P03 Single Source Justification MPT to SAT Redacted_Redacted.pdf

Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 1 of 3 Acquisition ID# 36C260-26-AP-3873

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO PART 12.102 Restricting Competition

For Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition

Threshold

Acquisition Plan Action ID: 36C260-26-AP-3873

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement

Office West, Network Contracting Office 20, on behalf of Portland VA Medical Center under purchase request number , for a Universal Removal System Instrument Set.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Portland VA Medical Center, Neurosurgery Service Line requires a second Shukla spine instrument set to support scheduled and emergent spine procedures that require explantation of previous implanted hardware. Per VA policy and standard operating procedures, all critical surgical instrument trays must have a backup set to ensure continuity of care, patient safety and operational readiness. Estimated Amount:

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Per VA Directive 1761 (1), The Clinical Products Review Committee (CPRC) is responsible for reviewing and approving all new expendable clinical items and Reusable Medical Equipment (RME) prior to their use for direct patient care so that compatibility with current processes and equipment is ensured. This Shukula Spine-CTL, will be used as a back-up kit in the Neurosurgical Service Line, and is a direct replica of the equipment currently in use. Shukla Spine-CTL Universal Spinal Screw Removal System possesses patented and proprietary design characteristics that are not available from other manufacturers and are required to meet the clinical needs of spine revision and extraction procedures at Portland VAMC.

Specifically:

The Shukla Spine-CTL system incorporates patented Helicopter Socket technology, which is uniquely designed to engage damaged, stripped, or broken spinal screws that cannot be removed using standard drivers, extraction tools, or vise-grip technologies.

The system contains more than 130 spinal drivers, including over 40 proprietary implant-specific drivers, allowing compatibility with a broad range of legacy and current spinal implant systems from multiple manufacturers.

Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID# 36C260-26-AP-3873

A comprehensive single-system design eliminates the need for multiple vendor-specific extraction trays, reducing reliance on vendor respresentatives for urgent or emergent cases.

Shukla offers ergonomic and efficiency focused design, offering ratcheting inline and T-handles that reduce surgeon fatigue. The multiple breaker bar extension lengths allow access to complex anatomy.

Shukla Spine-CTL is designed for revision and emergency use enabling immediate response when unexpected hardware removal is required and preventing case delays related to missing or incomplete extraction tools.

4. Description of market research conducted and results or statement why it was not conducted: Mandatory and non-mandatory sources were searched and it was determined that no other commercially available system meets the minimum clinical, operational, and safety requirements of the Neurosurgery Service Line. Shukla spine-CTL system satisfies the requirement for immediate, universal, and reliable spinal hardware extraction while meeting the VA Directive 1761 (1) compliancy. A letter was received from Shukla Medical indicating they are the manufacturer of this product and they have no authorized distributors. Due to the proprietary nature of this product to one manufacturer and Shukla Medical being the only source who can provide these highly specialized, patented extraction tools, this requirement will be sole sourced to Shukla Medical a division of S.S. White Technologies, Inc., a small business.

5. Contracting Officer's Certification: Purchase is approved in accordance with RFO

Part 12.102(a). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Tracy heath Date Contracting Officer

JOFOC Tracking # FY26 – NCO 20 – 1778

TRACY HEATH Digitally signed by TRACY HEATH Date: 2026.07.15 08:37:46 -07'00'