75H71026Q00294 - Amendment One (1).pdf

(x)

75H71026Q00294 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

Gallup NM 87301 1808 W. Aztec Avenue Acquisition Department Gallup Indian Medical Center

09/07/20260001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/07/2026

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Solicitation 75H71026Q00294 is hereby amended to reflect the following changes:

--Add a Questions and Answers document for reference.

--Incorporate updated Statement of Work (SOW).

--Extend RFQ end date from 09/11/2026 to 09/15/2026 at 12:00 PM MT.

ALL OTHER TERMS AND CONDITIONS WILL REMAIN THE SAME.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

JERICHO E. LEWIS

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Questions and Answers – 75H71026Q00294

1. Can you clarify the expected support time frame? The way it appears to be written is 10 years of full repair support after the OEM determines the system is “End of Life”. The industry norm for “end of life” determination is typically is due to parts availability, often driven by technology advancements that render older equipment obsolete. Typical requirements are supporting equipment purchased for 8-10yrs from date of purchase. This time frame is more in alignment with “Industry leading” POCUS life span and technology evolution for image quality. In some instances equipment may still be serviceable for significantly longer but image quality will not be comparable to newer equipment.

The Government agrees that clarification is necessary. The intent of the requirement is not to require ten (10) years of full repair and technical support after the OEM declares the system End of Life (EOL).

The Government anticipates an approximate ten (10)-year equipment lifecycle from the date of Government acceptance of the equipment. This is consistent with GIMC's general medical imaging equipment, lifecycle and replacement planning practices.

During this anticipated lifecycle, the Government expects the proposed equipment to have reasonable OEM support, including availability of technical assistance, repair services, replacement parts, and applicable software and cybersecurity support, subject to the manufacturer's established product-support lifecycle and parts availability.

The Government recognizes that advances in POCUS technology, image quality, cybersecurity requirements, parts availability, and OEM product lifecycle decisions may affect the useful and supportable life of the equipment. Equipment may remain clinically and mechanically serviceable beyond the anticipated replacement timeframe; however, continued use would be evaluated based on equipment condition, clinical performance, image quality, safety, cybersecurity, parts availability, and OEM supportability.

The SOW will be revised to remove the requirement for ten (10) years of support after End of Life and clarify that the Government's anticipated equipment lifecycle is approximately ten (10) years from Government acceptance.

2. Though “one model” maybe be able to do a reasonable job across all listed exam types, IHS would be better served with a couple different models that are optimized for the specific tasks. Typically OB and Cardiac systems are built with different focuses, not limited to transducers. Would a proposal be considered not technically acceptable for offering models specific to exam types needed?

The Government understands that dedicated ultrasound systems may be optimized for specific specialties such as Obstetrics or Cardiology. However, the intent of this acquisition is to obtain multi-purpose Point-of-Care Ultrasound (POCUS) systems that will be utilized by generalist clinicians across multiple clinical environments and for a diverse range of point-of-care examinations.

For this acquisition, the Government is seeking a standardized, one-model/platform approach, with the same ultrasound system configured with different transducers, software capabilities, and accessories as appropriate for the clinical needs of each department.

Standardization across GIMC and Tohatchi Health Center is important to support consistent clinical operation, provider training, workflow, equipment familiarity, Biomedical Engineering support, interoperability, accessories, and maintenance.

Therefore, the Government is not seeking separate specialty-specific ultrasound models for OB, Cardiac, or other individual examination types under this acquisition. Offerors should propose a single POCUS system model/platform capable of supporting the required clinical applications through the appropriate transducers and system configurations.

A proposal offering multiple different ultrasound system models in place of the required standardized platform would not meet the Government's stated requirement unless otherwise authorized through an amendment to the solicitation.

3. Would mail-in repairs/exchanges be consider adequate for service support in lieu of

BIOMED training? The BAA compliant POCUSs currently on the market don’t typically have much that’s serviceable onsite, or the instructions included with service parts is more than adequate for a BIOMED to perform the repairs.

Yes. The Government will accept an OEM-supported mail-in/depot repair, equipment exchange, or replacement program as an appropriate method of service support for the proposed Point-of-Care Ultrasound systems.

However, the Government would also like to maintain the opportunity to develop onsite Biomedical Engineering service capability when such training is available and appropriate for the proposed equipment. Therefore, if the OEM offers formal service training for Biomedical Engineering personnel, the Government would prefer that training be made available for up to two (2) GIMC Biomedical Engineering personnel.

The Government recognizes that some contemporary POCUS systems have limited components that are intended to be serviced onsite and that the OEM's standard service model may primarily utilize mail-in/depot repair or equipment exchange. In those circumstances, the absence of OEM Biomedical Engineering service training will not, by itself, make an otherwise technically acceptable system unacceptable.

The offeror shall describe its complete service and support model, including technical troubleshooting, mail-in/depot repair, equipment and transducer exchanges, shipping responsibilities, expected turnaround times, loaner equipment availability, and any repairs or preventive maintenance that may be performed onsite by GIMC Biomedical Engineering personnel.

If OEM Biomedical Engineering training is available, the offeror shall identify the training available, what level of service the training authorizes Biomedical Engineering personnel to perform, the number of personnel who may attend, training location or delivery method, and any associated costs.

The Government's preference is to utilize both approaches where available: OEM-supported mail-in/exchange services to minimize equipment downtime and OEM Biomedical Engineering training to provide GIMC with appropriate onsite troubleshooting and service capabilities.

4. Which POCUS are these Salient Characteristics built around? Or is this more of a “wish list”. There appears to only be 2 BAA compliant systems that come close and both are lacking two or more features listed. Which means that no one can legitimately bid.

“specifications shall be met” as written doesn’t leave room for “close enough” to prevent potential issues on a supplier’s side.

The listed salient characteristics are not intended to identify or restrict competition to a specific manufacturer or POCUS system. They were developed to describe the clinical, operational, imaging, workflow, interoperability, and support capabilities desired by the Government for the intended Point-of-Care Ultrasound applications at GIMC and Tohatchi Health Center.

The Government recognizes industry's concern that commercially available BAA-compliant POCUS systems may meet the overall clinical intent of the requirement while differing in certain individual technical characteristics or accomplishing the same clinical function through a different technology, software feature, transducer design, or workflow.

Accordingly, the Government will revise the SOW to clarify that an offeror may propose a system with equivalent or superior functional capabilities when an individual listed characteristic is not available in the exact form described. Offerors proposing an alternative shall clearly identify the deviation and explain how the proposed capability meets or exceeds the underlying clinical or operational requirement.

The Government is not establishing a general "close enough" standard. Proposed alternatives must demonstrate technical equivalency and remain subject to Government technical evaluation.

Certain requirements necessary for Government operation and system integration will remain mandatory, including the requirement for a standardized POCUS platform across the acquisition and required interoperability with the IHS/VA imaging environment.

The Government will review the salient characteristics and revise language where appropriate to distinguish mandatory minimum requirements from characteristics for which an equivalent functional capability may be proposed.

5. Does the solicitation/contract explicitly require the provider to deliver support — including repair parts and technical assistance — for a defined period (10 years) after the system reaches End of Life?

No. The Government's intent is not to require the Contractor/OEM to provide repair parts, technical assistance, or other support for ten (10) years after the system reaches an OEM-declared End of Life (EOL).

The language contained in the original SOW could reasonably be interpreted as establishing such a requirement; therefore, the SOW will be revised to clarify the Government's intent.

As clarified in the response to Question 1, the Government anticipates an approximate ten (10)-year equipment lifecycle from the date of successful Government acceptance of the equipment, rather than ten years beginning after the OEM declares the equipment End of Life.

The offeror shall identify the anticipated OEM support lifecycle for the proposed system, including warranty coverage, technical support, repair services, replacement-parts availability, software and cybersecurity support, and any known End-of-Life (EOL) or End-of-Service/End-of-Support (EOS) dates.

The Government recognizes that OEM support and parts availability may change during the equipment's useful life due to technology advancements, product discontinuation, cybersecurity requirements, parts availability, or other manufacturer lifecycle considerations. The Government therefore does not require an OEM commitment to provide support for ten years following EOL.

6. Is this a firm requirement or an optional requirement (in case no OEM’s would commit to that requirement)?

The ten (10)-year post-End-of-Life (EOL) support commitment is neither a firm nor an optional requirement, as this requirement will be removed from the revised Statement of Work.

As clarified in the Government's responses to Questions 1 and 5, the original language did not accurately reflect the Government's intent. The Government is not requiring an OEM or Contractor to guarantee repair parts and technical support for ten (10) years after the manufacturer declares the system End of Life.

Instead, the Government anticipates an approximate ten (10)-year equipment lifecycle from the date of successful Government acceptance. Offerors will be required to identify the anticipated OEM support lifecycle for the proposed equipment, including warranty coverage, repair and technical support, replacement-parts availability, software and cybersecurity support, and any known End-of-Life (EOL) or End-of-Service/End-of-Support (EOS) information.

The Government recognizes that actual OEM support duration may be affected by parts availability, technology advancement, cybersecurity requirements, and manufacturer lifecycle decisions.

Therefore, an OEM commitment to provide ten years of support following EOL will not be required for technical acceptability.

7. Will offerors be evaluated on their ability to meet this 10-year post-EOL commitment? Is it a

Go/No-Go requirement, or a scored/weighted factor?

No. Offerors will not be evaluated on their ability to provide ten (10) years of support following an OEM-declared End of Life (EOL). As clarified in the Government's responses to Questions 1, 5, and 6, the ten-year post-EOL support requirement will be removed from the revised Statement of Work.

Accordingly, the ten-year post-EOL commitment will not be a Go/No-Go requirement or a scored/weighted technical factor.

The Government does, however, consider the long-term serviceability and supportability of the proposed POCUS equipment important. Offerors will be required to provide information regarding the proposed system's anticipated OEM support lifecycle, including warranty coverage, repair and technical support, replacement-parts availability, software and cybersecurity support, and any known End-of-Life (EOL) or End-of-Service/End-of-Support (EOS) information.

Any evaluation of this information will be conducted in accordance with the evaluation criteria established in the solicitation by the Contracting Officer.

8. Does the contract define 'End of Life' in a way that's unambiguous (e.g., tied to a specific notice period or date), so there's no dispute later about when the 10-year clock starts?

The original SOW does not specifically define "End of Life" (EOL). However, as clarified in the Government's responses to Questions 1, 5, 6, and 7, the Government is removing the requirement for ten (10) years of support following an OEM-declared End of Life. Therefore, there will no longer be a ten-year post-EOL period requiring a specific EOL date to establish when that support period begins.

For purposes of the revised SOW, End of Life (EOL) will mean the date formally established and communicated by the Original Equipment Manufacturer (OEM) when the applicable system/model is discontinued or transitions out of the manufacturer's active product lifecycle.

If the OEM separately identifies an End of Service/End of Support (EOS) date, EOS will mean the date after which the OEM no longer provides some or all standard repair services, replacement parts, software support, cybersecurity updates, or technical support for the applicable system/model.

Offerors shall identify any known or anticipated EOL and EOS dates for the proposed equipment at the time of submission and shall describe the OEM's standard process for communicating future lifecycle or support-status changes.

The Government's anticipated equipment lifecycle remains approximately ten (10) years from the date of successful Government acceptance, independent of an OEM's subsequent EOL declaration.

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 Service (NAIHS), located in Gallup, New Mexico, and the Tohatchi Health Center (THC) are requesting the acquisition of eight (8) portable Point-of-Care Ultrasound (POCUS) systems. Seven (7) systems will be deployed at GIMC and one (1) system will be deployed at THC.

The purpose of this acquisition is to provide standardized, multi-purpose POCUS capability to support timely bedside diagnostic assessment and procedural guidance across multiple clinical departments. The systems shall be capable of supporting the diverse clinical applications and operational requirements identified within this Statement of Work (SOW).

GENERAL:

The Contractor shall furnish all equipment, transducers, accessories, software, licenses, documentation, warranties, training, technical support, shipping, and other supplies and services necessary for the successful delivery, installation, configuration, acceptance, and operation of the POCUS systems identified in this SOW.

The equipment shall be new, current-production equipment and shall be delivered complete and ready for its intended clinical use. The Contractor shall coordinate delivery, installation, configuration, acceptance, training, and applicable technical support with the designated Government representatives, including the requesting clinical program, Biomedical Engineering, Information Technology/OIT, Radiology/PACS, and the Contracting Officer's Representative (COR), as applicable.

BACKGROUND:

The Indian Health Service (IHS), an agency within the U.S. Department of Health and Human Services (HHS), is responsible for providing federal health services to American Indians and Alaska Natives. The provision of health services to members of federally recognized Tribes is based upon the unique government-to-government relationship between the Federal Government and Tribal Nations.

The mission of IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level. In support of this mission, IHS provides comprehensive health care services through hospitals, health centers, clinics, and other health programs serving American Indian and Alaska Native communities.

The Navajo Area Indian Health Service administers health care facilities and programs throughout the Navajo Nation and surrounding communities. GIMC and THC provide clinical services to patients within this service area. The acquisition of standardized POCUS systems will expand point-of-care diagnostic and procedural capabilities and provide clinicians with timely access to ultrasound imaging at or near the location of patient care.

Navajo Area Indian Health Service (NAIHS):

The Navajo Area Indian Health Service (NAIHS) administers hospitals, health centers, and health programs serving communities throughout the Navajo Nation and surrounding service areas in Arizona, New Mexico, and Utah. NAIHS provides a broad range of inpatient, outpatient, emergency, preventive, community, and specialty health care services. The geographic size of the service area and the diversity of clinical environments require medical equipment that is reliable, portable, standardized, and capable of supporting a wide range of patient care needs.

Gallup Indian Medical Center (GIMC):

Gallup Indian Medical Center (GIMC) is a 75-bed hospital located in Gallup, New Mexico.

GIMC provides inpatient, outpatient, emergency, and specialty health care services.

Clinical specialties include Internal Medicine, Cardiology, Anesthesiology, Obstetrics/Gynecology, General Surgery, Orthopedics, Ophthalmology, Ear, Nose and Throat (ENT), Radiology, Pathology, Pediatrics, Psychiatry, Emergency Medicine, and Urology.

GIMC maintains a high clinical workload and serves as an important referral and specialty-care facility within the Navajo Area. The proposed POCUS systems will support multiple clinical departments and are intended to provide clinicians with readily accessible ultrasound capability for bedside diagnostic assessment and procedural guidance.

Tohatchi Health Center (THC):

Tohatchi Health Center (THC) is an outpatient health care facility located approximately 25 miles north of Gallup, New Mexico. THC provides primary care and other outpatient health services, with additional specialty services supported by GIMC and other clinical programs.

Services provided at THC include primary care, pediatrics, internal medicine, family medicine, pharmacy, laboratory, public health nursing, optometry, dentistry, and health education. The POCUS system assigned to THC will expand point-of-care diagnostic and procedural capabilities within the outpatient clinical environment while maintaining equipment standardization and compatibility with the systems deployed at GIMC.

STATEMENT OF WORK:

Gallup Indian Medical Center (GIMC) is procuring seven (7) Point-of-Care Ultrasound (POCUS) systems, and Tohatchi Health Center (THC) is procuring one (1) POCUS system, for a total of eight (8) systems under this Statement of Work (SOW).

The GIMC Emergency Department is requesting Program Office and will coordinate this consolidated acquisition. The POCUS systems will be distributed as follows:

• GIMC Emergency Department – three (3) systems

• GIMC Internal Medicine Department – one (1) system

• GIMC Family Medicine Department – one (1) system

• GIMC Anesthesiology Department – one (1) system

• GIMC Intensive Care Unit – one (1) system

• Tohatchi Health Center Family Medicine Department – one (1) system

The Government requires a standardized, multi-purpose POCUS platform capable of supporting a broad range of point-of-care diagnostic examinations and procedural applications. All eight (8) systems shall be the same manufacturer and model/platform, although individual systems may be configured with different transducers, software packages, and accessories based upon the clinical requirements of the respective departments.

The Government is not seeking separate specialty-specific ultrasound systems under this acquisition. Standardization is required to promote consistency in clinical operation, provider training, workflow, equipment familiarity, accessories, Biomedical Engineering support, maintenance, and interoperability across GIMC and THC.

1. TECHNICAL REQUIREMENTS AND SPECIFICATIONS

The technical requirements and salient characteristics identified in Table 1 describe the Government's minimum clinical, operational, imaging, workflow, interoperability, and support needs for the POCUS systems.

Unless specifically identified as a mandatory requirement, an offeror may propose an alternative technical characteristic or functionality when the proposed solution provides an equivalent or superior clinical and operational capability. The offeror shall clearly identify each proposed deviation and provide sufficient technical documentation explaining how the proposed functionality meets or exceeds the underlying Government requirement. All proposed alternatives are subject to Government technical evaluation and acceptance.

Requirements specifically identified as mandatory for interoperability, information security, patient safety, or Government operational needs shall be met as stated.

All proposed POCUS systems shall support DICOM and applicable HL7 interoperability necessary for integration with the existing IHS/VA imaging environment. The proposed make/model shall be listed on the VA VistA Imaging Approved DICOM Modality Interfaces list and shall support integration with the existing IHS/VA VistA Imaging and RPMS environment.

The systems shall support secure image and data transfer capabilities necessary for Government-approved clinical workflows. Any wireless, USB, network, or other data-transfer capability shall comply with applicable IHS Information Security, Privacy, OIT, and medical-device security requirements. No external or vendor-hosted system shall receive or maintain IHS PII/PHI or clinical imaging information unless separately reviewed and authorized by IHS.

2. SYSTEM OPERATIONS, RELIABILITY, INSTALLATION, ACCEPTANCE,

COMMISSIONING, AND TRAINING

a. Operator Documentation:

The Contractor shall provide current operator/user manuals for the POCUS systems. Manuals may be provided electronically or in printed format and shall be accessible to Government personnel. Documentation shall include operating instructions, system safety information, cleaning and disinfection instructions, basic troubleshooting guidance, and other manufacturer-recommended user documentation applicable to the proposed equipment.

Current documentation shall be made available when manufacturer software, hardware, or operational changes materially affect system operation.

b. System Reliability and Data Protection:

The POCUS systems shall be designed to protect acquired patient images and associated data from loss or corruption during normal clinical operation, including interruption of external power.

Each system shall include an internal rechargeable battery or other OEM-supported power-management capability sufficient to permit safe system operation and shutdown in the event of an interruption of external electrical power.

If the OEM recommends or requires an external Uninterruptible Power Supply (UPS), surge protection device, or other power-protection equipment for the proposed system, the Contractor shall provide the recommended equipment and identify its specifications in the offer.

The system shall maintain acquired images and patient data in accordance with the manufacturer's intended design until the information has been successfully transmitted to the Government-approved imaging environment or otherwise managed through an approved clinical workflow.

c. Clinical Applications Training:

The Contractor shall provide qualified OEM or OEM-authorized clinical applications training sufficient to train designated Government personnel in the safe and effective operation of the POCUS systems and associated transducers, software, and clinical applications.

Training shall accommodate the clinical departments receiving the equipment and shall address system operation, image acquisition and optimization, applicable POCUS workflows, transducer selection and use, system cleaning and disinfection, data management, DICOM/worklist workflow, and other functionality included with the proposed system.

The offeror shall describe its proposed training plan, including training format, anticipated duration, number of training sessions or days, instructor qualifications, and any available follow-up or refresher training.

Training shall be coordinated with the Government following delivery and installation of the systems. Updated operator documentation shall be made available when software or system updates materially change clinical operation or workflow.

3. WARRANTY, MAINTENANCE, BIOMEDICAL ENGINEERING SUPPORT AND TRAINING,

MANUFACTURER SUPPORT, SOFTWARE/HARDWARE UPDATES, AND EQUIPMENT

LIFECYCLE

a. Warranty and Accidental Damage Coverage:

The Contractor shall provide the OEM's standard warranty for each POCUS system beginning on the date of successful Government acceptance of the equipment.

The proposed coverage shall include the ultrasound system and associated transducers and shall provide appropriate protection for equipment failures and accidental physical damage. The offeror shall describe the warranty and accidental-damage coverage included with the proposed equipment, including the duration of coverage, system and transducer repair or exchange provisions, battery coverage, limitations or exclusions, number of allowable exchanges if applicable, loaner equipment availability, shipping responsibilities, and applicable deductibles or additional charges.

b. Safety, Reliability, and Cybersecurity Updates:

During the warranty period, the Contractor/OEM shall provide applicable manufacturer-required safety, reliability, and cybersecurity updates necessary to maintain the system's safe and intended operation at no additional cost to the Government.

For any separately purchased post-warranty service agreement, the offeror shall identify which safety, reliability, cybersecurity, software, and system updates are included within the service agreement and identify any associated additional costs.

c. Warranty and Service Coverage:

During the applicable warranty period, the Contractor/OEM shall provide parts, labor, technical support, and other services included within the OEM's warranty for the POCUS systems and associated transducers.

The offeror shall clearly identify covered and excluded items, including coverage applicable to transducers, batteries, accessories, accidental damage, shipping, labor, travel, depot/mail-in repair, equipment exchange, and onsite service, as applicable to the proposed service model.

Coverage following expiration of the standard warranty shall be available through separately priced service agreement options as described within this SOW.

d. Corrective Maintenance and Technical Support:

Corrective maintenance and technical support shall be available during the warranty period and during any subsequently purchased service agreement in accordance with the OEM's proposed service model.

At a minimum, technical support shall be available Monday through Friday, excluding Federal holidays, during normal Government business hours of 8:00 AM to 5:00 PM Mountain Time.

The offeror shall identify its standard technical-support response time, troubleshooting procedures, repair or exchange process, escalation procedures, expected repair/exchange turnaround time, and availability of loaner equipment.

e. Equipment Lifecycle and Manufacturer Support:

The Government anticipates an equipment lifecycle of approximately ten (10) years from the date of successful Government acceptance of the equipment.

The Contractor/OEM shall identify the anticipated support lifecycle for the proposed system, including warranty coverage, availability of technical support, repair services, replacement parts, transducers and accessories, software support, cybersecurity support, and any known End-of-Life (EOL) or End-of-Service/End-of- Support (EOS) dates.

The Government does not require the Contractor/OEM to provide ten (10) years of repair parts, technical assistance, or other support following an OEM-declared End of Life.

The Government recognizes that actual equipment supportability may be affected by parts availability, technological advancement, cybersecurity requirements, product discontinuation, and other OEM lifecycle considerations.

f. Biomedical Engineering Service Support and OEM Training:

The Contractor/OEM shall provide an appropriate service and support program for the proposed POCUS systems. An OEM-supported mail-in/depot repair, equipment exchange, or replacement program is acceptable and shall be described in the offer.

The Government also desires to develop onsite Biomedical Engineering service capability where supported by the OEM. If OEM Biomedical Engineering service training is available for the proposed system, the offeror shall identify available training opportunities for up to two (2) Government Biomedical Engineering personnel, including the scope of training, authorized level of service following completion, training location or delivery method, and associated costs, if any.

The absence of OEM Biomedical Engineering service training shall not, by itself, render a proposed system technically unacceptable when the OEM's standard service model is primarily based upon depot/mail-in repair, exchange, or replacement.

The Contractor shall provide appropriate technical documentation and instructions to Government Biomedical Engineering personnel for routine troubleshooting, inspection, preventive maintenance, and any OEM-authorized repairs or component replacements that may appropriately be performed onsite.

g. Remote Diagnostic and Troubleshooting Capability:

The POCUS system may include technical capability for remote diagnostics or troubleshooting. However, vendor or manufacturer remote access to the POCUS systems or the IHS network is not authorized as part of the initial deployment and shall not be enabled without prior Government approval.

If remote diagnostic capability is available, the offeror shall describe how the capability operates, including connectivity requirements and whether the capability could access, transmit, display, or otherwise expose patient information or other Government data.

Any future activation of vendor/manufacturer remote access shall occur only after completion of all applicable IHS Privacy, Information Security, OIT, Biomedical Engineering, and remote-access reviews and approvals.

The POCUS systems shall remain fully operational for their intended clinical use without an active external vendor connection.

h. Manufacturer Software, Hardware, and Cybersecurity Support:

During the warranty period, the Contractor/OEM shall provide manufacturer-required software updates, operating-system updates, cybersecurity patches, safety updates, and reliability updates necessary to maintain the intended functionality and security of the system at no additional cost to the Government, unless otherwise specifically identified in the offer.

The offeror shall describe the software and hardware support available following expiration of the warranty, including the anticipated duration of support, update and upgrade policies, licensing requirements, cybersecurity support, and any anticipated costs to the Government.

Major feature upgrades or optional software packages that add functionality beyond the originally purchased system may be separately priced and shall be clearly identified by the offeror.

i. Delivery, Installation, Configuration, and Acceptance Support:

The Contractor shall provide all necessary equipment, supplies, labor, shipping, travel, and technical support required for successful delivery, installation, configuration, commissioning, and acceptance of the eight (8) POCUS systems at the designated GIMC and THC clinical locations.

The Contractor shall coordinate installation and configuration with the appropriate Government representatives, including the requesting clinical departments, Biomedical Engineering, Information Technology/OIT, Radiology/PACS, and the COR, as applicable.

This acquisition is for deployment of POCUS systems across multiple clinical departments and does not require removal of an existing Radiology ultrasound system unless specifically directed by the Government.

j. Five-Year Cost of Ownership:

The offeror shall provide a five (5)-year cost of ownership identifying all charges that the Government can reasonably anticipate during the first five (5) years following Government acceptance.

The cost-of-ownership information shall identify, as applicable, warranty extensions, service agreements, preventive and corrective maintenance, software and licensing fees, cybersecurity support, subscriptions, technical support, transducer or accessory coverage, training, shipping, and other recurring or anticipated costs.

k. Software Updates and Upgrades:

The offeror shall clearly identify responsibility for software updates and upgrades during the warranty period and following expiration of the warranty.

The offeror shall identify which updates are included at no additional cost, which updates or upgrades require a service agreement or subscription, and any known or anticipated costs to the Government.

l. Post-Warranty Service Agreement:

The offeror shall provide detailed pricing and coverage information for available post-warranty service agreement options.

The proposed service agreement information shall address, as applicable, technical support, emergency repairs, corrective maintenance, preventive maintenance, system and transducer repair, depot/mail-in repair, equipment exchange, loaner equipment, shipping, labor, travel, software support, and onsite service.

The offeror shall identify its standard response times and anticipated resolution or equipment-exchange timeframes for each applicable level of service. The Government recognizes that service delivery methods may vary by OEM; therefore, a mandatory four (4)-hour onsite repair requirement is not established when the OEM's standard support model utilizes remote troubleshooting, depot repair, mail-in service, or equipment exchange.

m. Lifecycle Definitions:

End of Life (EOL): For purposes of this SOW, End of Life means the date formally established and communicated by the Original Equipment Manufacturer (OEM) when the applicable system/model is discontinued or transitions out of the manufacturer's active product lifecycle.

End of Service/End of Support (EOS): If separately defined by the OEM, End of Service/End of Support means the date after which the OEM no longer provides some or all standard repair services, replacement parts, software support, cybersecurity updates, or technical support for the applicable system/model.

The offeror shall disclose any known or anticipated EOL and EOS information for the proposed equipment at the time of submission and shall describe the OEM's standard lifecycle notification process. If an EOL or EOS date has not been established by the OEM, the offeror shall state that no date has been announced as of the date of its offer.

4. SCHEDULE

a. Delivery, Installation, and Implementation Schedule:

The Contractor shall provide a proposed delivery, installation, configuration, training, and implementation schedule for the eight (8) POCUS systems. The schedule shall identify anticipated delivery dates and the sequence of installation, configuration, acceptance testing, and clinical applications training.

Implementation shall be coordinated with the Government to minimize disruption to clinical operations. Because the systems will be deployed across multiple clinical departments at GIMC and THC, installation and training may be phased or scheduled by department as mutually coordinated with the Government.

The final implementation schedule shall be coordinated with the Contracting Officer's Representative (COR) and other designated Government representatives.

b. Normal Hours of Operation:

Unless otherwise coordinated with the Government, Contractor activities performed onsite shall be scheduled Monday through Friday between 8:00 AM and 5:00 PM Mountain Time, excluding Federal holidays.

When installation, configuration, training, maintenance, or other required activities must be performed outside normal business hours to minimize disruption to patient care, the Contractor shall coordinate the proposed schedule and facility access in advance with the COR or designated Government representative.

Any work that may result in additional charges to the Government, including after-hours, weekend, or Federal holiday services, shall not be performed without prior authorization in accordance with the terms and conditions of the contract.

5. REVIEW, ACCEPTANCE, AND CONTRACT ADMINISTRATION

a. Contracting Officer and COR Responsibilities:

Overall administration of the contract is the responsibility of the Contracting Officer (CO). The Contracting Officer's Representative (COR), when formally designated, shall perform those technical monitoring, inspection, coordination, and acceptance functions delegated by the CO.

The COR does not have authority to modify the terms and conditions of the contract, authorize changes that affect contract price, scope, or delivery requirements, or otherwise obligate the Government beyond the authority specifically delegated by the CO.

b. Inspection and Acceptance:

The Government shall inspect delivered equipment, supplies, documentation, and services to determine compliance with the requirements of this SOW and the resulting contract.

Final acceptance of each POCUS system shall occur following successful delivery, installation, configuration, applicable interoperability verification, and completion of Government-required acceptance activities.

Equipment that does not conform to the contract requirements may be rejected or otherwise addressed in accordance with the terms and conditions of the resulting contract.

c. Service and Repair Documentation:

For warranty, maintenance, or repair services performed under the contract or an applicable service agreement, the Contractor shall provide appropriate service documentation identifying the equipment serviced, reported problem, diagnostic findings, corrective action performed, parts or components replaced, service date, and final equipment status.

Service documentation shall reference the applicable contract or purchase order number when required by the Government.

d. Contract Compliance:

The COR shall monitor Contractor performance and compliance within the scope of the COR's delegated authority. Identified instances of noncompliance, performance deficiencies, or other contractual concerns shall be documented and referred to the Contracting Officer as appropriate.

e. Documentation and Verification of Services:

The Contractor shall maintain sufficient documentation to demonstrate that equipment, supplies, training, maintenance, repairs, and other services required under the contract were provided.

The COR or designated Government representative may review applicable delivery, installation, training, service, and repair documentation to verify satisfactory performance and support Government acceptance and payment processes.

f. Invoicing and Payment Documentation:

Invoices and payment requests shall be submitted in accordance with the invoicing instructions and payment provisions established in the resulting contract or purchase order.

The Contractor shall provide supporting delivery, acceptance, service, repair, or other documentation when required to substantiate invoiced supplies or services.

The COR or other authorized Government representative shall verify performance and acceptance as required by the contract.

g. Service Performance Reporting:

When a post-warranty service agreement or other recurring maintenance service is purchased by the Government, the Contractor shall provide service history or performance reports upon request or at intervals established in the resulting contract.

Reports shall identify, as applicable, service calls, repairs, equipment exchanges, preventive maintenance activities, outstanding issues, and equipment status.

Routine reports required under an active service agreement shall be provided at no additional cost unless otherwise identified in the offer and accepted by the Government.

h. Service Personnel Qualifications:

Contractor and OEM personnel performing installation, maintenance, repair, or other technical services shall be appropriately trained, qualified, and, when applicable, authorized by the OEM to perform the assigned work.

Upon Government request, the Contractor shall provide documentation demonstrating the qualifications, certifications, or OEM authorization of personnel performing technical services on the equipment.

RATIONALE:

Gallup Indian Medical Center (GIMC) and Tohatchi Health Center (THC) require contemporary Point-of-Care Ultrasound (POCUS) technology to expand and standardize bedside ultrasound capabilities across multiple clinical departments. This acquisition supports the IHS mission by providing clinicians with timely access to high-quality ultrasound imaging for diagnostic assessment and procedural guidance at or near the point of patient care.

The Government requires reliable, portable, multi-purpose POCUS systems capable of supporting a broad range of clinical applications performed by generalist clinicians in emergency, inpatient, and outpatient settings. The systems shall provide high-quality diagnostic imaging, efficient clinical workflows, appropriate interoperability with the existing IHS/VA imaging environment, and warranty and service support designed to minimize equipment downtime.

All eight (8) POCUS systems shall be the same manufacturer and model/platform to promote consistency in clinical operation, provider training, workflow, equipment familiarity, Biomedical Engineering support, maintenance, accessories, and interoperability across GIMC and THC. Individual systems may be configured with different transducers, software packages, and accessories based upon the clinical requirements of the departments receiving the equipment.

This acquisition is not intended to procure separate specialty-specific ultrasound platforms. Rather, the Government seeks a standardized POCUS platform that can accommodate the diverse clinical requirements of the participating departments through appropriate system configurations, transducers, software, and accessories.

The Government also requires appropriate warranty, accidental-damage, repair, exchange, and technical-support provisions to promote equipment availability and minimize disruption to patient care throughout the anticipated equipment lifecycle.

SALIENT CHARACTERISTICS

The following technical requirements and salient characteristics describe the Government's minimum clinical, operational, imaging, workflow, interoperability, and support requirements for the Point-of-Care Ultrasound (POCUS) systems.

Unless specifically identified as Mandatory, the Government will consider alternative technical characteristics or functionality that provide an equivalent or superior functional capability and satisfy the underlying clinical and operational requirement.

When proposing an equivalent or alternative capability, the offeror shall clearly identify the deviation and provide sufficient technical documentation demonstrating how the proposed solution meets or exceeds the Government's stated requirement.

Requirements identified as Mandatory are necessary to support Government interoperability, information security, patient safety, standardization, or essential operational requirements and shall be met as stated.

Minimum Technical Requirements and Salient Characteristics

Line Item 1 – Point-of-Care Diagnostic Ultrasound System Quantity: Eight (8) Each

Each system shall be a portable, cart-based Point-of-Care Ultrasound (POCUS) system suitable for use in inpatient, Emergency Department, procedural, and outpatient/clinic environments. All eight (8) systems shall be the same manufacturer and model/platform, with department-specific configurations permitted as identified elsewhere in this SOW.

The proposed system shall provide the following minimum technical and clinical capabilities. Unless specifically identified as Mandatory, equivalent or superior functionality may be proposed in accordance with the Salient Characteristics provisions of this SOW.

System Configuration and Imaging Capabilities

• Portable POCUS system with mobile cart suitable for movement and operation within inpatient, Emergency Department, procedural, and outpatient/clinic environments.

• Capability to support multiple transducers appropriate for the clinical applications identified in this SOW. A system capable of connecting or readily supporting multiple transducers is required; four (4) simultaneous transducer connectors are preferred but not mandatory.

• Integrated touchscreen or equivalent user interface of sufficient size and resolution for point-of-care image acquisition, review, measurements, and system operation.

A display size of approximately 19 inches or greater is preferred but not mandatory when an alternative configuration provides equivalent clinical usability.

• Automated or AI-assisted image acquisition, image optimization, measurement, or assessment tools designed to improve workflow and reproducibility, where available.

• Real-time color flow imaging and optimization capabilities.

• Color Doppler imaging.

• Tissue Doppler Imaging (TDI) capability.

• Automated or assisted image-quality assessment functionality, or equivalent capability, where available.

Cardiac Applications

The system shall support cardiac POCUS imaging, measurements, and calculations appropriate for bedside clinical assessment. Automated or AI-assisted cardiac workflow capabilities are desired and may include:

• Ejection fraction assessment or calculation;

• Diastolic function measurements, including E/A and E/E′ where supported;

• Recognition or guidance for standard cardiac imaging planes;

• Velocity Time Integral (VTI) measurements;

• Inferior Vena Cava (IVC)…