ATTACHMENT B - Justification to Restrict Competition - Brand Name - Visual Field Analyzer-Eye Clinic_Signed (001)_Redacted.pdf
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- Solicitation number
- 75H71026Q00128
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This is a Justification to Restrict Competition document for a below-simplified acquisition threshold (SAT) procurement by the U.S. Department of Health and Human Services, Indian Health Service, Navajo Area, Gallup Service Unit.
The Government requires procurement, delivery, installation, and support of one Zeiss Humphrey Visual Field Analyzer system (HFA3 Model 860) for the Gallup Indian Medical Center Eye Clinic. The system will diagnose and monitor patients with vision-threatening conditions including glaucoma, stroke, optic neuropathies, and neurological disorders affecting visual fields. Deliverables include the complete analyzer system, delivery and installation at the Optometry Department, system calibration and validation, on-site clinical staff training, integration with IHS RPMS/VistA/Cerner systems, and warranty and maintenance support. Delivery is required within approximately 45 calendar days, with installation and training completed within 10 business days after delivery.
The Contracting Officer justifies restricting competition to Carl Zeiss Meditec, Inc. (5160 Hacienda Drive, Dublin, CA 94568) as the only reasonably available source based on proprietary technical specifications unique to the Zeiss Humphrey system, including SITA testing algorithms (Standard, Fast, Faster, SWAP), Guided Progression Analysis for longitudinal disease tracking, full DICOM compatibility and seamless integration with IHS systems, and advanced eye tracking and gaze monitoring capabilities. Market research determined that competing vendors lack equivalent validated algorithms, cannot fully integrate with IHS systems without additional middleware, offer reduced automation features, and would require increased cost and implementation time. The justification emphasizes that the current analyzer is at end-of-life and procurement delays would negatively impact patient care. The document was prepared by Clarissa John, Chief Information Officer, and signed by Jerlyn Begay, Supervisory Contract Specialist, both dated 03/31/2026.
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Solicitation or Award Number: TBD Page 1 of 3
Rev. 09/30/2025
JUSTIFICATION TO RESTRICT COMPETITION (below SAT) Pursuant to Revolutionary FAR Overhaul (RFO) 12.102, for acquisitions valued at or below the simplified acquisition threshold (SAT) using RFO 12.201-1 Simplified Procedures for commercial products and services, the Contracting Officer (CO) hereby documents the decision that only one source is reasonably available.
1. Agency and Contracting Activity.
U.S. Department of Health and Human Services Indian Health Service, Navajo Area, Gallup Service Unit
2. Name and Address of Only Source.
Carl Zeiss Meditec, Inc. (Zeiss Humphrey) 5160 Hacienda Drive Dublin, CA 94568
3. Description of Supplies/Services and Estimated Cost.
***THIS ONLY JUSTIFIES THE BRAND NAME DESCRIBED AS FOLLOWS.***
The Government requires the procurement, delivery, installation, and support of one (1) Zeiss Humphrey Visual Field Analyzer system for the Gallup Indian Medical Center (GIMC) Eye Clinic.
This system will be used to diagnose and monitor patients with vision-threatening conditions such as glaucoma, stroke, optic neuropathies, and other neurological disorders affecting visual fields. Visual field testing is a critical diagnostic tool and is required to meet the standard of care.
The contractor shall provide:
One (1) complete visual field analyzer system (HFA3 Model 860) Delivery and installation at GIMC Optometry Department System calibration and validation On-site training for clinical staff Integration with IHS RPMS/VistA/Cerner systems Warranty and maintenance support
Delivery is required within approximately 45 calendar days, with installation and training completed within 10 business days after delivery, consistent with the Statement of Work.
4. Description of Circumstances, including why only one source is reasonably available.
Solicitation or Award Number: TBD Page 2 of 3
Rev. 09/30/2025
IAW RFO 11.204(a)(1), specific characteristics of the Zeiss Humphrey Visual Field Analyzer that limit availability to only one source are based on the findings below:
The Zeiss Humphrey system is the only visual field analyzer that provides:
Proprietary SITA testing algorithms (Standard, Fast, Faster, SWAP), which are the clinical standard for glaucoma diagnosis and management
Guided Progression Analysis (GPA) for longitudinal disease tracking Full DICOM compatibility and seamless integration with IHS RPMS/VistA/Cerner systems Advanced eye tracking, gaze monitoring, and automated alignment
These features are proprietary to Carl Zeiss Meditec, Inc. and are not available from other manufacturers.
Only this source can meet the Government’s requirements without requiring additional middleware, third-party integration, or reduced clinical capability. Any alternative would result in diminished diagnostic accuracy, increased implementation risk, and disruption to clinical workflows.
Additionally, the Optometry Department current visual field analyzer is at the end of life, and delays in procurement will negatively impact patient care, including delayed diagnosis and increased risk of irreversible vision loss.
5. Description of Market Research.
Market research was conducted to identify available visual field analyzer systems capable of meeting the Government’s requirements.
The Government reviewed commercially available products from multiple manufacturers.
While other vendors offer visual field analyzers, they were determined to be unacceptable for the following reasons:
Lack of validated proprietary algorithms equivalent to SITA and GPA Inability to fully integrate with IHS RPMS/VistA/Cerner systems without additional software or middleware Reduced automation features such as eye tracking and gaze monitoring Increased cost and implementation time due to required modifications
No other vendor was identified that could meet all minimum technical, clinical, and interoperability requirements.
Based on this market research, Carl Zeiss Meditec, Inc. remains the only responsible source capable of fulfilling this requirement.
File details come from the government source that posted it. Updated .