Intent to Sole Source - Preventative Maintenance Agreement for 4 Apheresis Machines (Optias)
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 National Institutes of Health (NIH), Clinical Center has issued a Notice of Intent to Sole Source a Preventative Maintenance Agreement for two Spectra OPTIA Cell Separators (Apheresis Machines). The NIH intends to negotiate with Terumo BCT due to the specialized nature of the equipment, patient safety concerns, and regulatory compliance requirements. This is not a Request for Proposal.
Purpose & Justification
The NIH Clinical Center, Blood Services Section, requires a service agreement for its apheresis machines, which are critical for separating blood and blood products from donors and patients, including therapeutic procedures. The justification for other than full and open competition (FAR 6.302-1) is based on Terumo BCT being the sole responsible source. Reasons include:
- Unique Equipment: Terumo BCT manufactures the specialized Optia machines, possessing proprietary expertise for their maintenance.
- Patient Safety: Using unauthorized vendors for servicing is deemed unsafe, as patients are connected to these life-preserving devices.
- Regulatory Compliance: Maintenance must adhere to strict standards set by the Food and Drug Administration (FDA) and AABB.
- Operational Impact: Lack of a service agreement could lead to significant delays, extensive validation of new vendors, and potential life-threatening impacts on patient care.
Scope of Work
The service agreement covers comprehensive maintenance and support for the two Spectra OPTIA Cell Separators:
- Scheduled Maintenance: Perform preventive maintenance (PM) every six months, adhering to FDA Guidance and AABB Standards, including complete inspection and calibration.
- Emergency Servicing: Provide labor and replacement parts (excluding disposables) for equipment malfunctions.
- Parts & Support: Supply all necessary spare/replacement parts, offer full-service coverage, and provide telephone support.
- Logistics: All labor and travel are included at no additional cost.
Performance Standards
- PMs are to be scheduled within +/- 30 days of the due date.
- Emergency service response times: within 1 hour for telephone support and within 1 business day for on-site response.
- A completed checklist and calibration sticker must be provided after each PM service.
Contract & Timeline
- Type: Intent to Sole Source (Special Notice) for a Service Agreement.
- Proposed Vendor: Terumo BCT.
- Duration: One base year (June 02, 2026, through June 02, 2027) with two optional years.
- Estimated Value: The estimated total cost for the base year and two option years is $84,836.56.
- Place of Performance: Blood Services Section, Department of Transfusion, Clinical Center at NIH, Bethesda, MD 20892.
- Response Due: May 13, 2026, by 12:00 PM Eastern Standard Time.
- Published Date: April 29, 2026.
Action for Interested Parties
This is not a Request for Proposal. All responsible sources who believe they can provide the required preventative maintenance service for the Spectra OPTIA Cell Separators may submit a capability statement. Statements should be emailed to valerie.gregorio@nih.gov with the subject line "NOI-OLAO-CC-26-005158" by the response due date. The Government reserves the discretion to not compete this requirement.