This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following: Cryostat Units for Lease for Kansas City VAMC *** See Statement of Work below for details *** If this is within your capability, please respond with the information below: Company Name Address Point of Contact Phone, Fax, and Email UEI number GSA Contract (as applicable) Capability Statement that clearly and convincingly identifies your ability to fulfill this requirement. Brochures of product being offered to include specifications. Authorized service provider letter from OEM Must meet FAR 25.1 Buy American - Supplies standards Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.11 states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in VetCert at https://veterans.certify.sba.gov Point of Contact for this Sources Sought is: veronica.flores@va.gov (913) 946 - 1167 Department of Veterans Affairs Network Contracting Office -15 3450 S. 4th Street Trafficway Leavenworth, KS. 66048. STATEMENT Of REQUIREMENTS Kansas City VAMC Cryostat Units DESCRIPTION/SPECIFICATION/STATEMENT OF REQUIREMENTS INTENT: The Kansas City VA Medical Center requires the two (2) cryostat units and service maintenance lease contract to use in the preparation of tissue samples obtained from Veteran patients. REQUIREMENT: The instrumentation shall have the capability to preserve frozen tissue samples, slice tissue sections thin enough for microscopic examination, and provide a quick diagnosis during in-surgeries for a variety of diseases and medical conditions. The entire process is performed under cryogenic temperatures. New equipment shall be acquired for the required laboratory. Refurbished, discontinued, or previously owned units are not acceptable. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. GENERAL REQUIREMENTS: Analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Operational and Technical Features- The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and have the following: Required Salient Characteristics Must have an object head with reliable clamping Must be a floor standing model not to exceed the following dimensions: 27.5 x 33 x 60 inch (L x W x H) Must have a stable specimen mounting system Must have chamber-cooled cryosystem to maintain a stable temp range of 0 °C to -35 °C ±5 K, adjustable in 1 K increments, at ambient temperature of 20°C The blade holder must support the use of high and low profile disposable blades that can be laterally moved, allowing the use of the entire blade length Must have safety features to reduce biohazard exposure such as UV light for chamber decontamination Must have safety features that reduce risk of injury, such as blade ejector, finger guards and plastic touch points Must have a single function keys and easily readable LED displays Must be touchscreen Must safety features to safely remove the waste Provides designated large freezing shelves, tool trays and storage shelf for objects, holders, and tools Must cut specimens to a section thickness of 1 to 100 m Must have a vertical stroke length of 59 mm ± 0.5 mm Must have a trimming thickness range of 10 to 40 m Must have a specimen orientation ±8 ° (x-, y-axis) Must have a Cooling time to -25 °C of approx. 5 h at 20 °C ambient temperature Must have the capability of manual or auto defrosting Must have a minimum of 2 freezing stations Documentation: A current editable standard operating procedure shall be provided. A printed, electronic copy or both, of the Operator s manual and Technical manual shall be provided. The document(s) shall be formatted in accordance with current, approved CLSI guidelines. Electronic (CD Format). At a minimum, electronic copies of Safety Data Sheets (SDS) shall also be provided. Updates to all procedure manuals in Microsoft Word format and SDS sheets in electronic format shall be provided when package inserts are modified. Training: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. If applicable, off-site travel shall include the cost of airfare, room and board for each participant, if applicable. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on instrumentation, and any incremental support/ancillary equipment, e.g., UPS, line conditioner, etc. offered according to the following terms: Service Requirements Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour(s). Equipment repair service shall be provided during core business hours. Core business hours are 8:00 AM to 5:00 PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be on the same day or no more than 24 hours. Service must be provided by a local technician A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: Date and time notified Date and time of arrival Serial number, type, and model number of equipment Time spent for repair and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call. Vendor will supply any parts necessary to keep the equipment operational. If upgrades or changes in technology render a piece of equipment no longer necessary, contractor shall remove said piece at contractor s expense. Ancillary Support Equipment - The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), filters, preventative maintenance and repair, etc.), printers and universal interface equipment, UPS and UPS Batteries, line conditioners, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc. Commercial Offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the CONTRACT. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of a contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational by April 30 or mutually agreed upon date. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. Contractor shall provide with its quotation an implementation plan for installation of new equipment. The plan should include installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. At the end of 120 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded CONTRACT. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or contract] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification of effectiveness of 90% or more. If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when more than the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. The same terms and conditions apply to ancillary/support equipment provided under this contract, i.e., water system UPS, etc. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.
