6640--Werfen GEM Blood Gas Analyzer Service/Supply B+4, IND

Statement of Work (SOW) Blood Gas Analyzers Upgrade and Testing Introduction: This contract request seeks a base+4 reagent rental contract through GSA-07F-128DA for the continuation of blood gas testing by acquiring upgraded analyzers, to replace our current 2 units, GEM Premier 5000 equipment. This replaces contract 36C25020A0011. Background: The Chemistry section, Pathology and Laboratory Medicine Service, receives test orders across the VAMC region. Arterial blood gases are essential tests that give critical information to respiratory therapists and physicians in monitoring oxygen levels in patients from vital health care areas such as, but not limited to, the emergency room, surgery and intensive care, and outpatients requiring home oxygen. Because the condition of the patients requiring oxygen is so critical, these tests must be performed and results available within 10 minutes of receipt in the laboratory. A delay in reporting blood gas results seriously harm the patient and they may not get the necessary adjustment to their oxygen in time. This acquisition includes the procurement of two blood gas instruments, one is required as a backup for continuous testing when the other instrument is unavailable. The instruments must be able to perform the current test menu, with accurate and reliable results within 2 minutes of sample aspiration. There must be sufficient capacity and throughput to meet the volume and service demands. The use of any other equipment and reagents requires an unacceptable test validation period, development of new procedures and incompatible test factors which impact providers discerning test results. The Roudebush VA Pathology and Laboratory Medicine currently has two (Werfen Inc) Instrumentation Laboratory GEM Premier 5000 analyzers, with all reagents, quality control materials and waste contained into one reagent cartridge. The primary component of the GEM analyzer is the PAK cartridge. The disposable, multi-use PAK houses all components necessary to produce a blood gas result once the cartridge is validated. These components include the sensors, solutions, CO-Ox optical cell, and waste bag. The components and processes used to manufacture the solutions in the cartridge are traceable to NIST standards wherever possible. For those analytes where NIST materials are not available, primary analytical standards are used. All validations, calibrations, quality controls and corrective actions are documented on the analyzer in the iQM report. Once a month, the previous month s iQM data is downloaded to a CD and transferred to the S: drive. There reports are available to the chemistry pathologist for review. The new (GEM Premier 7000) equipment reagent cartridge contains the CVP and does not require operator involvement. New AutoPAK Validation is built into the GEM 7000 cartridges and runs the CVP automatically. iQM2 with IntraSpect technology provides real-time detection performing continuous quality checks before, during and after every sample checking for any errors including transient errors. Error detection time is reduced from hours to minutes and errors automatically corrected and documented for a complete picture of quality with each and every sample. This next-generation Intelligent Quality Management (iQM3) utilizes patented technology for hemolysis detection. Hemolysis is the number one source of preanalytical error and can impact potassium results and patient care. Based on a photometric measurement of whole blood, the hemolysis module includes: acoustofluidic flow cell for plasma separation and hemolysis detection and an optical detector and LED light source to illuminate the optical flow cell for absorbance calculation at each wavelength. When hemolysis exceeds institution-defined thresholds, potassium (K+) results are flagged on the results screen and on the printout. Scope: Award a base+4 contract with base year to overlap 4 months of the current contract to allow time for installation and validation. The contractor shall provide all equipment, reagent/assays, standards, controls, calibrators, calibration verification materials, supplies, consumable/disposable items, parts, accessories, linearity testing materials, interface to the VA lab package in VistA, training of end users, complete analyzer system/maintenance/preventive (including parts, labor and travel), shipping for the term of the BPA, and any other item required for the proper operation of its contractor-owned blood gas analyzers and peripherals necessary for the generation of a patient reportable blood gas test to the Richard L. Roudebush VA Medical Center (RLRVAMC), Pathology & Laboratory Medicine Service, Chemistry. The instrumentation shall perform all analyses for the required tests with safety and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI) and the College of American Pathologists (CAP) and Food and Drug Administration (FDA). All analyzers shall be FDA approved. The instrument must be compatible with DHCP/VistA. A barcode reader must be supplied with the analyzer that at the minimum, can read the patient s UID barcode label on the patient sample. Objectives: Maintain veteran direct care using updated equipment for blood gas testing, that minimizes and/or eliminates technologist intervention; providing consistent test results with established values. Tasks: Award a Reagent Rental contract for blood gas analyzers that perform the current test menu. The period of performance of this contract consists of a base year and four option years. The contract is effective upon signature by the Government and Contractor. Each instrument comes with a 5-year warranty with 24 hours/7 days a week customer service during the entire length of the contract for 5 years. Training: The Contractor will provide two (2) initial operator training sessions for the Base year and one additional operator training at a later date if it is needed. Safety: The Contractor shall immediately notify RLR VAMC of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations. Test Performance: All tests, procedures, and equipment must perform at manufacturer s specifications. Deviations from the performance specifications shall be corrected by the Contractor. Test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP proficiency testing peer evaluation. Supply Delivery: All new equipment shall be delivered within 30 days of contract award. All new instruments shall be installed and operational within 30 days of delivery. Reagents, QC products, and consumable supplies shall be shipped within one day after receipt of order except for rare instances which shall require overnight shipment. Contractor shall furnish a designated point of contact and method for placing orders upon establishment of contract. The delivery of reagents below and others not listed but deemed necessary to perform blood gas testing on the GEM Premier 7000 is covered under the contract and will be delivered when ordered: GEM Premier 7000 PAK cartridge, 450 tests. PVP material, printer paper, GEM 7000 Start Up Kit If a component or reagent deemed necessary to perform testing is broken or needs replacement, the delivery of these reagents will be required upon notification by RL Roudebush VAMC Chemistry Path & Lab personnel. Delivery time will be not more than 2 business days and paid for by the Vendor. In addition, the costs include all necessary maintenance, upgrades and emergency repairs and training for government personnel. Delivery, installation, and removal of equipment are provided at no additional charge to the government. Government Furnished Equipment: This is a reagent rental contract for two GEM Premier 7000 blood gas analyzers with all supplies and equipment included to perform blood gas analysis. Security: This equipment will be linked to VA LIS for posting completed test results. The vendor has completed the Manufacturer Disclosure Statement for Medical Device Security MDS2 on the current contract. Unique identification numbers and test results are maintained by the analyzer. Space & Utilities: Sufficient utilities and space will exist for this equipment and its reagents and materials upon removal of the old equipment. Performance Location: Chemistry Section, Path & Lab Service, Roudebush VAMC, Indianapolis, IN 46202 Period of Performance: Base plus four option years.