IHS Instructions For Use Software
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Indian Health Service (IHS) is conducting market research via a Sources Sought Notice to identify potential sources for a commercial off-the-shelf (COTS), automated, web-based Instructions for Use (IFU) and Safety Data Sheet (SDS) repository system. This system will serve federal IHS healthcare facilities, aiming to enhance patient safety, infection prevention, and regulatory compliance. Responses are due May 15, 2026.
Scope of Work
The required system must provide online access to all necessary manufacturer guidelines and resources for dental, medical/surgical, and biomedical instruments, equipment, supplies, consumables, tissues, implants, and chemicals used at IHS facilities. Key functionalities include:
- A centralized, searchable repository for IFUs, SDS, preventive maintenance manuals, service manuals, technical documentation, and manufacturer notices/recalls.
- Search capabilities by manufacturer, device name, model number, product type, or keyword.
- Real-time access to current, validated manufacturer documentation.
- Interoperability with existing Government systems like instrument tracking and asset management.
Technical & Compliance Requirements
The system must comply with:
- Applicable regulatory and accreditation standards (e.g., OSHA, CMS, Joint Commission, AAAHC, AAMI).
- Federal security requirements, including secure authentication, multi-factor authentication (MFA), FISMA, and NIST SP 800-53.
- Section 508 of the Rehabilitation Act and WCAG 2.1 Level AA accessibility standards.
- Information regarding FedRAMP certification or hosting arrangements is also requested.
Submission Requirements
- Response Due: May 15, 2026, by 12:00 PM EST.
- Submission Method: Email to Natasha.Bitsoi@ihs.gov.
- Subject Line: "SSN-Instructions For Use Software – Your Company Name".
- Capability Statement: Must be tailored, not exceed 15 pages (excluding Past Performance), use a minimum 10-point font, and include a cover page, executive summary, technical areas, and past performance. Generic statements are not sufficient.
Eligibility & Set-Aside
This Sources Sought seeks information from Indian Small Business Economic Enterprises (ISBEE), Indian Economic Enterprises (IEE), and small businesses. Responses will help determine the appropriate set-aside for a future solicitation. Organizations not meeting these criteria under NAICS code 518210 should not respond.
Additional Notes
This is a market research notice only and does not constitute a solicitation or commitment to award a contract. No direct or indirect costs will be reimbursed for submissions. Do not include classified, confidential, or sensitive information. Responses will not be acknowledged, and no feedback will be provided.