Description
The Medical Regional Contracting Office, West (MRCO-W) is issuing this Sources Sought Notice for Cost-Per-Test Arrangement for infectious and autoimmune diseases serology testing for anti-nuclear antibodies, Epstein-Barr virus, T. gondii, cytomegalovirus, Herpes simplex viruses 1 and 2, measles, mumps, rubella, and varicella-zoster, vasculitis, Syphilis, Lyme disease, and antiphospholipid syndrome. This requirement will include two (2) instrument/analyzers, reagents, and their associated calibrators and controls in support of 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 Sources Sought 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 Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerors 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 Section, Immunology Laboratory at the main hospital located at BAMC and surrounding area clinics require the following instrument/analyzers, reagents, supplies, calibrators, controls, materials and services required: Basic Requirements : The system must contain random multiplex access technologies that improve workflow and be approved by, and include test methods approved by, the Food and Drug Administration (FDA). The system must be scalable on site to accommodate anticipated increases in workload and to acquire improved technology. The 2 systems must fit in the current space available which is approximately 14’ x 3’ x 5’ (length x depth x height) Test Menu and Special Requirements for Awarded Contractor : Vendor must meet, or improve, each Laboratory's existing turn-around times at a minimum, by any change in instrumentation. Proposal should include automated pre-analytical specimen processing for: Anti-nuclear antibodies (ANA; quantitative dsDNA; semi-quantitative Chromatin, Ribosomal-P protein, SS-A, SS-B, Sm, SmRNP, RNP, ScI-70, Jo-1, and Centromere B) Epstein-Barr virus (EBV; IgG for VCA, NA-1, and EA-D; IgM for VCA and heterophile) T. gondii, rubella, and cytomegalovirus (ToRC; IgG quantitative for Toxoplasma gondii and Rubella, IgG qualitative for Cytomegalovirus; IgM qualitative for T. gondii, Rubella, and Cytomegalovirus) Herpes simplex virus 1 and 2 (HSV 1/2; differentiates IgG for types 1 and 2) Measles, mumps, rubella, and varicella-zoster (MMRV; qualitative detection of IgG for measles, mumps, rubella, and varicella-zoster) Vasculitis (semi-quantitative IgG for MPO, PR3, and GBM) Syphilis (qualitative IgG and IgM for Treponema pallidum Lyme Total (qualitative IgM and IgG for Borrelia burgdorferi) Antiphospholipid Syndrome (APLS; IgG, IgM, and IgA for anti-Cardiolipin and anti-Beta-2 Glycoprotein I) Vendor must also be capable of supplying reagent and associated consumables for either manual testing or automated testing on a government-owned instrument for the following: CT immunoscreen to include: Kits, slides, conjugate, QC, patient sample diluent, null strips, autoimmune stop solution, PBS buffer solution, and other consumables required for use of automated pipetting workstations for CTs Method Performance/Comparison shall be at the expense of the Vendor, shall include linearity material and reagents, and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following: Correlation studies for each analyte. A minimum of 20 samples, spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI. Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines. Precision study shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal and abnormal controls. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications. Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood and urine container are evaluated for interfering substances for each method performed. Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols should be used: If the suggested manufacturer's range is not appropriate for the patient population, a reference range must be established and may require additional reference individuals. If a laboratory is currently using the proposed instrument/reagent system, the "in-use" reference range can be transferred to the "new" system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternate test must be provided. Analytical Measurement range validation studies must be performed by vendor for applicable analytes. All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with each Laboratory's computer system, for local modification (editable) to meet CAP requirements. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms. Vendor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus. (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies). Analytical Systems : Ability to manage testing workflow of hospital laboratory. Analytical configuration of fully automated random multiplex testing platforms must provide for backup analyzer(s) with equivalent menus utilizing the same reagent formulation to ensure correlation with primary instrument and backup instrumentation. Analyzers must be capable of allowing simultaneous detection of multiple analytes from a single sample. Analyzers must be capable of running short sample runs (smaller volumes) while also maintaining a minimum throughput of 100 samples per hour. Vendor solution must be scalable and able to connect multiple modules together to increase efficiency and reduce space requirements in the laboratory. Integrated modules must only require one system control center (computer and screen) to simplify operations. Instruments must have load on the fly capabilities for reagents, samples, bulk solutions and consumables. Vendor instrument solution must provide a primary tube and aliquot sample loading capability to include automatic barcode reading. Analyzers must have clinically insignificant carryover and not require the use of disposable pipette tips or aliquots or specific aspiration order of assays. Analyzers must be able to perform “add-on” reflex testing on any previously run patient sample. Vendor must have commonality across all analyzer platforms for the following: Software Reagents Consumables Methodology Each analyzer reagent carousel must have a minimum of 20 reagent slots to allow for maximum load up of reagents to increase walkaway time and reduce technologist intervention. Instruments must be available for full front loading of samples, reagents, consumables and bulk solutions on the fly and STATs must take priority over routine testing. Analyzers must have flexible STAT testing options to prioritize the most critical samples based on workflow. Analyzers must feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups, probe crashes and unnecessary downtime. Instruments and automation must use point in space sampling to eliminate need for pipette tips and aliquots. Calibration of immunoassay analyzers must be easy and of minimal frequency. Immunoassay calibrations must only be required when QC is out of range or new lot numbers of reagent are put into use. Calibrators should be liquid and ready to use with no reconstitution or prep required prior to use. List any calibrators that require preparation and the required process. Analyzers must be capable of monitoring reagent usage, maintaining and storing on board supplies/reagents for 24 hours of patient testing on the combined platform, and providing reagent inventory upon request, in real time. Quality control frequency not to exceed once/24 hours/instrument platform. The analyzers must have a comprehensive QC Program for all tests which includes at minimum the following options: QC files may be edited or corrected for errors manually –. On-board quality control data storage and reporting capabilities- Ability to view and print daily and monthly QC results – Ability to view and print Levy Jennings graphs – On-line documentation of out of range QC – Read barcoded QC. Westgard rules built in –. If QC fails, instrument will stop running samples – Chosen analyzers must have minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including washes and wait time, for daily, weekly and monthly maintenance. Please include any hands on, automated non-maintenance activities. Vendor to provide average number of service calls per year per analyzer, provide access to a 24/7 on-call support system, and perform preventive maintenance as required. Analyzer must accommodate multiple tube sizes simultaneously. Instrument must have liquid level sensing, clot, foam and bubble detection. Please describe how analyzer detects. Vendor must provide BTU output for both analytics and automation systems. Meet space limitations of approximate. 14’ x 3’ x 5’ (L x D x H) Selected design must maintain walkways and clearances around track and instruments. Treponema/non-Treponema immunoassay test and reverse syphilis testing algorithms must be supported. LIS connectivity must be supported/available Analyzer must have an (Authority to Operate) ATO security authorization in order to meet US federal government IT security requirements. Reagents and Supplies: Vendor must provide multiple test kits sizes for immunoassays, including over 100 tests per kit options for IA testing to handle highest volume testing, if available. Vendor reagents must be 99% liquid ready to use from storage, requiring no reconstitution or mixing. List all Reagents that are not liquid, ready to use. Vendor calibrators must be at least 95% liquid ready to use from storage, requiring no reconstitution or mixing. List all assay calibrators that are not liquid, ready to use. Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission. In the event that the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order. Vendor must provide 5 years of FDA field action notifications