Sources Sought_FY26.pdf

Sources Sought Notice

Instructions For Use Software

Title: Instructions For Use Software

Agency: Indian Health Service, Office of Quality

Issue Date: Monday, May 4, 2026

Due Date: Friday, May 15, 2026 no later than 12:00pm EST

POCs: Responses must be submitted via email to Natasha.Bitsoi@ihs.gov. Include “SSN-Instructions For

Use Software – Your Company Name” in the Subject of the email.

This Sources Sought Notice (SSN) is for market research and planning purposes only and shall not be construed as a solicitation or an obligation or commitment to issue a solicitation by the Indian Health Service (IHS). This SSN is seeking information from the specific types of entities listed below to assess their capabilities in fulfilling the requirements set forth in this SSN. The information from this SSN will be used to determine the appropriate set-aside, if any, in accordance with the applicable regulations listed. The Government encourages the identified to respond to this Notice and will be assessed of their capabilities in the following priority:

1. Indian Small Business Economic Enterprise (ISBEE),

2. Indian Economic Enterprise’s (IEE) in accordance with HHSAR 326.603-1.

3. Small business concerns in accordance with FAR Overhaul 19.104.

Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether any ISBEE/IEE or small business set-aside is possible based on the Contracting Officer’s reasonable expectation of obtaining offers from two or more relevant concerns that will be competitive in terms of market price, product quality, and delivery capability. An organization that is not considered an ISBEE/IEE firm or small business under the applicable NAICS code should NOT submit a response to this notice. The applicable primary NAICS code for this requirement is 518210– Computing Infrastructure Providers, Data Processing, Web

Hosting, and Related Services. Generic capability statements are not sufficient and may not be considered when assessing entity capabilities.

Background

The IHS provides comprehensive primary health care and disease prevention services to approximately 2.8 million

American Indian and Alaska Native (AI/AN) people in 574 federally recognized tribes through a network of more than 605 hospitals, clinics, and health stations on or near Indian reservations. IHS facilities are located across 12 Areas and serve populations in rural and urban locations in 37 states. IHS healthcare facilities are accredited and Centers for

Medicare & Medicaid Services (CMS) certified to ensure high‑quality, safe, evidence‑based care and to support third‑party billing for eligible AI/AN patients.

Description of Supplies/Services

Background: IHS federal healthcare facilities are required by Joint Commission, Centers for Medicare and Medicaid Services (CMS) and other accrediting medical organizations to establish and maintain a safe and functional environment for everyone who enters the organization’s facilities. Manufacturers’ Instructions for Use

(IFU) and other critical infection control reference documents must be readily available to staff.

The objective of this requirement is to provide a reliable, accessible solution for consistent access to manufacturer

Instructions for Use and related documentation across all federal Indian Health Service (IHS) facilities. The system shall ensure IFUs are readily available and consistently accessible to support patient safety, infection prevention, and regulatory compliance.

The Contractor shall provide a commercial off-the-shelf (COTS), automated, web-based Instructions for Use (IFU) and Safety Data Sheet (SDS) repository system for use by federal Indian Health Service (IHS) healthcare facilities.

The software must provide online access to all required Instructions for Use, service manuals, safety data sheets, and other manufacturer guidelines, and resources for instruments, equipment, and supplies related to dental, medical/surgical and biomedical instruments and equipment, and consumables, tissues and implants, and chemicals that are in use at each IHS federal facility.

System Requirements:

The Contractor shall provide a centralized, searchable repository that includes, at a minimum: Instructions for Use

(IFUs) for medical, surgical, and dental instruments and equipment, IFUs and documentation for implantable and non-implantable devices, tissues, and biologics, Safety Data Sheets (SDS) and archived MSDS documents, Preventive maintenance (PM) manuals, service manuals, and technical documentation for biomedical and non-medical equipment, Documentation for consumables, including single-use items and chemical products, Facility maintenance equipment documentation (e.g., HVAC, fire safety systems), Manufacturer notices, recalls, alerts, and letters of obsolescence.

The system shall include search functionality by manufacturer, device name, model number, product type, or keyword.

The Contractor shall provide users with real-time access to current, validated manufacturer documentation. The system shall ensure access to the most current version of all IFUs, manuals, and SDS documents.

The Contractor shall ensure that all documentation supports compliance with applicable regulatory and accreditation standards by Occupational Safety and Health Administration (OSHA), Centers for Medicare & Medicaid Services

(CMS), Joint Commission (JC), Accreditation Association for Ambulatory Health Care (AAAHC), Association for the Advancement of Medical Instrumentation (AAMI), an ANSI-accredited standards development organization, and other applicable federal, state, and local medical regulatory authorities.

System Integration and Interoperability:

The Contractor shall ensure the system supports interoperability with Government systems and workflows. The system shall support integration with instrument tracking systems, asset management systems, and computerized maintenance management systems (CMMS).

User Access Control and Security:

The Contractor shall provide secure, role-based access controls and user management capabilities.

The system shall enforce appropriate access restrictions to prevent unauthorized access outside assigned levels while allowing higher-level users to maintain oversight. All access shall comply with applicable federal security requirements, including secure authentication and multi-factor authentication (MFA).

Information Technology and Accessibility Requirements

The system will comply with all applicable federal IT security requirements. The SaaS solution shall comply with Section 508 of the Rehabilitation Act and WCAG 2.1 Level AA accessibility standards. The Contractor shall also comply with applicable federal IT security requirements, including FISMA and NIST SP 800-53.

The system shall meet FedRAMP certification requirements or provide information if your system is hosted on a third-party non-federal FedRAMP cloud or if the system would require hosting on a federally approved server or cloud.

Capability Statement/Submission Information

To assist the Government in an expeditious review of your capabilities, the capability statement should be organized as follows:

• Cover page

• Executive Summary

• Technical Areas in the order listed

• Past Performance

• Other Information, as applicable

The tailored capability statement should not exceed 15 pages excluding Past Performance information. Font must not be less than 10 point (for readability) and may be submitted in either in either Microsoft Word or Adobe Portable

Document Format (PDF) but must be a standard 8-1/2 by 11 inch in paper size. All proprietary information should be marked as such.

Cover Page

Please provide a cover page to include:

1. Company Name

2. Company Designation (ISBEE/IEE/SB)

3. Type of Business – as applicable (e.g. 8(a), Woman Owned Small Business, HUBZone, etc.)

4. UEI Number

5. Point of contact

6. Primary NAICS Code(s)

7. Existing federal contracting vehicle(s) numbers, as applicable (e.g. GSA MAS number, NITAAC/CIO SP3, etc.)

8. System for Award Management (SAM) registration status. Note, all respondents must be registered on the

SAM located at http://www.sam.gov/ prior to any potential award.

Executive Summary

Provide a high-level overview of your services and include how it will benefit the Indian Health Service.

Technical Areas

Provide an overview of your IFU software/system for the anticipated requirement to include but not limited to:

- System capabilities & functionality

- System workflows & operability

- System access control

- System IT certifications i.e. FedRamp certification

- System reporting and analytics functionality

- Estimated general pricing of services

- Experience supporting federal or other healthcare organizations

- Customer support and technical assistance model

Past Performance

Please provide any past performance information to support a demonstration of your capabilities in the relevant technical areas and magnitude of work.

Other Information (Optional)

You may include any other information that may be helpful in developing or finalizing the requirements of the potential acquisition.

Generic capability statements are not sufficient and will not be considered compliant with the requirements of this notice.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract. Any information provided by industry to the

Government as a result of this SSN is strictly voluntary. Responses will not be returned. No entitlements to payment of direct or indirect costs or charges to the Government will arise as a result of contractor submission of responses, or the Government's use of such information or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s capabilities to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on a government GPE. However, responses to this Notice will not be considered adequate responses to any resultant solicitation.

Confidentiality. No classified, confidential, or sensitive information should be included in your response. The

Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

http://www.sam.gov/