Statement of Work Sample-Alinity mp.docx

STATEMENT OF WORK FOR THE VA Northern Healthcare System Mather Alinity mp (Preanalytical Sample) Background Alinity mp (Preanalytical Sample) will be used in Mather (clinical laboratory) BLDG 650 room 1D516a.

Objectives/Scope HPV is the most common sexually transmitted infection in the US and can lead to cervical, vulvovaginal, anal, penile, and oropharyngeal cancers. The Alinity mp System provides sample aliquoting for samples contained in liquid-based cytology (LBC) vials used for molecular testing of sexually transmitted infections (STIs) and/or human papillomavirus (HPV), according to assay-specific product documentation. The Alinity mp System provides for automation of the aliquoting of these specimens from the incoming vials to secondary (output) tubes compatible with the Alinity m System. Reduce Technologist handling in this step prevents error is handling samples for testing and mislabeling of aliquots. This also saves Technologist time; this is critical with the current staffing shortages to allow us to do the HPV testing in house versus sent out to a reference laboratory. Doing the testing in house also reducing turnaround time compared to the current reference laboratory turnaround time and has extended genetic genotyping that the current sends out test does not have available. From the 2022 study done by the VA published in the Journal of Medical Economics, Clinical and economic burden of HPV-related cancers in the US veteran population, they found that compared with the general population, US military are at higher risk of HPV-related conditions. Within the VHA, HPV-related cancer cases had approximately 4–15-times more inpatient hospitalizations of significantly longer duration, as well as 2–11-times higher total health care costs. Only 14% of female veterans of average risk undergo cervical cancer screening within the VHA system.

Selection Criteria Compatible with our Alinity m molecular analyzer. Preanalytical handling saves technologist time and there is less chance of preanalytical errors. It must fit into the space and due to space restrictions, it must be no bigger than 50 inches long, 30 inches deep and 36 inches high and must be a bench top not a floor standing system.

Technical Data

· Sample identification verification

· Prints labels directly on output tubes

· Decapping and re-capping of input and output tubes

· Automated vortexing

· Automated aliquoting

· Output tubes placed directly in Alinity m Universal Sample Rack

· 264 samples in 8 hours

· No daily maintenance

· 4-hour walkaway time

· 144 sample load up capacity

· Deliverables or Delivery Schedule The equipment shall be delivered to the following addresses:

VA Northern California Healthcare Systems-Mather 10535 Hospital Way

Place of Performance The place of performance will be:

VA Northern California Healthcare Systems-Mather Building 650, Clinical Laboratory, Microbiology/Molecular 10535 Hospital Way Mather, CA 94304

Period of Performance Everything must be delivered within 60 calendar days after the award date.

Installation An Abbott representative performs the installation and the relocation of the Alinity mp System. During installation, the representative unpacks, positions, and installs the system. During the installation, the representative performs the system setup and confirms that the system operates per installation and servicing instructions. After the installation, the customization or configuration of the system may be performed before any system processing is initiated. The system is supported by resourceful advocates consisting of dedicated professionals who excel in engineering, medical technology, training, and service. As part of a dedicated customer-training program, Abbott will teach how to operate, maintain, and troubleshoot the system.

Reference: Kunal Saxena, Rachel Souza Dawson, Anissa Cyhaniuk, Temitope Bello & Nora Janjan (2022) Clinical and economic burden of HPV-related cancers in the US