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…