Q301--Relabeling and Secure Mgmt of USAF Biospecimens to SDVOSB Suds Salty Sustenance

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 one that was poised to 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, organizing specimens in the biorepository.
The AFHS biorepository has different specimen types (serum, blood, urine, semen, fat biopsy), sample tubes of different sizes (1 ml, 2 ml, 6 ml, 15 ml, 50 ml and 200 ml) made of different materials (plastic and glass) that are stored in plastic bags in freezers at -80°C. The AFHS biospecimens are stored at VAGLA. Labels have already been purchased for this task. Labels will be printed by VA staff with QR code information 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 labels provided with QR code to the frozen sample tubes, scan the QR code, and enter the QR code information into an excel template next to the sample information.
The Contractor will sort sample tubes according to size and type.
The sample tubes will be removed from the bags, separated according to sample tube size and type and placed on dry ice.
The Contractor will place the sample tubes in boxes after they are labeled. We have six sizes of sample tubes and each will be placed in a specifically sized box accordingly.
The Contractor will attach labels to sample tubes in boxes.
A sample tube will be taken out of a box on dry ice and the surface of the tube will be wiped with microfiber cloth to adsorb frost.
A label containing a QR-code will be attached to the sample tube.
A sample tube will be removed from the box and the QR code will be scanned into an excel template next to the information of the sample.
The labeled sample tube with QR codes will be put into a box on dry ice.
To maintain the integrity of the sample, removing the frost and attaching the label will take no more than 4 seconds.
When all the sample tubes in a box are attached with labels containing QR codes, the box will be returned to a -80° C freezer.
When not being stored inside the freezers (e.g., samples are being labeled, scanned and organized), boxes will always be kept on dry ice to maintain the integrity of the samples. Both contractor and VA staff will be responsible for this task.
The contractor will provide guidance and support for preparation and during the CAP accreditation.
Guidance will include documentation and policy development, review of SOPs, internal review and quality improvement that align with CAP standards and compliance, review of adherence to CAP standards, as well as support during onsite inspection and addressing any findings and/or corrective actions should they be identified during CAP inspection.
The VAGLA biorepository requires 9,000 sample tubes will be processed per week (or 18,000 per two-week visit) which will allow for complete accessioning of all samples.
The Contractor is required to provide to the Biorepository Director a weekly summary of the number of sample tubes processed by close of business (16:30) on Friday of each week.
2.0 Contractor Qualifications
This requirement needs a contractor that is highly knowledgeable of this specific biospecimen collection and has years of familiarity working with these specimens. This type of historical knowledge cannot be readily taught to new personnel, as it is not available at VAGLA. Moreover, a team that has historical knowledge of these biospecimens as well as familiarity with the CAP accreditation criteria is critical to achieve success. CAP accreditation provides a structured framework that ensures the biorepository operates at the highest standards of quality, safety, and reliability, ultimately supporting research protocols and outcomes. To have a contractor that has both historical knowledge of the biospecimens and CAP accreditation provides us with a resource to both properly accession and organize the biospecimens as well as have guidance and support to prepare for CAP accreditation inspection.
2.1 Below are the roles and descriptions for the personnel to complete the required tasks:

Director:
Oversees all aspects of onsite operations to ensure project completion including ensuring the integrity and effectiveness of the process.
The Director maintains the necessary qualifications to be a CAP inspector.
Has the knowledge to provide guidance and advice on the steps in obtaining CAP accreditation.
This typically includes documentation and policy development of policies and procedures that align with CAP standards, review of SOPs, review of adherence to standards, and preparation for an onsite CAP inspection, as well as addressing any findings that may require corrective action or required improvements.
Credentials and Experience:
Over 15 years experience handling biospecimens across clinical laboratories and research to perform testing as well as secure and add specimens into biorepositories.
Extremely familiar with CAP procedures to ensure accreditation, as well as performing roles as a CAP inspector for over 10 years.
Scientific Degree and training should consider specialized training in Clinical Laboratory Sciences, Microbiology, Immunology and Cell Biology, and Pathophysiology. 
Program Manager:
Responsible for monitoring progress, milestones, and deadlines, as well as adjusting plans as needed, so the project is completed on time.
Responsible for creating and maintaining the travel and daily schedules and for managing the programs budget, including invoices, payments, and reporting.
Credentials and Experience:
Over 20 years of experience of handling biospecimens across clinical laboratories and research to perform testing as well as secure and add specimens into biorepositories.
Extremely well versed with CAP requirements and accreditation processes.
Over 10 years of experience as a program manager, the individual will ensure tasks and deadlines are met and the program is successful. 


Technicians:
Credentials and Experience:
The technicians experience with handling and performing testing of biospecimens with over 2 years of experience.
The technicians have familiarity with placing and retrieving specimens into a biorepository as well as the importance of inventory tracking and protocol adherence.
3.0 Other Information
Safety
Breaks in service are important for the safety of staff and integrity of the specimens. The tasks involved carry occupational safety risks to the contractors, including cold exposure, carbon dioxide exposure, and repetitive strain injury. With guidance from Industrial Hygiene, the Government has developed operating procedures to minimize these health risks, including specific workplace protections, modified work behaviors, and modified schedules (breaks in services) to the contractor and our on-site staff. Personnel from VAGLA industrial hygiene evaluated the risk of exposure to CO2 and working cold temperature contact, they have provided recommendations for the work environment including protective ware, required breaks, and guidelines.
CO2 exposure:
Continue to work under the designated air supply locations (this will assist in keeping the CO2 inhalation exposure to a minimum).
Continue to take breaks at the 50-minute mark or as needed
Keep all doors open and work in pairs
Cold Temperature Exposure:
There are multiple instances where cold exposure is present, including sorting the samples, adding more dry ice/breaking apart dry ice, and moving the trays with the samples across the room.
Staff shall use cryogenic gloves.
Direct contact with dry ice should not be used, only the scoop, tools, or cryogenic gloves with safety grip can be used.
Use of cryogenic gloves and aprons are to be used along with a face shield during crushing of dry ice.

Health.
The tasks involved carry occupational safety risks to the contractors, including cold exposure, carbon dioxide exposure, and repetitive strain injury. With guidance from Industrial Hygiene, we have developed operating procedures to minimize these health risks, including specific workplace protections, modified work behaviors, and modified schedules. Personnel from VA s industrial hygiene evaluated the risk of exposure to CO2 and working cold temperature contact, they have provided appropriate suggestions for the work environment (as stated above).
Data Access, Collection and Storage:
Internal Review Board (IRB) compliant measures will be used to maintain confidentiality, privacy, and data security that adhere to the standards of the VA privacy officer, Information Security Officer, and Chief Information Officer.
Contractor will not have access to VA computers
All paper data must be kept in locked, fire-proof file cabinets dedicated to the studies that are kept in locked offices at the Sepulveda or WLA campuses of the VA Greater Los Angeles Healthcare System.
All data access from the VA Laboratory Information Management system (LIM) which houses the information will be overseen by VA staff. Contractors will not have access to the system.
4.0 Delivery
Activities will occur during the normal tour-of-duty hours at VAGLA, 8:00 am to 4:30 pm, Monday through Friday, excluding Federal holidays. In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as Legal Federal official holidays .
5.0 Period of Performance:
The Contractor shall have all services rendered and equipment received no later than 12 months from the date of Contract Award and receipt of Contract Award.
6.0 Contractor Responsibilities:
The Contractor shall be responsible for all liability actions or suits when the Contractor is at fault or negligent. Pecuniary liability is also included for all damages to VA buildings and equipment caused by installation activities. The Contractor shall comply with all local building and fire codes in addition to VA policy and procedures at the site.
The vendor shall operate under, but not limited, to the following national codes, industry standards, and practices: VA Research regulations, including VHA Directive 1200.08 (Safety of Personnel and Security of Laboratories Involved in VA Research), the National Fire Protection Association (NFPA) 45 Standard on Fire Protection for Laboratories Using Chemicals, the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030), the U.S. Food and Drug Administration (FDA) regulations applicable to human specimens, the International Society for Biological and Environmental Repositories (ISBER) Best Practices for Repositories, the Centers for Disease Control and Prevention (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL), Good Laboratory Practice (GLP) principles, and relevant data security standards such as HIPAA to protect patient information, the National Electric Code (NEC) for electrical safety, the Americans with Disabilities Act (ADA) for accessibility, and all applicable standards for sample storage, transportation, biosafety, and data security. Additionally, the vendor shall adhere to the College of American Pathologists (CAP) Laboratory Standards, which include requirements for quality management, personnel competency, sample integrity, documentation, and compliance with regulatory and accreditation standards to ensure the highest level of biospecimen handling and data accuracy
7.0 VAGLA Responsibilities:
VA Project Manager assigned by Medical Research shall provide access to the service site and the appropriate personnel (management, technical, subject matter expertise, etc.) necessary to fulfill the Contractor s requirements in a timely fashion.
8.0 Travel:
All travel shall be responsibility of the Contractor and shall align with VA policy and Joint Federal Travel Regulation limits for the location.Travel is required to complete 140,000 assessions (labeling and organizing). Per safety guidelines it is recommended to divide up settings into two week increments for a total of 8 separate site visits, however, VA may ask the contractor to extend their visit by up to 5 working days should that be more suitable for task completion.
Coordinating travel arrangements shall be the responsibility of the contractor for on-site visits.
Travel expenses will be reimbursed in accordance with Federal Travel Regulations (Chapter 300 through 304) utilizing Government rates.
Contractors will be reimbursed for actual travel expenses, but the contractor will use the most economical method of travel available, including non-refundable airfares and mid-range hotels matching government per diem rates whenever possible.
Reimbursable costs include airfare, car rental, hotel, taxis, and meals and incidentals (M&IE). M&IE expenses are included only at the Federal Per Diem Rate.
Travel time shall not be invoiced separately.
To receive reimbursement, the Contractor shall submit his/her DRAFT invoices along with travel expense worksheet (which is supplied at the time of award), receipts and all other supporting documents to the Government POC for review/approval prior to final invoice submission. This is to ensure final invoice is correct, so time is not spent redoing the final invoice.
Documentation to support lowest cost available is required for reimbursement.
Contractor (PRIME if there are Subcontractors) will submit all required documents noted above.
If travel dates or location are changed at the request of the program, the change fee for new date and/or location will be reimbursed, however no expenses will be reimbursed for changes made for the convenience of the VA.
Changes for convenience (personal reasons) are the responsibility of the contractor.
Documentation supporting change in location or dates must come from VA officials and /or site staff and must be submitted when invoicing.
The requirement will take place at a VA facility in West Los Angeles, California. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Friday, Sept 18, 2026, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.