6515--NX EQ Monitors: Physio: Hemodialysis (VA-26-00027838)

Description

1. DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Monitors - Physio: Hemodialysis product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. The anticipated period of performance is for one (1) 12-month base period with four (4) 12-month option periods from the date of award. However, the Government's decision as to whether or not to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The North American Industry Classification System (NAICS) code for Monitors - Physio: Hemodialysis is 334510 Endoscopic equipment, electromedical (e.g., bronchoscopes, colonoscopes, cystoscopes), manufacturing: 6515 Medical and Surgical Instruments, Equipment, and Supplies. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. 2. SCOPE This requirement will be IAW FAR clause 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirement - Brand Name which requires the quoter indicates that the product being offered is Monitors - Physio: Hemodialysis from Fresenius USA, Inc. Monitors - Physio: Hemodialysis is designed to measure oxygen saturation/hematocrit during hemodialysis treatment. These fluid management monitoring tools incorporate photo-optical technology to provide continuous, non-invasive measurement of a dialysis patient s hematocrit (percentage of whole blood volume made up of red blood cells) and oxygen saturation (the fraction of oxygen-saturated hemoglobin relative to total hemoglobin) in real-time. A sensor attached to the blood chamber shines light into the blood, while a second sensor on the other side of the chamber measures the absorbed and scattered light to calculate hematocrit and oxygen saturation levels. Contract Line Items Manufacturer Part Number Description 0001 Fresenius USA, Inc CL10051001 Crit-Line IV Color Touchscreen Monitor (Includes: 6-inch Touchscreen Monitor, Power Cord, Console Cover, User Manual, Quick Reference Guide, and 2 year warranty) 0002 Fresenius USA, Inc CL10041001 CLiC Device, Photo-Optical Sensor Clip, with USB Connector, and 2 year warranty 0003 Fresenius USA, Inc 03-2722-9C Bloodline, CombiSet (Bloodline + Blood Chamber) SMARTECH with HeparinLine (24 per Case) 0004 Fresenius USA, Inc 03-2742-9C Bloodline, CombiSet (Bloodline + Blood Chamber) SMARTECH without Heparin Line (24 per Case) 0005 Fresenius USA, Inc CL10041021 Blood Chambers, Disposable, Sterile, Single-Use, Optical Cuvette (36 per Box) The Department of Veterans Affairs (VA) is seeking vendors who can provide Fresenius USA, Inc Monitors - Physio: Hemodialysis as listed below which meet all the following salient characteristics: CLIN s 0001-0002 apply to the following SC s: SC # Salient Characteristics Method of Evaluation SC Literature Map SC 1 Must be FDA approved to non-invasively measure hematocrit, hemoglobin, oxygen saturation, and percent change in blood volume in real-time during hemodialysis treatment Literature Review FDA Ltr (K141997) dtd 4/1/2015; Crit-Line IV User s Guide Pages #14, 54, 55 SC 2 Must have a touchscreen user interface with continuous hematocrit, hemoglobin, oxygen saturation, and percent change in blood volume feedback displayed in graphical and trendline formats Literature Review Crit-Line IV User s Guide Pages #14, 51-59, 62, 67 SC 3 Must Provide Visual and Audible Alerts and/or Messages for Clinically Relevant Measurements Per User Defined Levels Literature Review Crit-Line IV User s Guide Pages #55, 56, 58, 59, 77-80 SC 4 Must be capable of printing and storing basic patient monitoring sessions for up to 30 days Literature Review Crit-Line IV User s Guide Pages #14, 50, 60, 64, 65 SC 5 Must support compatibility with other Hemodialysis Systems Literature Review Crit-Line IV Technology Brochure Page #9 SC 6 Must be mountable to common medical grade intravenous poles (pole mount) Literature Review Crit-Line IV User s Guide Pages #14, 17 Responses to this Sources Sought Notice shall include the following:� � � � � � � � � � � 1)� � � Full name and address of company 2)� � � SAM Unique Entity Identifier (UEI)/CAGE Code 3)� � � Business Size 4)� � � Manufacturer or Distributor a.� � � If distributor provide full name, business size and address of manufacturer. 5)� � � Country of Origin designation for all products. 6)� � � Ability to provide uninterrupted supply of products on a national scale. 7)� � � Technical Literature that clearly shows product(s) meet the identified salient characteristics (if submitting an or-equal item). 8)� � � Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. 9)� � � All small businesses, VOSB, SDVOSB distributors, shall provide a valid letter of authorization from the manufacturer of the product/brand that you intend to offer. The letter shall be printed on the manufacturer s letter head with a current date. The letter shall also be signed by a legally authorized representative of the manufacturer. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement. Contractors submitting capability statements in response to this RFI must specifically address the questions outlined above. Generic capability statements that do not directly pertain to this RFI will not be considered. Additionally, links requesting capability statements or further information will not be accessed. All responses must be submitted as an actual attachment.