Inactive

The Medical Regional Contracting Office, West (MRCO-W) is issuing this Pre-solicitation Notice for Human papillomavirus High Risk testing, detection, and genotyping (genotypes 16 & 18) for the Brooke ... The Medical Regional Contracting Office, West (MRCO-W) is issuing this Pre-solicitation Notice for Human papillomavirus High Risk testing, detection, and genotyping (genotypes 16 & 18) for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services Microbiology Laboratory, Fort Sam Houston, Texas. A base period of performance of twelve (12) months plus four (4) twelve (12) month option periods are contemplated. THIS IS NOT A SOLICITATION ANNOUNCEMENT - This is a Pre-solicitation Notice and is issued solely for information and planning purposes - it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this pre-solicitation notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerers to monitor this site for additional information pertaining to this requirement. The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. MRCO-W is seeking the following information (please answer paragraph below with your response): Company name, UEI number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Our customer, the Department of Pathology, Microbiology Laboratory at the main hospital located at BAMC and surrounding area clinics require the following reagents, supplies, calibrators, controls and materials: Instrumentation: Instruments/Equipment. Testing system must be FDA-certified Primary screening for cervical carcinoma and shall include testing for the following: HPV High Risk pool plus HPV 16 & 18 Genotype simultaneously eliminating the need to re-run a sample; as well as a traditional High Risk pool (14 HR Genotypes) with no grey zone or indeterminate results. Testing shall be performed on a fully automated IVD platform. Each analyzer and all associated reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time. Testing shall contain an internal control for cellularity check such as? globin. Testing shall detect HPV DNA Testing shall show no cross-reactivity with low-risk HPV genotypes. Testing shall accept multiple primary vial formats, including liquid-based cytology PreservCyt containers, for automatic nucleic acid extraction so that no routine pipetting into secondary tubes is required. Automated pipetting of specimens shall have a system to prevent cross-contamination by securely locking pipette tips in place to avoid motions that could create aerosols of samples/reagents. Pipetting aspiration and dispensing shall be monitored by pressure within the tips to detect low volumes and clogs to ensure valid results. The system shall have criteria that exist to report an error when low volumes and/or clogs are detected. Testing shall offer detection and separation of multiple targets from 1 reaction tube. The testing system shall provide bi-directional LIS communication with MHS Genesis to simplify test ordering and support the integrity of results so that no manual data entry is required. The testing system shall offer a fully automated pre-analytical component that standardizes sample handling and automates mixing and uncapping of PreservCyt containers and automated barcode check and sample alignment. This pre-analytical step shall have minimal hands-on time requiring less than 5 minutes of setup; and automated mixing and uncapping of 94 samples completed in less than 30 minutes. Pipetting shall be performed utilizing aerosol barrier tips. Platform shall be compatible with facility data transfer systems. A data management system, to include middleware, not contained within the Molecular analyzer The system shall provide a central data management hub, to which all major systems connect to: Unit 1- Sample processing/extraction unit; Unit 2 Amplification/detection unit. The system shall not require remote communication to outside sources to be functional. The system shall be capable of interfacing with the MHS Genesis. Software shall track instrument maintenance requirements. Software shall have interface capabilities. The analyzers will have an interface that is compatible to the government system (MHS Genesis) and will be able to recognize MHS Genesis generated bar-code labels (both code 39 and 128) on primary sample tubes. Peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs, printers to include toner for each as needed, and other equipment where required. Sample Processing System to perform the requested processing: Processing shall be performed on a fully automated IVD platform. Offeror shall be able to perform automated uncapping of various samples to include PCR Media tubes, SurePath containers, and PreservCyt containers Shall be able to perform automated recapping of various samples to include PCR Media tubes, SurePath containers, and PreservCyt containers Shall perform standardized sample handling to include automated barcode check and alignment Shall perform automated mixing produces consistent homogeneity Shall contain built in feature to reduce the risk of crosscontamination Shall decap or recap 94 samples in less than 30 minutes (walkaway time) The system shall not require remote communication to outside sources to be functional. Platform shall operate using one computer. Software shall track instrument maintenance requirements. Pedestal(s) capable of supporting each workcell system as appropriate, to include computer terminals or other automated instruments/peripherals as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance).