JOFOC-ENT_SurgicalNavigationSystem-36C24922Q0600.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE/BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-22-AP-3803

1. Contracting Activity: Department of Veterans Affairs (VA), VISN 09, Network Contracting Office (NCO) 9, on behalf of Tennessee Valley Healthcare System (TVHS), Nashville Campus, 1310 24th Avenue South, Nashville, TN 37212. PR/2237: 626-22-3-313-0245

2. Nature and/or Description of the Action Being Processed: This procurement is for new equipment with installation services for TVHS Eyes/Nose/Throat (ENT) clinic 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.

The action will be awarded as a new firm-fixed price purchase order/contract.

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

Brand: Stryker Medical

Item No.

(CLIN)

PRODUCTS Model Number Quality

1 HYBRID NAVIGATION UNIT,

ELECTRONMAGNETIC (EM)

8000-010-003 1

2 FIELD GENERATOR PLANAR 8000-010-004 1

3 FIELD GENERATOR MOUNTING ARM 8000-010-005 1

4 SCOPIS ENT WITH TARGET GUIDED

SURGERY (TGS)

8000-020-002 1

5 MOUSE, WIRED 8000-030-020 1

6 MEDICAL KEYBOARD US/INTL 8000-030-010 1

7 TGS GUIDEWIRE, FINAL PAC 8000-060-009 1

8 PATIENT TRACKER TABS (PU 100) 8000-100-001 1

9 PATIENT TRACKER EM-D MINI 8000-040-001 2

10 REGISTRATION POINTER EM-D 8000-050-003 2

11 PRECISION POINTER EM 8000-050-001 4

12 SUCTION TUBE FRAZIER EM 8000-050-005 4

13 SUCTION TUBE EIKEN EM 8000-050-006 4

14 INSTRUMENT CLAMP ELECTROMAGNETIC

SPHERE

8000-060-020 4

15 INSTRUMENT CLAMP ELECTROMAGNETIC

UNIVERSAL

8000-060-021 4

SERVICES

16 Installation, Calibration & On-Site Training 1

OPTION(S)

OPT1 In the next Fiscal Year, Government seeks to procure additional quantity of Line Items 1

Effective Date: 02/01/2022 Page 2 of 4 through 16 that equals the base quantity given

AT PRICES NO HIGHER THAN THE INITIAL

BASE REQUIREMENT.

Intended Use: 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 with option exercised: $485,000.00.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Only One Responsible Source –Stryker’s Hybrid Navigation System with SCOPIS software unique qualities are:

1. The SCOPIS software unifies optical and electromagnetic measurement technologies in one system. It is possible to use both technologies in the course of one procedure. The “Augmented Reality” software makes it possible for the first time to show planning information together with distance information directly on top of the endoscopic video

2. Takes up less space in the operating room, particulary in display units. Facility’s current Medtronic Fusion EM Navigation System requires a minimum of two physical image displays/monitors; whereas, Stryker’s system can have split images on one monitor.

3. Is easier to setup

4. Universal tracking ability of different manufacturer-branded instruments versus other manufacturers who resort to proprietary practices with regard to instrument use with their surgical navigation system.

Reason no other supplies or services can be used is based on facility experience with similar products from Medtonics and Karl Storz, 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 is able to 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.

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

Stryker submitted an authorized distributor letter identifying four authorized SDVOSB distributors for their ENT navigation system(s).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable based on several price evaluation techniques like comparison with the Independent Government Cost Estimate (IGCE); comparison with other quotes received; and past purchase for similar products and services. Price analysis does not consider certified cost or pricing data, technical evaluations, and audits (FAR 6.303-2(b)(7)) but will consider price realism.

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 (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, and found that this 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.

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

TVHS surgical services has Medtronic’s Stealth System 8 navigation system for neurosurgery and Karl Storz endoscopic surgical equipment and found through its research that Stryker’s ENT navigation system with its previously-mentioned unique characteristics in section 5. gives them a more robust operating room workflow.

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

Beacon Point Associates (SDVOSB) Trillamed (SDVOSB) Four Points Technology (SDVOSB) Veteran’s Healthcare Supply Solutions (SDVOSB)

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: For future acquisitions, the Government will continue to assess the market for new opportunities that remove or overcome any barriers to competition and meets the needs of the Government.

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.

Thelisia Miller Administrative Program Specialist TVHS, Surgical Services

THELISIA MILLER Digitally signed by THELISIA MILLER Date: 2022.08.23 09:33:37 -05'00'

Effective Date: 02/01/2022 Page 4 of 4

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.

Corey Malik NCO9, Contracting Officer

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

John McComas NCO9, Branch Chief, Supply East

Corey A. Malik 325920

Digitally signed by Corey A.

Malik 325920 Date: 2022.08.23 10:02:57 -05'00'

JOHN

MCCOMAS

Digitally signed by JOHN

MCCOMAS

Date: 2022.08.23 12:03:36 -05'00'