36C26018Q9749-002.pdf

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Stryker Surgical Tools Brand Name Only Federal contract opportunity
Solicitation number
36C26018Q9749
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 20

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36C26018Q9749 P03 Brand name JA STRYKER.pdf

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OFOC SOP Revision 06 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K to

$700K

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K to $700K) Brand Name

Acquisition Plan Action ID: VA260-18-AP-6237/531-18-3-203-0087

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 20 procuring on behalf of the Boise VA Medical Center.

2. Nature and/or Description of the Action Being Processed: This is a new requirement to upgrade and supplement existing surgical equipment used in Operative Care at the Boise VA Medical Center. This equipment is utilized for both complex surgical procedures and general surgery. This is a brand-name procurement that will be competed amongst the manufacturer and authorized distributors.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for commercially available medical equipment in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is a brand-name justification for the following Stryker items:

• 4505000000 System 8 Cordless Driver x 9 EA

• 4100125000 Pin Collet (2.0-3.2mm) x 5 EA

• 4100400000 Sagittal Saw Attachment x 9 EA

• 4100131000 1/4" Drill with Key x 5 EA

• 8212000000 SYSTEM 8 BATTERY PACK, SMALL x 9 EA

• 1900015000 F1 Micro Drill x 9 EA

• 1900034000 F1 Sag Saw x 9 EA

• 1900099000 F1 U-Driver x 9 EA

• 1900031000 F1 Osc Saw x 9 EA

• 1900037000 F1 Recip Saw x 9 EA

• 1900062000 F1 Wire Collet x 9 EA

• 1900110000 F1 Small AO Chuck x 9 EA

• 1900132000 F1 5/32" Chuck x 9 EA

Revision 06 Date: 08/30/2017

• 1900013000 Pencil Battery Pack x 18 EA

• 1900012000 Pistol Battery Pack x 18 EA

• 4405654000 TRAUMA SOLID CONTAINER BUNDLE x 9 EA

4. Statutory Authority Permitting Other than Full and Open Competition:

The Authority permitting Other than Full and Open Competition is 41 USC §3304(a), as implemented by FAR 6.302.

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This requirement is for surgical equipment which has been approved for use by the facility Clinical Products Review Committee

(CPRC). Per VHA Directive 1761 (1), the CPRC is responsible for reviewing and approving all new

Reusable Medical Equipment (RME) prior to their use for direct patient care so that compatibility with current processes and equipment is ensured. This requirement is to upgrade and supplement existing surgical equipment. The required equipment must be compatible and interchangeable with existing Stryker batteries, battery chargers, handpieces, saws and attachments. No other manufacturer provides similar equipment that is compatible with Stryker.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A RFQ will be posted to FBO on an unrestricted basis, allowing the manufacturer and all authorized distributors to provide a quote.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be determined as fair and reasonable based on the competition received.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market research was conducted in accordance with

Revision 06 Date: 08/30/2017

FAR 10 and VAAR 810.001-70. These items are not available from small business manufacturers, and there is no waiver to the non-manufacturing rule for NAICS 339113 and PSC 6515. These items are only available from Stryker (manufacturer) and their network of authorized distributors.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Beacon Point Associates, LLC 1216 SW 4th Street, Suite 4 Cape Coral, FL 33991

(239) 673-6965

SDVOSB

Stryker Corporation 4100 E Milham Ave Portage, MI 49002-9704

(844) 427-4688 Manufacturer

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

Standardized medical equipment is a bona fide clinical need for patient safety. Future changes in available technologies or standards will require review and approval from the facility Clinical Products Review Committee (CPRC). However, market research will continue to be completed for all subsequent acquisitions to ensure to promote competition from authorized sources.

12. 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 and belief.

Amanda Micheli-Pennington, RN Date Supply and Equipment Coordinator, Surgery VA Boise Healthcare System

08-03-18

Revision 06 Date: 08/30/2017

13. Approvals in accordance with the VHAPM, Part 806.3 OFOC SOP.

a. Contracting Officer's Certification (Required for All – Approval Less Than $150K): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jacob P. Jackson Date Contracting Officer, Supply Branch II

Network Contracting Office 20

b. One Level Above the Contracting Officer (Required over $150K – Approval to $700K): I certify the justification meets requirements for other than full and open competition.

Jonathan D. Jewel Date Branch Chief, Supply Branch II Network Contracting Office 20

8/3/2018

2018-08-03T11:52:18-0700
Jacob P. Jackson 457690
2018-08-06T10:35:27-0700
Jonathan D. Jewel 198381

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