6550--VA Portland HCS BIOPLEX 2200 REAGENTS

36C26021Q0274 Sources Sought Request for Information Only This is not a Request for Quote (RFQ), or Invitation for Bid (IFB); nor does it restrict the Government to an ultimate acquisition approach The Department of Veterans Affairs Portland Health Care System in Portland, Oregon (VAPORHCS) is looking for certified Service-Disabled Veteran Owned Small Business (SDVOSB) and/or certified Veterans Owned Small Business (VOSB) sources capable of providing an instrument, reagents, calibrators, and consumables to perform immunoassay testing for the analytes listed below for the VAPORHCS Pathology and Laboratory Medicine Service (PLMS). Statement of Work (SOW) Automated Immunoassay Instrument (Cost Per Test) Intent: It is the intent of the Pathology and Laboratory Medicine Service of the VA Portland Health Care System (herein referred to as VAPORHCS) to establish an order for CPT or CPRR for Automated Immunoassay Instrumentation(s). The order shall be under the Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/Cost Per Reportable Results (CPRR), Clinical Laboratory Analyzers. The Government will award a CPT/CPRR order to a single Contractor of Automated Immunoassay Instrumentation(s). Contractor agrees to the following terms of the order exclusively with VA Portland Health Care System listed by Attachment. The instrument(s) shall be able to perform immunoassays for ANA Screens, Syphilis IgG, RPR, Measles, Mumps, Rubella, VZV, Herpes Simplex virus (HSV) antibodies, Cytomegalovirus (CMV) antibodies, Epstein-Barr virus (EBV) antibodies, Vasculitis Panel, Anti-CCP Panel, Celiac Panels, Antiphospholipid Panels, 5th Generation HIV Antibody Panel, HIV 1/2 Supplemental testing for the confirmation and differentiation of individual antibodies to HIV-1 and HIV- 2, and Toxoplasma. Additional tests/reagents/instrumentation may be added to the order as new technology becomes available on the market and adder to the order. Prices and Terms: VAPORHCS PLMS will proved an estimated volume by test as reflected in Attachment A. Pricing is based on the average daily test volume pre/instrument/analyzer. We estimate the yearly volume of patient tests at 22,000 annually. The Government estimates the volumes as listed in Attachment A but does not guarantee volumes as listed; they are estimates only. Ordering Method: VAPORHCS may order products via E-mail, telephone, facsimile, or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. Statement of Work/Services to be Provided: General Requirements: The vendor shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to VAPORHCS PLMS A list of the estimated yearly quantities of tests performed by the PLMS will be provided under this agreement as reflected in Attachment A. The quantity listed is an estimate, based upon prior history of the actual volume and is intended to provide the contractor a basis for calculating pricing. It is not a guaranteed minimum. The estimated yearly test volume is 22,000. The pricing shall be based on new equipment. Remanufactured or used models will not be accepted. The analyzer shall streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround time, supporting improved patient outcomes, and improving the productivity of the facility. Vendors shall provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment/reagent/controls/ calibrators, and any consumable necessary for analyzing/testing. Vendor shall list the consumable parts provider. System Requirements: 2.1 Offered analyzer must be capable of producing accurate and reproducible results by established diagnostic methods. The analyzer shall provide accurate test assay results without excessive malfunctions, breakdowns, or service calls. 2.2 Total time to analyze a single test shall be less than 1 hour. 2.3 Vendor must provide at least two levels of commercial quality controls to be analyzed to meet the facility s and regulatory requirements. 2.4 Analyzer shall have the capability of providing printouts of all patient results, calibrations and quality control runs. 2.5 All consumable supplies (reagents, calibrators, controls, disposable, etc.) required for the proper operation of the contractor s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the contractor. 2.6 The system shall have a design that supports the result integrity/removes the possibility of sample carry over. 2.7 The vendor shall state the open date stability for all reagents, controls, quality control material and supplies in the kit. 2.8 The vendor shall supply equipment that shall perform satisfactory at any laboratory relative humidity (between 15 and 85 percent) and temperature (between 50° and 90° Fahrenheit or 10° to 30° Celsius). 2.9 The system shall have a design that supports on demand testing. 2.10. The system shall have a design that utilizes ready-to-us reagents. 2.11. The system shall be able to process 2200 samples per hour. 2.12. The system robotic arm should possess clot detection. 2.13. The system shall have autocalibration capabilities. 2.14. The system shall have a design for Bi-directional, LIS connectivity. 2.15. The system shall have the design to run autoimmune and infectious disease tests in single test format. 3. Instrumentation and Software: 3.1. The vendor is to conduct and complete the Medical Equipment Pre-procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI&T) for the facility for any medical device that will be connected to the VA s information network. The vendor shall provide evidence of VACO approved remote network communication system that continuously collects and monitors performance data of the analytical system following the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place. 3.2. The equipment shall include 120-volt UPS that has a 2-3-hour back-up capability. The vendor shall be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed. 3.3. The system shall support multiple barcode formats including, but not limited to, Code 39, Code 128, and Codabar, or current VA standardized barcode that may be enabled concurrently. 3.4. The system shall have a barcode reader for sample identification. The c=barcode reader must be able to read current standardized VA formats. 3.5. VA patient information cannot reside at the vendor s location or on a removable media. Only the instrument configuration can be stored on removable media. 3.6. The vendor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government. 3.7. Request for upgrades or replacement, due to workload increase, excessive instrumentation/test kit failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually by the facility with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/test kits may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement with equipment/tests kits that can produce the required criteria of this BPA satisfactorily to the user. 3.8. The contractor shall remove all equipment within 90 days after notification of the expiration of the terms of this contract but not until the completion of the new vendor s equipment installation inclusive of the completed cross over studies. The facility, per protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If VAPORHCS choose to retain the hard drive, it will be at no additional cost to the VA. 3.9. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to, the Federal Information Security Management Act (FISMA), Appendix III of the OMB Circular A-130, and guidance and standards available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web Site: http://checklists.nist.gov 3.10. To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site: http://www.iprm.oit.va.gov 4. installation and validation 4.1 The vendor shall provide the participating facility with all reagents, calibrators, controls, linearity material and supplies needed at installation and during training of staff. The vendor shall pay all shipping cost for the analyzer and all supplies needed for installation, validation studies, and staff training. 4.2. At installation of the new equipment, the vendor will provide all the manpower and the technical support specialist(s) to assist in equipment installation/set-up, method validation studies (evaluation/comparison if data sufficient to satisfy CAP standards and CLSI (Clinical and Laboratory Standards Institute), related documents and Federal Regulations), staff training, methodology problems and questions resolution. Method validation studies include but are not limited to: 4.3. Accuracy studies for the analytes: A minimum of 20 samples, consisting of an adequate number of both high and low samples will be ran by the present and proposed method. Contractor will analyze the results and provide the data to support acceptance of the new method. The evaluation will include validation of accuracy, in concordance to current method and meet current standards as defined by CLSI. 4.4. Precision Studies: A total of 10 low and 10 high control materials will be analyzed. This will consist of a within run precision study. 4.5. Specificity Studies: Manufacturer s package inserts, including limitations and/or interferences, will be provided by the contractor. 4.6. Sensitivity Studies: Manufacturer s package inserts will be provided by contractor. 4.7. Carryover Studies: Presence of assay carryover shall be ruled out during the contractor s instrument validation process. 4.8. At installation/set-up the vendor/technical support specialist shall perform and place in a labeled binder all validation studies including; installation/set-up, correlation, linearity precision and crossover studies. Evaluation/comparison data. The validation documentation shall be sufficient to satisfy CAP standards and shall be completed within two weeks of installation into the facility. The support specialist shall assist with staff training, in services to laboratory personnel and clinicians, and assist with any methodology problems and questions. 4.9. The vendor shall provide equipment installation and possible reinstallation cost of the equipment is required to be removed due to construction or laboratory redesign. 4.10. The vendor shall supply quarterly shipment and indicate how much storage space would be needed. The vendor shall ensure that all reagents/supplies received quarterly have at least a six-month expiration date. The vendor shall work with the facility to adjust reagent supply to match workload changes and to provide the option annually for the facility to adjust the shipment table. The vendor shall state what their policy is in regard to adjusting a standing order an additional shipment of supplies. 5. Support Systems (Service, Preventative Maintenance, and Shipping of Supplies 5.1 Vendor shall provide technical support services at no additional charge to the facility. Technical support by telephone shall be available 7 days a week. 24 hours a day. Technical support shall return all downtime calls within hour. Should on-site service be required, the contractor s field service organization shall provide on-site service response within 24 hours after being contacted. The repair person shall also, prior to departure, provide the visited site with written documentation of the services performed. 5.2. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of trouble-shooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline die to the facilities staffing. 5.3. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs. 5.4. The vendor shall provide instrument support service sufficient to provide assistance with troubleshooting and repairs of the analyzer. The vendor may list their service options available. Ir the following service option may be available: 24 hours/day, 7 days/week. The support service shall follow up all down calls within 2 hours. The FSR, at all times, shall keep that facility informed of the time line for when repairs are to be completed. All repairs on the instrument shall be completed (at no cost to the facility) within 24 hours from the time the field service engineer arrives. 5.5. The vendor shall pay for the laboratory testing at a reference laboratory facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the facility totally more than 24 hours. Downtime of each incident shall start from the time the facility makes a bona fide attempt to contact the vendor s designated representative until the analyzer is returned in good operating order. 5.6. In the event that the consumables are found to be defective and unsuitable for use with the vendor s equipment, or the vendor failed to comply with the requirements for routine supply delivery, the contract shall deliver the consumable supplies with a period of 24 hours after receipt of the verbal order for priority delivery from the Government activity. If wither circumstance has occurred, the contractor shall deliver to the requesting facility, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to support operation of the contractor s instrument for one week, under normal Government test load volume. 5.7. Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing. 5.8. The vendor must provide replacement parts and components necessary for the operation of the instrument to produce patient results at no charge. 5.9. The vendor s technical service representatives must comply with the facility s requirements for onsite vendor representatives. This may require a low risk background investigation by federal authorities paid for by the vendor. 6. Training and Procedures 6.1. Vendor must provide all education/training on site during installation or updates to the equipment. Training shall include staff on all requested shifts. Training must include basic operations, quality control, calibration, interpretation and reporting results, required user performed maintenance and troubleshooting. Vendor must provide a documented record of training (training checklist) completed fir all trained staff before leaving the facility following installation. 6.2. The vendor shall provide initial in-depth training for two key operators. Key operator training is to include all cost of off-site training, i.e., transportation (air and ground) room and board, etc. 6.3. The vendor shall provide on-site refresher instrument training in renewal option years of the contract if so exercised. 6.4. Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals and SDS s (also available on CD format or on-line). Procedures must be in the CLSI format. Vendor must provide assistance in creating preventative maintenance and quality control records or logs to meet the needs of the facility. 7. Other Terms and Conditions 7.1. Vendor shall specify calibration frequency, time required to perform calibration, and any specific steps that must be followed prior to calibration. 7.2. Vendor shall state if the instrument paper is included in the consumable parts. 7.3. Vendor shall provide documented evidence confirming the system design removes the possibility of any sample carryover. 7.4. The vendor shall list the frequency and the supplies needed to check the pipetting mechanism of the instrument. 7.5. The vendor shall list all of the reagents and supplies needed for testing, state if the reagents/supplies are stored at room temperature or refrigerated, state id the reagents/supplies are color-coded and state the size of the reagent kits (as it relates to the amount of storage space required for a quarterly shipment). 7.6. The vendor is to define the actual hands on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The vendor is to include the analyzer and technologist time required to perform each task. The vendor shall list which tasks are user level and which are service level. 7.7. The vendor shall list the analyzer utility requirements (electrical, water, plumbing, reagent, and bio-hazardous disposal, etc. 7.8. The vendor shall provide weight and dimensions of the proposed analyzer. Footprint of the system should be small and fit in a typical laboratory. 7.9. The vendor shall indicate any routine and/or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to; paper, printer cartridges, drainage systems, surge suppressors, UPS, etc. Any items excluded by the vendor shall be delineated in their proposal. The cost of the excluded items must be incorporated into the price proposal. 7.10. The vendor shall provide information if the system had a data management system that allows the user to monitor and analyze data and quality control. System included flags for unusual results and failed quality control. 7.11. The vendor shall indicate if electronic operating manual and troubleshooting guide as well as a preventative maintenance guide and log are provided to the facility. Sources Sought Request for Information Only The Department of Veterans Affairs Portland Healthcare System in Portland, OR is looking for certified Service-Disabled Veteran Owned Small Business (SDVOSB) and/or certified Veteran Owned Small Business (VOSB) sources capable of providing the microbiology testing media products listed below for the Portland Division Microbiology Department. STATEMENT OF WORK (SOW) Automated Immunoassay Instrument (Cost Per Test) Salient Specifications for Autoimmune and Immune Testing 1. The instrument system shall be a fully automated, random access multiplex testing platform that uses sets of coated magnetic beads as the basis for a range of autoimmune, infectious disease, and other immunoassays. 2. The system can automatically process up to 100 samples per hour for a maximum of 2200 reportable results (assay dependent) with eight hours of walk-away capability. First results are available in approximately 40-60 minutes (assay dependent), with subsequent patient samples completed approximately every 30 seconds. 3. Bead sets are mixed in a single reagent pack, allowing for simultaneous detection of multiple analytes from a single sample, processing a minimum of 150 individual bead results for each assay. 4. Order add-on tests from previously processed samples without a patient redraw. 5. Create custom test groups, fine-tune quality control rules to accommodate facility needs and analyze results using interpretive software algorithms. 6. On demand STAT capability with on-the-fly loading and unloading of reagents and waste. 7. On-board refrigerated storage, capable of storing up to 20 reagent packs allowing for the processing of up to 2,000 samples. 8. Bi-directional LIS/ASTM standard interface with touchscreen operation. 9. Required floor space should require no more than a height of 4 5 , width of 4 3 , and depth of 2 10 . 10. Voltage input should require no more than 1--=240 VA at 50-60 Hz, 1000 Watts. 11. The instrument(s) can perform the following autoimmune and infectious disease testing: ANA Screen EBV, IgM dsDNA VCA, IgM Chromatin Syphilis Ribosomal P Syphilis SS-a RPR SS-b RPR Titration Sm ToRC IgG SN/RNP CMV, IgG RNP ToRC IgM Scl-70 CMV, IgM Jo-1 - Herpes IgG Centromere B HSV-1 IgG Vasculitis HSV-2 IgG MPO MMRV IgG GBM Measles IgG PR3 Mumps IgG Cyclic Circulating Protein Rubella IgG (Qual) CCP VZV IgG Celiac IgA HIV Ag-Ab - tTG IgA HIV Ag-Ab Celiac IgG HIV-1 Ab (M and O) - tTG IgG HIV-1 p24 antigen Antiphospholipid Syndrome (APLS), IgG HIV-2 Antibody Cardiolipin, IgG Antiphospholipid Syndrome (APLS), IgM - Cardiolipin, IgM EBV, IgG VCA, IgG EA-D, IgG EBNA, IgG Period of Performance Base period: April 1, 2021 through March 31, 2022 Option year 1: April 1, 2022 through March 31, 2023 Option year 2: April 1, 2023 through March 31, 2024 Option year 3: April 1, 2024 through March 31, 2025 Option year 4: April 1, 2025 through March 31, 2026 Potential sources shall provide, at a minimum, the following information to Point of Contact listed below: Company name, address, and point of contact, phone number, e-mail address, and DUNS. Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 325413 In-Vitro Diagnostic Substance Manufacturing. To be considered a small business your company must have fewer than 1,250 employees. Any Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who responds to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. The Non-Manufacturer Rule (NMR) will apply if there is a decision to set-aside the procurement. Potential sources shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. This procurement is for new products ONLY; no remanufactured or "gray market" items. All products must be covered by the manufacturer's warranty. Responses are due by 2/12/2021 10:00 AM PST, to the Point of Contact. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). Point of Contact: Ty Draszt | Contract Specialist contact@example.gov | +1 (555) 000-0000