P03_SSJ Karl Storz CO signed 1.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-25-AP-4708

1. Contracting Activity: Department of Veteran Affairs, VISN 1, West Haven VAMC, 950

Campbell Avenue, West Haven, CT 06516-2770.

2237: 689-25-3-7910-0401

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The VA Connecticut Healthcare System is currently seeking a comprehensive service agreement that fully covers repairs, exchanges, replacements and warranty of Karl Storz laparoscopic surgical instruments currently used in the West Haven Operating Room (OR). In addition to the comprehensive service agreement, a one-time, joint review, with the vendor and VACHS staff, of all Karl Storz laparoscopic surgical instruments is required at the beginning of the contract to ensure accurate accounting of instruments that are to be covered by the service agreement.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: VA Connecticut Healthcare System (VACHS) uses Karl Storz laparoscopic instruments and associated accessories. The single source request is based on critical requirements for system compatibility, patient safety, clinical standardization, and sterile processing efficiency. VACHS surgeons and OR staff are trained on Karl Storz instrumentation, which they rely on for its consistent feel, mechanical precision, and ergonomic handling. Introducing different brands would create variation in instrument design, adding unnecessary complexity, increasing cognitive load during procedures and elevating the risk of surgical errors.

Sterile Processing and Tray Standardization: VACHS surgical trays are standardized with Karl Storz instruments, allowing for efficient assembly, inspection, and reprocessing.

Introducing instruments from another manufacturer would necessitate mixed trays, which could lead to:

• Instrument confusion during surgery (different lengths, locking mechanisms, labeling)

• Inspection errors due to non-standard wear patterns and mechanisms

• Inability to interchange components (e.g., shafts, handles, inserts), which are designed as part of a matched system.

Additionally, these systems are proprietary, and instruments from other vendors are not guaranteed to function correctly with the existing hardware. Mixing components will create risk of potential damage or equipment failure. Use of alternative vendors could introduce clinical risk, increase costs, and disrupt established instrument tray configurations and SPD workflows. Remaining with Karl Storz will support the cost-effective and seamless integration of replacement instruments.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#

4. Description of market research conducted and results or statement why it was not conducted: SDVOSBs were identified via market research efforts conducted on DSBS, AddsUp, FPDS, GSA and Sam.gov. A market research survey was sent to OEM Karl Storz Representative Brad Dillard, Director, Federal Healthcare – East, identifying SDVOSB L1 Enterprises as their designated reseller. A sole source letter was provided and contained within the file.

5. Contracting Officer's Certification:. Purchase is approved in accordance with FAR13.106-

1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Manasés Cabrera Date Contracting Officer

MANASES

CABRERA

Digitally signed by MANASES

CABRERA

Date: 2025.08.13 09:33:28 -04'00'