Attachment A.pdf

STATEMENT OF WORK

GALLUP INDIAN MEDICAL CENTER

Project: Point of Care Ultrasound Units

PURPOSE OF CONTRACT: The Gallup Indian Medical Center (GIMC), part of the Navajo Area Indian Health Services (NAIHS) located in Gallup, NM, and Tohatchi Health Center (THC) are requesting eight (8) portable point of care ultrasound machines: Seven (7) for GIMC and one (1) ultrasound machine for the THC clinic.

GENERAL: Contractor shall furnish all necessary equipment and supplies for the successful delivery and performance of new equipment required by the Biomedical Engineering Department.

Background: IHS is an agency within the U.S. Department of Health and Human Services and is responsible for providing federal health services to American Indians and Alaska Natives. The provision of health services to members of federally recognized tribes grew out of the special government to government relationship between the federal government and Indian Tribes. The goal is to ensure comprehensive, culturally acceptable personal and public health services are available and accessible to American Indians and Alaska Natives. The IHS currently provides health services to approximately 1.5 million American Indians and Alaska Natives who belong to more than 557 federally recognized tribes in 34 states.

Navajo Area Indian Health Service (NAIHS) administers health centers and hospitals providing health care to approximately 201,583 members of the Navajo Nation. The Navajo Nation is the largest Indian tribe in the United States and has the largest reservation, which encompasses more than 25,516 square miles in northern Arizona, western New Mexico, and southern Utah, with three satellite communities in central New Mexico. The NAIHS is the primary provider of inpatient, ambulatory care, preventive and community health, and environmental health services for members of the Navajo Nation and the San Juan Southern Paiute Tribe.

Gallup Indian Medical Center (GIMC) is a 75-bed hospital in Gallup, New Mexico, on the border of the Navajo Reservation. Clinical specialties at GIMC includes Internal Medicine, Cardiology, Anesthesia, OB/ GYN, General Surgery, Orthopedics, Ophthalmology, ENT, Radiology, Pathology, Pediatrics, Psychiatry, Emergency Medicine, and Urology. The workload at Gallup is one of the largest in the Indian Health Service with 380,000 out patient encounters and 3,300 inpatient admissions annually. GIMC has the largest staff of all Navajo Area IHS facilities.

Attachment A

Tohatchi Health Center (THC) is located in the southeastern portion of the Navajo Nation approximately 25miles north of Gallup. THC is an outpatient health care facility staffed by primary care providers and specialty clinics are operated by consultant staff from Gallup Indian Medical Center (GIMC). It provides services for approximately 8,000 nearby residents. In addition to pediatrics, internal medicine and family medicine, services provided include pharmacy, laboratory, public health nursing, optometry, dentistry and health education.

STATEMENT OF WORK: The Gallup Indian Medical Center is procuring seven (7) point of care ultrasound machines and the Tohatchi Health Center is procuring one (1) point of care ultrasound machine, for a total of eight (8) machines purchased as part of this Statement of Work. The GIMC Emergency Department is the program office requesting this purchase and will accept procurement responsibility, however the following departments will be considered a part of this consolidated purchase: GIMC Emergency Department (3 machines), GIMC Internal Medicine Department (1 machine), GIMC Family Medicine Department (1 machine), GIMC Anesthesiology Department (1 machine), GIMC Intensive Care Unit (1 machine), and the Tohatchi Health Center Family Medicine Department (1 machine). The items to be acquired shall match the features and functions described.

1. TECHNICAL REQUIREMENTS AND SPECIFICATIONS: The items to be acquired shall match the features and functions identified below in Table 1. Additionally, the acquired items will have DICOM compatibility and certification on the VA VistA Imaging Approved DICOM Modality Interfaces list to ensure seamless integration with IHS and VA imaging systems, as well as USB and wireless data transfer options for image export and review.

2. SYSTEM OPERATIONS AND RELIABILITY, INSTALLATION, ACCEPTANCE AND

COMMISSIONING, TRAINING OF PROVIDERS AND OEM TRAINING:

a. Shall include two (2) Operator’s manual or digital equivalents for the Ultrasound Imaging systems delivered.

b. Reliability: The system must be protected against the loss of acquired images and data. For this reason, the vendor must supply an Uninterruptible Power Supply (UPS) with Surge Protector and sufficient capacity to support the computer system/image storage in case of power failure, and guarantee against loss of information. Provide details of the UPS system offered.

c. Training: The supplier must provide an application specialist for an adequate period of time for the training of all involved groups of personnel (up to two weeks or more, if needed). All manuals must be updated appropriately to reflect each new software update release and implementation phase.

3. WARRANTY, MAINTENANCE CONTRACT, TRAINING OF SERVICE ENGINEERS,

MANUFACTURER SUPPORT AND SOFTWARE HARDWARE UPDATES AND

UPGRADES FOR THE ULTRASOUND SYSTEMS:

a. Warranty and Service Contract Periods: The Ultrasound Imaging systems offered will have a Total Care Accidental Damage Coverage Ultrasound System and 3 Probes under Standard Warranty (4 exchanges over term) starting on the date of successful completion of the acceptance testing of the unit.

b. All updates related to the safety and reliability of the system shall be made available at no-cost during both the warranty period and during the service contract.

c. During the warranty and service contract periods, the Tenderer must cover parts (including all probes), labor, and all associated costs, including damages caused by power failure.

d. Corrective Maintenance work services during the warranty and maintenance contract duration under this contract must be available from Monday to Friday with an exception of Federal Holidays, and must be available from 8:00 AM to 5:00 PM.

e. A commitment to provide a full support of ten (10) years after “End of Life” of the system. This will include repair parts and technical support.

f. Training for Service Engineers: Must include two (2) Service Engineer (Bio- Med) OEM Training to be included in the purchase.

g. The Ultrasound Imaging System must have the capabilities for remote diagnose for troubleshooting should the system experience malfunctions.

h. Manufacturer support, software and hardware updates and upgrades: The Tenderer must provide all updates/upgrades of software on the Operating System for ten (10) years free of charge.

i. The contractor shall provide all necessary equipment, supplies, labor, and travel for the successful removal of the old ultrasound equipment and the installation and performance of the new ultrasound imaging system in the required area of the Radiology Department.

j. Provide a five (5) year cost of ownership detailing all charges that we can expect over the first five (5) years of ownership.

k. In a response, state who will be responsible for software up-grade/updates during warranty & when warranty expires, will it be the responsibility of GIMC or vendor to cover the cost.

l. Provide a detailed cost of a service agreement after warranty expires for services such as emergency repairs and preventive maintenance on the system. The contractor shall respond within two (2) hours of contact (telephone) and a service call shall be resolved within a minimum of 4 hours after contact if need to be on-site.

4. SCHEDULE

a. Submit a proposed installation schedule allowing for removal of old system and installation of new system. This schedule shall reflect a “rolling” transition so as to ensure maximum monitor coverage at all times. This schedule will be coordinated with the Government Project Officer/COR.

b. Normal hours of operation: 8 Hour days between 8:00am – 5:00 pm, Monday through Friday, excluding federal holidays. Overtime and holiday pay are not authorized. However, some services may be required to be performed after normal hours of operation. In this case, the contractor shall coordinate times and access to the building with the On-Site Project Officer.

5. REVIEW AND APPROVAL

a. Review and evaluation of the overall performance of this contract is the responsibility of the Contracting Officer. Unless otherwise specified in writing, the Contracting Officer’s Representative (COR) is the delegated authority to accept or reject supplies and services delivered under this contract following necessary review.

b. The government reserves the right to consider changing the method of inspection from Periodic to 100% Inspection at any time; however, deteriorating contractor performance may result in immediate 100% surveillance.

c. The contractor shall provide itemized repair service invoices. All correspondence invoices shall include the current purchase order number.

All repairs shall be completed according with all terms within this Statement of Work.

d. The Contracting Officer's Representative (COR) will be responsible for verifying contract compliance. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer by the COR.

e. Documentation of services performed will be reviewed by the COR prior to certifying payment. The COR will perform periodic documents checks with the using service to ensure records monitoring. GIMC will pay only for services actually performed at GIMC and at the contractor's location, and in strict accordance with the schedule of prices/costs shown in the schedule of items. Contract monitoring and record keeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided.

f. Invoices shall be submitted to the COR by the contractor. The COR, or designee, will verify that services were actually performed against contractors certified delivery repairs document. Only after verification are invoices submitted for payment.

g. In addition to the visit per requirements listed above, a quarterly repair report, business review, shall be provided to the COR. This report should be free of charge.

h. The Contractor must provide validation letters certifying contractor’s competency of all representatives performing service. Letters are to be provided to the COR and the CO prior to the provision of services. Validation letters must be provided within one week for all new representatives that are sent to perform repair, sharpening and educational services.

RATIONALE: Contemporary industry-leading point of care ultrasound equipment is being requested to expand the current equipment to support the IHS mission of providing high quality point of care ultrasound for patients seeking medical care. We require ultrasound systems with superior image quality and use for point-of-care ultrasound, with extensive accidental damage coverage and warranty to ensure minimal downtown for the unit. We expect that all of the ultrasound machines be the same model, although configured with different probes as required by different departments as noted below.

These specifications (Salient Characteristics) shall be met:

Table 1: Minimum Technical Requirements and Specifications

Line Item

Product Description Qty Unit

1 Point of Care Diagnostic Ultrasound System with the following components:

• Portable point-of-care ultrasound machine with mobile cart appropriate for inpatient, Emergency Department, and clinic use

• Four transducer connectors

• >19 inch Integrated Touch Screen

• AI-assisted image acquisition and optimization tools

• Real time color flow tracking and optimization

• Color Wave Doppler

• TDI Tissue Doppler

• Smart TTQA

• AI-assisted assessment tools for Cardiac

Workflows, including Auto Ejection Fraction calculation support, Auto Diastolic function E/A E/E' measurement, Auto detection support for the heart standard planes, Velocity Time Interval, IVC assessments

• Comprehensive software bundles for advanced ultrasound calculations and measurement tools for: Abdomen/General, Obstetrics, Gynecology, Cardiac, Small parts, Urology, Vascular, Nerve, Emergency & Pediatric package

• AI-assisted assessment tools for Pulmonary work flows, Shock workflows, Respiration workflows, Trauma workflows, and Nerve block workflows

• Built in scan tutorial software

• Qpath or other Quality Assurance Program

Accessibility

• DICOM Basic, HL7 worklist, MPPS, Query/Retrieve & Dicom Structured Report for Cardiac, Vascular, OB/GYN, Breast, Small parts, Abdomen

8 each

• Anti-virus software

• Lithium-ion Battery Pack (with long-lasting capability)

• Mobile Cart with Retractable Cord & disinfection canister holder

• Internal Wifi

2 Needle Visualization Enhancement 8 each

3 Single Crystal Convex Array transducer (approx.

bandwidth 1.2 – 6 MHz, Field of View 60˚, convex radius 60mm)

8 each

4 Endocavity convex array transducer (approx.

bandwidth 3.0 – 11.0 MHz, Field of View 170˚, convex radius 11mm)

3 each

5 Linear array transducer (approx. bandwidth 6.0 – 23.0 MHz, field of view 28.5mm)

3 each

6 Single crystal phased array transducer (approx.

bandwidth 1.5 – 4.5 MHz, Field of View 90˚)

8 each

7 Linear array transducer (approx. bandwidth 3.0 – 15.0 MHz, Field of View 38mm, with procedural features to adjust depth and gain from transducer)

8 each

8 TEE phased array transducer 1 each

9 Printer and Cable Package 3 each

10 Printer bracket assembly on the bottom of the cart 3 each

11 Total care program covering mail-in exchanges or repairs on covered products (unit or standard transducers) subjected to physical damage or abuse during the standard warranty period, including battery exchanges and a system loaner as needed.

8 each

508 STANDARDS

The included standards that must be met for this contract are taken from the following two resources. Compliance with these standards is mandatory for Federal agencies subject to Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d).

• Section 508 Standards and Guidelines: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

• Web Content Accessibility Guidelines (WCAG) 2.1: https://www.w3.org/TR/WCAG21 Software Accessibility - Non-Web Based

• All WCAG A & AA Success Criteria apply – EXCEPT the following:

o 2.4.1 Bypass Blocks o 2.4.5 Multiple Ways o 3.2.3.Consistent Navigation o 3.2.4 Consistent Identification

• 502 Interoperability with Assistive Technology

• 503 Application

• 602 Support Documentation

• 603 Support Services

• 302 All Functional Performance Criteria - Note: Applies when Chapter 5 does not address one or more functions of ICT (E204), or when an agency invokes "equivalent facilitation" (E101.2)

For Hardware with display screens include

• 408 Display Screens

For Hardware with multimedia include

• 413 Closed Caption Processing Technologies

• 414 Audio Description Processing Technologies

• 415 User Controls for Captions and Audio Descriptions https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.w3.org/TR/WCAG21

SHIPPING, HANDLING, AND DELIVERY:

All shipping, handling and freight charges must be included in the overall quote. The delivery date for this requirement is thirty (30) days after receipt of purchase order.

Contractor shall provide medical equipment and delivery to the following location:

PLACE OF PERFORMANCE:

Gallup Indian Medical Center 1808 West Aztec Ave.

Gallup, NM 87301

REQUESTING PROGRAM OFFICE:

Gallup Indian Medical Center Emergency Department

516 E. Nizhoni Blvd.

Gallup, NM