36A77620Q0225-015.pdf

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

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36E776-20-AP-0050

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity Central (PCAC), Is procuring the following items on behalf of the new VA Omaha Ambulatory Care Clinic. PR (2237) 636-20-1-1337-0081 has been approved and submitted for this action.

2. Nature and/or Description of the Action Being Processed:

This is a requirement for a Zimmer Brand Name Ortho Instrument Sets.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is being conducted 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:

Veteran Affairs Nebraska-Western Iowa Healthcare System (VANWIHS) needs Zimmer Brand Ortho Instrument Sets in support of the activation of the new VA Omaha Ambulatory Care Center for surgical use in the new operating rooms.

Zimmer Brand Ortho Instrument Sets consisting of the following items:

Item # Description Part Number Qty Price Extended

Amount

1 1.5mm drill bit 00480608515 4 2 2.0mm drill bit 00480610020 4 3 2.5mm drill bit 00480611025 4 4 2.7mm drill bit 00480610027 4 5 3.5mm drill bit 00480611035 4 6 Bone pick 00481700100 4 7 Zimmer Z retractor 00598308400 4 8 3.5mm Zimmer ULS Plates 00493603510 1 9 3.5mm ULS Locking Screws 00483603520 1 10 3.5mm ULS Cortical Screws 00483603525 1 11 4.0mm Cancellous Screws 00483603540 1 12 3.5mm ULS Std & Lock Inst. 00483603534 1 13 3.5mm Partial THD Cannulated Screw Set Standard 00114700135 1

Revision 06 Date: 08/30/2017

14 3.5mm Full THD Cannulated Screw Set Standard 00114700235 1 15 4.0mm 1/3 THD Cannulated Screw Set Standard 00114700140 1 16 4.0mm 1/2 THD Cannulated Screw Set Standard 00114700240 1 17 3.5mm, 4.0mm Cannulated Instrument Set 00114700035 1 18 7.0mm 16mm THD Cannulated Screw Set Standard 00114700170 1 19 7.0mm 32mm THD Cannulated Screw Set Standard 00114700270 1 20 7.0mm Full THD Cannulated Screw Set Standard 00114700370 1 21 7.0mm Cannulated Screw Instrument Set 00114700070 1

22 Cont Dual Comp PLT Small Crew Set, Self Tap w/o Case 00480003503 2

23 Cont Dual Comp PLT Small Frag Plate Set w/o Case 00480003511 2 24 Cont Dual Comp PLT Small Frag Inst. w/Case and Lid 00480003521 2 25 Peri 2.7, 3.5, 4.0 Screw Set W/O Case 00234800001 1 26 Peri 2.7, 3.5, 4.0 Inst Set W/Case Per 2 00234800002 1 27 Pressure Sentinel Flexible Reamers 00222800003 1 28 Peri Screw Caddy for 3.5mm Screw w/2.7 Head 00234803050 1 29 3.5mm Cortical Screw, Self-Tap, Small Hex 55mm 00483505501 4 30 3.5mm Cortical Screw, Self-Tap, Small Hex 60mm 00483506001 4 31 3.5mm Cortical Screw, Self-Tap, Small Hex 65mm 00483506501 4 32 3.5mm Cortical Screw, Self-Tap, Small Hex 70mm 00483507001 4 33 3.5mm Cortical Screw, Self-Tap, Small Hex 75mm 00483507501 4 34 3.5mm Cortical Screw, Self-Tap, Small Hex 80mm 00483508001 4 35 3.5mm Cortical Screw, Self-Tap, Small Hex 85mm 00483508501 4 36 3.5mm Cortical Screw, Self-Tap, Small Hex 90mm 00483509001 4 37 3.5mm Cortical Screw, Self-Tap, Small Hex 95mm 00483509501 4 38 3.5mm Cortical Screw, Self-Tap, Small Hex 100mm 00483510001 4 39 3.5mm Cortical Screw, Self-Tap, Small Hex 105mm 00483510501 4 40 3.5mm Cortical Screw, Self-Tap, Small Hex 110mm 00483511001 4 41 Peri Screw 3.5mm x 50mm W/2.7mm Head, Self-Tap 00234805035 2 42 Peri Screw 3.5mm x 52mm W/2.7mm Head, Self-Tap 00234805235 2 43 Peri Screw 3.5mm x 54mm W/2.7mm Head, Self-Tap 00234805435 2 44 Peri Screw 3.5mm x 56mm W/2.7mm Head, Self-Tap 00234805635 2 45 Peri Screw 3.5mm x 58mm W/2.7mm Head, Self-Tap 00234805835 2 46 Peri Screw 3.5mm x 60mm W/2.7mm Head, Self-Tap 00234806035 2 47 Peri Screw 3.5mm x 65mm W/2.7mm Head, Self-Tap 00234806535 2 48 Peri Screw 3.5mm x 70mm W/2.7mm Head, Self-Tap 00234807035 2 49 Peri Screw 3.5mm x 75mm W/2.7mm Head, Self-Tap 00234807535 2 50 Peri Screw 3.5mm x 80mm W/2.7mm Head, Self-Tap 00234808035 2 51 Peri Screw 3.5mm x 85mm W/2.7mm Head, Self-Tap 00234808535 2 52 Peri Screw 3.5mm x 90mm W/2.7mm Head, Self-Tap 00234809035 2 53 Peri Screw 3.5mm x 95mm W/2.7mm Head, Self-Tap 00234809535 2 54 Peri Screw 3.5mm x 100mm W/2.7mm Head, Self-Tap 00234810035 2 55 Peri Screw 3.5mm x 105mm W/2.7mm Head, Self-Tap 00234810535 2 56 Peri Screw 3.5mm x 110mm W/2.7mm Head, Self-Tap 00234811035 2

Revision 06 Date: 08/30/2017

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

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):

The VA currently has Zimmer sets, including all implants, stocked at the VA Omaha Medical Center.

Zimmer surgical sets must be purchased because these instruments are the only ones that work

Revision 06 Date: 08/30/2017 with the implants that are stocked at the VA Omaha Medical Center for Orthopedic trauma surgery.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A sources sought notice was posted to Contract Opportunities at www.beta.sam.gov on 1/3/2020 with responses due 10 days after posting. The manufacturer was contacted for a list of authorized distributors. Additionally, the requirement will be posted on the Governmentwide Point of Entry at www.beta.sam.gov.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Price reasonableness will be determined by utilizing the procedures at FAR 13.106-3(a) prior to award.

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

Market Research Was Not Conducted:

The Vendor Information Pages (VIP) database was reviewed in accordance with VAAR Class Deviation 810.001-70 to determine if two or more service-disabled veteran-owned businesses (SDVOSBs) and veteran-owned small businesses (VOSBs), in the applicable NAICS code, are listed as verified in the VIP database. Furthermore, the manufacturer was contacted to provide a list of authorized distributors who are veteran-owned small businesses. A Sources Sought notice was posted on Contract Opportunities at www.beta.sam on 1/3/2020.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The Zimmer surgical sets are designed to be contoured intraoperatively so that surgeons can address very specific patient needs. All instruments are engineered to restore anatomic shape to fractured bones. Additionally, the Zimmer Biomet trauma implants and TiMax screws have been shown in mechanical testing to have increased fatigue strength.

Zimmer’s proximity to the VA Omaha Medical Center reduces down time for sets and loss to patient care. Zimmer is located in Omaha and provides a representative for each case, which is required by the surgeon. Zimmer provides a quick turnaround if multiple sets are needed and the VA Omaha Medical Center is able to borrow additional pans from the company. Zimmer brings in replacement handpieces or instruments until the VA Omaha’s handpieces/instruments are fixed. This translates to no down time for VA’s sets and no loss to patient care. The turnaround time for this is 24 hours.

Revision 06 Date: 08/30/2017

10. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by Sandra J. Johnson 749522 Date: 2020.03.11 16:28:19 -04'00'

Sandra Johnson Date Contracting Officer Program Contracting Activity - Central

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Grace Kelly Date Supervisory Contract Specialist Program Contracting Activity - Central

Sandra J. Johnson 749522

Grace E. Kelly- Burnsworth 1384242

Digitally signed by Grace E. Kelly- Burnsworth 1384242 Date: 2020.03.13 15:21:46 -04'00'