LSJ.pdf

VHAPG Part 808.405-6 Limiting Sources Page 1 of 11 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-1699

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-25-AP-1699

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 22, located at 4811 Airport Plaza Drive Suite 600, Long Beach, CA 90815, in support of VISN 22 VA New Mexico Health Care System (“NMVAHCS”) at 1501 San Pedro Drive, Southeast, Albuquerque, NM 87108, and in reference to 2237 ID 501-25-2-302-0007.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The NMVAHCS Surgical Services is seeking to upgrade its currently leased Olympus surgical 4K towers, which would involve new (upgraded) equipment, equipment returns, and transfer title (roll-over) equipment. The requirement is for a lease of surgical 4K towers, secondary monitors, and associated instruments (e.g., endoscopes, surgical tools) and accessories (e.g., cables).

Order against: FSS Contract Number: 36F79721D0168

Name of Proposed Contractor: Olympus America, Inc.

Street Address: 3500 Corporate Parkway City, State, Zip: Center Valley, PA 18034 Phone: (484) 896-5000

(3) Description of Supplies or Services:

The lease term proposed consists of a base period plus four option periods for a total term of 60 months. The lease will also include an option to extend services under FAR 52.217-8. The estimated value of the proposed base year is $411,212.76. The overall estimated value of the proposed action (60-month term) is $2,114,243.50.

The NMVAHCS Surgical Services requires an equipment lease and full-service equipment repair service in support of its Olympus America, Inc., (“Olympus”) surgical 4K tower systems. This addresses the need to upgrade the current endoscopic equipment and instrumentation. Specifically, the NMVAHCS utilizes Olympus laparoscopic surgical 4K towers where the tower is a system that comprised of 4K technology, monitors, video processors, light sources, camera control units, camera heads and lenses, and insufflation units. The camera and telescope connect to the tower providing an image on the monitor to give the surgeon a view of a veteran patient’s anatomy. Additionally, a full-service

VHAPG Part 808.405-6 Limiting Sources Page 2 of 11 equipment repair service is needed for Olympus telescopes, camera heads, semi-rigid scopes, and other associated equipment.

Laparoscopic procedures cover multiple specialties, and the equipment is used for the following procedures: (1) knee arthroscopy, (2) shoulder arthroscopy, (3) endoscopic wrist/hand, (4) laparoscopic cholecystectomy, (5) laparoscopic hernia, (6) laparoscopic appendectomy, (7) laparoscopic colon resection, (8) endoscopic plantar fasciotomy (EPF), (9) ankle arthroscopy, (10) sinus endoscopy, (11) robotic surgeries, (12) CT vein harvesting, and (13) urology cystoscopy.

The equipment lists below state the equipment upgrades and transfer title listings from the current lease.

Brand Name Manufacturer: Olympus America, Inc.

Upgraded and New Equipment Listing

Quantity Type Model Equipment Description 5 New ISM-1007409 NCARE, REC, DUAL, 2 DIR SDI 5 New ISM-1000230 22" MEDICAL GRADE, TOUCHPANEL 6 New A70950A A70950A SHEATH HIGH FLOW, 4MM 1 STOPCOCK 5 New OTV-S400 OTV-S400 VISERA 4K UHD Camera Contl Unit 5 New OL-0015-10 TALL HEAVY ROLL STAND FOR 32" MONITOR LM 1 New MAJ-1871 MAJ-1871 Communication cable short 1 New MAJ-1876 MAJ-1876 Docking fixture 1 New MAJ-619 MAJ-619 ADAPTER FOR THE OLYMPU S A-CORD 7 New LAPROTRAY1 LAPROTRAY13INSRTS:CH/SCP/INST&TRC SC06FG 8 New WA4KA430 WA4KA430 Telesc. "ULTRA", 4 mm, 30 2 New A70950A A70950A SHEATH HIGH FLOW, 4MM 1 STOPCOCK 6 New WA4KL100 WA4KL100 UHD 10mm/0 degree telescope 6 New WA4KL130 WA4KL130 UHD 10mm/30 degree telescope

10 New WA4KL500 WA4KL500 UHD 5mm/0 degree telescope 10 New WA4KL530 WA4KL530 UHD 5mm/30 degree telescope 12 New WA05990A WA05990A INSTRUMENT TRAY FOR T ELESCOPES 5 New K10035366 WM-NP3 MOBILE WORKSTATION US GI 20A 5 New MAJ-1653 MAJ-1653 DUAL CO2 CYLINDER HOLDER WM-P2 5 New MAJ-2167 MAJ-2167 NURSES CONTROL ARM 8 New ARTHROTRAY1 ARTHROTRAY12INSRTS:CH/SCP/INST&TRC(SC06Q 8 New A70951A A70951A SHEATH HIGH FLOW, 4MM 2 STOPCOCK 8 New SC06QG SC06QG MID SIZE CONTAINER (18.1xX11x6) 5 New MAJ-2254 MAJ-2254 4K Cable 28FT

VHAPG Part 808.405-6 Limiting Sources Page 3 of 11

8 New A70954A A70954A TROCAR SPIKE, 4MM TRIA NGULAR FO 8 New A70955A A70955A TROCAR SPIKE, 4MM BLUN T FOR A70

10 New LMD-X310S LMD-X310S 31 inch 4K Sony Monitor 15 New CH-S400-XZ-EA VISERA 4K UHD AUTOCLAVABLE CAMERA HEAD 5 New CLV-S400 CLV-S400 VISERA 4K UHD Xenon Light Sourc 5 New UPDR-80MD UPDR-80MD SONY DYE SUB. LETR W/ 12' USB 6 New WA03310A Light-guide cable, 4.25 mm, 3 m, CF type 2 New CS-W7S CS-W7S CIRON SEAL (6/BOX)

12 New A42091A A42091A OES-PRO Working Insert 8.5mm 8Fr 12 New WA03310A Light-guide cable, 4.25 mm, 3 m, CF type 5 New WA2UR22A URETEROSCOPE DUALCH, STRAIGHTOC, 330MM 1 New WA2UR21A URETEROSCOPE DUALCH, ANGLEDOC, 430MM 6 New WA2BSKTB WA2BSKTB Ster.Tray OES Elite Semi-Rigid

12 New A20906A A20906A BLIND OBT 22.5FR FOR A20914A 12 New A20976A A20976A CYSTO BRIDGE SINGLE CHANNEL 12 New A22026A A22026A OUTER SHEATH 2 STPCCK ROT 26FR 12 New A22040T A22040T INNER 24 FR W/ TIMBER FOR 26FR 12 New A22071A A22071A OBTURATOR OPTICAL 24 FR 14 New 75U 75U UNIVERSAL STOPCOCK LUER LOCK 12 New CH-S190-08-LB CH-S190-08-LB HD ULTRA-LIGHT URO CAMERA 5 New WA2T400A Telescope "OES Elite", 4 mm, 0 deg, HD,a

11 New WA2T430A Telescope "OES Elite", 4 mm, 30 deg,HD,g 12 New WA2T470A Telescope "OES Elite", 4 mm, 70 deg, HD, 4 New WA4KA470 WA4KA470 Telesc. "ULTRA", 4 mm, 70° 1 New WA91327U ESG-410 Surgical Energy Platform 1 New WA91302W Footswitch Double Pedaled, Wireless 1 New WA91301W Footswitch Double Pedaled, Wired 1 New TC-E410 TC-E410 CART 110-120V US SET 1

14 New 03664 03664 ADAPTER FOR ELLIK EVACUA TOR 12 New ST-CR ST-CR STERILIZATION TRAY SINGLE LAYER

Transfer Title Listing Quantity Model Equipment Description

6 A70950A A70950A SHEATH HIGH

2 A70950A A70950A SHEATH HIGH

8 A70951A A70951A SHEATH HIGH

8 A70954A A70954A TROCAR SPIKE

8 A70955A A70955A TROCAR SPIKE

8 ARTHROTRAY1 ARTHROTRAY12INSRTS:C

VHAPG Part 808.405-6 Limiting Sources Page 4 of 11

3 ISM-1000230 22 MEDICAL GRADE TOU

2 ISM-1000230 22 MEDICAL GRADE TOU

1 K10021611 K10021611 WM-NP2 CAR

1 K10021611 K10021611 WM-NP2 CAR

1 K10021611 K10021611 WM-NP2 CAR

1 K10021611 K10021611 WM-NP2 CAR

1 K10021611 K10021611 WM-NP2 CAR

7 LAPROTRAY1 LAPROTRAY13INSRTS:CH

5 MAJ-1664 MAJ-1664 Nurses Cont 1 MAJ-1871 MAJ-1871 Communicati 1 MAJ-1876 MAJ-1876 Docking fix 5 MAJ-2254 MAJ-2254 4K Cable 28

1 MAJ-619 MAJ-619 ADAPTER FOR

5 OL-0015-10 TALL HEAVY ROLL STAN

7 SC06FG SC06FG FULL SIZE CON

8 SC06QG SC06QG MID SIZE CONT

2 WA03310A Light-guide cable 4.

13 WA03310A Light-guide cable 4.

22 WA05990A WA05990A INSTRUMENT

14 3664 03664 ADAPTER FOR EL

14 75U 75U UNIVERSAL STOPCO

2 A20712A A20712A BIOPSY FRCPS

6 A20712A A20712A BIOPSY FRCPS

2 A20712A A20712A BIOPSY FRCPS

1 A20712A A20712A BIOPSY FRCPS

1 A20712A A20712A BIOPSY FRCPS

4 A20714A A20714A OPT GRSPING

1 A20714A A20714A OPT GRSPING

2 A20714A A20714A OPT GRSPING

2 A20714A A20714A OPT GRSPING

1 A20714A A20714A OPT GRSPING

2 A20714A A20714A OPT GRSPING

1 A20914A A20914A CYSTO SHEA T

1 A20914A A20914A CYSTO SHEA T

3 A20914A A20914A CYSTO SHEA T

6 A20914A A20914A CYSTO SHEA T

1 A20914A A20914A CYSTO SHEA T

12 A20976A A20976A CYSTO BRIDGE

6 A22026A A22026A OUTER SHEATH

6 A22026A A22026A OUTER SHEATH

12 A22071A A22071A OBTURATOR OP

VHAPG Part 808.405-6 Limiting Sources Page 5 of 11

4 A42091A A42091A OES-PRO Work 8 A42091A A42091A OES-PRO Work

12 A5976 A5976 TRAY INSERT UR

2 CS-B612 CS-B612 Seal Kit 6-1

1 TC-E400 TC-E400 ENERGY CART

12 WA03310A Light-guide cable 4.

12 WA05970A WA05970A HIQ+ STERIL

5 WA22367A WA22367A PASSIVE WOR

7 WA22367A WA22367A PASSIVE WOR

1 WA95622A WA95622A: USA POWER

1 WB50403W WB50403W ESG-400 Foo

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 6 of 11 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-1699

Price Information on the Base and Option Periods is the following:

Contract Period (12 months) Equipment and Service Annual Payment Base March 9, 2025, to March 8, 2026

$411,212.76

March 9, 2026, to March 8, 2027

$411,212.76

March 9, 2027, to March 8, 2028

$411,212.76

March 9, 2028, to March 8, 2029 $411,212.76

March 9, 2029, to March 8, 2030 $411,212.76

Estimated Value of Total Contract $2,056,063.80

Per the FSS terms and conditions, the estimated property tax cannot be included in the total award. This amount is billed and paid in arrears annually and may change because it is only an estimate. The estimated property taxes for five years (base plus four option periods) is $58,179.70.

The estimated grand total of the contract value with property taxes is $2,114,243.50.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

Olympus is the original equipment manufacturer (“OEM”) and is the only vendor that can service, repair, supply replacement parts, and lease Olympus surgical 4K towers and associated equipment that is currently utilized at NMVAHCS through the Federal Supply Schedule (“FSS”).

Olympus does not have any authorized resellers on FSS (or in the open market) that can provide equipment through a lease and a full-service equipment repair service. Olympus lease agreements with the US Government are offered solely by Olympus. The use of non-Olympus parts may invalidate the manufacturer’s warranty, and it may invalidate the reprocessing (e.g., cleaning and disinfection) instructions provided in the equipment instructions for use. It is in the Government’s best interest for its leased and owned equipment to be maintenance and

VHAPG Part 808.405-6 Limiting Sources Page 7 of 11 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-1699 serviced by the OEM to preserve equipment integrity and specifications. NMVAHCS has determined that leasing provides the flexibility to (1) have equipment repaired to assist with managing the lifecycle maintenance costs, and (2) to trade-in and upgrade the equipment at the end of the period of performance to ensure that NMVAHCS has access to the latest equipment advances to maintain a high level of patient care.

All equipment, instrumentation, and systems must perform and meet the standards of Olympus that is currently being utilized throughout the NMVAHCS Surgical Services operating rooms.

Inserting other manufacturer’s equipment with the current Olympus equipment would result in the equipment not being natively compatible (i.e., adapters and additional cables may be needed to utilize two different brands). This may result in less optimal results regarding operability and ability to support the technology and affect patient outcomes. Additionally, all equipment services must be performed by Olympus’s certified service personnel to ensure the equipment warranty is not voided.

The physicians are familiar with the Olympus scopes which influences patient care outcomes.

Additionally, sterile processing services have equipment and procedures in place to re-process Olympus. Changing manufacturers would impact both patient care and introduce more processes that increases the potential for error. By allowing for continued use of Olympus that supports the standardization within the entire facility, this enhances the safety and quality of patient care and reduces the potential for error by reducing the variability in the number of different processes required for endoscope setup and reprocessing.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

Direct replacement parts that are natively compatible may be required in performance of this work.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

VHAPG Part 808.405-6 Limiting Sources Page 8 of 11 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-1699

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

NMVAHCS Surgical Services standardized their endoscopes to Olympus because it was already using Olympus towers since 2019, if not longer. A large-scale change in equipment would affect the quality of patient care because clinicians and sterile processing would need training to familiarize themselves a different brand and would need to change their practices, which may also include purchasing additional supplies to utilize a different brand. In accordance with FAR Part 8.404(d), a separate determination of fair and reasonable pricing is not required because “GSA has already determined the prices of supplies and fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable.”

Additionally, pricing proposed by Olympus for the equipment upgrade and full-service equipment maintenance is similar with the pricing previously paid by NMVAHCS and with other medical centers within VISN 22 that are currently utilizing Olympus endoscopy equipment and instrumentation. Thus, placing a task order against the Olympus GSA FSS Contract 36F79721D0168 represents the best value to the Government.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

The VA Rule of Two is not met because the Government does not have a reasonable expectation of obtaining offers at a fair and reasonable price from two or more SD/VOSBs or Small Businesses that are Schedule holders and that are also authorized to lease and service Olympus equipment and instrumentation.

National Acquisition Center (NAC) and Strategic Acquisition Center (SAC): No mandatory contract was found using either of the keyword search terms “Olympus” and “endoscope.”

GSA Federal Supply Schedule (FSS): A search utilizing the keyword “Olympus endoscope” resulted in only the manufacturer Olympus America, Inc., offering Olympus endoscopy equipment through its FSS contract # 36F79721D0168.

ECAT: A searching utilizing the keyword “Olympus” resulted in Olympus endoscopy equipment and instrumentation being offered by the SDVOSB Alliant Enterprises, LLC, through its contract # SPE2D1-20-D-7008.

FPDS and SAM.gov: A search utilizing the keyword “Olympus” resulted in awards made to Olympus America, Inc., and its SDVOSB Alliant Enterprises, LLC. Per Olympus and from the search results, Olympus lease agreements with the VA are only offered through Olympus either through its GSA FSS contract # 36F79721D0168 or through the open market.

Small Business Administration (SBA) Veteran Small Business Certification (VetCert) was accessed on 12-16-2024. Although the VetCert Database search yielded 669 SDVOSBs and VOSBs under NAICS Code 339112, further research indicated a lack of guarantee that they offer the brand name or equal-to-product.

VHAPG Part 808.405-6 Limiting Sources Page 9 of 11 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-1699

SBA Dynamic Small Business Search (DSBS) was accessed on 01-16-2025. A search utilizing NAICS Code 339112 and the keyword “endoscope” yielded zero results.

Request For Information (RFI) # 36C26225Q0249 was posted from 12-12-2024 to 12-20- 2024 on SAM.gov and received no SDVOSB or VOSB responses and 1 Small Business response. The Small Business response only indicated its interest but did not follow-up with additional information, such a response to the RFI questionnaire or further details on its capabilities as it pertained to this requirement. The RFI received two detailed responses from the Large Business manufacturers Olympus and Karl Storz Endoscopy- America (Karl Storz) stating that their equipment is available through FSS. Olympus has one authorized SDVOSB distributor, but this SDVOSB distributor does not offer a leasing option. Karl Storz indicated that it has an authorized SDVOSB distributor; however, that SDVOSB distributor did not respond separately to the RFI indicating that it can offer a leasing option through FSS.

(7) Any Other Facts Supporting the Justification:

The NMVAHCS has standardized its entire facility to utilize Olympus towers and scopes, including having purchased its own Olympus towers to ensure every room is fitted with a tower. Because it has standardized to Olympus, the NMVAHCS seeks to upgrade certain Olympus assets (see Section 3, Description of Supplies or Services) to continue to provide the highest quality of care to its veteran patients. By utilizing Olympus endoscopes, the native compatibility between Olympus endoscopes to the already in-use Olympus towers has allowed NMVAHCS to reduce patient safety risks and to eliminate the need for additional attachments that were misplaced during sterile reprocessing and during endoscopic setups.

Additionally, because NMVAHCS already utilizes Olympus equipment facility-wide, changing the OEM may affect other service lines, such as Sterile Processing Services, due to needing to learn new processing procedures that comes with changing manufacturers.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Due to the specialized nature and scope of equipment and instrumentation requested, it would be difficult to remove barriers at the agency level. Instead, this would have to be accomplished at the manufacturer level due to compatibility requirements stemming from propriety equipment and patented technology and FDA regulations (e.g., the variability originates from the competing manufacturers).

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

VHAPG Part 808.405-6 Limiting Sources Page 11 of 11 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-1699

c. Director of Contracting Acknowledgment

DATE

Office West

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

d. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

DATE

West