Gallup Indian Medical Center: Brand Name Visual Field Analyzer

Statement of Work (SOW)

To provide a fully functional visual field analyzer that meets all performance, compatibility, and safety requirements for the Eye Clinic at Gallup Indian Medical Center (GIMC). This will ensure continuity of care, compliance with clinical standards, and enhanced diagnostic accuracy.

• Provide one (1) complete visual field analyzer system.

• Supply all required equipment, accessories, and software.

• Deliver and install the system at the GIMC Eye Clinic.

• Conduct on-site training for up to 12 clinical staff members.

• Perform calibration and validation tests.

• Provide ongoing service and support throughout the warranty period.

• Begins upon purchase order issuance.

• Delivery within 45 calendar days.

• Installation and training within 10 business days of delivery.

• Minimum one-year comprehensive warranty covering parts, labor, and onsite service.

• Maximum temporal range: 90 degrees.

• Bowl illumination: 31.5 ASB.

• Testing distance: 30 centimeters.

• Test capabilities: 24-2, 30-2, 10-2, 24-2C, 60-4, Nasal Step, Macula, Esterman Monocular, and Esterman Binocular.

• Threshold strategies: SITA Standard, SITA Fast, SITA Faster, Full Threshold, and SITA-SWAP.

• DICOM compatibility for EMR/EHR integration.

• Automated Guided Progression Analysis (GPA) reporting.

• Automated eye alignment with video eye monitor, gaze tracking, head tracking, and vertex monitoring.

• Embedded touchscreen interface.

• Connectivity: Ethernet and USB (wireless optional).

• Self-calibration capability.

• Dimensions: approx. 23" H x 20" W x 18" D.

• Weight: not to exceed 63 pounds.

• Compliance with FDA 510(k), ISO 13485, and IEC 60601 standards.

• Integrate with GIMC's secure network and existing EHR infrastructure.

• DICOM-compatible for transmission to PACS or imaging repository.

• Support bidirectional data exchange with EHR systems.

• Produce standardized digital reports (PDF, DICOM, or HL7 formats).

• Align with RPMS and VistA Imaging or Cerner-based modernization systems.

• Enable storage and retrieval of visual field test data within the patient's longitudinal record.

• Data exchange to include patient name, DOB, MRN, exam date, test type, and results.

• Comply with IHS IT Security Policy, HIPAA, and HITECH regulations.

• Software to support role-based access, password protection, and audit logging.

• Encrypted data transmissions using secure protocols (e.g., TLS 1.2 or higher).

• Install equipment in the designated Eye Clinic testing room.

• Include power configuration, system calibration, and network connectivity verification.

• On-site training to cover operation, data management, maintenance, and troubleshooting.

• Provide preventive maintenance annually.

• Onsite repair response time not to exceed 72 hours.

• Service personnel must be manufacturer certified.

• Provide remote technical support and software updates during the warranty period.

• Comply with FAR, HHSAR, and IHS procurement policies.

• Contractors must be registered and active in SAM.gov.

• Comply with the Buy American Act and Trade Agreements Act.

• Ensure equipment meets FDA medical device regulations.

Gallup Indian Medical Center, Eye Clinic, 516 East Nizhoni Blvd., Gallup, NM 87301.

• Successful delivery, installation, operational verification, completion of staff training, and written acceptance by the COR.

• Project Lead: Dr. William Thibodeaux

• COR: Clarissa John

Solicitation / RFP / RFQ

This solicitation is for the procurement of a Carl Zeiss HFA3 Model 860, Visual Field Analyzer. The acquisition is set aside 100% for small businesses.

• The primary deliverable is the Carl Zeiss HFA3 Model 860, Visual Field Analyzer.

• The Statement of Work (SOW) referenced as Attachment A details the specific requirements.

• The contract type is not explicitly stated, but it is an "Order for Commercial Items."

• The period of performance is not detailed in this document.

• The offer due date is April 9, 2026, at 1300 MDT.

• The solicitation number is 75H71026Q00128.

• The North American Industry Classification Standard (NAICS) code is 339115, with a size standard of 1,000 employees.

• This acquisition is a 100% Small Business Set-Aside.

• The solicitation incorporates FAR clauses 52.212-1, 52.212-4, and 52.212-3 by reference. FAR 52.212-5 and any addenda are attached.

• Payment requests are to be submitted electronically through www.ipp.gov, as per clause 352.232-71.

Form / Attachment / Pricing Sheet

This document is a Justification to Restrict Competition, indicating that the government intends to sole-source the procurement of a specific brand-name item. It explains the rationale for limiting competition to a single source.

• Agency: U.S. Department of Health and Human Services, Indian Health Service, Navajo Area, Gallup Service Unit.
• Sole Source: Carl Zeiss Meditec, Inc. (Zeiss Humphrey).
• Supplies/Services: Procurement, delivery, installation, and support of one (1) Zeiss Humphrey Visual Field Analyzer system (HFA3 Model 860) for the Gallup Indian Medical Center (GIMC) Eye Clinic.
• System Use: To diagnose and monitor patients with vision-threatening conditions.
• Contractor Responsibilities: Includes delivery, installation, system calibration, validation, on-site training, integration with IHS RPMS/VistA/Cerner systems, and warranty/maintenance support.
• Delivery Timeline: Approximately 45 calendar days for delivery, with installation and training completed within 10 business days after delivery.
• Justification: The Zeiss Humphrey system is the only one that provides proprietary SITA testing algorithms, Guided Progression Analysis (GPA), full DICOM compatibility with seamless integration with IHS systems, and advanced eye tracking features. Alternatives would require significant middleware, third-party integration, or result in diminished diagnostic accuracy and increased implementation risk. The current system is at end-of-life, necessitating timely procurement.

This document signals a sole-source procurement, meaning that direct competition is not expected. Vendors who do not offer the specified brand-name product or cannot meet the unique technical and integration requirements may not be eligible to bid on this specific opportunity as currently defined.

Form / Attachment / Pricing Sheet

This document is Appendix C: Business Associate Agreement, which is attached to and fully incorporated into the main contract. It outlines the terms and conditions under which a "Business Associate" must handle Protected Health Information (PHI) when performing services for the Indian Health Service (IHS), the "Covered Entity."

• Definitions: Defines key terms such as Business Associate, Covered Entity, HIPAA Rules, and Master Patient Index (MPI).
• Obligations and Activities of Business Associate: Details requirements for compliance with HIPAA Rules, handling of subcontractors, safeguarding PHI (including electronic PHI), reporting unauthorized uses/disclosures and breaches, individual access to PHI, accounting of disclosures, amendment of PHI, and carrying out Covered Entity's obligations.
• Permitted Uses and Disclosures: Specifies how the Business Associate may use or disclose PHI, generally limited to performing functions for the Covered Entity, with individual authorization, or for treatment, payment, or healthcare operations, and in compliance with HIPAA Rules and minimum necessary policies.
• Obligations of Covered Entity: Outlines what the IHS must provide to the Business Associate, such as its Notice of Privacy Practices and any limitations or restrictions.
• Termination: Defines the term of the agreement, termination for cause, obligations upon termination (including returning or destroying PHI), and survival of obligations.
• Indemnification: Requires the Business Associate to reimburse the Covered Entity for costs related to investigations or legal actions arising from non-compliance with HIPAA Rules.

Vendors responding to the opportunity must understand and agree to the terms of this Business Associate Agreement if their work involves accessing, using, or disclosing Protected Health Information (PHI) on behalf of the IHS. This document is critical for ensuring compliance with HIPAA regulations and protecting sensitive patient data. Bidders should review these obligations carefully as they pertain to their proposed services and capabilities.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, specifically a Request for Quotation (RFQ) for a Carl Zeiss Brand - Visual Field Analyzer. The acquisition is a 100% Small Business Set-Aside. The North American Industry Classification System (NAICS) code is 339115 - Ophthalmic Goods Manufacturing, with an employee size standard of 1,000.

• The primary deliverable is one (1) HFA3 Model 860 – Carl Zeiss Visual Field Analyzer.

• Delivery is required within 45 days After Receipt of Order (ARO) and is FOB Destination.

• The solicitation includes a Statement of Work (SOW) and Brand Name Justification as an attachment.

• The contract type is not explicitly stated, but it is an RFQ for commercial products/services.

• Delivery is 45 Day ARO.

• Offerors must submit proposals in three volumes:

  • Volume 1: Administrative Documents (Signed SF-1449, SF30 amendments, representations and certifications).
  • Volume 2: Technical Specifications and Delivery/Schedule (detailed technical description, product literature, feasibility/conceptual designs, manufacturing, delivery, and installation schedule).
  • Volume 3: Price (total price, price components, and supporting narrative).

• Quotations failing to address all volumes will be marked "Non-Responsive."

• Evaluation will be based on the Lowest Priced Technically Acceptable (LPTA) method.

• Key deadlines:

  • Quote Due Date: April 9, 2026, 1:00 PM Mountain Daylight Time.
  • Location for Submission: Gallup Indian Medical Center.

• This acquisition is a 100% Small Business Set-Aside.

• The solicitation incorporates provisions and clauses by reference, accessible electronically at www.acquisition.gov and www.acquisition.gov/hhsar.

• Addenda are included to FAR provision 52.212-1.

• For additional information or questions, contact Adrian.Segay@ihs.gov.