SAM #36C24E26Q0130

Sole Source Contract for Relabeling and Secure Management of USAF Biospecimens at VA Greater Los Angeles

This opportunity involves a sole source contract for relabeling and secure management of USAF biospecimens at the VA Greater Los Angeles Healthcare System biorepository. - Agency: Department of Veterans Affairs, Office of Research and Development, Regional Procurement Office East - Sole source vendor: Suds Salty Sustenance (Fairborn, Ohio) - Scope of work: - Organize, relabel, and accession approximately 140,000 biospecimens (serum, blood, urine, semen, fat biopsy) - Scan QR codes into Laboratory Information Management System (LIMS) - Maintain sample integrity and ensure compliance with safety and data security standards - Provide guidance and support for College of American Pathologists (CAP) accreditation, including documentation, SOP review, and onsite inspection support - Process 9,000 sample tubes per week - Travel for eight two-week site visits to the biorepository in West Los Angeles, CA - Personnel requirements: Technicians, director, and program manager with CAP accreditation expertise - Sole source justification: Unique historical knowledge of AFHS biospecimens and CAP accreditation criteria - Period of performance: 12 months from contract award, with possible extensions for site visits - No competing vendors or products identified; only Suds Salty Sustenance is mentioned

Description

The Veteran's Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with Suds Salty Sustenance based in Fairborn, Ohio, on behalf of the VA Greater Los Angeles Healthcare System (VAGLA). Medical Research has been tasked to store the biorepository from the Air Force Health Study (AFHS). For nearly two decades, the U.S. Air Force Research Laboratory's 711th Human Performance Wing was responsible for housing the biospecimens as they worked with the VA and Vietnam Veterans for America to identify a site best suited to not only preserve the specimens but also promote future research. A VAGLAHS Principal Investigator and member of VA SHIELD acknowledged the effort. The specific work to be performed includes: Technicians are needed to organize and relabel 140,000 specimens and maintain the integrity of the biospecimens. Accession tasks include data entry, labeling tubes with the appropriate label, scanning barcode information into LIMS, and organizing specimens in the biorepository. The AFHS biorepository contains different specimen types (serum, blood, urine, semen, fat biopsy), sample tubes of various sizes (1 ml, 2 ml, 6 ml, 15 ml, 50 ml, and 200 ml), made of different materials (plastic and glass), stored in plastic bags in freezers at -80°C. The biospecimens are stored at VAGLA. Labels have already been purchased for this task, and VA staff will print labels with QR codes obtained from a program analyst at the VA Center for Data and Computations Sciences (C-DACS) and the LIMS support team at C-DACS. 1.0 Specific tasks The Contractor will: Attach the provided labels with QR codes to the frozen sample tubes, scan the QR code, and enter the QR code information into an Excel template next to the sample information. Sort sample tubes according to size and type. Remove sample tubes from bags, separate them by size and type, and place them on dry ice. Place labeled sample tubes in boxes according to their size, using six different box sizes. Attach labels to sample tubes in boxes. Wipe the surface of a sample tube with a microfiber cloth to remove frost, then attach a label containing a QR code. Scan the QR code into an Excel template next to the sample's information. Put the labeled sample tubes with QR codes into a box on dry ice. To maintain sample integrity, the process of frost removal and label attachment should take no more than 4 seconds per tube. Once all tubes in a box are labeled, the box will be returned to a -80°C freezer. When not stored inside freezers, boxes will always be kept on dry ice, with both contractor and VA staff responsible for this task. The contractor will also provide guidance and support for preparation and during CAP accreditation. This includes documentation, policy development, SOP review, internal review, quality improvement aligned with CAP standards, and support during onsite inspections and corrective actions. The VAGLA biorepository requires processing 9,000 sample tubes weekly (or 18,000 every two weeks) to complete accessioning of all samples. The contractor must provide a weekly summary of the number of sample tubes processed by 4:30 PM each Friday to the Biorepository Director. 2.0 Contractor Qualifications This requires a contractor highly knowledgeable about this specific biospecimen collection, with years of experience working with these specimens. Such historical knowledge is critical and cannot be easily taught to new personnel. Familiarity with CAP accreditation standards is also essential to ensure high-quality operations and successful accreditation. 2.1 Personnel Roles and Descriptions Director: Oversees all onsite operations, ensuring project completion and process integrity. Maintains qualifications to be a CAP inspector. Provides guidance on obtaining CAP accreditation, including documentation, SOP review, and addressing inspection findings. Credentials and Experience: Over 15 years handling biospecimens, familiar with CAP procedures, and has served as a CAP inspector for over 10 years. Educational background in Clinical Laboratory Sciences, Microbiology, Immunology, Cell Biology, or Pathophysiology. Program Manager: Monitors progress, milestones, and deadlines; adjusts plans as needed. Manages schedules, budget, invoices, and reporting. Credentials and Experience: Over 20 years handling biospecimens, well-versed with CAP requirements, and over 10 years as a program manager. Technicians: Handle and perform testing of biospecimens with over 2 years of experience. Familiar with placing and retrieving specimens, inventory tracking, and protocol adherence. Credentials and Experience: At least 2 years of relevant experience. 3.0 Other Information Safety: Breaks are important for safety and specimen integrity. Risks include cold exposure, CO2 exposure, and repetitive strain injury. Operating procedures have been developed with Industrial Hygiene guidance, including protective gear, work behavior modifications, and schedules. CO2 exposure: Work under designated air supply locations. Take breaks at 50-minute intervals or as needed. Work in pairs with doors open. Cold Temperature Exposure: Occurs during sorting, dry ice handling, and moving trays. Use cryogenic gloves and tools; avoid direct contact with dry ice. Wear cryogenic gloves, aprons, and face shields when crushing dry ice. Health: Risks include cold exposure, CO2 exposure, and repetitive strain injury. Procedures are in place to minimize these risks, with recommendations from Industrial Hygiene. Data Access, Collection, and Storage: IRB-compliant measures will be used to ensure confidentiality, privacy, and data security. Contractors will not access VA computers or the VA Laboratory Information Management System (LIMS). Data will be stored securely in locked, fireproof cabinets at VA facilities. 4.0 Delivery Activities will occur during normal hours (8:00 AM to 4:30 PM, Monday through Friday), excluding federal holidays. Observed holidays include those defined by federal law. 5.0 Period of Performance The contractor shall complete all services and receive equipment within 12 months of contract award. 6.0 Contractor Responsibilities The contractor is responsible for liability, damages, and compliance with all relevant codes, standards, and regulations, including VA research policies, NFPA, OSHA, FDA, ISBER, CDC, GLP, HIPAA, NEC, ADA, CAP standards, and others to ensure biospecimen handling and data security. 7.0 VAGLA Responsibilities The VA Project Manager will provide access and necessary personnel to support the contractor’s work. 8.0 Travel Travel is the contractor’s responsibility, aligned with VA policy and federal regulations. Travel is required to complete 140,000 assessments, with site visits divided into two-week increments. Expenses will be reimbursed per federal rates, with documentation required for reimbursement. Changes in travel dates or locations must be supported by VA officials. This is a sole source requirement at a VA facility in West Los Angeles, California, pursuant to FAR 6.302-1. Any responsible source may submit a capability statement by September 18, 2026, to Michael Haydo at Michael.haydo@va.gov. Responses by phone will not be accepted. The government may decide not to compete based on responses.

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