TRANSFUSION SERVICES AUTOMATION
STATEMENT OF WORK
VAMC Hampton Blood Bank (Transfusion Service) performs diagnostic testing to provide compatible blood products to its patients. The Blood Bank is requesting an FDA approved walk away/automated analyzer for use in the Transfusion Medicine Service. The proposed analyzer shall utilize Capture Solid Phase Technology for the detection and identification of Red Blood Cell Antibodies. to eliminate extensive validation and training. This analyzer runs the majority of tests performed in the Blood Bank and is vital in maintaining efficiency, improve patient safety meeting required turnaround times for patients that may need blood products and reduce hands on labor in the blood bank.
2.0 GENERAL REQUIREMENTS:
2.1 The analyzer shall use Capture Solid Phase Technology.
2.2 The analyzer shall be capable of producing accurate and reproducible assays on biological samples with FDA approved methods for in vitro diagnostic methods. Model shall provide accurate tests assays results up the manufacturer s define maximum test per hour without excessive malfunction, breakdowns, or service call.
2.3 The model being purchased shall be in current production as of the date the purchase is made. Discontinued models will not be accepted.
2.4 The analyzer shall sit on a table top (bench) and can not be greater than 24 H x 40 W x 23 D and weigh below 150 pounds.
2.5 The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, UPS, barcode scanners, and a computer monitor. The cost of the excluded items shall be incorporated in the price proposal.
2.6 The vendor will provide Hampton VAMC laboratory with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, wash solution, disposables, and any consumable part(s) necessary for analyzing/testing on the analyzers. Vendor must list the consumable parts provided.
2.7 If there is a newer instrument released during the duration of the contract, VA Hampton facility should be given the opportunity to replace existing instrument with the newer instrument on the same contract.
3.0 EQUIPMENT FUNCTIONALITY:
3.1 The instrument shall be fully automated walkaway analyzer with continuous random access and capable of processing multiples runs simultaneously.
3.2 The analyzer shall use a combination of hemagglutination and Capture technology.
3.2 The analyzer will perform the following tests: ABO forward and reverse grouping, Rh typing, Antibody Screen, Antibody Identification (panel with auto control), IgG DAT, Crossmatching Blood Units with patient samples, Rh/Kell Phenotype, Eluate panel and Donor Confirmation.
3.3 Turnaround time for a Type and Screen shall be within 30 minutes.
3.4 The instrument must be able to handle and aspirate directly from the standard 6.0mL K2 EDTA (13×100 mm) and the 4.0mL K2 EDTA (13×75 mm) tubes.
3.5 The reagents used for ABO/Rh testing shall also be capable of being used with the manual tube testing method.
3.6 The vendor shall provide a daily quality control kit that is processed like real patient samples to verify the functionality of the instrument and all required reagents
3.7 The analyzer shall increase productivity with: random access, discrete testing, STAT interrupt capability and continuous throughput.
3.8 The analyzer s software functions shall include positively identify samples, reagents and strips, interpret test results (image analysis), verify batch results against the results of quality control samples, and provide data storage of test results. The system shall have the ability to alert the operator of QC failures.
3.9 The analyzer shall provide: Dispense verification, bar-code tracking from start to finish, multi-level password protection, automatic monitoring of reagent expiration dates and strip integrity. The analyzer shall alert the operator when reagents are low.
3.10 The analyzer shall have bi-directional interface with VistA Blood Establishment Software (VBES)that helps reduce transcriptional errors.
3.11 The analyzer barcode scanning must fully support the following barcode symbologies: Code 39, ISBT 128, Code 128, and Codabar.
3.12 The analyzer shall have reagent liquid level sensing and an indicator for short sample detection and must have sample clot detection.
3.13 The analyzer may have the ability to replenish reagents/consumables while in operation, without halting/ pausing the analyzer.
3.14 The system may provide on-board reagent inventory, in real time that can be printed at selected time intervals for reagent documentation.
3.15 The vendor will supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 to 85 percent and any laboratory temperature between 50 to 90 degrees Fahrenheit (10 to 30 degrees Celsius).
3.16 Analyzer may have the capability of printing/retrieving/storing printouts for all patient results and controls, with minimal operator intervention or delay in workflow/analysis. Reagents/consumables lot numbers and expiration dates used on patient testing must be included on the report.
3.17 The instrument must be capable of performing the College of American Pathologists (CAP) Transfusion Medicine Automated Test (JAT) survey directly from the proficiency testing tubes.
4.0 INSTALLATION AND VALIDATION:
4.1 Vendor shall move instruments, free of additional charge, to final testing location upon completion of validation process.
4.2 Vendor shall work with incumbent to provide removal of the existing analyzer upon the expiration of the contract, but not before the validation of the new equipment is completed.
4.3 The vendor shall list analyzer/utility requirements and weight/dimensions of the analyzer.
4.4 At installation of new equipment, vendor must provide the physical installation of the equipment. Installation shall include, at a minimum, uncrating and/or un-packaging of all equipment, hardware set-up and hook-up of the system, removal of trash, and documentation that the analyzer is functioning within the correct specifications.
4.5 The vendor shall provide at installation/set-up and when bringing new tests on-line, a technical support specialist who shall help guide the facility with validation studies including: installation/ set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. Method Performance/Comparison shall include but is not limited to: accuracy, precision, specificity, sensitivity, and carryover studies on the analyzer. This service shall be available during regular office hours on a 5 days/week basis. The vendor will state the hours the technical support specialist will be available for installation/set-up/validation studies/training, etc.
4.6 The vendor shall have the ability to provide technical support to perform method validation as outlined in the solicitation and to submit all data and/or required statistical analysis in a binder for on-site staff approval. This process must be completed within 6 weeks of installation of the analyzer.
4.7 The vendor shall provide all supplies used for validation and during training of staff at no charge to the government. Supplies include, but not limited to: reagents, diluents, controls, and consumables. The vendor will pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies, and training of staff.
4.8 The instrument must be furnished with an uninterruptible power supply, capable of a 2-3 hour back-up.
4.9 The UPS to be provided with service/maintenance or replacement as needed per service contract.
4.10 The vendor shall provide a printer. The service contract will include replacement, repair or upgrade if applicable.
4.11 The instrument computer screen must have color image analysis to aid in the visual interpretation of reactions.
5.0 SERVICE AND MAINTENANCE:
5.1 Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm).
5.2 The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. Hotline service shall follow-up all down calls within one hour.
5.3 All repairs on instrument must be complete within 24 hours from the time the serviceman arrives.
5.4 Service is to include, at no charge, all labor, travel and all replacement parts necessary to make repairs.
5.5 The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required.
5.6 Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).
5.7 Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level.
5.8 Vendor will state what parts or maintenance kits are included at no charge to the govern.
5.9 The vendor shall provide hardware and software upgrades as they become available, to include antivirus software, as well as any necessary training without additional charge to the government.
5.10 The vendor shall have the capability of providing remote support for the instrument using SSL technology to expedite service, troubleshooting and minimize downtime. The remote support shall only be initiated from the instrument computer via an instrument user request.
6.1 The vendor shall provide primary user training for the use and maintenance of the analyzer for two individuals. Training will include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Competency assessment must be performed and documented by the vendor trainer. Primary user training must include all costs, i.e., transportation (air and ground), room and board, etc.
6.2 Vendor will provide on-site refresher instrument training in renewal option years of the contract if so exercised.
6.3Vendor shall provide all necessary procedure manuals, troubleshooting manuals, operator manuals, and MSDS s. Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) form.
7.1 All supplies shall be delivered FOB Destination to the Hampton VA Medical Center, Hampton, Virginia at no charge to the government.
7.2 A Standing Delivery Order will be placed with the requirement for delivery of product every 28 days.
(See Appendix A for estimated volumes. The vendor will list the quantity and price of all reagents and consumables based on those volumes.
All other items will be ordered as needed rather than being shipped on a standing order.
7.3 Deliveries shall be made to:
Hampton VA Medical Center (590/113)
100 Emancipation Drive
Pathology and Lab Service, Building 110A, Room C-118 Blood Bank
Hampton, Virginia 23667
7.4 Delivery Times: Between 8:00 a.m. and 3:30 p.m., Monday-Friday except on the following Federal Holidays:
New Year s Day 1st of January
Martin Luther King s Birthday 3rd Monday in January
President s Day 3rd Monday in February
Memorial Day Last Monday in May
Independence Day 4th of July
Labor Day 1st Monday in September
Columbus Day 2nd Monday of October
Veterans Day 11th of November
Thanksgiving Day 4th Thursday in November
Christmas Day 25th of December
7.5 All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain: vendor s name, order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped.
8.0 SHELF LIFE:
8.1 All Products must be received in the Laboratory with at least 2/3 of shelf life remaining. The manufacturer/distributor will provide an update when necessary a shelf life list (time from production to outdate) for each product purchased.
9.0 RECALLED AND/OR DEFECTIVE PRODUCTS:
9.1 The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products.