Brand Name Justification (Redacted).pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 12

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-23-AP-2028

1. Contracting Activity:

The Department of Veterans Affairs (VA), Network Contracting Office 10, 3140 Governors Place Boulevard, Suite 210, Kettering, OH 45409, on behalf of requirements for the John D.

Dingell VA Medical Center, 4646 John R Street, Detroit, MI 48201.

[VA Form 2237: 553-23-2-063-0126]

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

This procurement is for brand name, Stryker Corporation, leased equipment 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. A new firm-fixed price contract with a 12-month base period and four (4) 12-month option periods for the lease of brand name equipment is contemplated.

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

The John D. Dingell VA Medical Center has a requirement for the following leased brand name supplies and related support:

Base Period (12-Month Lease)

Item Number Description Qty

1688-011-002P 1688 CAMERA CONTROL UNIT,L11 AIM LIGHT

SOURCE,HDMI TO DVI CABLE

0240-200-300 CONNECTED OR HUB BASE W/SDP1000

PRINTER KIT

0620-050-003 PNEUMOCLEAR PLUS INSFFLATOR-DUAL

SWITCHING VALVE BOTTLE

1688-610-122 1688 CAMERA HEAD W/INTEGRATED COUPLER 24

0233-050-200 PKG SAFELIGH FIBER OPTIC CABLE GREY 24

0502-538-030 SPY LAPAROSCOPE,AUTOCLAVABLE,DIA

5.4MM 30 DEG,30CM

0502-538-010 SPY LAPAROSCOPE,AUTOCLAVABLE,DIA

5.4MM 0 DEG,30CM

0502-938-030 SPY LAPAROSCOPE,AUTOCLAVABLE,DIA

5.4MM 30 DEG,33CM

0502-938-010 SPY LAPAROSCOPE,AUTHOCLAVABLE,DIA

10MM,0 DEG,33CM

0502-444-030 PRECISION 4K EYEPIECE

ARTHROSCOPE,AUTOCLAVABLE,4MM X

30,140MM SPEEDLOCK

Effective Date: 02/01/2022 Page 2 of 12

0747-031-510 OBTURATOR FOR 5.8MM SPEEDLOCK

CANNULA PENCIL TIP

0747-031-650 INFLOW/OUTFLOW CANNULA 6

0747-031-550 5.8MM CANNULA 2 ROTATING STOPCOCKS 6

0502-123-030 HD 2.3MM X 30 ARTHROSCOPE J-LOCK A/C 2

0502-713-530 3.2MM CANNULA W/1 ROTATING STOPCOCK 2

0502-713-560 3.2MM CANNULA W/2 ROTATING STOPCOCK 2

0502-713-500 PENCIL TIP OBTRUATOR FOR 3.2MM

CANNULA

0233-032-116 AUTOCLAVABLE ARTHROSCOPE AND

HARDWARE STERILIZATION TRAY

0240-030-952 75' 5-PIN DC EXTENSION CORD 3

0233-032-301 PKG, AIM STERILIZATION TRAY 24

0233-032-108 LAPAROSCOPE STERILIZATION TRAY (HOLDS

2 LAPAROSCOPES)

0240-031-300 32" 4K OLED SURGICAL DISPLAY 15

PC9001K VIDEO PROCESSOR/ILLUMINATOR (VPI), US

KIT

HH9030K SPY-PHI HANDHELD IMAGER, US KIT 1

0240-031-075 PKG,SYNK 4K WIRELESS RECEIVER US 8

0240-031-065 PKG,SYNK 4K WIRELESS TRANSMITTER US 8

0502-729-012 HYSTEROSCOPE 2.9MM 12 DEG 6

0502-729-030 HYSTEROSCOPE 2.9MM 30 DEG 6

0502-729.051 SHEATH 2.9MM DIAGNOSTIC INNER 6

0502-729.052 SHEATH 2.9MM DIAGNOSTIC OUTER 6

0502-729-061 SHEATH 2.9MM OPERATIVE INNER 6

0502-729-062 SHEATH 2.9MM OPERATIVE OUTER 6

0502-729-050 OBTURATOR 2.9MM DIAGNOSTIC 6

0502-729-060 OBTURATOR 2.9MM OPERATIVE 6

0502-729-012 HYSTEROSCOPE 2.9MM 12DEG 2

0502-990-322 SHEATH 22/24FR RESECTOSCOPE INNER 2

0502-990-324 SHEATH 22/24FR RESECTOSCOPE OUTER 2

0502-990-424 22/24 CONTINOUS FLOW RESECTOSCOPE

SHEATH (INNER/OUTER)

0502-990-414 STANDARD OBTURATOR 22/24FR

RESECTOSCOPE

0502-990-401 WORKING ELEMENT 22/24FR RESECTOSCOPE 2

0233-032-880 CYSTOSCOPY STERILIZATION TRAY (1 TIER) 2

0233-050-087 ESST HENKE SCOPE ADAPTER 38

0620-010-104 CO2 TANK HOSE 8

0620-010-103 CO2 TANK YOKE 8

0351-600-000 MICRO CART 1

P44007 CABLE,DVI-D-SL-F O HDMI-M,0.5M 8

0240-050-845 DVI CABLE KIT 8

0240-099-155 CONNECTED OR CART, 120V 8

Effective Date: 02/01/2022 Page 3 of 12

0240-099-100K FLAT-PANEL ROLL STAND 4

8888-888-664 1YR DATAMEDIATOR 1 EMR 1

8888-888-673 1YR DATAMEDIATOR CONN DVC 8

8888-888-691 1YR DATAMEDIATOR ADD DICOM CONN 1

P47839 DATAMEDIATOR, LICENSE, DICOM

CONNECTION

0678-005-003 WORKFLOW SERVER, LICENSE, DEVICE

CONNECTION, SDC3

0678-005-008 DATAMEDIATOR, LICENSE, HL7 INTEGRATION

ENGINE

8888-888-233 INSTALLATION ORIS-DATAMEDATOR

INSTALLATION

0678-005-000 DATAMEDIATOR, SOFTWARE BUNDLE 1

8888-888-235 INSTALLATION ORIS-DATAMEDATOR

ADDITIONAL INSTALLATION

8888-888-223 INSTALLATION ORIS-STUDIO3 SDC

INSTALLATION

8888-888-401 INSTALLATION-BASE INSTALLATION CHARGE 1

8888-888-900 ICTS ENGINEERING SERVICES 1

8888-888-720 OR RENOVATION SERVICES 3

1688010000SC ANNUAL SERVICE CONTRACT FOR ITEM 1688-

010-000

220230300SC ANNUAL SERVICE CONTRACT FOR ITEM 0220-

230-300

240200100SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

200-100

240080230SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

080-230

620050000SC ANNUAL SERVICE CONTRACT FOR ITEM 0620-

050-000

1688610122SC ANNUAL SERVICE CONTRACT FOR ITEM 1688-

610-122

502538030SC ANNUAL SERVICE CONTRACT FOR ITME 0502-

538-030

502538010SC ANNUAL SERVCE CONTRACT FOR ITEM 0502-

538-010

502938030SC ANNUAL SERVCE CONTRACT FOR ITEM 0502-

938-030

502938010SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

938-010

502444030SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

444-030

747031510SC ANNUAL SERVICE CONTRACT FOR ITEM 0747-

031-510

747031650SC ANNUAL SERVICE CONTRACT FOR ITME 0747-

031-650

Effective Date: 02/01/2022 Page 4 of 12

747031550SC ANNUAL SERVICE CONTRACT FOR ITEM 0747-

031-550

502123030SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

123-030

502713530SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

713-530

502713560SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

713-560

502713500SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

713-500

240031300SC ANNUAL SERVICE CONTRACT FO ITEM 0240-

031-300

PC9001SC ANNUAL SERVICE CONTRACT FOR ITEM

PC9001

HH9030SC ANNUAL SERVICE ONTRACT FOR ITEM

HH9030

240031075SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

031-075

240031065SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

031-065

502729012SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

729-012

5025729030SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

729-030

Option Periods 1-4 (Each a 12-Month Lease)

Item Number Description Qty

1688-011-002P 1688 CAMERA CONTROL UNIT,L11 AIM LIGHT

SOURCE,HDMI TO DVI CABLE

0240-200-300 CONNECTED OR HUB BASE W/SDP1000

PRINTER KIT

0620-050-003 PNEUMOCLEAR PLUS INSFFLATOR-DUAL

SWITCHING VALVE BOTTLE

1688-610-122 1688 CAMERA HEAD W/INTEGRATED COUPLER 24

0233-050-200 PKG SAFELIGH FIBER OPTIC CABLE GREY 24

0502-538-030 SPY LAPAROSCOPE,AUTOCLAVABLE,DIA

5.4MM 30 DEG,30CM

0502-538-010 SPY LAPAROSCOPE,AUTOCLAVABLE,DIA

5.4MM 0 DEG,30CM

0502-938-030 SPY LAPAROSCOPE,AUTOCLAVABLE,DIA

5.4MM 30 DEG,33CM

0502-938-010 SPY LAPAROSCOPE,AUTHOCLAVABLE,DIA

10MM,0 DEG,33CM

0502-444-030 PRECISION 4K EYEPIECE

ARTHROSCOPE,AUTOCLAVABLE,4MM X

30,140MM SPEEDLOCK

Effective Date: 02/01/2022 Page 5 of 12

0747-031-510 OBTURATOR FOR 5.8MM SPEEDLOCK

CANNULA PENCIL TIP

0747-031-650 INFLOW/OUTFLOW CANNULA 6

0747-031-550 5.8MM CANNULA 2 ROTATING STOPCOCKS 6

0502-123-030 HD 2.3MM X 30 ARTHROSCOPE J-LOCK A/C 2

0502-713-530 3.2MM CANNULA W/1 ROTATING STOPCOCK 2

0502-713-560 3.2MM CANNULA W/2 ROTATING STOPCOCK 2

0502-713-500 PENCIL TIP OBTRUATOR FOR 3.2MM

CANNULA

0233-032-116 AUTOCLAVABLE ARTHROSCOPE AND

HARDWARE STERILIZATION TRAY

0240-030-952 75' 5-PIN DC EXTENSION CORD 3

0233-032-301 PKG, AIM STERILIZATION TRAY 24

0233-032-108 LAPAROSCOPE STERILIZATION TRAY (HOLDS

2 LAPAROSCOPES)

0240-031-300 32" 4K OLED SURGICAL DISPLAY 15

PC9001K VIDEO PROCESSOR/ILLUMINATOR (VPI), US

KIT

HH9030K SPY-PHI HANDHELD IMAGER, US KIT 1

0240-031-075 PKG,SYNK 4K WIRELESS RECEIVER US 8

0240-031-065 PKG,SYNK 4K WIRELESS TRANSMITTER US 8

0502-729-012 HYSTEROSCOPE 2.9MM 12 DEG 6

0502-729-030 HYSTEROSCOPE 2.9MM 30 DEG 6

0502-729.051 SHEATH 2.9MM DIAGNOSTIC INNER 6

0502-729.052 SHEATH 2.9MM DIAGNOSTIC OUTER 6

0502-729-061 SHEATH 2.9MM OPERATIVE INNER 6

0502-729-062 SHEATH 2.9MM OPERATIVE OUTER 6

0502-729-050 OBTURATOR 2.9MM DIAGNOSTIC 6

0502-729-060 OBTURATOR 2.9MM OPERATIVE 6

0502-729-012 HYSTEROSCOPE 2.9MM 12DEG 2

0502-990-322 SHEATH 22/24FR RESECTOSCOPE INNER 2

0502-990-324 SHEATH 22/24FR RESECTOSCOPE OUTER 2

0502-990-424 22/24 CONTINOUS FLOW RESECTOSCOPE

SHEATH (INNER/OUTER)

0502-990-414 STANDARD OBTURATOR 22/24FR

RESECTOSCOPE

0502-990-401 WORKING ELEMENT 22/24FR RESECTOSCOPE 2

0233-032-880 CYSTOSCOPY STERILIZATION TRAY (1 TIER) 2

0233-050-087 ESST HENKE SCOPE ADAPTER 38

0620-010-104 CO2 TANK HOSE 8

0620-010-103 CO2 TANK YOKE 8

0351-600-000 MICRO CART 1

P44007 CABLE,DVI-D-SL-F O HDMI-M,0.5M 8

0240-050-845 DVI CABLE KIT 8

0240-099-155 CONNECTED OR CART, 120V 8

Effective Date: 02/01/2022 Page 6 of 12

0240-099-100K FLAT-PANEL ROLL STAND 4

8888-888-664 1YR DATAMEDIATOR 1 EMR 1

8888-888-673 1YR DATAMEDIATOR CONN DVC 8

8888-888-691 1YR DATAMEDIATOR ADD DICOM CONN 1

P47839 DATAMEDIATOR, LICENSE, DICOM

CONNECTION

0678-005-003 WORKFLOW SERVER, LICENSE, DEVICE

CONNECTION, SDC3

0678-005-008 DATAMEDIATOR, LICENSE, HL7 INTEGRATION

ENGINE

8888-888-233 INSTALLATION ORIS-DATAMEDATOR

INSTALLATION

0678-005-000 DATAMEDIATOR, SOFTWARE BUNDLE 1

8888-888-235 INSTALLATION ORIS-DATAMEDATOR

ADDITIONAL INSTALLATION

8888-888-223 INSTALLATION ORIS-STUDIO3 SDC

INSTALLATION

8888-888-401 INSTALLATION-BASE INSTALLATION CHARGE 1

8888-888-900 ICTS ENGINEERING SERVICES 1

8888-888-720 OR RENOVATION SERVICES 3

1688010000SC ANNUAL SERVICE CONTRACT FOR ITEM 1688-

010-000

220230300SC ANNUAL SERVICE CONTRACT FOR ITEM 0220-

230-300

240200100SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

200-100

240080230SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

080-230

620050000SC ANNUAL SERVICE CONTRACT FOR ITEM 0620-

050-000

1688610122SC ANNUAL SERVICE CONTRACT FOR ITEM 1688-

610-122

502538030SC ANNUAL SERVICE CONTRACT FOR ITME 0502-

538-030

502538010SC ANNUAL SERVCE CONTRACT FOR ITEM 0502-

538-010

502938030SC ANNUAL SERVCE CONTRACT FOR ITEM 0502-

938-030

502938010SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

938-010

502444030SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

444-030

747031510SC ANNUAL SERVICE CONTRACT FOR ITEM 0747-

031-510

747031650SC ANNUAL SERVICE CONTRACT FOR ITME 0747-

031-650

Effective Date: 02/01/2022 Page 7 of 12

747031550SC ANNUAL SERVICE CONTRACT FOR ITEM 0747-

031-550

502123030SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

123-030

502713530SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

713-530

502713560SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

713-560

502713500SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

713-500

240031300SC ANNUAL SERVICE CONTRACT FO ITEM 0240-

031-300

PC9001SC ANNUAL SERVICE CONTRACT FOR ITEM

PC9001

HH9030SC ANNUAL SERVICE ONTRACT FOR ITEM

HH9030

240031075SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

031-075

240031065SC ANNUAL SERVICE CONTRACT FOR ITEM 0240-

031-065

502729012SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

729-012

5025729030SC ANNUAL SERVICE CONTRACT FOR ITEM 0502-

729-030

The estimated value of the base period (12-months) is $ The total estimated value of the base period (12-months) and four option periods (48-months) is $ .

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The John D. Dingell VA Medical Center has a brand name (Stryker Corporation)

Effective Date: 02/01/2022 Page 8 of 12 requirement for the lease of endoscopy equipment. The Stryker Corporation tower and scope solution, described in Paragraph 3 above, offers a unique combination of product features endoscopy/surgery teams can utilize that are not offered by any other product/device solution in the same industry. The Stryker Corporation L-11 Light Source and Auto-Light Technology is proprietary auto-light technology designed to automatically adjust based on anatomy to provide consistent lighting, which will enable the Detroit VA surgeons to focus on the procedure without lighting distractions. The Stryker Corporation Camera Control Unit (CCU) comes equipped with nine different surgical modes to select from, allowing standardization with one camera across all specialties. Stryker is the only company that can provide both a white light picture and advanced imaging capabilities through the same camera and camera box. Stryker offers three different advancing imaging modes: Overlay (white light with fluorescence overlayed on top), black and white, and ENV (greyscale with fluorescence overlayed on top). These imaging modes allow the surgeon to identify critical anatomy and assess blood flow to assist in clinical decision-making. Fluorescent imaging is shown to be a vital component in reducing adverse patient outcomes. Stryker has been approved for more on-label (FDA compliance) indications for fluorescent across multiple specialties than any other current video system on the market. In regard to patient safety, the Stryker Corporation Safelight scope-sensing technology automatically (rather than manually) turns off the light source as soon as the light cord is disconnected from the scope adapter.

This safety feature is designed to help reduce the intra-operative risk of patient burns and drape fires when changing scopes. The Stryker PneumoClear Insufflation is a heating, humidification, and smoke evacuation platform. The device is designed to increase image quality through an inflow and outflow management system, while actively evacuating smoke.

The smoke evacuation technology is built into the device which eliminates the need for other devices or foot pedals to activate it. The PneumoClear Insufflation can be controlled from the sterile field using the camera head, remote control, touch panel, and voice-controlled headset.

This includes control over the insufflator flow rates, pressure settings, and smoke evacuation levels. Detroit’s VA surgeons require a system able to desufflate the abdomen. When activated at the end of a procedure, Stryker’s PneumoClear desufflation automatically pulls carbon dioxide out of the abdomen at a slow and consistent rate to remove the remaining/leftover gas. Due to this unique feature, the need to apply manual pressure to the cavity is lessened and allows ample time to check for internal bleeding before closing the operation, which meets the VA requirement. The VA requires the ability to use near infrared (NIR) technology and indocyanine-green (ICG) fluorescence because it allows for better visualization and real time accuracy of blood flow during surgery. The Stryker 1688 4K System offers Spy NIR florescence imaging. Spy NIR fluorescence imaging allows surgeons to see ICG dye, which is typically injected into the patient's blood. The light source excites the ICG with NIR radiation, causing it to fluoresce; the camera is then able to detect the output and display it visibly on the screen. This feature is most commonly used to assess tissue perfusion after anastomosis and to identify the bile ducts. Blood flow is an important factor involved in tissue healing. Being able to visualize blood flow mitigates the risk of complications caused by poor perfusion. Stryker Corporation’s fluorescent technology is not limited to minimally invasive capabilities. The Spy-PHI is a portable handheld imaging device used in open procedures to assess blood flow, tissue perfusion, and lymphatic mapping from the sterile field. The Spy-Phi integrates seamlessly with the Stryker 1688 video system, resulting in one platform providing both minimally invasive and an open assessment of tissue perfusion, which no other vendor in the same industry (other than the Stryker Corporation) has the capability to provide both. This greatly improves the clinical

Effective Date: 02/01/2022 Page 9 of 12 tools surgeons have at their disposal, resulting in better patient outcomes. Additionally, only Stryker Corporation provides a handheld capability via the Spy-PHI Open Field Handheld Fluorescence Imaging System, which is an imaging system used to capture and view fluorescence images for visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion and related tissue-transfer circulation in the tissue and free flaps used in plastic, micro– and reconstructive surgical procedures. The SPY-PHI Portable Handheld Fluorescence Imaging System is intended to provide fluorescence images to visually assess blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures. Due to the unique features and capabilities of brand name devices described in this paragraph, only Stryker Corporation, and no other sources of supply or brand name products are able to fully satisfy the requirements of the John D. Dingell VA Medical Center. The use of such brand name (Stryker Corporation) descriptions in the acquisition is essential to the VA’s requirements, thereby precluding consideration of the lease of products manufactured by another company.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Sources Sought Notice 36C25023Q0362 was posted to the Government Point of Entry (SAM.gov) from 24 February 2023 to 2 March 2023. The notice listed the manufacturer (Stryker Corporation) part numbers and a general description of the leased equipment required by the John D. Dingell VA Medical Center. As a result of the notice, two (2) sources (listed in Paragraph 10 below) responded with product brochures and capability statements to convey their interest in the VA requirement. In response to the notice, Beacon Point Associates, LLC, provided a capabilities statement and a Stryker Corporation authorized distributor letter, which listed Beacon Point Associates as an authorized distributor. Given this information, the VA has a reasonable expectation Beacon Point Associates, LLC, can satisfy the requirements of the John D. Dingell VA Medical Center as either a prime contractor or a subcontractor. Smith & Nephew, Inc., provided two product brochures. One brochure was for the INTELLIO Connected Tower Solution and other brochure was for Smith & Nephew ARTHROSCOPES and LAPAROSCOPES. The John D. Dingell VA Medical Center reviewed both Smith & Nephew brochures and determined the products described within the brochures did not evidence meeting the following VA requirements: a.) System must permit surgeons to activate and control all devices from the camera head on the field during operation; b.) System must have an insufflator controlled from the camera head and has the ability to offer an all-in-one heated, humidified, and smoke evacuation console with six operating modes (TAMIS, Advanced Flow, Standard, Vessel Harvest, Bariatric and Pediatric). The insufflator must also be able to desufflate the abdomen after the procedure safely removing the surgical plume and preventing it from being released into the operating room; c.) System must have an open field handheld illuminator imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for evaluation of tissue perfusion and related tissue transfer circulation; and d.) System must have three imaging modes: white light with fluorescence overlayed on top, black and white, and greyscale with fluorescence overlayed on top. Must have the ability to utilize indocyanine-green and detect its fluorescence in real time. Based upon the product brochures and literature received, the VA has determined the Smith and Nephew products cannot fully satisfy the requirements of the John D. Dingell VA Medical Center. In addition to Sources Sought Notice 36C25023Q0362, market research efforts described in Paragraph 8 below determined the presence of at least four (4) sources of the brand name supplies able to meet the requirements

Effective Date: 02/01/2022 Page 10 of 12 of the John D. Dingell VA Medical Center: Stryker Corporation, Beacon Point Associates, TrillaMed, and Four Points Technology. The VA will pursue an open market, unrestricted acquisition among all offerors of the brand name (Stryker Corporation) equipment to ensure offers are solicited from as many potential sources available in the commercial marketplace.

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

Reasonable: The CO will ensure that the proposed pricing is fair and reasonable using one or more of the price analysis techniques in FAR 13.106-3(a)(1).

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: The following market research efforts occurred between 7 February 2023 and 7 March 2023: The John D. Dingell VA Medical Center requested market research quotes for the lease of Stryker Corporation equipment from Stryker Corporation and Beacon Point Associates, LLC. Network Contracting Office 10 (NCO 10) reviewed the market research quotes and used the part numbers from the quotes to describe the requirements of the John D. Dingell VA Medical Center on Sources Sought Notice 36C25023Q0362, as described in Paragraph 6 above. The Small Business Administration (SBA) Dynamic Small Business Search (DSBS) website was searched using NAICS 339112, keyword “Scope”, and SDVOSB concerns, which resulted in 10 profiles.

The SBA’s VetCert website was used to verify the socio-economic status of the veteran-owned businesses. The VA’s Market Research Assistant website was searched, which resulted in 10 small business profiles. Both the small business profiles from the VA Market Research Assistant results and the SBA DSBS website results did not yield any specific sources related to endoscopy equipment. The GSA Advantage website was searched using the part numbers shown in Paragraph 3 above; however, the search yielded no sources of supply. NCO 10 reached out to the original equipment manufacturer (OEM), Stryker Corporation, to ascertain if authorized resellers exist and could fulfill the lease requirements of the John D. Dingell VA Medical Center. Stryker Corporation confirmed to have three SDVOSB resellers that are capable of fulfilling the VA requirements. The confirmed SDVOSB resellers are Beacon Point Associates, TrillaMed, and Four Points Technology.

While the market research efforts identified two or more SDVOSB concerns, the SBA’s Nonmanufacturer Rule precludes an SDVOSB set aside since the brand name (Stryker Corporation) equipment are not manufactured by a domestic small business nor has the SBA granted a Nonmanufacturer Rule Class Waiver under NAICS 339112 for endoscopy equipment. The VA’s Rule of Two cannot be met. The VA National Acquisition Center MedSurg Catalog was searched. Federal Supply Schedule (FSS) Contract V797P-40196 was identified and included line items for the required Stryker Corporation equipment; however, the OEM confirmed the FSS contract does not offer leased equipment (sales only). Further, no other small business concerns of any socio-economic status were identified during market research. The SBA Rule of Two cannot be met. The System for Award Management was utilized to confirm active registrations of Stryker Corporation, Beacon Point Associates, TrillaMed, and Four Points Technology. The Buy American Act applies to this acquisition.

While the estimated value of the acquisition exceeds the World Trade Organization (WTO) Government Procurement Agreement (GPA) threshold ($183,000.00) for the Trade Agreements Act (TAA), the exception found at FAR 25.401(a)(5), acquisitions not using full and open competition, applies, rendering the TAA as not being applicable to this acquisition.

Therefore, the Buy American Act applies to acquisitions not covered by the TAA, which is the case in this acquisition. The John D. Dingell VA Medical Center requirement for leased

Effective Date: 02/01/2022 Page 11 of 12

Stryker Corporation equipment conforms to the Buy American Act as the equipment produced are domestic end items.

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:

a. Beacon Point Associates, LLC (SDVOSB) 1216 SW 4th Street, Suite 4 Cape Coral, FL 33991 USA

b. Smith & Nephew, Inc. (Large Business) 150 Minuteman Road, Andover, MA 01810 USA

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 any forthcoming procurements related to the lease of endoscopy equipment, market research will be conducted to identify comparable, compatible, and competitive products in the commercial marketplace.

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.

Date

Logistics, Assistant Chief John D. Dingell VA Medical Center