377 MDG Hematology Analyzer

COMBINED SYNOPSIS/SOLICITATION NOTICE: This is a combined synopsis/solicitation notice for commercial product/services prepared in accordance with the format in the Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation is attached. Solicitation RFQ FA9401-18-Q-0012 incorporates provisions and clauses effective through Federal Acquisition Circular (FAC) 2005-99, dated 16 Jul 2018. This requirement will be solicited Full and Open competition. North American Industry Classification System Code (NAICS) is 334516 - Analytical Laboratory Instrument Manufacturing, with a size standard of 1,000 employees. All qualified small businesses under this industry are encouraged to submit quotes. DESCRIPTION OF REQUIREMENT: Purchase medical equipment lease for a hematology analyzer and services for a base year and foru-one year options. REFERENCES: The following publications are available electronically at http://farsite.hill.af.mil/ Federal Acquisition Regulation (FAR) Defense Federal Acquisition Regulation Supplement (DFARS) Air Force Federal Acquisition Regulation Supplement (AFFARS) SPECIAL INSTRUCTIONS: Offerors shall be required to return the attached Standard Form 1449 Solicitation FA9401-18-Q-0012, signed and filled in appropriately as their offer along with any additional information required to be submitted by FAR 52.212-1 Instructions to Offerors Addenda and any additional fill-in provisions. **NOTE** responses to the above solicitation shall be submitted electronically if the capability is there to do so. If not, please contact the personnel below under the Contracting Office Contact Information for additional instructions. 52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: i - Technical Acceptability, technical evaluation team will evaluate by assigning a rating of "acceptable" or "unacceptable". The Government will evaluate a minimum of three (3) lowest priced offers for technical acceptability in accordance with the solicitation. If none of the lowest three (3) are technically acceptable, the Government will evaluate the next three (3) lowest priced proposals until one proposal is technically acceptable, or until all offers have been evaluated. Only those proposals considered technically acceptable will receive further consideration for award. Once a proposal is deemed acceptable, all technical proposals are considered equal. - A. Contractor shall provide the government with a BRAND NAME OR EQUAL to Sysmex XN 550 Hematology Analyzer and services over a period of one (1) base year and four (4) option years, on a cost per test/cost per reportable result lease basis. - B. Cost per test/per reportable result basis must include all necessary equipment, reagents, 24/7 technical/specialist support, equipment maintenance and repair, replacement, the option of newer technology upgrades if available will be offered in contract option years. - C. Analyzer: The contractor shall provide one (1) analyzer that meets the requirements and the performance characteristics identified in this SOW for accuracy and precision as defined in the 1988 Clinical Laboratory Improvement Act (CLIA '88) and the Clinical Laboratory Standards Institute (CLSI formerly NCCLS) as follows: - D. The hematology analyzer s h a l l h a v e a self-contained waste management, does not require water, plumbing or drains. The contractor shall maintain, replace, repair, provide supplies, and replacement as required, in order to ensure the equipment is fully operational and within manufacturer specifications. - E. Instruments and assays shall be FDA approved (the contractor shall provide proof of approval), and had no FDA warning letters or no more than 3 FDA recalls issued over the past 24 months. - F. The hematology analyzer may have a standby modem, but must be available/in normal operation including no manual priming, purging or tubing maintenance, and liquid reagents must be capped while onboard. It shall be ergonomically designed with flat touch screen monitor and on-board instructions, and help functions. - G. The unit must be able to house all reagent assay packs. No preparation, mixing or reconstitution shall be required for reagent packs and the packs shall have on-board calibration stability of at least 90 days. Reagent packs will have a shelf life of at least 60days from receipt. - H. The unit must have self-contained onboard waste management and must not require external water/plumbing, drains, stirring mechanisms, mixing assemblies, or floor vents. - I. The Hematology Analyzer shall utilize " s h a l l n o t u s e " disposable tips. The system must not use reusable probes to aspirate the sample and reagent. - J. The analyzer shall be able to mix and aspirate the sample from a track. - K. No dedicated reagent positions shall be required, and the unit shall have minimal reagent preparation. - L. Can utilize universal sample trays which can accommodate common primary EDTA tubes including pediatric tubes with or without adapters. - M. Have positive patient identification via on-board barcode scanner. - N. Measure White Blood Cells (WBCs) using Flow Cytometry. Perform 6-Part WBC differential counts using Fluorescent Flow Cytometry. Capable of measure WBCs in Low WBC Mode. - O. Possess auto repeat and auto reflex capability. Be self-monitoring and alert operators to prompt action. - P. Provide sample management with clot detection, bubble detection, liquid level-sensing, and short-sample detection. The system must save the sample if a clot or bubble is detected during primary aspiration. - Q. Use a cyanide-free hemoglobin measurement method. - R. Support multiple lots onboard, have random access and capable of performing automatic calibration/lot switching with on-board linearity program and the use of ready-to-use calibration materials. Shall have stable (six month or longer) calibrations and only require calibration every 6 months or as indicated after change of reagent lot use; when critical system parts are changed due to service or maintenance, if quality control results are consistently outside acceptable ranges, or when government regulations require. - S. Foot print - for analyzer, analyzer clearance, monitor, keyboard, CPU, printer and UPS. - T. Provide Cost-Per-Test (CPT) or Cost-Per-reportable Result (CPRR) pricing for 100% of tests listed in Appendix B. The price shall include costs covering: - U. All necessary maintenance to keep the equipment in good operating condition. This includes both preventive maintenance and emergency repairs. - V. The contractor shall provide during initial install on-site technical support and new test validation reagent & materials needed to bring the analyzer to full operational status. - W. System must be capable of interfacing with current and future laboratory management software: "The current LIS" is a Composite Health Care system (CHCS ver. R2W). MHS Genesis by Cerner will be the LIS installed in the future. System must possess a host-query bidirectional interface compatible with in-use LIS barcode system. - X. The hematology analyzer system must have a windows-based printer, read/write disk drive for data input and archiving up to 25,000 results using CD-ROM or USB flash drive. All contractors must be registered in the System for Award Management http://www.sam.gov database prior to any contract award. OFFER DUE DATE AND TIME: 11:00 AM, 12 SEP 2018 LATE OFFERS: Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in this solicitation by the time specified in the solicitation. Quotations/offers or modification of quotes/offers received at the address specified for the receipt of offers after the exact time specified for receipt of offers WILL NOT be considered (ref. FAR 52.2121(f)). CONTRACTING OFFICE CONTACT INFORMATION: All offers and questions pertaining to this solicitation shall be sent by mail or email to the address below. Virginia S. Garcia 377 MSG/PKB 8500 Gibson Blvd, Bldg 20202 Kirtland AFB, New Mexico 87117 Brenda Hamilton 377 MSG/PKB 8500 Gibson Blvd, Bldg 20202 Kirtland AFB, NM 87117