P03 36C249-23-AP-1503 Single Source Justification MPT to SAT.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C249-23-AP-1503

1. Contracting Activity: Department of Veterans Affairs (VA), VISN 09, Network Contracting Office

(NCO) 9, on behalf of Tennessee Valley Healthcare System (TVHS), Murfreesboro Campus, Alvin C.

York TN 37129. PR/2237: 626-23-2-313-0075

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Brand name Stryker Medical Scopis ENT Navigation System: Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Estimated Value: $246,110

Description Part # Qty

HYBRID NAVIGATION UNIT (EM) 8000010003 1

FIELD GENERATOR PLANAR 8000010004 1

FIELD GENERATOR MOUNTING ARM 8000010005 1

SCOPIS ENT W/TARGET GUIDED SURGERY 8000020002 1

MOUSE, WIRED 8000030020 1

MEDICAL KEYBOARD US/INTL 8000030010 1

TGS GUIDEWIRE, FINAL PAC 8000060009 10

PATIENT TRACKER TABS (PU 100) 8000100001 1

PATIENT TRACKER EM-D MINI 8000040001 2

REGISTRATION POINTER EM-D 8000050003 2

PRECISION POINTER EM 8000050001 5

SUCTION TUBE FRAZIER EM 8000050005 5

SUCTION TUBE EIKEN EM 8000050006 5

INSTRUMENT CLAMP ELECTROMAGNETIC SPHERE 8000060020 5

INSTRUMENT CLAMP ELECTRONMAGNETIC SPHERE 8000060021 5

MINIFESS SUCTION SET SID STK-00 5

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Only One Responsible Source – Brand name requirement for Stryker’s Hybrid Navigation System with SCOPIS software unique qualities are as follows:

The SCOPIS software unifies optical and electromagnetic measurement technologies in one system making it possible to use both technologies during one procedure. The “Augmented Reality”

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2 software makes it possible for the first time to show planning information together with distance information directly on top of the endoscopic video which takes up less space in the operating room, particularly in display units. Facility’s current EM Navigation System requires a minimum of two physical image displays/monitors, whereas Stryker’s system can have split images on one monitor.

In addition, the system is easier to setup Universal tracking ability of different manufacturer-branded instruments versus other manufacturers who resort to proprietary practices regarding instrument use with their surgical navigation system.

No other supplies or services can be used is based on facility experience with similar products and market research of other brands of these highly technical and complex medical devices. Similar systems from Medtronic, Acclarent (includes Biosense), and Karl Storz compare their products through the FDA 510k procedure to Fiagon, the leader in electromagnetic-based surgical navigation.

Fiagon gives Stryker exclusive distributor rights to their products in the United States. Scopis Medical was acquired by Stryker in 2017. Since Stryker’s system is interchangeable and interoperable with other manufacturer brand products without negatively impacting product warranty, the Government can increase workflow efficiency and minimize taxpayer expense by not divesting its current inventory to one manufacturer-specific brand.

Market research could not determine whether Medtronic, Acclarent, and Karl Storz could modify their products to possess the same or similar unique qualities that Stryker’s system offers.

Accordingly, Stryker Medical is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted in accordance with (IAW) Federal Acquisition Regulation (FAR) part 10 and VA Acquisition Regulation (VAAR) part 810. Mandatory and non-mandatory sources were checked. TVHS ENT clinic in December 2021, completed a 90-day trial of Stryker’s Hybrid Navigation System with SCOPIS software, reviewed the Instructions for use (IFU) for Acclarent’s TruDi Navigation System V2, and Karl Storz Nav1 EM Navigation System, and searched Government databases (list not all inclusive) like Vetbiz.vip.gov, GSA Advantage, GSA eLibrary, SAM.gov, FPDS.gov, fda.gov, and commercial sites on the Internet. Market research revealed that the complete system is not available on any mandatory contracts or other government agency contracts but are only available open market through authorized distributors or direct from the manufacturer.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

John McComas Date Contracting Officer