ATTACHMENT A - Statement of Work Visual Field Analyzer.pdf

Statement of Work (SOW) Visual Field Analyzer Procurement and Implementation

Gallup Indian Medical Center (GIMC), Eye Clinic

1. Background

1.1. The Eye Clinic at Gallup Indian Medical Center provides comprehensive ocular and vision care for patients with conditions that can cause irreversible vision loss.

1.2. Visual field testing is essential for diagnosing, monitoring, and managing ocular and neurological conditions such as glaucoma, stroke, optic neuropathies, and compressive lesions.

1.3. The absence of a functional visual field analyzer limits the clinic’s ability to provide care in accordance with the standard of practice and restricts its diagnostic and management capabilities.

1.4. Procurement of a new visual field analyzer will ensure continuity of care, compliance with current clinical standards, and enhanced diagnostic accuracy in ophthalmic services.

2. Objectives

2.1. The objective of this contract is to provide a fully functional visual field analyzer that meets all performance, compatibility, and safety requirements.

2.2. Specific goals include:

2.2.1. Acquisition and installation of the visual field analyzer.

2.2.2. Integration of the equipment into existing clinic infrastructure.

2.2.3. Training of all designated clinical staff.

2.2.4. Establishment of warranty and maintenance support.

2.2.5. Compliance with all applicable federal procurement, safety, and clinical standards.

3. Scope of Work

3.1. The contractor shall provide one (1) complete visual field analyzer system including delivery, installation, calibration, training, documentation, and warranty support.

3.2. The contractor shall:

3.2.1. Supply all required equipment, accessories, and software necessary for operation.

3.2.2. Deliver and install the system at the Gallup Indian Medical Center Eye Clinic.

3.2.3. Conduct on-site training for clinic personnel.

3.2.4. Perform calibration and validation tests.

3.2.5. Provide ongoing service and support throughout the warranty period.

4. Period of Performance

4.1. The period of performance begins upon issuance of the purchase order.

4.2. Delivery shall occur within the time frame specified in the order, typically within forty-five (45) calendar days.

4.3. Installation and training shall be completed within ten (10) business days of delivery.

Gallup Indian Medical Center (GIMC), Eye Clinic

4.4. The warranty shall commence on the date of government acceptance and remain in effect for a minimum of one (1) year.

5. Deliverables

5.1. The contractor shall furnish the following deliverables:

5.1.1. One (1) visual field analyzer meeting all technical specifications.

5.1.2. Ancillary equipment such as tables, power cords, and accessories.

5.1.3. User manuals, service manuals, calibration certificates, and warranty documentation.

5.1.4. Comprehensive training for up to 12 clinical staff members.

5.1.5. Installation verification report and performance validation checklist.

5.1.6. Training completion documentation.

6. Technical and Commercial Specifications

6.1. The visual field analyzer shall meet or exceed the following minimum specifications:

6.1.1. Maximum temporal range: 90 degrees.

6.1.2. Bowl illumination: 31.5 ASB.

6.1.3. Testing distance: 30 centimeters.

6.1.4. Test capabilities: 24-2, 30-2, 10-2, 24-2C, 60-4, Nasal Step, Macula, Esterman

Monocular, and Esterman Binocular.

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

6.1.6. DICOM compatibility for EMR/EHR integration.

6.1.7. Automated Guided Progression Analysis (GPA) reporting.

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

6.1.9. Embedded touchscreen interface with internal patient database and data backup functionality.

6.1.10. Connectivity: Ethernet and USB (wireless optional).

6.1.11. Calibration: self-calibration capability with daily or scheduled prompts.

6.1.12. Power: 100–240 V, 50/60 Hz.

6.1.13. Dimensions: approximately 23 inches (H) × 20 inches (W) × 18 inches (D).

6.1.14. Weight: not to exceed 63 pounds.

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

7. System Integration and Connectivity

7.1. The visual field analyzer shall integrate with the Gallup Indian Medical Center (GIMC) secure network and existing electronic health record (EHR) infrastructure in accordance with Indian Health Service (IHS) and Department of Health and Human Services (HHS) information security and interoperability standards.

7.2. Network Configuration

7.2.1. The equipment shall connect to the facility’s internal network via secure Ethernet connection or approved wireless configuration in compliance with IHS Office of Information Technology (OIT) policies.

7.2.2. The analyzer shall not require direct internet access. All communications shall occur through the internal, firewalled IHS network environment.

7.2.3. The contractor shall coordinate with Biomedical Engineering and IT Services for network validation, port authorization, and device security scanning prior to deployment.

7.3. System Interoperability

7.3.1. The visual field analyzer shall be fully DICOM-compatible, supporting the transmission of diagnostic data and images to the facility’s Picture Archiving and Communication System (PACS) or other approved imaging repository.

7.3.2. The analyzer shall support bidirectional data exchange, enabling patient demographic import and test result export consistent with IHS EHR workflows.

7.3.3. The system shall be capable of producing standardized digital reports (PDF, DICOM, or HL7 formats) for automated or manual integration into the Resource and Patient Management System (RPMS) or successor EHR systems.

7.3.4. The contractor shall ensure configuration aligns with RPMS and VistA Imaging or Cerner-based modernization systems currently in use at GIMC.

7.4. RPMS / EHR Integration

7.4.1. The analyzer shall enable storage and retrieval of visual field test data within the patient’s longitudinal record in RPMS or associated EHR systems.

7.4.2. Data exchange shall include, at minimum: patient name, date of birth, medical record number, examination date, test type, and visual field result files.

7.4.3. Integration shall permit authorized clinicians to access visual field results directly from the patient’s chart without separate login or manual re-entry of patient information.

7.5. Security and Compliance Requirements

7.5.1. The contractor shall comply with IHS IT Security Policy, HIPAA, and HITECH regulations concerning data integrity, access control, and transmission security.

7.5.2. The analyzer’s software shall support role-based access, password protection, and audit logging.

7.5.3. All data transmissions shall be encrypted using secure protocols (e.g., TLS 1.2 or higher).

7.5.4. Any connection to the IHS network must be approved by the local Information

Systems Security Officer (ISSO) prior to go-live.

7.6. System Testing and Validation

7.6.1. The contractor shall perform connectivity and data transfer testing with the facility’s PACS/EHR environment before final acceptance.

7.6.2. A written System Integration Validation Report shall be provided, documenting successful data transmission, user access, and compliance verification.

7.6.3. The report shall be reviewed and signed by the Contracting Officer’s Representative (COR), Biomedical Engineering, and IT representatives.

8. Installation and Training

8.1. The contractor shall install the equipment in the designated Eye Clinic testing room.

8.2. Installation shall include power configuration, system calibration, and verification of network connectivity.

8.3. On-site training should cover operation, data management, maintenance, and troubleshooting.

8.4. The contractor shall provide a written training completion certificate to the Contracting

Officer’s Representative (COR).

9. Performance and Quality Assurance

9.1. The contractor shall perform acceptance testing and calibration validation during installation.

9.2. All performance parameters must meet manufacturer specifications prior to acceptance.

9.3. A Performance Verification Report shall be completed and signed by the COR.

9.4. Any deviations from specifications shall be corrected prior to final acceptance.

10. Maintenance and Service

10.1. The contractor should provide preventive maintenance according to manufacturer guidelines at least annually.

10.2. Service response time for onsite repairs shall not exceed seventy-two (72) hours following notification.

10.3. All service personnel must be manufacturer certified.

10.4. The contractor should provide remote technical support and software updates during the warranty period.

11. Procurement and Compliance

11.1. All activities under this contract shall comply with applicable Federal Acquisition

Regulations (FAR), Health and Human Services Acquisition Regulations (HHSAR), and Indian Health Service (IHS) procurement policies.

11.2. Contractors must:

11.2.1. Be registered and active in SAM.gov.

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

11.2.3. Ensure all equipment meets FDA medical device regulations.

Gallup Indian Medical Center (GIMC), Eye Clinic

12. Documentation and Reporting

12.1. The contractor shall provide Installation and Acceptance Report, Preventive Maintenance Schedule, Operation and Service Manuals, Calibration Certificates, Warranty Documentation, and Training Attendance Record.

13. Risk Management and Safety

13.1. All equipment shall conform to FDA, ISO, ANSI, and IEC safety standards for medical electrical equipment.

13.2. The system shall include patient-safety features such as overheat protection and automatic test abort.

13.3. The contractor shall supply Material Safety Data Sheets (MSDS) if applicable.

14. Budget and Cost

14.1. The total cost shall include all equipment, delivery, installation, training, warranty, and service fees.

14.2. No additional charges shall be authorized without prior written approval from the Contracting Officer.

14.3. A detailed cost breakdown must be submitted with the proposal.

15. Government-Furnished Property

15.1. No government-furnished property will be provided.

16. Contractor-Furnished Property

16.1. The contractor shall provide all tools, cables, and consumables required for delivery, installation, and setup.

17. Security Requirements

17.1. No special security clearance is required.

17.2. Contractor personnel must check in with Gallup Indian Medical Center Security and follow all facility access procedures.

18. Place of Performance

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

87301.

19. Acceptance Criteria

19.1. Acceptance shall be based on successful delivery, installation, operational verification, completion of staff training, and written acceptance by the COR.

20. Warranty

20.1. The contractor shall provide a minimum one-year comprehensive warranty covering parts, labor, and onsite service.

20.2. Extended warranty options shall be available for up to five (5) years.

20.3. All repairs or replacements during the warranty period shall be provided at no additional cost to the government.

21. Hours of Operation:

21.1. Normal hours of operation are Monday through Friday from 8:00am to 4:30pm, excluding national holidays. All deliveries/pick-ups shall be performed during normal working hours.

21.2. Federal Holidays observed by the government are Columbus Day, Veterans Day, Christmas Day, New Year’s Day, Martin Luther King Jr. Birthday, Presidents Day, Memorial Day, Juneteenth, Independence Day, and Labor Day.

22. Points of Contact

22.1. Project Lead: Dr. William Thibodeaux, Optometrist, (505) 722-1326, William.thibodeaux@ihs.gov

22.2. COR: Clarissa John, CIO, (505) 726-8664, Clarissa.john@ihs.gov mailto:William.thibodeaux@ihs.gov

7. System Integration and Connectivity