6515--KARL STORZ BLUE LIGHT CYSTOSCOPY SYSTEM

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C246-23-AP-2645 (1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 6, located at 100 Emancipation Blvd, Hampton VA 23667, in support of Fayetteville VA Health Care System at 2300 Ramsey St, Fayetteville NC 28301. Purchase Request Number 565-23-3-090-0106. (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). NCO 6 intends to award a new, brand name, firm-fixed-price delivery order for Karl Storz. Order against: FSS Contract Number: V797D-30255 Name of Proposed Contractor: Karl Storz POC: Patrick Luciani Street Address: 2151 E. Grand Avenue. City, State, Zip: El Segundo CA 90245 Phone: 1-910-612-4200 (3) Description of

Supplies or Services: The estimated value of the proposed action is $ 268,213.16. Karl Storz Blue Light Cystoview System. The Blue Light Cystoscopy with Cysview (BLCC) uses Karl Storz photodynamic Diagnosis system to identify the presence of bladder cancerous tumors by highlighting the tumors in a bright color during procedures. This system increases the potential detection and removal of tumors. (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; This is new and proprietary technology for the identification and removal of bladder cancer. Karl Storz Photodynamic Diagnostics (PDD) technology is the only FDA approved bladder cancer detection system that is used in conjunction with Cysview® drug (sold and distributed in the U.S. by Photocure, Inc.). PDD or Blue Light Cystoscopy causes bladder cancer to fluoresce, greatly enhancing its detection and exposing potentially missed tumor sites. 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. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. (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: Pricing on the VA FSS contract has been determined to be fair and reasonable. A separate determination of fair and reasonable pricing is not required, but prior to award the Contracting Officer will confirm offered prices against the contract prices and seek additional discounts before placing an order. (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 available sources and to evaluate the availability of the marketplace to meet the requirement. The SBA VetCert database was searched using the applicable NAICS, however no service-disabled veteran-owned businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) were identified. The VA rule of two cannot be met. The VA National Acquisition Center Med Surg Catalog was searched and one vendor was identified to provide this requirement, Karl Storz (OEM), contract number V797D-30255. Karl Storz is the sole authorized distributor and service/maintenance provider. (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 conduct market research to ascertain if there are changes in the marketplace that would enable future requirements of this type to be competed. (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.