36A77620Q0149-040.pdf

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

OFOC SOP Revision 08 Page 1 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36E776-20-AP-0061

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity – Central (PCAC) in support of the activation of the new VA Omaha Medical Center Ambulatory Care Center (ACC).

2. Nature and/or Description of the Action Being Processed: This is a new requirement for a surgical ortho imaging tower and ortho instruments for the Nebraska-Western Iowa Healthcare System Omaha VAMC ACC. This is an individual J&A to support other than full and open competition for a brand name procurement of a firm, fixed-price contract using FAR Part 13 procedures.

The anticipated award date is April 10, 2020. The anticipated delivery date is April 27, 2020.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a surgical ortho imagining tower and ortho instruments 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) has a requirement to purchase Surgical Ortho Imaging Tower and Ortho Instruments, including (JSNs: U0011-U0028, U0036, U0041 and U0042) from an authorized vendor to supply, deliver and install the item(s) identified in Table 1 below.

Table 1 – Package Items Summary

Item Item Description Quantit 1 ACL Screwdriver and Taps (JSN U0011) 1

2 ACL Sets (JSN U0012) 1

3 Ankle Distractor (JSN U0013) 1

4 Arthroscopy Equipment (JSN U0014) 1

5 Tap and Drive Set (JSN U0015) 1

6 Biters (JSN U0016) 1

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7 Compaction Pliers (JSN U0017) 1

8 Dr Crosby Set (JSN U0018) 1

9 Shoulder Set (JSN U0019) 1

10 Hip Arthroscopy Set (JSN U0020) 1

11 Hip Positioner (JSN U0021) 1

12 XL Hip Set (JSN U0022) 1

13 Resection Equipment (JSN U0023) 1

14 Small Joint Scope Set (JSN U0024) 1

15 Small Joint Set (JSN U0025) 1

16 Leg Positioner (JSN U0026) 1

17 Shoulder Positioner (JSN U0027) 1

18 Western Arm Positioner (JSN U0028) 1

19 Ortho Set (JSN U0036) 1

20 Integration Service (JSN U0041) 1

21 Ortho Image Tower (JSN U0042) 1

This requirement is in support of a brand name only requirement based on the following need of this Surgical Ortho Imaging Tower and Orthopedic Instruments to be integrated with new ACC OR Video Integration system that already meets all the required VA IT standards.

This requirement is in support of the activation of VA Nebraska-Western Iowa Healthcare System Ambulatory Care Center. The new Ambulatory Care Center has the need for Ortho instruments and Ortho Imaging tower for the Ambulatory Surgery department. The current manufacturer (Smith & Nephew) is the basis for design for newly constructed space.

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

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

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This must be sole sourced to Smith & Nephew per National Consignment Agreement VA119-16-D- 0050. The VA currently stocks all implants for non-trauma Orthopedic surgery through Smith & Nephew off this national consignment agreement. The equipment and instruments requested from Smith & Nephew are the only ones that work with these implants. No other companies’ equipment or instruments work with the vast array of implants stocked on consignment at our VA.

The GoFlow pump is very small, taking up almost no space on a boom and can be pole mounted. It has continuous self-calibration which ensures the joint does not fill up with fluid, which can be a patient safety risk. It has a very easy set up for staff, only three steps (turn on, load tubig, press start). It has automatic cannula detection which means flow regulation is optimized. It maintains distention throughout the procedure and continuous self-calibration ensures settings are reproducible. It has a wireless remote and the automatic cannula detection executes in the first 20 seconds of run cycle.

The Elite Shoulder Set of Instruments include a pinless design which reduces the risk of having an instrument break apart in the shoulder. There is a tremendous amount of soft tissue that broken pieces can get lost in, and this eliminates having to bring a C-arm and radiology into the case.

The Werewolf Coblation system has five operating modes which provides more control. The Coag gives 2 coagulation settings to provide hemostasis during surgery. The low mode is designed specifically for articular cartilage. The Medium mode is for dense tissue like meniscus and labrum.

The high mode it designed for bulk debridement like an ACL stump. And the VAC is designed for keeping a clear view, removing bubbles and debris. The Coblation technology allows lower temperatures than other RF based technologies, and the Ambien technology allows for accurate monitoring of intra-articular fluid. The controlled plasma field allows means you can target soft tissue while preserving surrounding healthy tissue. The two zone monitoring measures both intra-articular fluid temperature and outflow temperatures with the hand piece. This is the only system offering real-time temperature monitoring of intra-articular fluid. When the temperature in the joint space exceeds the user-selected set point, the controller will emit visual and audible alarms.

The Arthoscopis hip cannula set give optimal access to joint spaces. The cannulas are color coded and are compatible with standard length knee scopes. They have rounded ends which provide a smooth surface to protect soft tissue and they have a variety of sizes (4.5mm, 5.0mm and 5.5mm).

It has a pinless design. It has the active heel traction boot which conforms to the patient’s anatomy for added security, minimal heel lift and a quick disconnect for intraoperative assessment. It has a patented ball joint systems which give the greatest range of motion. The fine and gross traction is controlled by adjustable carriage.

Handheld resection instruments (biters, graspers, punches): The biggest difference is in the manufacturing process. These tips aren’t sharpened, they are polished to their sharpened edge.

This means it creates a smooth cut that doesn’t tear the tissue. Tearing the tissue is traumatic and causes extra bleeding during and after the case. The less swelling incurred during the procedure, the faster the patient can do physical therapy and get back to baseline state of health. These also have a pinless hinge. Hinges with pins can get brittle, rusty and can break during a case. Pinless hinges eliminate this concern.

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The video 4K platform has a 2 in 1 camera box which means the light source is housed in the same machine, saving space. The CCU is a smart system which can scale any image captured and transfer it to PACS, wireless printer, etc. There is a 3 chip UHD 4K sensor in the camera heads. The more chips you have, the more enhanced the image is, helping you to see the slightest defects in the patient. They can be sterilized two ways – autoclave and steam.

The Dyonics Power II allows you to choose soft tissue cutting modes to adapt to surgeon preferences and procedure demand. There are dual hot ports which enable simultaneous activation of shaver and power handpieces. There is blade family auto-recognition which can quickly recall preferred settings. It provides flexibility to activate the handpiece and footswitch controls during a procedure. It resects soft tissue faster than comparable arthroscopic resection systems.

The Acufex director guide has an anti-impingement device which simplifies monitoring of the intra-chondral notch prior to the creation of the tibial tunnel. It keeps everything highly organized on the back table. It offers a complete system of instruments for accurate, reproducible placement and drilling of tibial an dfemoral tunnels during ACL proceudres. The guide wire placement is crucial to the outcome of surgery and if surgeons have to re-drill to find the optimal spot, the bone loss creates a tunnel that could lose its form. If the wire is not in the exact, anatomic position, the tunnel could be off which could compromise the integrity of the graft.

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 Contract Opportunities on an unrestricted basis, allowing the manufacturer and all authorized distributors to provide a quote.

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

Reasonable: The anticipated cost will be determined fair and reasonable based on the competition received. In accordance with FAR 13.106-3(a)(1), a price reasonableness determination will likely be made based on a comparison of competitive quotes if more than one quote is received in response to the solicitation. However, if only one quote is received in response to the solicitation, the Contracting Officer will use one or a combination of procedures found at FAR 13.106-3(a)(2) to determine the price to be fair and reasonable prior to award.”

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 FAR Part 10 and VAAR Part 810.001-70. These items are not available from a small business manufacturer, and there is no waiver to the non-manufacturing rule for NAICS 339112 and PSC Code 6515. These items are only available from Smith & Nephew (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:

Vendor Metro Medical 500 Northwest Plz, Ste 512, Saint Ann, MO, 63074-2220

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RCG of North Carolina, LLC, 404 Overlake Dr. Ste A, Raeford, NC, 28376-5602 New Market Veterans, LLC, 14151 Netherfield Dr, Midlothian, VA, 23113-6333

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: A RFQ will be posted to Contract Opportunities on an unrestricted basis, allowing the manufacturer and all authorized distributors to provide a quote.

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.

Name Date Contracting Officer Representative Omaha VA Medical Center

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

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Scott Elias Date Contracting Officer

VHA-PCAC

c. VHA DOC Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition.

Richard Dahmen Date Director of Contracting

VHA-PCAC

Name

3/26/2020

Scott C. Elias 202867

Digitally signed by Scott C. Elias 202867 Date: 2020.03.26 09:37:17 -04'00'

Richard C. Dahmen 199197

Digitally signed by Richard C.

Dahmen 199197 Date: 2020.03.26 14:53:13 -04'00'

OFOC SOP Revision 08 Page 6 of 6 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Date

Terry Spitzmiller Executive Director Re Procurement Office Central (VHA)

04/02/2020

TERRY L.

SPITZMILLER

394683

Digitally signed by TERRY

L. SPITZMILLER 394683

Date: 2020.04.02 14:29:43 -05'00'