Justification and Approval 22 Jun.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

FOR OFFICIAL USE ONLY

18 Jun 2019 FOR OFFICIAL USE ONLY Page 2 of 5

Department of the Air Force, Air Mobility Command, 60th Contracting Squadron, Travis AFB, CA 94535

The Operating Room Connected/HUB System will be awarded as a new contract as these items have never been acquired by Travis Air Force Base. No exception provided in paragraph (b) of section FAR

12.207 is applicable; therefore, the contracting activity shall use a firm-fixed-price contract for the acquisition of the Connect/HUB System as it has been previously determined to be a commercial item.

The 60 SGCS/OR Department has a requirement for a 4K visualization HUB System that is compatible with the Stryker Endoscope Model 1688 AIM System currently in David Grant Medical Center's inventory. The 4K visualization HUB System is an extension of the existing Operating Room equipment and will allow the surgeon to perform safe feedback to patients and enact better decision-making strategies during critical time.

Equipment: 1688 Advanced Imaging Modalities 4K Platform

Total Estimated Value of the Acquisition:

Estimated Delivery Date: 90 Days ARO

Type of Appropriation: F67100/6B Funds

Product Description:

CLIN 0001 - 10 Each - Connected Operating Room (OR) HUB Base with Voice Control and 4K Recording Kit

Approximate price each item =

The equipment also allows for staff to control compatible Stryker Equipment from the touch panel.

The equipment serves as the central station the controls interconnected equipment into one visualization system.

CLIN 0002 - 10 Each - iSuite Room Control System - Audio/Video Routers powered by Switchpoint Infinity 3.

Approximate price each item =

The configuration offers a tailored view to each individual in the operating room. The advantage allows doctors, nurses, and assistants greater flexibility during or after surgical procedures as the technology can be upgraded with limited/no down-time.

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

18 Jun 2019 FOR OFFICIAL USE ONLY Page 3 of 5

CLIN 0003 - 10 Each - Infinity Upgrade w/ Cable Installation

Approximate price per line item =

The Infinity Upgrade is a mandatory ancillary service provided with the purchase of the iSuite Room Control System. Professional cable assembly is required to connect existing components with the Control System without experiencing degradation or loss of full functions.

CLIN 0004 - 1 Each - ICTS Engineering Service Support

Approximate price per line item =

The Engineering Service support is a one time fee charged to the customer for on-going customer support and frequent upgrades to the HUB Base to ensure that customers have readily available updates. An authorized engineer will be assigned to manage the equipment.

AFFARS 5313.501 - 10 U.S.C 2302b, Implementation of Simplified Acquisition Procedures (41 U.S.C.

1901)

41 USC 1901, as implemented by FAR 13.501(a)(1)(ii) and required by FAR 13.501(a)(1)(i)

The Stryker Endoscopic System Model 1688 AIM is currently used at DGMC. No equal brand will interact with the current existing items due to the proprietary nature of the Stryker system.

According to market research conducted on 22 April 2021, Stryker is the only company able to manufacture the required Stryker Connected/HUB Systems that are compatible with the Government's existing Stryker Endoscopic System Model 1688 AIM, currently used at DGMC. Stryker has four authorized distributors of their equipment. Each of these authorized distributors are service Disabled Veteran Owned Small Businesses.

The mission partner, David Grant Medical Center (DGMC)/ 60SGCS/OR, researched the Medical Master Catalog to include DLA/ECAT and Prime Vendor Programs for product availability and was unable to find the needed products. An Internet search for Interconnect HUB Systems by checking medical supply and equipment manufacturers was unable to find a compatible product. The contracting activity emailed an RFI to Stryker on 22 April 2021, and received input that they are the only manufacturer of compatible systems that work with the existing Stryker Endoscopic system Model 1688 AIM, which is Stryker Endoscopy. The representative stated that Styker has four

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

18 Jun 2019 FOR OFFICIAL USE ONLY Page 4 of 5 authorized distributors of the required equipment that is compatible with the Stryker Endoscopy system Model 1688 AIM, Light Source, and Insufflator. Therefore, although a brand name requirement competitive quotes will still be requested.

A fair and reasonable price determination is expected to occur through adequate price competition among the authorized commercial distributors of Stryker's equipment. The Contacting Officer (CO) will determine the price fair and reasonableness through the use of price analysis techniques described within FAR 13.106-3.

Market research was conducted by the end user from a multitude of sources. The end user searched Medical Master Catalog to include DLA/ECAT and Prime Vendor Programs. An internet search was conducted with no other sources located. On 22 April 2021, an RFI was emailed to the manufacturer of the equipment and the contracting activity received input from Stryker Endoscopy that they are the only manufacturer of compatible Connected/HUB Systems to work with the existing Stryker Endoscopic system Model 1688 AIM, which is Stryker Endoscopy. The assumption to contact the manufacturer directly ensued as the contracting activity had previous knowledge with prior acquisitions of the nature of Stryker Endoscopy authorizing only specific distributors of their products. The assumption revealed to be accurate as they have four authorized distributors of the required Connected/HUB Systems compatible with the Stryker Endoscopy system Model 1688 AIM.

Due to the propriety nature of Stryker products and that they are the only company able to provide the needed compatible Connected/HUB Systems for the current system within the hospital makes the requirement suitable for other than full and open competition. There are currently only four authorized distributors of these products.

The components described in this acquisition are associated with a refresh project for David Grant Medical Center's upgrade toward 10 of their operating rooms. Each Stryker Connected/HUB System identified above will be designated to each operating room. This information provides justification regarding the number of units being acquired.

Furthermore, the items listed in Section III (above) were not purchased previously with the other Stryker equipment that David Grant Medical Center possesses due to them being purchased through a mandatory source, Electronic Medical Catalog (ECAT) and ECAT did not have the items currently being requested from the Medical Equipment Office. Since the items listed above are not listed on ECAT they must be purchased from the open market authorized distributors. David Grant Medical Center has invested into the Operating Room Refresh Project and the Government would be face substantial mission degradation if non-compatible equipment was procured.

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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All four authorized distributors of the Connect/HUB Systems expressed interest in providing the required equipment needed by the David Grant Medical Center (DGMC). Each authorized distributor has provided updated quotes to the equipment during the Market Research phase.

The government will continue to monitor the market of other companies or authorized distributors who are able to provide the needed Connected/HUB Systems compatible with the Stryker Endoscopic System 1688 AIM. To preclude future brand-name awards, the 60th Contracting Squadron will continue to research vendors with similar products and work with David Grant Medical Center end users/customers to ensure that the requested items are compatible with the current system and/or revisit other similar brands complete systems that would enable to Government to meet it's future requirements.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.