6550--MPLS - Blood Bank Automation System - Grifols

This is a Pre-Solicitation notice for the Department of Veterans Affairs, Network Contracting Office 23, for the procurement of Blood Bank Automation System Supply at the Minneapolis VAMC, located at Minneapolis, MN. The NAICS code for this procurement is 325413 In Vitro Diagnostic Substance Manufacturing with a size standard of 1,250 employees. Potential offerors are responsible for monitoring this site for the release of the solicitation package and any other pertinent information and for downloading their own copy of the solicitation package. Any amendments issued to this solicitation will ONLY be available on this site. Offerors are advised that they are responsible for obtaining all amendments. All questions must be submitted in writing to the Contracting Specialist at contact@example.gov. No telephone inquiries will be accepted. This notice does not obligate the Government to award a contract neither does it obligate the Government to pay for any quotes or proposal preparation costs. The Government is not obligated to issue a solicitation as a result of this notice. No other information is available until issuance of the solicitation. All interested parties must be registered in System for Award Management (SAM) to be eligible for award. Registration information can be found at www.sam.gov. Blood Bank Automation System 1. Basic Requirement: The Minneapolis VA Health Care System Blood Bank Laboratory located at 1 Veterans Drive, Minneapolis, MN 55417, hereinafter referred to as MVAHCS, is in need of a contract to provide a cost-per-test or reagent rental for one primary automated blood bank analyzer and two backup manual blood bank analyzers. Both primary automated and backup manual analyzers must be column-agglutination based technology for red cell antibody detection. All costs shall be figured into the price of the reagents, supplies, and consumables. This agreement is to include one primary automated analyzer, two backup manual analyzers (including both an incubator and centrifuge), one uninterruptible power supply (UPS), installation, validation, training, customer service, technical support, preventative maintenance, equipment service (including parts, labor, and travel), and all shipping costs. The analyzers may be placed in a temporary location for validation and need to be moved to a permanent location after they re validated for use. Contractor will be responsible for moving analyzers for this one time move, at no cost to the Government. 2. Contract Type and Terms: The MVAHCS will award a 5-year firm fixed price IDIQ contract with 6 ordering periods for all items listed in the Schedule of Items. Contract use will be limited to the MVAHCS. All reagents, supplies, and consumables to support testing will be requested on an on demand, as needed basis. Test Menu ABO Rh and (3 cell) Antibody Screen = 11,000 ABO Rh = 1500 Antibody ID = 230 Donor unit retypes ABO Rh = 300 Donor unit retypes ABD = 1000 Anti-C = 200 Anti-c = 100 Anti-E = 200 Anti-e = 25 Immediate Spin (IS) Crossmatch = 900 Anti-Human Globulin (AHG) Crossmatch = 600 Direct Antiglobulin Test (DAT) = 350 3. Technical Requirements & Salient Characteristics: The LIS interface system must be established with VBECS prior to contract award. Both primary automated and backup manual analyzers must be approved by the Food and Drug Administration (FDA). Both primary automated and backup manual analyzers must be column-agglutination based technology for red cell antibody detection. Primary analyzer must have capabilities to load reagents and supplies to process multiple specimens without reloading consumables. Primary analyzer must use regular saline without the addition of an external buffer. Primary analyzer average turn-around-time for a Type and Screen must not exceed 35 minutes. Primary analyzer must sit on the counter and not exceed dimensions of 31 D x 48 W x 42 H. Primary analyzer must have sample capacity for at least 10 samples. Primary analyzer must have continuous access with STAT capability. Primary analyzer must have automatic cap detection. Primary analyzer must have automatic clot detection. Primary analyzer must have automatic liquid level detection. Primary analyzer must be capable of performing the following tests: ABO/Rh Antibody Screen Antibody Identification Select Cell Panel Crossmatch (IS and AHG) Patient ABO/Rh retypes DAT Donor Unit ABO confirmations Antigen typing Primary analyzer must have a barcode scanner compatible with the standard 128 code. Primary analyzer must accept at minimum 10 alphanumeric characters in the specimen identifier. Primary analyzer must have capabilities to backup and retrieve instrument QC results, patient results, and reagent info for 10 years. Primary analyzer must have capabilities to retransmit records in the event of interface outage. A process for antibody work-up for patients on anti-CD38 monoclonal antibody treatment is preferred. Only one type of diluent for preparing red cell dilutions is preferred. Contractor qualifications (including manufacturing qualifications) shall be available upon request. 4. Software: The analyzer s computer operating system must be Windows 10 or higher. Contractor is required to have established a LIS interface with VBECS, which is the internal software used by the MVAHCS to support blood bank testing, prior to contract award. 5. Customer Service/Technical Support: A contractor representative shall be available to the MVAHCS during the contract period to review the account, provide product information, handle problems or defective merchandise (if required) and address any other issues or concerns that may arise. Customer service must be available 7 days per week, 24 hours per day. If necessary, on-site support must be available 7 days per week, 7:00am-7:00pm. On-site response time shall not exceed 24 hours of determination that service is required. 6. Ordering Procedures: Orders will be placed via contractor s preferred method, on an on-demand, as-needed basis by the MVAHCS. A list of approved personnel will be provided at the request of the contractor. Contractor shall provide the following preferred ordering information: Preferred method of ordering: ________________________________ Telephone Number: ________________________________________ Email address: _____________________________________________ 7. Delivery: All equipment shall be shipped within 30 days after award. All supplies shall be delivered FOB Destination to the MVAHCS (unless otherwise indicated on the response to the solicitation) and shall arrive at the MVAHCS no later than 5 calendar days after receipt of an order. Deliveries shall be made to: VA Medical Center, Bldg. 70 Warehouse (90D), PO# (Provided for each order) One Veterans Drive Minneapolis MN 55417 Delivery Times: Between 8:00am and 3:30pm (Monday-Friday except Federal Holidays) All deliveries shall be accompanied by a packing slip which shall contain contractor s name, purchase order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped. 8. Product Quality: All products offered to the MVAHCS must be of the same consistent high quality as would be offered to the general commercial public in the United States. All products are purchased subject to acceptance in conformance with Contractor s warranty and product s published specifications. All products must be tested for Quality Control by the supplier, and only those products that pass Quality Control may be sent to the MVAHCS. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the MVAHCS. Any substitutions of product must have the written approval of the MVAHCS and the Contracting Officer or his/her designee. All products that do not meet Contractor s published specifications must be replaced within 48 business hours at no cost to the MVAHCS. The MVAHCS is not required to return unacceptable product but may do so in the rare case where a limited number of items may be returned to solve a quality control problem. It is the contractor s responsibility to provide the MVAHCS with recall notices on any product that has been delivered to this facility that may be defective. Notification shall be made to the MVAHCS via the most expedient method. The contractor shall provide MVAHCS with a listing of the contractor s products that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing in the sink or trash. SDS shall be available upon request. To assure rotation of stock at the distributor, each lot of a product received must have an outdate later than previously received. Only one lot number per product may be shipped per order. Multiple lot numbers per product per order will not be accepted. All products must be received with at least 2/3 of the shelf-life remaining. The contractor shall provide a shelf-life list (time from production to outdate) for each product purchased if requested by the MVAHCS. Contractor shall allow reagents, supplies, and consumables to be set up on a delivery schedule to ensure a months worth of reagents and supplies remain stocked at MVAHCS. The MVAHCS will determine the products, quantities and frequency required for the delivery schedule. If the incorrect products or quantities as established in the delivery schedule was delivered incorrectly, the contractor is required to deliver the correct supplies within 24 hours of notification by the MVAHCS. The contractor is required to provide a continuously stocked inventory of all reagents, supplies and consumables required to properly perform tests on the equipment such that equipment operations are not interrupted. 9. Equipment Installation, Validation and Training: The Contractor shall provide site preparation requirements for the equipment prior to installation. The Contractor shall provide documentation and information characterizing the physical, electrical, technological, and environmental requirements of the equipment prior to installation. A risk assessment shall be completed before instrumentation can be placed on the MVAHCS network/LIS system. Contractor shall provide installation, validation, and training of the equipment, including labor and travel. The Contractor will install all equipment at no additional expense to the MVAHCS. The installation date shall be mutually agreed upon by the contractor and MVAHCS. Contractor is required to provide all necessary items to establish normal operation. Remote access cannot be guaranteed to the contractor. Instrumentation shall be installed and be fully operational without remote access being granted to the contractor. No additional cost to the government shall incur if remote access is not granted. If the instrument requires a server attached to the MVAHCS network or LIS System, the contractor shall provide it. The contractor shall assist with the performance of all validation studies to include precision, method comparison with the current instrumentation, accuracy, calibration verification, and determination of sensitivity and specificity. The contractor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. The contractor will provide and coordinate training with the MVAHCS at a mutually agreed upon date. 10. Equipment Maintenance: Contractor shall provide enhanced warranty response, agrees to maintain the equipment in good working condition and will repair or replace any defects in the equipment during the contract period (including parts, labor, and travel) at no additional cost to the Government. The contractor shall include all ancillary components that are customarily sold or provided with the equipment proposed (ex: computers, monitors, printer, UPS, starter kits, etc). Contractor shall provide the equipment operator manual. Contractor shall retain ownership of the equipment. Maintenance/Service Calls: Technical support, maintenance and repair service must be available. Customer service must be available 7 days per week, 24 hours per day. If necessary, on-site support must be available 7 days per week, 7:00am-7:00pm. On-site response time shall not exceed 24 hours of determination that service is required. Preventive Maintenance: Contractor will provide scheduled preventive maintenance (PM) service calls as required by manufacturer s recommended PM schedule, procedures, and checklists. Contractor will work with MVAHCS to schedule at a time that works for both parties. A field service report shall be supplied to the MVAHCS at the completion of each PM inspection. Updates: The contractor must provide updates to instrument hardware and software to maintain the integrity of the system and state-of-the art technology at no additional charge to the Government. This must be provided as they become commercially available and at the time as they are being provided to commercial customers. This requirement only applies to system updates that enhance the model of equipment being offered (. i.e., new version of software, correction of hardware defect, update offered to commercial customers at no additional charge). If equipment repair records reflect a downtime of 10% or greater during a 3-month period, the MVAHCS may request a replacement of malfunctioning equipment with new equipment at no additional cost to the Government. Upon termination of the contract, the MVAHCS Biomedical department will remove the hard drive and terminate it according to policies and procedures. The equipment will be the contractor s responsibility to dismantle, decontaminate, and remove from MVAHCS premises within 60 days after expiration of contract. All costs for removal and return to contractor shall be borne by the contractor.