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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 01, 2014 FBO #4572
DOCUMENT

65 -- Request for Information EP Catheters - Attachment

Notice Date

5/30/2014
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

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

ZIP Code

22408
 

Solicitation Number

VA11914I0183
 

Response Due

6/4/2014
 

Archive Date

6/14/2014
 

Point of Contact

Antionette R. Collins-Somerville
 

E-Mail Address

400<br
 

Small Business Set-Aside

N/A
 

Description

SYNOPSIS: This is a request for information (RFI) in accordance with FAR 15.201(e). This is not a solicitation for quotes, neither unsolicited proposals nor any other kinds of offers will be considered in response to this RFI and there will be no contract award from this RFI. There will be no reimbursement for any costs associated with providing information in response to this RFI or follow-up information requests. The purpose of this RFI is to help determine the availability and technical capabilities of qualified sources and their size classifications (small business, large business, Veteran Owned Small Business (VOSB) etc.). Your responses to the information requested will assist the Government in determining the appropriate acquisition method. The Department of Veteran Affairs Strategic Acquisition Center (SAC) is interested in procuring multiple Electrophysiology Catheters or EP Catheters. Standardization of Electrophysiology (EP) Catheters ensures continuity of care from one Department of Veterans Affairs (VA) hospital to another across the United States and Puerto Rico. We intend to establish Multiple Award Blanket Purchase Agreements (BPAs) that will provide Electrophysiology (EP) Catheters and products. The Government seeks to establish up to twelve (12) BPA's to include a manufacturer's complete product line for Electrophysiology Catheters and products. Electrophysiology is a medical branch related to the study of electrical activity within the heart. These catheters are slim, bendable or deflectable multi-electrode wires used in recording intra-cardiac electrical signals or in ablation of cardiac tissues responsible for heart rhythm disorders. In addition, sheaths are tubes that are used to direct the catheters to specific areas in the heart and connectors linking the catheters to monitoring or ablation systems. The EP Catheters and products are used for diagnostic testing and treatment for both invasive (intra-cardiac) and non-invasive procedures and are a critical part of cardiac patient care. These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures. The Contractor shall furnish all necessary equipment, supplies, and materials to provide EP Catheters and products to VA Medical Centers (VAMCs) in the continental United States and Puerto Rico. For standard delivery, the Contractor shall provide the requested items within 3 business days. The vendor must have the capability to receive payment upon delivery utilizing the Government Purchase Card (GPC). To be eligible for award of a BPA, the Contractor shall ensure that any product provided under this BPA meet the following minimum technical requirements: Intended Use: These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures in accordance with the minimum technical requirements (MTRs) below MTR NumberMinimum Technical Requirement MTR 1Diagnostic electrophysiology catheters: Multi-pole, non-deflectable or multiple deflectable MTR 2Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radiofrequency, or cryoablation catheters MTR 3Intracardiac Ultrasound imaging catheters (equipment specific) MTR 4Electrophysiology introducer sheaths: nondeflectable or deflectable MTR 5Trans-septal catheterization needles MTR 63D mapping electrodes and patches (equipment specific) MTR 73D mapping catheters (equipment specific) APPLICABLE DOCUMENTS The following document applies to this requirement and shall be adhered to by the Contractor on all items offered. CFR - Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Subchapter H--Medical Devices, Part 814 - Premarket Approval of Medical Devices REQUIREMENTS The Contractor shall furnish all supplies, and materials to provide EP Catheters and products as defined by the Minimum Technical Requirements (MTRs). Contractor shall provide a Product Listing of all items and sizes relating to Electrophysiology Catheters provided by their company. The Contractor shall ensure that all products provided are new and free from defect. The Contractor shall ensure that the products are properly packaged to maintain the item's integrity (e.g., sterilization); and shall clearly identify the item and the expected shelf-life on the outside of the packaging. Emergency Turnaround When identified on the individual order, the Contractor shall provide emergency shipping service for the requested item(s) within 24 hours after receiving the Emergency Order Request. FDA Approvals The Contractor shall ensure that any product provided under this BPA is approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly. Product Recalls The Contractor shall report all equipment recalls in writing, within 48 hours of discovery to the Contracting Officer. Package Marking The Contractor shall ensure the addressee information for any delivered item includes the Ordering Office point of contact(s) information on the outside packaging to ensure delivery to the correct location and correct person. WARRANTY The Contractor shall provide a commercial warranty to industry standards for all products under this effort. ENVIRONMENTAL REQUIREMENTS The Contractor shall comply with all environmental federal, state, and local laws and regulations; and policies, instructions, and plans. RETURNED UNITS In the event a procedure is cancelled or an item is otherwise not needed, the Contractor shall accept unopened and undamaged EP Catheter packages in salable condition returned for full credit to the Government. In addition, the Contractor shall accept returned products for full credit to the Government where the shelf-life has reached expiration for unopened and undamaged products. Unused products shall be returned to the Contractor within 30 calendar days by the Ordering Official. NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS The Contractor shall notify the Ordering Office point of contact within one (1) business day for non-emergency Orders and within four (4) hours of an emergency Order if any parts/materials cannot be delivered in accordance with the individual BPA Order delivery requirements. To ensure that the correct EP Catheter items are shipped, the Contractor shall not substitute items without prior approval by Ordering Official. Instances where the Contractor cannot meet the Government's requirement(s), the Contractor shall notify the Ordering Office of the shortest delivery period available. If the Contractor's shortest delivery period is not acceptable to the Government, the Government reserves the right to procure the item(s) from other sources. This effort includes a "product refresh" provision whereby the Contractor provides notification of new FDA-approved products, and if approved by the Government, the new products are included for ordering under this effort. Product Refresh: A. All consumable items offered shall be state-of-the-art. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. B. If upgrades of the consumable items become available after establishment of this Agreement, the contractor will substitute them for the initial items per Item C below. C. The Contractor will provide to the contracting officer the following information: (1) A list of specific initial items which shall be updated. (2) Product literature for the new items and a detailed description of the differences between the initial items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved. D. The Contracting Officer will provide the information to the Program Office for approval. Upon approval, this Agreement will be modified to acknowledge the updated items. E. All new products that replace initial items and released to the market during the term of the contract will be made available to the Government at a discount price agreed to upon based on commercial sales practices disclosure. If pricing for new products is unacceptable, medical centers will continue to use current products on Agreement and contractor will be required to continue to supply the contracted item. F. All other new products that are added to a vendor's catalog and released to the market during the term of the Agreement will be made available to the Government at a discount price agreed to base on commercial sales practices disclosure. Pricing on new technologies will be negotiated separately. The Contractor shall provide a commercial warranty to industry standards for all products under this effort. The Contractor shall ensure that any product provided under this BPA is approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly. CFR - Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Subchapter H--Medical Devices, Part 814 - Premarket Approval of Medical Devices. The BPA will be for a 60 month ordering period after establishment of the BPA. The government will only establish BPA's with firms who comply with the above criteria, offer a competitive price, and who the government determines represents a benefit to the government to establish the BPA. All vendors must be registered in the System For Award Management (SAM) database a https://www.sam.gov/portal/public/SAM/#1. This procurement is unrestricted. The NAICS code is 339112. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality, No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Antionette Collins-Somerville, Contract Specialist, via e-mail to Antionette.Collins-Somerville@va.gov. Please include a point of contact, company name, business size standard, phone number, e-mail address and website information in your response to the RFI. Responses must be received by this office on or before 12:00 PM EST on June 4, 2014. This RFI is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/d2411c21081f7ddc1c35a23e858125c0)
 

Document(s)

Attachment
 

File Name: VA119-14-I-0183 VA119-14-I-0183_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1396783&FileName=VA119-14-I-0183-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1396783&FileName=VA119-14-I-0183-000.docx

 

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

Place of Performance

Address: TBD

Zip Code: TBD
 

Record

SN03380498-W 20140601/140531021330-d2411c21081f7ddc1c35a23e858125c0 (fbodaily.com)
 

Source

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

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