36C25919Q0713-001.doc

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

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C259-19-AP-2867 Tracker ID: 2019-09-12T07:54:14

1. Contracting Activity:

Organizational Activity:

Department of Veterans Affairs (VA)

George E. Whalen VA Medical Center

Network Contracting Office 19 (NCO 19)

Salt Lake City VA Medical Center (SLC VAMC)

6162 s. Willow Drive, Suite 300

500 Foothill Drive

Greenwood Village, CO 80111

Salt Lake City, UT 84148 2237:

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

The George E. Wahlen SLC VAMC requires the issuance of a new, base plus (4) option year (60 month) lease for Stryker Surgical Power Tools manufactured by Stryker Instruments. The resulting lease will be a firm-fixed-price lease that will allow for the purchase of the equipment should it later be determined a purchase at fair market value is in best interest of the Government. This justification and approval is for soliciting quotes using other than full and open competition (brand name only) to establish a lease of Stryker Surgical Power Tools.

The George E. Wahlen VAMC currently owns Stryker Surgical Power Tools but due recent events with sterile processing, a portion of the of the stock was damaged and must be replaced. Rather than repurchase the equipment that was damaged, it has been determined leasing would be more advantageous and cost effective. This lease will better enable the SLC VAMC to serve Veterans by having necessary equipment on hand at all times. Another benefit with leasing is that when a model is upgraded, the leased equipment will be replaced with a newer model at no additional cost to the Government.

Base Period (9/27/2019 – 9/26/2020)

Option Year 1 (9/27/2020 – 9/26/2021)

Option Year 2 (9/27/2021 – 9/26/2022)

Option Year 3 (9/27/2022 – 9/26/2023)

Option Year 4 (9/27/2023 – 9/26/2024)

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

This requirement is for a 60-month lease of the Stryker System 8 (x10 ea), Stryker Small Bone System (x10 ea), Stryker RemB System (x10 ea); all associated equipment, attachments, batteries, and accessories leased will include a 60-month procare service; inclusive of all shipping, repair and replacement costs.

Stryker Power Tools are powered instruments and accessories used to cut, shape, fixate, and dissect bone as well as to fragment, emulsify and aspirate soft tissue in all types of procedures, from reconstructive, sports med and extremities, to the most complex in neurosurgery, spine and ENT. Stryker is the manufacturer of the power tools the SLC VAMC currently owns and uses for surgical procedures in the operating room. The Stryker power tools include sagittal saws, reciprocating saws, reamers, drills, cement mixing equipment, and total joint arthroplasty revision tools for removing existing implants in preparation for the application of new implants. The Stryker sternal saw will be used for performing cardiothoracic surgery requiring a midline sternal incision. The Stryker Surgical Power Tools described above are either exact match or compatible with the other surgical power tools and implants currently stocked and in use at the SLC VAMC.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1.

( 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):

Stryker power systems are highly specialized, and are used in all orthopedic surgeries all cardiothoracic surgeries requiring a sternotomy incision at the SLC VAMC. The SLC VAMC must continue to use Stryker to maintain the ability to perform total joint arthroplasties because changing to another manufacturer would require changing all of the orthopedic power tools currently owned, along with all of the implants. This would be an unnecessary cost to the Government if the SLC VAMC is unable to continue using current manufacturer, Stryker.

The current Stryker Surgical Power Tools were previously purchased, but the SLC VAMC experienced a total loss of all power systems twice in the past two (2) years, resulting in over $1,000,000.00 in damaged surgical power instruments which requires replacement. Leasing the surgical power tools rather than purchasing them will protect the SLC VAMC from future loss due to damage, will ensure SLC VAMC always has the newest technology, and will prevent the facility from being forced to cancel surgeries due to surgical power tools being sent out for repair. Stryker is the only brand of surgical power tools the SLC VAMC can use at this time because no other brand of power system is compatible with existing Stryker systems and Stryker implants. These Stryker Surgical Power Tools are fully backward compatible with the SLC VAMC’s existing consoles, batteries, chargers, cutting accessories, and sterilization insert trays, representing a significant capital cost savings of over $500,000.00 by avoiding a duplication of cost through both capital purchase as well as the additional training and implementation of new sterilization processes.

Changing brands at this time would mean replacing all of the SLC VAMC’s orthopedic surgery equipment. Stryker is the only brand that will fulfill this request because no other brand of surgical power tools are compatible with the George E. Wahlen VAMC’s current brand name (Stryker) equipment to perform total joint arthroplasties. Changing brands would require the VAMC to replace all of the owned orthopedic surgery equipment and Stryker implants causing an unreasonable cost in excess of $300,000.00 to the Government.

This lease is needed to replace damaged instruments in the SLC VAMC’s existing owned sets. Facility staff and sterile processing have been trained on the use and reprocessing of these specific Stryker Surgical Power Tools. Any change in vendor equipment would require retraining of staff at the facility and establishment of a second set of unique sterilization processes for the same/similar equipment. It would require the development and adherence to multiple sterilization operating procedures. Having two (2) different brands of surgical power tools in place would create confusion for the sterilization processing staff. Multiple operating procedures for the same sterilization process would greatly increase the possibility of the equipment not being sterilized and inspected correctly. If this were to happen, it would create a biohazard for the patients receiving surgical procedures performed with the equipment.

Additionally, the specific Stryker Surgical Power Tools tied to this requirement have been approved for use in the facility by the Clinical Products Review Committee (CPRC). This reusable medical equipment has been approved by the committee to be used with the power tools already owned by the facility. Stryker, and its authorized distributors to the government, are the only vendors that can provide a single solution for each of the product categories/specialties represented on the current requirement. No other manufacturer or authorized distributor can provide the full breadth of products required on the SLC VAMC’s current request. Products other than the Stryker brand name items would require additional training for surgical staff resulting in delays in patient care.

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

In accordance with FAR 19.502(b) the market research performed identified three (3) Service Disabled Veterans Owned Businesses (SDVOSBs) capable of supplying the Government with the lease of Stryker Surgical Power Tools at fair market prices. As such, NCO19 looks to issue an open market, SDVOSB set-aside Request for Quote (RFQ) on FedBizOpps in accordance with 38 U.S.C. 8127(d) and Public Law 109-461, Sec. 8127 for the lease of Stryker Surgical Power Tools.

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

A determination of fair and reasonable pricing will be made in accordance with FAR Part 13.106-3(a)(1) through adequate price competition. The Contracting Officer has determined based on market research that there is expectation of receiving acceptably priced offers from SDVOSB concerns capable of performing the requirements of the acquisition. Due to the competitive environment for the supply of Stryker Surgical Power Tools, the Contracting Officer will use the prices submitted by all offerors as a comparison for the basis of determining fair and reasonable pricing. Additionally, in accordance with FAR 13.106-3(a)(2), comparison of the proposed price with prices found reasonable on previous purchases/leases will be utilized to support the determination of fair and reasonable pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A market analysis was conducted by obtaining historical and current information from sources such as the System for Award Management, Federal Procurement Data System, FedBizOpps, Small Business Administration, VA Vendor Information Pages, Federal Supply Schedule/GSA, CPARS, Google, calling manufacturers, as well as speaking with subject matter experts at the VA medical centers. All searches confirm that the brand name (Stryker) surgical power tools cannot be replaced or substituted with items of another manufacturer.

Market Research was also conducted by utilizing the VA’s Vendor Information Pages (VIP) database and exchanges with Stryker to identify VIP verified capable SDVOSBs. It was identified that there are three (3) CVE certified SDVOSBs, (Beacon Point Associates, LLC, TrillaMed, LLC and Four Points Technology, LLC) that are capable and authorized to provide the lease of Stryker equipment at a fair and reasonable price.

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

There is a Defense Logistics Agency (DLA) Troop Support agreement that permits the Veterans Health Administration (VHA) to authorize individuals within VAMCs to utilize the DLA Electronic CATalog (ECAT) contracts to make purchases up to $250,000.00. It was discovered that many of the Stryker Surgical Power Tools are available for purchase on ECAT. However, it has been determined that leasing the Stryker Surgical Power Tools will be most beneficial to the Government as opposed to making a capital equipment purchase. The ECAT contracts do not allow for the lease of Stryker Surgical Power Tools.

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

· Beacon Point Associates (SDVOSB) - 1216 SW 4th St Ste 4, Cape Coral, FL, 33991-2129

· TrillaMed (SDVOSB) - 30100 Telegraph Rd., Suite 366, Bingham Farms, MI 48025

· Four Points Technology (SDVOSB) - 14900 Conference Center Dr Ste 100, Chantilly, VA 20151

· Stryker Instruments (Large) - 2825 Airview Boulevard, Kalamazoo, MI, 49002

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:

NCO19 acknowledges the importance of protecting the integrity of the procurement system and are committed to working in manner that promotes competition to the greatest extent practicable in order to compete requirements and overcome barriers to competition in future acquisitions. The VA has and will continue to meet with industry on a periodic basis for continued input and feedback on acquisition strategies. The SLC VAMC will continue to utilize additional product options that will ensure quality service to the veteran as well as continue working with the NCO19 in conducting market research to identify opportunities to compete future requirements.

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.

April Thomas Date

OR Nurse Manager Salt Lake City 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.

Kim Cooper Date

Contracting Officer

NCO 19

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

Danny O. Freeman Date

Director of Contracting

NCO 19

c. 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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Curtis M. Jordan Date

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018