Karl Storz JOFOC_Redacted.pdf

GSAR 538.7104-4 Brand Name Justification Page 1 of 6 Acquisition ID#:

BRAND NAME JUSTIFICATION

General Services Administration Acquisition Regulation (GSAR) 538.7104-4

Acquisition Plan Action ID: Tracking Number:

(1) Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office (NCO) 19, 6162 S Willow Drive, Suite 300, Greenwood Village, CO 80111 in support of Salt Lake City Health Care System (SLCHCS) at George E. Wahlen VA Medical Center, 500 Foothill Dr., Salt Lake City, UT 84148.

2237 #:

(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 purpose of this requirement is to establish a new, firm-fixed-price task order under one of two existing Federal Supply Schedule (FSS) contracts for the one-time purchase of Karl Storz video equipment and a base year plus four option-years (+4OYs) comprehensive support services. The Karl Storz video equipment is vital for SLCHCS to perform urology and Ear, Nose, Throat (ENT)/Otolaryngology surgical procedures in its operating rooms (ORs) for Veteran patients.

Order against: FSS (Federal Supply Schedule) Contract Number: 36F79723D0185

Name of Proposed Contractor: Karl Storz Endoscopy-America (YF3JPZJUAJ14) Street Address: 2151 E. Grand Ave.

City, State, Zip: El Segundo, CA 90245 Phone: (714) 814-6839

Order against: FSS (Federal Supply Schedule) Contract Number: 36F79719D0097

Name of Proposed Contractor: L1 Enterprises (RK5ZXQ77CN73) Street Address: 618 W. Patrick St.

City, State, Zip: Frederick, MD 21701 Phone: (301) 785-6434

(3) Description of Supplies or Services:

The estimated value of the proposed action is

GSAR 538.7104-4 Brand Name Justification Page 3 of 6

(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.

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by GSAR 538.7104-4. Mark the applicable exception:

BRAND NAME (GSAR 538.7104-4)

Items peculiar to one manufacturer: The particular brand name, product, or feature is essential to the ordering activity’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the need GSAR 538.7104-4(b)(1).

The SLCHCS currently has two ongoing contracts for leasing Karl Storz endoscopes that are used for urology and ENT/Otolaryngology surgical procedures. It is standard practice for surgeons to use corresponding video equipment with these endoscopes during procedures to view real-time digital images of the patient’s urinary tract, nasal cavity, and/or sinus openings. The manufacturer of the endoscopes, Karl Storz, has confirmed their technology is proprietary and that no other brand of video scope is compatible with their endoscopes. As a result, in order to continue using the leased urology and endo-sinus endoscopes and VA-owned Karl Storz integrated video tower/console systems, only Karl Storz brand video equipment can be acquired for use with these scopes in surgical procedures. All brands (Karl Storz, Stryker, Olympus) may be used in the same space, but they are not interchangeable within specific types of surgical procedures such as urology and ENT.

Competing manufacturers (such as Olympus or Stryker) cannot interface with Karl Storz urology and ENT full integrated video tower/console systems. As a result, acquiring any non-Karl Storz scopes or peripherals would require SLCHCS to replace the entire existing Karl Storz fully integrated video tower/console systems for urology and ENT procedures currently valued at more than in Government-owned and leased equipment. Additional costs include required facility adjustments, revalidation of sterile processing workflows, extensive staff retraining for surgeons, Operating Room (OR) nurses, and clinical engineering personnel, and multiple cancellations of scheduled procedures while the ORs are closed for installation and implementation of a new system.

In contrast, the purchase of Karl Storz video equipment and components for urology and ENT endoscopes and comprehensive maintenance service cover for the base +4OYs total is:

. The requirement for Karl Storz video equipment and components are fully compatibility with the medical center’s already-owned and leased Karl Storz equipment.

Maintaining Karl Storz brand continuity avoids complete system replacement costs for urology and ENT equipment, disruption to patient care and surgical scheduling, loss of imaging

GSAR 538.7104-4 Brand Name Justification Page 4 of 6 capability during removal and installation, revalidation of sterile processing workflows, and retraining of ENT and Urology staff.

Karl Storz has verified they have only one authorized distributor of their equipment, L1 Enterprises. Both Karl Storz and L1 Enterprises have established FSS contracts for the video equipment.

(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7104-4 to aid the contracting officer in making this best value determination:

The requirement is determined to be fair and price-reasonable from comparing the initial FSS quotes from Karl Stroz and L1 Enterprises against the Independent Government Cost Estimate (IGCE) to make a best-value determination.

(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 cannot be met with this requirement since L1 Enterprises is the only authorized distributor for the large business manufacturer, Karl Storz.

Numerous email exchanges occurred with the manufacturer, Karl Storz, between 5/5/2026 – 7/20/2026, regarding their authorized distributors, country of origin for equipment, and delivery lead times. Karl Storz provided a formal document on 5/28/2026 confirming their products can only be purchased through Karl Storz or their sole authorized distributor, L1 Enterprises. Both Karl Storz and L1 Enterprises have active FSS contracts. The document also confirmed the software used with their equipment is proprietary. Therefore, no other brand equipment may be substituted for the Karl Storz brand.

Contracts #36C25925P0251 and #36C25925P0012, which cover corresponding leased scopes and equipment for the SLCHCS, were reviewed. The SLCHCS has also previously purchased additional Karl Storz equipment that remains in use in the operating rooms. To ensure continuity and compatibility, the equipment required under this new procurement must integrate with both the Karl Storz equipment currently leased under contracts #36C25925P0251 and #36C25925P0012, as well as the equipment previously purchased.

A review of the Supply Chain Master Catalog using the keyword “Karl Storz” found no mandatory Strategic Acquisition Center (SAC) or National Acquisition Center (NAC) contracts.

Several Medical/Surgical Prime Vendor (MSPV) contracts with Concordance and Medline were identified; however, Karl Storz confirmed that these contracts cover only single-use disposable items. Karl Storz no longer works with those vendors due to significant consolidation within the MSPV program. As of May 2026, L1 Enterprises is the sole MSPV distributor.

Analytics, Data, and Decision Support Unified Platform (ADDS UP) was reviewed to verify items needed in this requirement are included in the FSS contracts for both Karl Storz