SAM #PCA-NHLBI-03869

NIH Seeks Automated -80°C ULT Freezer System for NHLBI Biospecimen Core

The National Institutes of Health (NIH), Office of Acquisitions, is seeking small business sources for an advanced automated -80°C Ultra-Low Temperature (ULT) Freezer System for the National Heart, Lung, and Blood Institute (NHLBI) Biospecimen Core in Bethesda, MD. - Government Buyer: - Department of Health and Human Services (HHS), National Institutes of Health (NIH), Office of Acquisitions, Office of the Director (OD) - End user: National Heart, Lung, and Blood Institute (NHLBI) Biospecimen Core - Products/Services Requested: - Automated -80°C ULT Freezer System - Minimum usable capacity for at least 3.5 million FluidX 1.0 mL 2D-barcoded screw-cap tubes - Support for multiple tube formats (FluidX, Sarstedt, cryogenic, PAXgene RNA tubes) - Dual-redundant refrigeration and liquid nitrogen (LN2) backup - Advanced environmental controls and monitoring - Integration with laboratory information management systems (LIMS) - Regulatory compliance (21 CFR Part 11), robust audit trails, secure authentication - Facility constraints: must fit within 52 ft x 15 ft footprint, max 12 ft ceiling height - Services: On-site installation, site acceptance testing, and comprehensive operator training - Unique/Notable Requirements: - High-capacity, technology-enabled storage and retrieval for biospecimens - Secure, auditable, and regulatory-compliant system - No specific OEMs, vendors, part numbers, or quantities provided (sources sought for capability assessment) - Place of Performance: - National Institutes of Health, Bethesda, MD (NHLBI Biospecimen Core)

Description

Scientific Automated -80°C Ultra-Low Temperature (ULT) Freezer System Sources Sought Notice # PCA-NHLBI-03869

Contracting Office Address Department of Health and Human Services, National Institutes of Health, Office of Acquisitions, OA Office of the Director, OD 6701 Rockledge Drive, Room 537-S, Bethesda, MD, 20892.

Introduction This is a notice issued on behalf of the National Institutes of Health (NIH), Office of Acquisitions, OA Office of the Director, OD, DHHS, UNITED STATES. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this Sources Sought is to seek the availability and capability of small business concerns, including 8(a) small business and/or small qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB), and Service-Disabled Veteran-owned Small Businesses (SDVOSB)] that are interested in and capable of performing the work described in the statement of work. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Background The National Institutes of Health, Office of Acquisitions, OA, Office of the Director, OD is seeking small businesses with the ability to provide an Automated -80°C Ultra-Low Temperature (ULT) Freezer System for the NIH, National Heart, Lung and Blood Institute (NHLBI).

Statement of Need: Establishing a new laboratory facility for the NHLBI Biospecimen Core that includes a state-of-the-art automated -80°C biospecimen freezer is a strategic step to strengthen biospecimen stewardship and increase the value of these resources across the DIR scientific ecosystem. The upgraded space will expand the Core’s capacity to deliver high-quality biospecimen handling, processing, banking, storage, and distribution in support of all NHLBI Division of Intramural Research (DIR) programs. A primary objective is to centralize biospecimen processing and storage to streamline workflows and reduce duplication across DIR laboratories. The Core currently supports about 60 labs conducting 150 clinical trials and manages roughly 35,000 biospecimens linked to 7,700 participant visits each year. It also provides continuous oversight of more than 300 manual freezers and 200 temperature probes across the Bethesda campus, along with backup storage when needed. Automated -80°C ultra-low temperature (ULT) freezers offer secure, high-capacity, technology-enabled storage and retrieval. By maintaining a stable -80°C environment for long-term preservation of materials such as blood products (including serum and plasma), cells, DNA, RNA, other bodily fluids (such as urine), and tissues (including bone marrow), these systems protect sample integrity. Robotic handling reduces manual touches and minimizes sample exposure during retrieval, while high-density storage helps conserve laboratory space. Integration with sample tracking and inventory software further improves traceability and inventory control. A return on investment (ROI) analysis indicates that, while the automated freezer requires a substantial initial capital investment, annual operating costs are significantly lower compared with a manual freezer farm—delivering approximately $1 million in savings by Year 2, with savings increasing thereafter. The investment is recovered in just under five years, driven largely by reductions in labor (88%), energy (67%), and floor space (66%). Transferring legacy collections into the automated unit will allow the DIR to phase out many manual freezers and enhance the long-term sustainability of biospecimen storage. Key benefits of integrating an automated biospecimen freezer into the new facility include: Operational efficiency and quality control: Centralized management enables standardized workflows and consistent quality oversight for research-ready samples. Modernized storage and faster retrieval: Barcoded tube storage with automated retrieval and continuous monitoring improves specimen integrity and accelerates access compared with manual searches. Improved data systems and accessibility: Integration with laboratory information management systems enhances location tracking, data management, and research workflows. Resource optimization: Consolidation reduces redundancy and strengthens inventory management, improving use of space, funds, and personnel. Regulatory and ethical compliance: The facility supports adherence to applicable requirements and ethical standards, including NIH Human Biospecimen Program expectations (3008). Collaboration and sharing: Centralized resources broaden access to diverse collections, supporting cross-lab collaboration within the scientific ecosystem. Scalability and future readiness: The facility can more readily adopt new technologies and scale to meet growing research demand. Overall, establishing this facility with an automated -80°C freezer is a forward-looking investment that enhances biospecimen integrity, operational performance, and sustainability while strengthening the DIR scientific ecosystem and enabling high-impact biomedical research.

Product Specifications/Features/Salient Characteristics The vendor shall furnish, install, test, and provide training for an automated -80°C ULT freezer system that meets or exceeds the following minimum functional requirements. Environmental Performance (Storage and Cold Chain) Storage temperature performance (minimum): Maintain storage bank air temperature at -80°C ± 3°C. Enhanced temperature performance: The system design shall support: Temperature stability: ± 1.5°C from set temperature within the storage bank. Temperature homogeneity: < 3°C across the storage compartment. Cold chain protection for Input/Output (I/O) and exceptions: Provide an internal -80°C buffer capability to stabilize samples during input, output, and exception handling (e.g., barcode read errors), preserving cold chain until resolution. Input/Output (I/O) temperature: I/O area temperature shall be -20°C or lower with minimal time in the I/O area; samples must be queued at -80°C for all scenarios, including instrument operational errors. Humidity/frost prevention: Provide active humidity control designed to prevent frost accumulation that can impair barcode reading and mechanical reliability; include frost removal capabilities. Capacity, Labware Support, and Handling Usable storage capacity: Provide usable capacity to store ≥ 3.5 million FluidX 1.0 mL 2D-barcoded screw-cap tubes (9 mm diameter). Supported labware formats (SBS and legacy): Support automated storage and retrieval of 2D barcoded vials/tubes in SBS format, including (but not limited to) internally and externally threaded 2D barcoded vials/tubes in nominal sizes 0.5 mL, 1.0 mL, 1.5 mL, and 1.9 mL. Legacy and diverse workflow support: Must also support scanning of side-labeled barcodes (in addition to bottom-coded formats) and securely store/individually pick: 1.8 mL Sarstedt tubes 2.0 mL cryogenic vials PAXgene RNA tubes Accommodate standard cryoboxes with a 5-inch square footprint Automated identification and validation: Provide automated imaging/identification functions at minimum for: Reading tray barcodes, rack barcodes, 2D codes on tube bases, and 1D/2D codes on tube sides Measuring container height for storage validation Detecting presence/absence of containers Picking throughput: Sample picking rate/speed shall be optimized for highest practical rate and support automated picking between SBS and other density formats. Resilience, Refrigeration, Monitoring, and Alarms Dual-redundant refrigeration: Provide two independent refrigeration circuits per -80°C storage bank, each capable of maintaining required temperature conditions. Emergency backup cooling: Provide liquid nitrogen (LN2) backup refrigeration capability for emergency backup when mechanical refrigeration is unavailable. Independent environmental controls: Provide an environmental control system that operates separately from automation or control software to ensure resilient monitoring and regulation of environmental conditions. This way, environmental monitoring and regulation will continue uninterrupted even if the automation or software systems experience downtime. Alarm/notification and integration: Provide alarm/notification capability and support external alarm integration (i.e., REES Scientific Alarm Monitoring hardware). Software, Security, Integration, and Data Integrity User interface and API: Provide control software with a web-based UI and RESTful API for order submission/status and inventory query workflows. Hosting: Provide cloud or cluster server hosting that is internet-accessible, consistent with NIH security requirements and implementation constraints. Inventory/LIMS capability: Include onboard inventory management (LIMS-like functionality) enabling full inventory tracking and equipment operation. Third-party integration deliverables: Provide third-party integration capabilities (e.g., independent LIMS), including API code and use documentation. Authentication: Support enterprise authentication integration (e.g., Active Directory/LDAP) or equivalent secure authentication method. Audit trails and logging: Provide comprehensive audit trail/event logging for user actions, orders, inventory changes, and system/environment events with exportable records. Regulatory readiness: System must be designed to support 21 CFR Part 11 compliance. Order management: Must support: (1) submitting orders even if all vials are not present in the physical unit at the time, (2) reprioritizing submitted orders, (3) partial fill and queue, and (4) order and inventory audits. Consolidation/defragmentation: Must support automated consolidation/defragmentation during system downtime to optimize storage space and group like specimens together based on predetermined and occasionally updated sample metadata. Software updates: Minimize workflow interruptions; provide UAT for updates, plus release notes and an anticipated function impact summary. Physical/Facility Constraints The entire freezer system—including all required service clearances, access panels, and ancillary equipment—must fit within a designated footprint of 52 feet by 15 feet. Total system height, including any overhead infrastructure or ventilation requirements, must not exceed a 12-foot ceiling height. Installation, Testing, Training, and Acceptance Installation: Provide on-site installation. Site Acceptance Testing (SAT): Provide on-site SAT with clear pass/fail criteria including, at minimum: Environmental performance (-80°C control; I/O cold chain; humidity/frost controls) Redundancy/failover performance (dual refrigeration; LN2 backup capability) Barcode read performance (bottom and side codes; trays/racks) Pick/place accuracy and throughput Inventory reconciliation Integration deliverables including UAT for third-party/API workflows Training: Provide comprehensive on-site training to operators.

Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capability statement should include 1) Name and address of the vendor, 2) Size and type of business, 3) Point of contact with the name, title, phone, fax, and email, 4) UEI number, 5) the professional qualifications of experts and technical personnel as it relates to the above outlined requirements, and any other relevant information. The statement must not exceed 7 pages. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted. Responses indicating proprietary information will be safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact with authority and knowledge to discuss responses. Responses lacking sufficient information for evaluation will be considered non-responsive. When submitting, reference the solicitation notice number.

Point of Contact: Lynda Cole, Contract Specialist, Office of the Director, OD, Lynda.cole@nih.gov. Department of Health and Human Services, National Institutes of Health, Office of Acquisition, Office of the Director, 6701 Rockledge Dr., Rm 537-S, Bethesda, MD 20892, USA

Submission Instructions: Interested parties shall submit capability statements via email to Lynda Cole at Lynda.cole@nih.gov. Due Friday, April 24, 2026, at 10:00 am EST. All responses must be received by the specified due date and time to be considered. This notice does not obligate the Government to award a contract or pay for the information provided. No proprietary, classified, confidential, or sensitive information should be included. The Government reserves the right to use the information for any necessary purpose. Respondents should ensure their response is complete and detailed. The Government is under no obligation to acknowledge receipt or provide feedback. After review, pre-solicitation and solicitation notices will be published in SAM.GOV. Responses to this notice are not considered adequate responses to a solicitation.

View original listing