-17003.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C25219AP0233

1. Contracting Activity:

Department of Veterans Affairs

Great Lakes Acquisition Center, NCO-12

115 South 84th Street, Suite 101

Milwaukee, WI 53214-1476

Edward Hines Jr. VAH

5000 South 5th Avenue

Hines, IL 60141-1457

2237 Number: 556-19-1-2993-0007

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

This is a justification and approval for a KARL STORZ brand name only procurement, which will be awarded as a new firm-fixed-priced purchase order for required Endoscopy Carts &

Equipment that will be used in the ENT Service at the Edward Hines Jr. VAH.

3. FAR13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for KARL STORZ brand name only Endoscopy Carts & 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.

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

The estimated value of the proposed action is $596,370.97.

The equipment required under this action is KARL STORZ brand name only Endoscopy Carts and Equipment which will be used in the ENT Service at the Edward Hines Jr. VAH.

LINE

ITEM

DESCRIPTION

ITEM

NUMBER

QUANTITY

OFFICE CART W/T-POST, KEYBOARD

TRAY 1 SHELF, 3.5" DRAWER, AND

TRANSFORMER

9805T-HN 5

2 IMAGE1 S CONNECT, CONNECT MODULE TC200US 5

SILICONE KEYBOARD WITH US

CHARACTERS FOR USE WITH IMAGES1 S

AND TELE PACK X

20040240US 5

IMAGE1 S H3-LINK, LINK MODULE FOR

IMAGE1 HD + IMAGE1 S CAMERA HEADS

TC300US 5

IMAGE1 S X-LINK, LINK MODULE FOR

FLEX VIDEOENDOSCOPES, D1, HX, HX-P

TC301US 5

ADAPTER, USB TO ACC FOR AIDA

CONTROL INCLUDES ACCESSORY

CABLES

TC009 5

26" LED MONITOR, 1920X1080

RESOLUTION, 16:9 ASPECT RATIO

9826NB-US-

HN

POWER LED 175 LIGHT SOURCE W/SCB

100-240 VAC

20161401-1-

HN

IMAGE1 S H3-Z HIGH DEF CAMERA

HEAD, FOR H3-LINK MODULE

TH100 5

ADAPTER, VIDEOENDOSCOPE FOR X-

LINK

TC001 6

STROBO VIDEO-RHINO-LARYNGOSCOPE

KS UPGRD /COMPETITIVE TRD,NTSC,

OD:3.5MM, WL:30CM

P-

R11101VNSK-

CCD

FLEXIBLE VIDEO CYSTOSCOPE, 16FR X

35CM CHNL:6.5FR, REVERSE

DEFL:210ºU/140ºD

11272VNK 2

FLEXIBLE BIOPSY FORCEPS, DOUBLE

ACTION JAWS, 5FR X 60CM

27425ZG 4

AIDA HD CONNECT W/ DVD <(>&<)>

SMARTSCRE

20205501-140-

HN

FLEXIBLE VIDEO NEURO-

ENDOSCOPE,TIP:3.3MM SHAFT:2.9MM,

WL:35CM, WRK CHANNEL: 1.2MM

11161VK 2

INTERFACE LICENSE FOR USE WITH

PACS AND EHR

20041406-V01 7

STREAMCONNECT BASE APPLICATION

VM

WUIS2258-

ENT

VOD - ENT - VM LICENSE - UP TO 5

CAPTURE DEVICES

WUIS2261-

ENT

19 ehrLINC ARCHIVE LICENSE WUIS2272 1 ehrLINC ARCHIVE

IMPLEMENTATIONPROFESSIONAL

SERVICES

WUIS2276 1

21 ehrLINC WORKLIST LICENSE WUIS2271 1 ehrLINC WORKLIST

IMPLEMENTATIONPROFESSIONAL

SERVICES

WUIS2274 1

CABLE, CAT 6, 24 AWG, TWSTD PAIR, 25

FT

WUIS105 5

24 OR1 PROJECT MANAGEMENT KSIS-PM 1

5. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source (BRAND NAME) 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).

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

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

The equipment required under this action is needed to integrate with existing equipment for the system to function as intended. Only the KARL STORZ ENDOSCOPY – AMERICA, INC.

brand name can meet the VA’s need. The required KARL STORZ videoscopes offer unique features such as SPIES Clara and Chroma to eliminate dark areas in the image and shows vascularity better without altering the adjacent tissue color. Clara Enhancement: Camera Control

Unit MUST include KARL STORZ Clara technology. IMAGE1 S Clara is a unique feature that allows in real time (no visible lag time) to eliminate dark areas in an image, allowing the surgeon to keep their telescope in the right distance from the surgical target and being able to effectively perceive and discern additional content. With other/current systems in the market, the surgeon needed to move his/her telescope closer to the target for proper illumination that reduced space for instruments, lost overview and came with the risk to get mucous on the lens hence impeding clarity of the surgical field - the Clara has the potential to reduce procedural time and reduces errors / complications as the surgeon will not need to remove clean and reinsert which is time consuming during a procedure. Chroma Enhancement: Camera Control Unit MUST include

KARL STORZ Chorma technology. IMAGE1 S Chroma identifies and brightens up dark areas and does this dynamically and in real time without overexposing the bright part of the image.

The Chroma enhancement increases the visibility and vascularity of blood vessels that minimizes the likelihood of injuring delicate ENT procedures.

Three other brands were represented in responses from vendors in response to the Sources

Sought Notification. Each were found not to be acceptable by the facility. The NITOR brand name endoscopes are too big, as well as the carts being too large for the space at the facility. The

PENTAX brand name scope diameters are too large, and the endoscopes cause a lot of discomfort for the patients. This brand also does not manufacture their own rigid camera’s resulting in poor technical support. The PENTAX brand name equipment carts are also too large for the space at the facility. With the OLYMPUS brand name equipment, the diameter of the endoscope is 3.9mm instead of 3.7mm. Also, the bending angulation of the endoscope is 130 degrees instead of 140 degrees which is required. Also, the facility currently utilizes the KARL

STORZ system in the operating room. There is user experience, plus the images captured in both

OR and clinic can be integrated and stored in one system instead multiple systems.

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

Sources Sought was published to FBO on February 13, 2019, with responses due by February 19, 2019. The following vendors responded:

- AMERICAN MEDICAL DEPOT (AMD) – 06-272-2038 – Open Market – Small Business –

Offering KARL STORZ brand name.

- NITOR INC. – 01-984-9242 – Open Market - SDVOSB – Offering NITOR brand name.

- ALLIANT HEALTHCARE PRODUCTS – 12-117-0653 – Open Market – SDVOSB –

Offering OLYMPUS brand name.

- THUNDERCAT TECHNOLOGIES, LLC – 80-988-7164 – NNG15SD26B – SDVOSB –

Offering PENTAX brand name.

- KARL STORZ ENDOSCOPY-AMERICA, INC. – 07-529-3423 – V797D30255 – Other Than

Small Business – Offering KARL STORZ brand name.

- L1 ENTERPRISES – 80-019-0782 – Open Market – SDVOSB – Offering KARL STORZ brand name.

L1 ENTERPRISES is the only authorized SDVOSB distributor of the manufacturer KARL

STORZ ENDOSCOPY – AMERICA, INC. On March 14, 2019 pricing information was received from the SDVOSB vendor, L1 ENTERPRISES. CO has determined that the price cannot be determined fair and reasonable, as it is 29.6% more than the IGCE. Therefore, the

Government does not anticipate quotes that can be determined fair and reasonable from two or more small business vendors.

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

Reasonable:

The steps to be taken to find that the price will be determined fair and reasonable will be competion.

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

Market Research Was Not Conducted:

Market Research Sources:

In accordance with FAR Part 10, VAAR 810 and VAAM M810, market research has been conducted for this acquisition. The following techniques were used:

- Used VA’s VIP database to identify verified capable SDVOSBs and VOSBs. - All results must be attached to this report.

- Applying personal knowledge in procuring supplies/services of this type.

- Contacting knowledgeable individuals in Government and industry regarding market capabilities to meet requirements.

- Querying the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and other

Government and commercial databases that provide information relevant to agency acquisitions.

Market Research Findings:

VIP search was conducted using the search criteria of NAICS Code: 334510, the search resulted in 163 matches. A second search was conducted using the search criteria of NAICS Code:

334510 and the Keyword: KARL STORZ, the search resulted in no matches.

Ability One website search was conducted; Ability One does not provide the requirement.

FSS search conducted, resulting in one FSS contract holder that can provide the majority of the full requirement:

- KARL STORZ ENDOSCOPY – AMERICA, INC. (07-529-3423) – V797D30255 – Other

Than Small Business.

Sources Sought was published to FBO on February 13, 2019, with responses due by February 19, 2019. The following vendors responded, indicating they are capable of providing the requirement:

- AMERICAN MEDICAL DEPOT (AMD) – 06-272-2038 – Open Market – Small Business –

Offering brand name requested equipment.

- NITOR INC. – 01-984-9242 – Open Market - SDVOSB – Offering equal equipment.

- ALLIANT HEALTHCARE PRODUCTS – 12-117-0653 – Open Market – SDVOSB –

Offering equal equipment.

- THUNDERCAT TECHNOLOGIES, LLC – 80-988-7164 – NNG15SD26B – SDVOSB –

Offering equal equipment.

- KARL STORZ ENDOSCOPY-AMERICA, INC. – 07-529-3423 – V797D30255 – Other Than

Small Business – Offering brand name requested equipment.

- L1 ENTERPRISES – 80-019-0782 – Open Market – SDVOSB – Offering brand name requested equipment.

Other pertinent information:

Non-Manufacturer Rule (NMR): Definition - for small business set-asides, other than for construction or services, any concern proposing to furnish a product that it did not itself manufacture, must furnish the product of a small business manufacturer unless the SBA has granted a waiver. If the IGCE is less than $250,000.00 the NMR does not apply and a set aside shall be sought. If the IGCE is equal to or greater than $250,000.00 the NMR applies.

The NMR does not apply to this procurement, as SBA has granted a waiver.

On March 14, 2019 pricing information was received from the SDVOSB vendor, L1

ENTERPRISES. CO has determined that the price cannot be determined fair and reasonable, as it is 29.6% more than the IGCE.

Therefore, the Government does not anticipate quotes that can be determined fair and reasonable from two or more small business vendors.

Determination:

Based on the information provided above, it is determined this procurement will be fulfilled by issuing an unrestricted, brand name only RFQ onto FBO, i/a/w: FAR 13.5.

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

The equipment required under this action is needed to integrate with existing equipment for the system to function as intended. Only the KARL STORZ ENDOSCOPY – AMERICA, INC.

brand name can meet the VA’s need.

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

- KARL STORZ ENDOSCOPY – AMERICA, INC. (07-529-3423).

- AMERICAN MEDICAL DEPOT (AMD) – 06-272-2038.

- NITOR INC. – 01-984-9242.

- ALLIANT HEALTHCARE PRODUCTS – 12-117-0653.

- THUNDERCAT TECHNOLOGIES, LLC – 80-988-7164.

- L1 ENTERPRISES – 80-019-0782.

12. 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:

None.

13. 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.

Stephen Campbell

Administrative Officer & Business Manager

Edward Hines Jr. VAH

14. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

Thomas H. Chesak

Contracting Officer NCO-12

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.

Daniel Rasmussen

Equipment Team Branch Chief NCO-12 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx