36C26318Q9970-001.pdf

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Minneapolis VA Biosense Catheters
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36C26318Q9970
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36C26318Q9970 JandA - updated - redacted.pdf

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VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 3 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: _36C263-18-AP-2717____________________

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23 (NCO

23), 4801 Veterans Drive, MN 56303. Organization Activity: Minneapolis VA Health Care System (MVAHCS), One Veterans Drive Minneapolis, MN 55417, 618-19-1-4001-0005.

2. Description of Action: Firm fixed price BPA call for Carto Catheters and related supplies from Biosense Webster off their SAC BPA VA119-16-A-0066 for the Electrophysiology Lab at the Minneapolis VA Health Care System.

Order against: FSS Contract Number: _VA119-16-A-0066_______________________

Name of Proposed Contractor:

Biosense Webster Inc

Street Address: 4705 Littlejohn Street City, State, Zip: Baldwin, CA 91706 Phone: 732-562-3689

3. Description of Supplies or Services: Catheters and Supplies for use with the Carto Mapping

System; which provides mapping capability of certain nerve pathways in the heart. These catheters and supplies are used during ablation procedures to locate and terminate abnormal rhythms that can be detrimental to the patient.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 3 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition.

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

The Minneapolis VA Health Care System’s Electrophysiology lab currently utilizes a Carto 3D mapping system manufactured by Biosense Webster Inc. The Minneapolis VA requires additional catheters for utilization with the system. The new catheters need to be compatible with the existing ablation equipment. No other manufacture’s catheters are compatible with the Carto system. The Strategic Acquisition Center awarded a multiple award BPA to Biosense Webster, St. Jude Medical Inc and Boston Scientific.

Neither St. Jude Medical Inc nor Boston Scientific can provide compatible catheters.

Biosense Webster also verified that there are no authorized distributors for their catheters and that they are only available directly from Biosense Webster.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH

FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: This procurement represents the best value to the government as Biosense Webster is the manufacture and sole distributor for the required catheters and there is a SAC BPA available for ordering the catheters and supplies.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

VetBiz was searched under NAICS code 339112 which returned 302 results. The Strategic Acquisition Center awarded a multiple award BPA to Biosense Webster, St. Jude Medical Inc and Boston Scientific. Neither St. Jude Medical Inc not Boston Scientific can provide catheters compatible with the current Biosense Webster system used at the Minneapolis VA. Biosense Webster was contacted to determine if there are any authorized distributors for their catheters and they responded that there are no authorized distributors for their items and that they are only available directly from Biosense Webster.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: NA

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY

SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: For future catheter needs the Minneapolis VA will continue to verify with Biosense Webster if there are any authorized distributors.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 3 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

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