shocks: 3 shocks per direction per axis – (18 total) o At a minimum, handheld equipment must withstand: Peak acceleration: 30 g (300 m/s2) Duration: 11 ms Number of shocks: 3 shocks per direction per axis – (18 total) At a minimum, Equipment must withstand random vibration testing: Acceleration amplitude: 10 Hz to 100 Hz: 1.0 (m/s2)2/Hz 100 Hz to 200 Hz: -3 db per octave 200 Hz to 2000 Hz: 0.5 (m/s2)2/Hz Duration: 30 minutes per perpendicular axis – (3 total) Lithium Battery Vibration Testing (IEC 62133-2) Frequency Range: 7 Hz – 200 Hz – 7 Hz Duration: 15 minutes Number of cycles: 12 per axis (36 total) Acceleration: 1 g from 7 Hz to 18 Hz, 8 g up to 200 Hz Small cell dimensions: up to 26 mm x 65 mm Gross mass: ? 12 kg, typically < 100 g Trade and Service Specifications: The components and/or equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. The entire system shall be warranted for parts, labor, and freight, including software service and support for a minimum of 12 months from the date of formal government acceptance. This shall consist of items and parts supplied including but not limited to factory-certified replacement parts, engineer labor and travel costs. Parts used for product maintenance or repairs must be guaranteed, factory tested, quality parts. All equipment maintenance or repair work shall be performed by a factory trained engineer. The warranty must include unlimited telephone and email support for questions regarding operation. The offered system should be a turn-key solution, i.e. the Contractor shall be responsible for providing all hardware, software, components, and that which is otherwise required to meet these specifications and shall be fit for intended purpose. The Contractor shall provide on-site assembly, installation, and startup of the test system during the time of delivery, at which point the equipment shall be ready to operate. The Contractor shall demonstrate that the system meets or exceeds performance specifications and shall provide Operation qualification certification to a WEAC employee as proof. The test system will not be accepted until the necessary performance specifications are met. Onsite training of basic operations, system repair and maintenance, and test system calibration shall be provided to all 25 WEAC Engineers. Instruction manuals with operation and system maintenance information is required. Only personnel employed by the Contractor shall be utilized for instrument service. Deliverables: Deliverable Description Quantity Due Date Delivery and Installation of Vibration Test System Within 8 Weeks after award of Contract 2 Inspection and verification of full system functionality Within 8 Weeks after award of Contract 3 Onsite training on basic operation and annual calibration procedures Within 8 Weeks after award of Contract Security: Check in with Security guard at the front entrance. Delivery Location/Place of Performance: Delivery must be coordinated with ORA/WEAC at least 48 hours in advance: U.S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award 109 Holton Street Winchester, MA 01890 Period of Performance: The Period of Performance begins on the date of contract award execution and it continues for one year from the date of formal government acceptance. The instrument is to be delivered no later than 90 days after award. (if applicable) FAR provisions can be found on the following website: http://Acquisition.gov The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 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 including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed?price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non?cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email to Julia.Savage@fdahhs.gov and be received by 5:00 PM (1700) on June 15, 2021 to the attention of Julia Savage, Julia.savage@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.