Justification.pdf

36C246-25-AP-3760

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C246-25-AP-3760

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C246-25-AP-3760

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 06, 100 Emancipation Dr., Hampton, Virginia 23667, in support of the Salisbury VAMC, 1601 Brenner Ave, Salisbury, NC 28144. Purchase Request: 659-25-3-1039-0050.

(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). Network Contracting Office 6 intends to award a new, sole source, firm-fixed-price delivery order to Olympus America, Inc.

for Olympus colonoscopes. The purchase of the colonoscopes will allow the Salisbury VA Medical Center to provide diagnostic, therapeutic, and interventional care of Veteran patients.

Order against: FSS Contract Number: 36F79721D0168

Name of Proposed Contractor: Olympus America, Inc.

Street Address: 3500 Corporate PKWY

City, State, Zip: Center Valley, PA 18034

Phone: (720) 387-0621

(3) Description of Supplies or Services: This requirement is to provide 23 Olympus EVIS Exera III High Definition Colonoscopes, model CF-HQ190L. The current fleet of colonoscopes have reached the end of their service life. A colonoscope is a flexible and steerable endoscope to evaluate the entire colon. A colonoscope is engineered so that biopsies of suspicious areas can be obtained, and polyps can be removed. The aging equipment poses increased risks of failures, higher maintenance costs, and potential disruption of vital diagnostic and therapeutic procedures. To maintain the clinical standards and minimize risks, timely replacement with new, reliable endoscopes is critical. The Olympus scopes are the only compatible instruments for operation on the existing Olympus Endo Suite owned by the Salisbury VA Medical Center.

These scopes allow medical practitioners to conduct endoscopy procedures for the Veteran beneficiaries to diagnosis and treat gastrointestinal conditions.

delivery date is September 15, 2025.

(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.

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024

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 America, Inc. is the is the sole manufacturer of the required endoscopes and the only source identified on VA FSS Schedule 65 contract. The Salisbury VA Medical Center has a substantial and sophisticated infrastructure centered around Olympus endoscope suites. This infrastructure includes a wide range of endoscopic equipment, software, and specialized accessories that are specifically designed to function with Olympus endoscopes.

The Olympus endoscopes incorporate proprietary technology that ensures optimal integration and functionality with the Olympus endoscope surgical suite used at the Salisbury VA Medical Center. The sophisticated design and calibration of the Olympus surgical suite are specifically configured to interface seamlessly with Olympus endoscopes, making it the only viable option for high-efficiency performance and precision in medical procedures. Olympus is the only manufacturer that provides endoscopes that are fully compatible with their surgical suite.

Attempts to use non-Olympus endoscopes would elevate the risk of operational downtime and associated costs. The surgical staff has undergone extensive training specifically on Olympus endoscopes and the Olympus endoscope surgical suite. Introducing endoscopes from another manufacturer would necessitate additional training, leading to increased operational risks, potential errors, additional costs for new compatible equipment, and a temporary reduction in procedural efficiency.

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:

is:

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

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

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 Revision: 01 Effective Date: 09/01/2024

(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: The required equipment, Olympus endoscopes, available on FSS contract 36F79721D0168, ensures a competitive and justified pricing structure. While FSS prices are already deemed fair and reasonable, the Contracting Officer will seek additional discounts to maximize cost savings for the Government. Considering FSS price determination, the additional discounts, seamless compatibility with existing infrastructure, and lifecycle cost efficiency, the procurement of Olympus endoscopes represents the best value consistent with FAR 8.404(d). This ensures that the Salisbury VA Medical Center receives high-quality, reliable, and cost-effective equipment to meet its critical healthcare needs of their Veteran beneficiaries.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research was conducted to identify potential sources that could meet the requirements to procure endoscopes for the Salisbury VA Medical Center. The following sources were queried: SBA Small Business Search, General Services Administration (GSA), National Acquisition Center (NAC), Strategic Acquisition Center (SAC), and Medical-Surgical Prime Vendor Program (MSPV). Queries of the SBA Small Business Search revealed one SDVOSB, Alliant Enterprises, authorized reseller/distributor.

Based on the information collected, there are no expectations of any other sources submitting quotes in which an award can be made at a fair and reasonable price; therefore, the VA Rule of Two has not been met. Queries on the GSA Advantage! website revealed listings under the FSS contract 36F79721D0168 associated with the Federal Supply Classification (FSC) Group

65IIA.

(7) Any Other Facts Supporting the Justification: None.

(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: The Government will continue to monitor the market for any future competition. Once the equipment currently in use reaches the end of its lifecycle, the marketplace will be surveyed to determine other sources that can provide the equipment to satisfy the Government’s future needs.

(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 Revision: 01 Effective Date: 09/01/2024

Matthew Biles, RMD Coordinator, Salisbury VAMC

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jamie R. Sullivan Contracting Officer, NCO 6

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Keeshia Newman Division Chief, NCO 6

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Irma Ferro Director of Contracting, NCO 6

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.

Gerald F. Jacobs Executive Director, Regional Procurement Office East

IRMA FERRO Digitally signed by IRMA FERRO Date: 2025.08.12 08:39:03 -04'00'

GERALD JACOBS

Digitally signed by GERALD

JACOBS

Date: 2025.08.13 12:49:45 -04'00'