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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 27, 2014 FBO #4478
DOCUMENT

65 -- Negative Pressurem Wound Therapy Device - Attachment

Notice Date

2/25/2014
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
 

ZIP Code

22408
 

Solicitation Number

VA11914I0093
 

Response Due

3/10/2014
 

Archive Date

6/8/2014
 

Point of Contact

Berneta Ellis
 

Small Business Set-Aside

N/A
 

Description

This is a Sources Sought Notice to determine availability of potential sources capable of providing Negative Pressure Wound Therapy (NPWT) devices and associated maintenance services. The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) National Standardization Wound Care Integrated Product Team (IPT) has identified NPWT devices as candidate items for standardization. The organization desires to procure both a lightweight NPWT device and a standard NPWT device, including associated maintenance services, that should allow for use of foam based products and provide compliance across the continuum of care. Additionally, both purchase and rental options are required for both the standard and lightweight devices to satisfy demand. The required devices and associated maintenance service must meet the Minimum Technical Requirements (MTRs) contained in Attachment 1 - Minimum Technical Requirements. The information received as a result of this Sources Sought Notice may result in the award, or multiple awards of enterprise-wide contracts. Potential contractors are encouraged to submit a non-binding statement of interest along with the below documentation substantiating they have products that meet the stated requirement. Further, it is intended to assess industry's capability to support and/or develop an adequate solution to the Governments continuing need(s). REQUESTED INFORMATION: (1)Statement of Capability: Submit a brief description, twenty (20) pages or less that indicates: (a)your product's ability to meet the Minimum Technical Requirements as indicated on the attachment, (b)whether your company provides the required products for purchase and/or rental, (c)your sales and rental history for the past 12 month period, (d)whether you have a maintenance service contract for your NPWT device. If so, please state coverage and exclusions under your plan. If multiple plans are available, please provide information for each, (e) are maintenance services provided under a GSA schedule? If so, please provide the GSA schedule number. (f) do you have authorized distributors for the devices? (g) are any other contractors authorized to perform maintenance service to the NPWT devices? If so, will the warranty still be valid or negatively impacted in any manner? (h) does your company allow customers to perform preventative maintenance and INTERNAL cleaning of the equipment? If so, does your company provide training? (i) if your company does not allow customers to perform internal cleaning of the equipment, are you willing and/or able to negotiate a change to the terms and conditions to accommodate VHA's need to perform internal device preventative maintenance without impact to the warranty. (j) are maintenance services available for all NPWT devices available for purchase? If not, please state exceptions. (k) provide your current commercial pricing for both your maintenance service agreement(s). (l) if maintenance services are provided, does your cost for maintenance include parts and labor? (m) provide your current commercial pricing for both the standard and lightweight NPWT devices. (n) provide documentation/literature evidencing the coverage and exclusions under your maintenance service agreement(s). If multiple plans are available, provide documentation for each plan. (o) is there a standardized testing method for demonstrating that cross-contamination does not occur between patients utilizing NPWT devices (p) does your NPWT device have evidence of human factors engineering analysis of the device design, usability test results and clinical evaluations? If so, is there a mitigation plan for resolution of identified errors? (q) do you have an extended warranty option for NPWT device? If so, please state the cost and describe what is covered under the extended warranty. (r) do you have a service contract option for your NPWT device? If so, please state the cost and describe what is covered under the service contract. (s) what type of assurance can you provide that the NPWT devices are new, never-used units? (t) are all of your newest-generation of NPWT devices available for rental and purchase? (2)Indicate whether you hold a GSA Federal Supply Schedule Contract that covers the subject products and if so, please provide the Schedule Number and Contract Number; (3)State whether you are a manufacturer of the required product. The Strategic Acquisition Center (SAC) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 339113 - Surgical Appliance and Supplies Manufacturing. (4)Provide BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered in the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM; to receive award based on VOSB or SDVOSB status, you must be registered in the VetBiz Registry. Responses are due by noon, March 10, 2014. Please submit e-mail responses to Mr. James W. Poe, III, Contracting Officer, at email address: james.poe@va.gov and Ms. Berneta Ellis, Contract Specialist, at email address Berneta.Ellis@va.gov. Your response should include the STATEMENT OF CAPABLILITY, GSA SCHEDULE INFORMATION, NAICS CODE INFORMATION and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Be advised that all correspondence sent via e-mail shall contain a subject line that reads "Negative Pressure Wound Therapy". Disclaimer: Issuance of this Sources Sought Notice is to assist the VA in determining sources only and does not commit or bind the Government under any circumstances nor does it constitute any obligation whatsoever on the part of the Government to procure these commodities/supplies or to issue a solicitation nor to notify respondents of the results of this notice. No solicitation documents exist at this time. The Department of Veterans Affairs is neither seeking proposals nor accepting unsolicited proposals, and responses to this Sources Sought Notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative costs incurred in response to this Sources Sought Notice. As part of a Department of Veterans Affairs (VA) acquisition project team, I am researching product information for the subject item. This is not a formal request for quotation, but research aimed to identify suppliers. If the government decides to solicit offers, it will come from the contracting office. MINIMUM TECHNICAL REQUIREMENTS (MTRS) INTENDED USE: NPWT is intended for use to promote wound healing by secondary or tertiary intention by preparing the wound bed for closure through promoting growth of granulation tissue, promoting tissue perfusion, decreasing tissue edema, in the most time efficient manner, while managing exudate and protecting the wound from infection. NPWT is indicated for, but not limited to, chronic, acute, traumatic, surgical, and dehisced wounds, partial-thickness burns, diabetic, pressure, or venous ulcers, flaps and grafts. a.Negative Pressure Wound Therapy LIGHTWEIGHT Device: MTR1a Minimum battery run time: 4 hours (pneumatic power acceptable) MTR1bMaximum Battery recharge time: 8 hours MTR2Must be equipped to include an integrated exudate collection canister that secures to main device. MTR3Alarm volume must be sufficiently loud, at least 50dB and distinctive, to be heard over noise commonly occurring in the areas where the device is used. The alarm volume shall be adjustable, but it should not be possible to turn the volume down so low that it is unlikely to be heard 20 feet from the patient's room. MTR4The device shall be capable of being cleaned, disinfected and reprocessed or disposable. MTR5Technical support by telephone must be available 24 hours per day, 7 days per week (24x7). MTR6Clinical education and training: Hands on clinical education for clinicians and trainers must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available on the company's web site. MTR7Service training for Biomedical Services to maintain and inspect the repair the device must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available on the company's web site and change notices must be provided to Biomedical Engineering. MTR8Education and training for Sterile Processing Services (SPS) for exterior and disinfecting, and reprocessing must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available on the company's web site and change notices must be provided to SPS. MTR9 Provide Manufacturer's recommendations for cleaning agents that will not damage the device materials. MTR10The device must provide a range of negative pressure in continuous and/or intermittent modes. MTR11Minimum of 1 year manufacturer's warranty MTR12No cost replacements shall be provided for devices that are deemed not repairable during the warranty period. MTR13No cost loaner devices shall be provided while warranty repairs are in process. MTR14Human Factors: The vendor shall provide evidence of human factors engineering analysis of the device design, usability test results and clinical evaluations. The vendor shall provide an analysis of and a mitigation plan for identified use errors. MTR15Cross contamination: Vendor must provide testing results demonstrating cross contamination between patients cannot occur. A description and specifications of the filters and backflow prevention technique must be provided. MTR 16Provide certification of date of manufacture for device. Must be newest generation model of device. MTR 17Device weight: ?2.5 lbs b.Negative Pressure Wound Therapy STANDARD Device: MTR1a Minimum battery run time: 4 hours MTR1bMaximum Battery recharge time: 8 hours MTR2Must be equipped to include an integrated exudate collection canister that secures to main device. Two canister sizes are required. MTR3*Alarm volume must be sufficiently loud, at least 50dB and distinctive, to be heard over noise commonly occurring in the areas where the device is used. The alarm volume shall be adjustable, but it should not be possible to turn the volume down so low that it is unlikely to be heard 20 feet from the patient's room. MTR4The device shall be capable of being cleaned, disinfected and reprocessed or disposable. MTR5Technical support by telephone must be available 24 hours per day, 7 days per week (24x7). MTR6Clinical education and training: Hands on clinical education for clinicians and trainers must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available on the company's web site. MTR7Service training for Biomedical Services to maintain, inspect and repair the device must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available on the company's web site and change notices must be provided to Biomedical Engineering. MTR8Education and training for Sterile Processing Services (SPS) for exterior and interior device cleaning, disinfecting, and reprocessing must be provided at initial installation of product and upon request for the life of the product. Educational materials must be available on the company's web site and change notices must be provided to SPS. MTR9 Provide Manufacturer's recommendations for cleaning agents that will not damage the device materials. MTR10The device must provide a negative pressure range of from 25 mmHg to 200 mmHg in both continuous and intermittent modes. MTR11Minimum of 1 year manufacturer's warranty MTR12No cost replacements shall be provided for devices that are deemed not repairable during the warranty period. MTR13No cost loaner devices shall be provided while warranty repairs are in process. MTR14Human Factors: The vendor shall provide evidence of human factors engineering analysis of the device design, usability test results and clinical evaluations. The vendor shall provide an analysis of and a mitigation plan for identified use errors. MTR15Cross contamination: Vendor must provide testing results demonstrating cross contamination between patients cannot occur. A description and specifications of the filters and backflow prevention technique must be provided.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/e1cf360a9f7c4594b3576b3e7a47b5b5)
 

Document(s)

Attachment
 

File Name: VA119-14-I-0093 VA119-14-I-0093.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1224557&FileName=VA119-14-I-0093-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1224557&FileName=VA119-14-I-0093-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03295847-W 20140227/140225234349-e1cf360a9f7c4594b3576b3e7a47b5b5 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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