DOCUMENT
65 -- Negative Pressure Wound Therapy System - Acelity - BNOE - Attachment
- Notice Date
- 10/24/2017
- Notice Type
- Attachment
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- U.S. Department of Veterans Affairs;Office of Acquisition Operations;Strategic Acquisition Center;10300 Spotsylvania Avenue, Suite 400;Fredericksburg VA 22408
- ZIP Code
- 22408
- Solicitation Number
- 36C10G18Q0055
- Response Due
- 11/3/2017
- Archive Date
- 12/3/2017
- Point of Contact
- Ninatile Bacote
- E-Mail Address
-
le.Bacote@va.gov<br
- Small Business Set-Aside
- N/A
- Description
- 1.0 DESCRIPTION: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program identified Negative Pressure Wound Therapy System (NPWTS) as a candidate for VHA-wide (otherwise referred to as national ) single award Requirements contract. The Department of Veterans Affairs (VA) Office of Acquisition Operations (OAO) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Request for Information (RFI) in accordance with the Federal Acquisition Regulation 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders in accordance with FAR 16.503, Requirements Contract to a supplier of this equipment. The SAC in conjunction with VHA is seeking a qualified source to provide the Acelity brand name or equal Negative Pressure Wound Therapy System on an agency wide basis. Vendors will be required to deliver Negative Pressure Wound Therapy Systems to VHA facilities throughout the United States, U.S. Territories, Guam, and the Philippines. Delivery requirements shall be specified under each individual order. The proposed acquisition will consists of a 12 month base period and two (2) twelve (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 applicable North American Industry Classification System (NAICS) code is 339113, Surgical Appliance and Supplies Manufacturing. All interested companies must be Registered in the System for Award Management (SAM) prior to receiving an award. You may access SAM at https://www.sam.gov/portal/public/SAM/. All Offerors must be certified with the appropriate NAICS code on VA Vendor Information Pages at https://www.vip.vetbiz.gov/. This notice is for planning purpose 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 RFI 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. 2.0 SCOPE: The scope of this effort falls in line with VA s mission, goals, and objectives in support of providing Veterans care. Negative Pressure Wound Therapy Systems are designed to treat open wounds by locally applying negative pressure to the wound site. These systems consist of dressings, an evacuation tube, a collection canister, and a computer-controlled vacuum pump. The dressings usually include a foam (e.g., black polyurethane, polyvinyl alcohol) dressing with an evacuation tube embedded in it and a transparent film dressing that is applied over the foam package to seal the foam and the tube. The other end of the tube is connected to a fluid-collection canister, which, in turn, is attached to the vacuum pump. The computer-controlled vacuum pump applies either continuous or intermittent negative pressure through the tube to the foam dressing, drawing off excess of interstitial fluids from the wound. Negative-pressure wound-therapy systems decompress the capillaries and lymphatic vessels, thus improving blood flow to the wound and reestablishing normal circulation of interstitial fluids; they are intended to promote healing of wounds (e.g., chronic wounds, burns) that are difficult to heal using conventional treatments. This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires that the offeror indicate each product that is being offered as an equal product. For each equal product, the company must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The company must also clearly identify the item by brand name (if any) and make/model number. Finally, the company must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. Negative Pressure Wound Therapy System (NPWTS) SC# SALIENT CHARACTERISTICS METHOD OF EVALUATION SC1 NPWTS must provide safe and effective wound therapy, be state-of-the-art technology and provide compatibility with wound therapy accessories. Literature Review SC2 NPWTS must demonstrate compliance with requirements of widely accepted product safety standards, as determined through independent testing by organizations such as the American National Standards Institute (ANSI), Underwriters Laboratories (UL), and International Electrotechnical Commission (IEC). Must be FDA approved. Literature Review SC3 NPWTS must operate on 110 -120 VAC, 60Hz. The power cord must be no shorter than 8 feet in length and must connect to existing power receptacles. The power cord must be durable and able to withstand the force of being pulled from the wall receptacle while still charging a unit as it s rolled away for use. Literature Review SC4 NPWTS must be easy to program, provide a user-friendly Graphic User Interface and intuitive touch screen. Literature Review SC5 NPWTS must have audible and visual alarms including leak detection and provide alarm history recall. Literature Review SC6 NPWTS must monitor pressure in real time at the wound site and self-adjust based on wound unique attributes. Literature Review SC7 NPWTS must provide continuous and intermittent negative pressure (from 25 to 200mmHg). Literature Review SC8 NPWTS design must be durable, non-absorbing, corrosion-resistant and able to be cleaned using hospital grade cleaning solutions. Vendor must provide training instructions, procedures, and documentation necessary to properly and safely clean and disinfect the equipment and accessories between patient uses. Literature Review SC9 NPWTS must include a battery with capacity to provide full operation for at least 10 hours. Literature Review Salient Characteristics (SC) 1-9 are associated with the following CLINS: Contract Line Item# Manufacturer Part Number Description 0001 Acelity (KCI) ULTDEV01/US Wound Therapy Unit with power cord 0002 Acelity (KCI) ULTDEV01/US Service Manual for ULTDEV01/US 0003 Acelity (KCI) ULTDEV01/US User Manual for ULTDEV01/US 0004 Acelity (KCI) ULTVFL05SM.S Dressing Kit - Small, 5 pack 0005 Acelity (KCI) ULTVFL05MD.S Dressing Kit - Medium, 5 pack 0006 Acelity (KCI) ULTVFL05LG.S Dressing Kit - Large, 5 pack 0007 Acelity (KCI) ULTVFL05SM.S Dressing Kit - Small 0008 Acelity (KCI) ULTVFL05MD.S Dressing Kit - Medium 0009 Acelity (KCI) ULTLNK0500 V.A.C. Veralink Cassette with instillation tubing and 38mm spikeable cap adaptor 0010 Acelity (KCI) ULTDUO0500.S Tube Set, 5 pack 0011 Acelity (KCI) 400230 Irrigation Solution 0012 Acelity (KCI) 320000 Wound Therapy Unit with power cord and carrying case 0013 Acelity (KCI) 320000 Service Manual for 320000 0014 Acelity (KCI) 320000 User Manual for 320000 0015 Acelity (KCI) 414063 Wound Therapy Unit with power cord and carrying case 0016 Acelity (KCI) 414063 Service Manual for 414063 0017 Acelity (KCI) 414063 User Manual for 414063 0018 Acelity (KCI) VIAKIT077D01/US.S 7-Day Wound Therapy System Kit 0019 Acelity (KCI) VIAKIT07S05/US.S Wound Therapy Starter Kit 0020 Acelity (KCI) VIAGFM05.S Spiral Dressing Kit Medium 0021 Acelity (KCI) VIAGFS05.S Spiral Dressing Kit Small 0022 Acelity (KCI) VIACAN05.S 250cc Canister with Isolyzer, 5 pack 0023 Acelity (KCI) 340000.S Wound Therapy Unit 0024 Acelity (KCI) 340000.S Service Manual for 340000.S 0025 Acelity (KCI) 340000.S User Manual for 340000.S 0026 Acelity (KCI) M8259999.S Wound Therapy Unit with power cord 0027 Acelity (KCI) M8259999.S Service Manual for M8259999.S 0028 Acelity (KCI) M8259999.S User Manual for M8259999.S 0029 Acelity (KCI) M8275026/5.S Open Abdomen Dressing, 5 pack 0030 Acelity (KCI) PRE1055US.S Dressing Kit 20cm (for use on up to 20cm linear incisions), 5 pack 0031 Acelity (KCI) PRE1155US Dressing Kit 13cm (for use on up to 13cm linear incisions) 0032 Acelity (KCI) PRE2055US Dressing Kit (for use on non-linear or up to 90cm linear incisions) 0033 Acelity (KCI) M8275041/10.S Small Dressing Kit with Drape, 10 pack 0034 Acelity (KCI) M8275041/5.S Small Dressing Kit with Drape, 5 pack 0035 Acelity (KCI) M8275040/10.S Medium Dressing Kit with Drape, 10 pack 0036 Acelity (KCI) M8275040/5.S Medium Dressing Kit with Drape, 5 pack 0037 Acelity (KCI) M8275042/5.S Bridge Dressing Kit, 5 pack 0038 Acelity (KCI) M8275042/10.S Bridge Dressing Kit, 10 pack 0039 Acelity (KCI) M8275044/5.S Bridge XG Dressing, 5 pack 0040 Acelity (KCI) M8275098/5.S Small Dressing Kit, 5 pack 0041 Acelity (KCI) M8275098/10.S Small Dressing Kit, 10 pack 0042 Acelity (KCI) M8275096/5.S Medium Dressing Kit, 5 pack 0043 Acelity (KCI) M8275096/10.S Medium Dressing Kit, 10 pack 0044 Acelity (KCI) M8275099/5.S Large Dressing Kit, 5 pack 0045 Acelity (KCI) M8275099/10.S Large Dressing Kit, 10 pack 0046 Acelity (KCI) M8275051/5.S Small Dressing Kit, 5 pack 0047 Acelity (KCI) M8275051/10.S Small Dressing Kit, 10 pack 0048 Acelity (KCI) M8275052/5.S Medium Dressing Kit, 5 pack 0049 Acelity (KCI) M8275052/10.S Medium Dressing Kit, 10 pack 0050 Acelity (KCI) M8275053/5.S Large Dressing Kit, 5 pack 0051 Acelity (KCI) M8275053/10.S Large Dressing Kit, 10 pack 0052 Acelity (KCI) M8275065/5.S X-Large Dressing Kit, 5 pack 0053 Acelity (KCI) M8275075/10.S Round Dressing Kit, 10 pack 0054 Acelity (KCI) M8275075/5.S Round Dressing Kit, 5 pack 0055 Acelity (KCI) M8275081/5.S Thin Dressing Kit 0056 Acelity (KCI) M8275064/5.S Hand Dressing Kit, 5 pack 0057 Acelity (KCI) M6275033/10.S Small Dressing (foam only), 5 pack 0058 Acelity (KCI) M6275034/10.S Large Dressing (foam only), 10 pack 0059 Acelity (KCI) M8275068/10.S Small Dressing Kit, 10 pack 0060 Acelity (KCI) M8275068/5.S Small Dressing Kit, 5 pack 0061 Acelity (KCI) M8275067/5.S Large Dressing Kit, 5 pack 0062 Acelity (KCI) M8275067/10.S Large Dressing Kit, 10 pack 0063 Acelity (KCI) M6275033/10.S Small Dressing (foam only), 10 pack 0064 Acelity (KCI) M8275063/5.S 500ml Canister with Gel, 5 pack 0065 Acelity (KCI) M8275063/10.S 500ml Canister with Gel, 10 pack 0066 Acelity (KCI) M8275071/10.S 500ml Canister without Gel, 10 pack 0067 Acelity (KCI) M8275071/5.S 500ml Canister without Gel, 5 pack 0068 Acelity (KCI) M8275093/5.S 1,000ml Canister with Gel, 5 pack 0069 Acelity (KCI) M8275057/10.S Pad Only, 10 pack 0070 Acelity (KCI) M6275066/5.S Y-Connector, 5 pack 0071 Acelity (KCI) M6275066/10.S Y-Connector, 10 pack 0072 Acelity (KCI) M6275069/5.S Tubing Cap, 5 pack 0073 Acelity (KCI) M6275069/10.S Tubing Cap, 10 pack 0074 Acelity (KCI) 320058/5.S 300ml Canister with Gel, 5 pack 0075 Acelity (KCI) 320058/10.S 300ml Canister with Gel, 10 pack 0076 Acelity (KCI) M6275009/10.S Drape, 10 pack 0077 Acelity (KCI) M8275058/5.S 300ml Canister with Gel, 5 pack 0078 Acelity (KCI) M8275058/10.S 300ml Canister with Gel, 10 pack Biomedical Training SC# SALIENT CHARACTERISTICS METHOD OF EVALUATION SC10 Vendor must incur all transportation, tuition and lodging costs for service and maintenance for technical one (1) day training for up to two (2) Biomedical Engineer staff per facility. Literature Review SC11 Two (2) Service and Two (2) operators manuals must be provided for each NPWTS. Literature Review Biomedical Training Salient Characteristics (SC) 10-11 is associated with the following CLIN: Contract Line Item# Manufacturer Part Number Description 0082 Biomed Training User Training SC# SALIENT CHARACTERISTICS METHOD OF EVALUATION SC12 Initial On-site User Training shall include information on how to operate and clean the equipment safely and effectively. Literature Review User Training Salient Characteristics (SC) 12 is associated with the following CLIN: Contract Line Item# Manufacturer Part Number Description 0083 Clinical Training 3.0 RFI SUBMISSION INSTRUCTIONS: Companies are encouraged to respond if they have the capability and capacity to provide Acelity brand name or equal Negative Pressure Wound Therapy System which meet all of the salient characteristics. However, be advised that generic capability statements are not sufficient for effective analysis of respondents' capacity and capability to provide the required product. If your company has an interest in responding to the requirement described above, please provide the following: Corporate Capability Statement Information: Corporate Capability Statement; demonstrates capabilities, knowledge and experience related to the Negative Pressure Wound Therapy System described above (please detail if capability exists to meet each spec listed). If significant subcontracting or teaming is anticipated in order to deliver technical capability and scale, organizations should address the administrative and management structure of such arrangements. Responses shall be: Identified with the RFI number; and include: Company s name, CAGE code, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. Also please include Small Business designation if applicable. Interested parties shall submit a Corporate Capability Statement not exceeding 10 single-sided, type-written pages using 12-point type or larger. The page limit does not apply to advertising material such as company brochures and catalogs. If there is any information you deem proprietary, please mark accordingly. SUBMISSIONS ARE DUE 3 NOV 2017, by 2:00PM, Eastern Standard Time. All responses under this RFI must be emailed to ninatile.bacote@va.gov. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the OAO/SAC view of the information received. Do not send any material that requires a non-disclosure agreement or identify information that is business sensitive. Responses to this notice will not be returned. Telephone calls/questions or inquiries will not be accepted If you have any questions concerning this opportunity please contact Ninatile Bacote at ninatile.bacote@va.gov.
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