Sources Sought Notice - Cost-Per-Test - Reagents for BCR-ABL Tests

Sources Sought Notice - Cost-Per-Test - Reagents for BCR-ABL Tests The Regional Health Contracting Office - Central is issuing this Sources Sought Notice on behalf of San Antonio Military Medical Center, JBSA - Fort Sam Houston, Texas. Any responses to this Sources Sought Notice will be used for planning purposes only. This notice is not a solicitation of binding offers, nor is it a notice to proceed. The San Antonio Military Medical Center (SAMMC) has a requirement for a Cost-Per-Test Agreement to include to include reagents, consumables, controls, supplies, training and maintenance service to conduct BCR-ABL testing at the Brooke Army Medical Center (BAMC) in Fort Sam Houston TX. The QuantideX qPCR BCR-ABL IS Kit is FDA-cleared for the ultra-sensitive detection and precise monitoring of BCR-ABL1 transcripts resulting from the Major breakpoints (e13a2, e14a2). The QuantideX qPCR BCR-ABL minor Kit is a clinical research tool enabling ultra-sensitive and precise detection of BCR-ABL1 minor fusion transcripts (e1a2) from whole blood specimens. These real-time Polymerase Chain Reaction (PCR) assays are designed to run on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instruments. The instrument is controlled by an external computer with SDS Software. By rapidly quantifying BCR-ABL translocations, the clinicians can order tests, make referrals, and treat as appropriate, thus saving time, eliminating unnecessary costs, and providing best patient care to soldiers and their beneficiaries to maintain a state of physical and mental health readiness. Vendors that consider themselves capable of providing the required testing are invited to submit a capability statement for the Government to consider via email to the Point of Contact listed herein. This capability statement shall include the following information. If the capability statement does not address ALL of the points below, the vendor will not be considered as capable of providing the required testing: Vendor name (to include CAGE code and DUNS number); Point of Contact (to include email address and phone number); business size. Documentation that demonstrates its ability to provide Cost-Per-Test Agreement to include reagents instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing to include: CDC Basic panel, Leukemia/Lymphoma, and Stem Cell/CD34. Food and Drug Administration (FDA) approval if applicable. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Basic Requirements: - Provide consumable reagents for the operation of select quantitative BCR-ABL reagents. - Provides reagents and controls for translocation assays: - Quantitative BCR-ABL of major fusion transcripts (e13a2, e14a2) and minor fusion transcripts (e1a2) - All reagents for each assay must be FDA approved to provide quantitative BCR-ABL results on the international scale and Include In-run IS calibrators - Ensures proper of cold-chain management of supply during shipping - Offers overnight shipping when requested - Orders are processed and received at facility no more than 5 days after order placement, excluding weekends and federal holidays - Ensures no cost replacement of supplies if damaged or out of temperature upon arrival as determined by end user. - Ensures reagents expiration date is at least six months or more from received date. - Provides direct customer service during normal business hours, excluding weekends and holidays - Provides recall or advisory information within 2 days of notice to end user. - All reagents must be FDA Approved for the 7500 Fast DX - Turnaround time is 5 hours or less