36C261-26-AP-2840-FY26-1984 JOFOC NCO21 Leica Operatin Print_Redacted.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C261-26-AP-2840

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAM Subpart 538.71— Federal Supply Schedule Ordering Procedures

Acquisition Plan Action ID: 36C261-26-AP-2840 JOFOC Tracker 26: FY26-NCO 21-1554

(1) Contracting Activity: Department of Veterans Affairs (VA), Office of Acquisition, Logistics, and Construction (OALC), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Networks (VISN) 21, VA Palo Alto Health Care System (VAPAHCS).

2237: 640-26-3-394-0044

(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 action being reviewed and approved is a new requirement for a sole source delivery order with Melling LLC, dba Melling Medical, a Service-Disabled Veteran-Owned Small Business (SDVOSB).

Order against: FSS Contract Number: 36F79722D0189

Name of Proposed Contractor: Melling LLC, dba Melling Medical

Street Address: 658 S. COLUMBUS ST

City, State, Zip: ALEXANDRIA, VA 22314

Phone: (844) 635-5464

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 1,024,738.24

All deliverables are required within six (6) months after receipt of award (6 months ARO).

VAPAHCS requirement covers two neurosurgical-grade surgical microscopes, Leica ARveo 8x Hybrid, and Leica M530 OHX (ULT530), with advanced fluorescence/AR visualization, deep-cavity illumination, and integrated digital workflows, including PACS/DICOM and neuronavigation.

The two operative microscopes currently supporting Ear, Nose, and Throat (ENT) and Neurosurgery services at the VA Palo Alto Health Care System have

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C261-26-AP-2840 reached their manufacturer-designated end-of-life status. As a result, the microscopes can no longer be reliably supported with parts, software updates, or factory-certified service. This lifecycle replacement is therefore essential to maintain existing surgical capability and ensure uninterrupted delivery of complex surgical care.

(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.

GSAM 538.7104-3(b)(i): The need is of such unusual urgency that following the procedures would result in unacceptable delays in fulfilling that need:

GSAM 538.7104-3(b)(ii): Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized:

At VAPAHCS, Neurosurgery and ENT services are fully standardized on Leica systems, and this requirement is a lifecycle replacement of existing Leica equipment. Leica platforms support established clinical workflows, surgeon proficiency, and specialized visualization technologies.

Carl Zeiss Meditec (CZM) (Germany) is one of the manufacturers of neurosurgical grade operating room microscopes. Although CZM produces comparable microscope classes, no vendors responding to market research proposed CZM solutions meeting VAPAHCS’s technical or integration needs. CZM systems are not fully interoperable without significant integration work, added cost, and potential downtime. Transitioning to CZM would require revalidating procedures, introduce clinical variability, and create unnecessary risks to surgical efficiency and patient safety.

Domestic manufacturers, including Seiler Medical, were evaluated but do not make neurosurgical-grade microscopes comparable to the Leica ARveo 8x or M530 OHX; their available models lack the capabilities required for modern neurosurgical and advanced ENT procedures.

VAPAHCS operating rooms are already built around Leica-integrated components, including PACS/DICOM workflows, neuronavigation interfaces, optical accessories, and digital documentation systems. Staff are fully trained and credentialed on Leica systems, and switching manufacturers would require retraining and could reduce Operating Room throughput. The Government’s minimum requirements rely on Leica-specific capabilities such as fluorescence imaging workflows, augmented visualization, and integrated safety/illumination features critical to maintaining clinical continuity and significantly impacting Veteran patient care.

Therefore, the appropriate procurement method is a sole-source order to Melling LLC, dba Melling Medical, a Service-Disabled Veteran-Owned Small Business.

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GSAM 538.7104-3(b)(iii): The order should be issued on a sole source basis in the interest of economy and efficiency because it is a logical follow-on to an FSS order already issued on a competitive basis:

GSAM 538.7104-3(b)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA:

GSAM 538.7104-3(b)(v): A law expressly authorizes or requires that the purchase be made from a specified source:

(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAM 538.7102-2(b)(4) to aid the contracting officer in making this best value determination:

By placing an order against a schedule contract, the ordering activity has concluded that the order represents the best value. Although the General Services Administration (GSA) has already negotiated fair and reasonable pricing, the Contracting Officer will seek an additional discount before awarding the 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 identified Leica Microsystems (Singapore) and Carl Zeiss Meditec (CZM) (Germany) are the only major manufacturers of neurosurgical grade operating room microscopes.

Small Business Administration’s (SBA’s) Small Business Search (SBS) database was used to identify certified capable Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB). The database search utilizing NAICS code 339112 Surgical and Medical Instrument Manufacturing yielded sixteen (16) SDVOSB and VOSB matches.

A Sources Sought Notice was posted on Contracting Opportunities (36C26126Q0477) on 03/11/2026 and closed on 03/25/2026.

Two responses were received from SAM.gov posting:

Melling Medical, a SDVOSB selling surgical microscopes, Leica ARveo 8x Hybrid and Leica M530 OHX (ULT530) from Singapore. BHPE LLC, the vendor provided no relevant information for supplying two stand- mounting surgical operating microscope systems, instead proposing to develop a custom solution, which is not suited for this procurement.

Sources Sought Notice was also posted on GSA e-Buy and seven (7) vendors responded to the notice, Truer Medical, Inc, Electramed Corporation, Surgical Tools, Inc., Alpin Surgical

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Specialties, Inc., Marathon Medical Corporation, Beacon Point Associates, LLC, and Geo-Med, LLC. None of these vendors indicated selling surgical operating microscope systems.

As of June 1, 2026, the Leica ARveo 8x Hybrid and Leica M530 OHX are available under Melling Medical’s Federal Supply Schedule (FSS) contract (36F79722D0189).

(7) Any Other Facts Supporting the Justification: Melling Medical has provided satisfactory performance on previous acquisitions for NCO 21.

(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:

Future competition may be considered if VA Palo Alto elects to replace the existing Leica surgical microscope platforms at a later date. At that time, other manufacturers may be able to provide systems that demonstrate full interoperability with VA’s clinical infrastructure, meet all neurosurgical and ENT operational requirements, and support clinical continuity without disrupting patient care.

(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 GSAM Subpart 538.71.

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(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.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K):

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

HIGHER LEVEL APPROVAL (Required for orders over $900,000):

c. OALC RPO HCA Review and Approval (over $900,000 to $90 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 GSAM Subpart 538.71.