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The purpose of amendment 2 is to answer question(s) and extend closing date: Q- Is the requirement a cost per reportable contract structure? No, it is a cost per test. Revised SOW attached Closing dat... The purpose of amendment 2 is to answer question(s) and extend closing date: Q- Is the requirement a cost per reportable contract structure? No, it is a cost per test. Revised SOW attached Closing date is currently 9/17/2020 @1PM EST. Closing date is now changed to 9/18/2020 @1pm EST. Thanks Stephanie Henderson Contract Specialist Hershel Woody Williams VA Medical Center Statement of Work Blood Culture Analyzer SCOPE: The Hershel Woody Williams VA Medical Center listed below requires an analyzer and consumables (test kits) to perform blood culture testing at their respective location. The participating VISN 5 Medical Center is located as follows: Hershel Woody Williams VA Medical Center 1540 Spring Valley Drive Huntington, WV 25704 PRICING SCHEDULE: A schedule of items offered and per item cost with any tiered pricing for volumes and/or percentages of use should be included with the offer. Offer will be for a Cost Per Test Contract Structure which will include all reagents and materials, repairs, preventative maintenance, validation studies and quality control support/ materials required for an automated blood culture analyzer. STATEMENT OF WORK/SERVICES TO BE PROVIDED: 1. GENERAL REQUIREMENTS: 1.1. The vendor(s) shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to the participating VAMC facilities in accordance with the applicable Federal Supply Schedule contract. Attachment 1 (Test Volumes) shall be utilized by interested contractors to submit their cost proposal. Additional Department of Veteran Affairs VISN s and medical facilities from the Department of Defense are eligible to participate if agreed in writing by an authorized representative of the contractor and the Contracting Officer. This BPA will be fixed-price for the duration of the contract in accordance with the terms and conditions of the contractors Federal Supply Contract. 1.2. A listing of estimated yearly quantities is provided under this agreement and is located in Attachment 1 (Test Volumes). Quantities as listed in the attachment to this BPA are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum. The Government anticipates single award of a Blanket Purchase Agreement (BPA). 1.3. The system shall streamline all aspects of testing, thereby enhancing operational efficiency, supporting improved patient outcomes, and improving the productivity of the using facilities. Vendor shall define measures to streamline testing to promote efficiency. 1.4. The pricing shall be based on new state of the art equipment. Remanufactured or used models will not be accepted. The vendors offered Blood Culture analyzer shall conform to the facilities/clinics existing space. The vendor shall work with each facility to place an analyzer that best accommodates their defined space requirements. 1.5. Vendors shall provide the facility with an Food and Drug Administration (FDA) approved analyzer, blood culture media bottles, disposables, and any consumable part necessary for analyzing/testing. Vendor shall list the consumable parts provided. Vendor shall state any parameter/function that is pending FDA approval at the time of this BPA submission. 1.6. The vendor will list and provide the contract price, for the base year, and the additional option years for any consumable item that is not included in this BPA. 2. SYSTEM REQUIREMENTS: 2.1. The blood culture system will be automated and must have the capability of detecting the growth of microbes (bacteria/yeast) in blood by qualitative culture using either colorimetric or fluorescent technology. 2.2. User Friendliness: a) must provide software and/or supporting instrumentation required to maintain, or improve levels of data retrieval, which may be used for epidemiology, or cost-saving measures; b) ease in handling: simple bottle management, ability to place bottles anywhere, ability to identify and trouble-shoot misplaced or unidentified bottles, and/or to resolve bottle errors; c) a system that will alert user of expired media. 2.3. Vendor will allow flexibility in the selection of blood culture bottle types (ex. antibiotic neutralizing resin or lytic broth for fungus). 2.4. Blood culture bottles with antibiotic resins must not contain a charcoal matrix, which can interfere with Gram stain preparations and interpretations. 2.5. Vendor should provide hard copy, or access to electronic copies of all certificates of analysis for the documentation of media as required by CLSI and CAP regulations. 2.6. Vendor should provide initial media inventory based on previous use, then establish a standing weekly/monthly/quarterly shipment, if requested by the facility, based on current use with the capability to fill emergency requests on-demand. 2.7. Instrument/Bottles must comply with OSHA s Bloodborne Pathogens Standards. 2.8. Vendor shall provide a data management system with barcode scanning capabilities to provide rapid entry of bottles into the instrumentation while linking patient demographics to the specimen. 2.9. Instrument has the capability to flag or alert positive cultures by visual alert, audible alert and remote alert systems. System should also detect and document "time to positivity". 2.10. Vendor will supply documented information (QC records, journal articles) about the contamination rates of un-inoculated blood culture bottles. 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 any medical device that will be connected to the VA information network. The vendor then shall provide evidence of VACO approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place (see attached Addendum). If there will be web communication between VA facilities, the data/transmission must be encrypted per FIPS 140-2 standards. 3.2 The equipment must include 120 volt UPS system that has a 24 hour backup 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 and download from host. The barcode reader must be able to read current standardized VA barcode formats. 3.5 The vendor shall provide the following interfacing requirements for the system: a. Instrument LIS physical connection and translation (drivers); b. Routing must be fully supported by all laboratory instrument interface partners, VistA laboratory information systems c. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer; d. Any required (additional) interface connection license(s); e. Instrument-LIS interface must be bi-directional; f. Provide documentation of successful interfacing with other VA facilities (provide two VAMC references to include contact person, address and telephone number); g. Interface must use automatic host query to download sample IDs, test requests, and patient demographics; h. Automatic host query must seamlessly integrate with onboard patient sample barcode scanning and translation; i. Instrument interface must transmit test results to the host computer system via automatic upload; 3.4 The system shall be able to store and retransmit records (24 hours of maximum instrument throughput) in case of interface downtime. The vendor is to state how many samples can be stored. The system shall have the ability to edit sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification. 3.5 The system shall have an automatic back-up function to store all data from the hard drive. Vendor shall describe the back-up option. The preferred back-up option is storage directly to a VA SAN or other VA storage system. Only the instrument configuration can be stored on removable media. VA patient information cannot reside at the vendor s location or 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. These enhancements to the vendor s equipment shall be delivered and installed at the site within two months of their issuance or date of first commercial availability. The vendor will at all times maintain compatibility of systems with whatever host LIS or TCP/IP interface is in place, especially when vendor software is upgraded. 3.7 Requests for additional instrumentation, upgrades, or replacement, due to workload increase, excessive instrumentation/ blood culture bottle recalls/ malfunctions, breakdowns, or service calls will be evaluated as needed and annually by the facility laboratory with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/ blood culture bottle supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement with equipment/ blood culture bottle 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 new vendor s equipment installation inclusive of completed cross over studies. The Hershel Woody Williams VAMC , per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If the VAMC chooses 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 Federal Information Security Management Act (FISMA), Appendix III of 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 at: 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 . 3.11 System should include blood volume monitoring software for automatic determination of blood volume collected in blood culture bottles. 3.12 System must offer LCD display monitor with built-in speakers and printer. 3.13 System must be a continuous monitoring system with the capability of tracking bottle growth by plot graph data. 3.14 Software package capable to track or flag internal calibration, error messages, and internal temperature. 3.15 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 each facility for any medical devices that will be connected to the VA information network. The vendor then must provide an approved remote network communication system that allows the VA to remotely connect with the vendor s technical services department for purposes of instrument troubleshooting/problem resolution, following all the policies and procedures outlined in VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place. 3.16 Computer equipment will contain antivirus software supplied by the vendor. 4. INSTALLATION AND VALIDATION: 4.1 The vendor shall list analyzer/utility requirements (electrical, water, plumbing, bio-hazardous disposal, etc.). The vendor shall provide weight and dimensions of proposed analyzer. At installation of new equipment, vendor will provide technical support specialist(s) to assist in equipment installation/set-up, correlation studies (evaluation/comparison of data sufficient to satisfy CAP standards, CLSI and related documents, and Federal Regulations), staff training, methodology problems, and questions. 4.2 The vendor shall provide the facility with all supplies needed at installation and during training of staff. The vendor shall pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff. Test counts for billing will begin after all CAP required studies, performed at installation of new equipment, are reviewed, approved, by the department supervisor, Laboratory Manager and the Chief Pathologist, and the analyzer has been placed in use for patient testing. 4.3 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 studies, linearity and cross-over studies. Evaluation/comparison data shall be sufficient to satisfy CAP standards and shall be completed within two weeks of installation. The support specialist shall assist with staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. The technical support specialist must be available for installation/set-up/validation studies/training for a minimum of 40 hours during regular office hours on a 5 days/week basis. 4.4 The vendor shall provide equipment installation and possible reinstallation costs if the equipment is required to be moved due to construction or laboratory redesign. 4.5 The vendor shall specify their routine shipment table of supplies, whether monthly or quarterly, and how much storage space would be needed for each. The vendor shall ensure that all reagents/supplies received, whether it is monthly or quarterly standing order, 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 regards to adjusting a standing order or ordering an additional shipment of supplies. 5. SUPPORT SYSTEMS (SERVICE, PREVENTATIVE MAINTENANCE AND SHIPPING OF SUPPLIES): 5.1 Vendor will 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 one 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. All replacement instrument/ equipment must be received within 24 hours from the time the on-site service arrives. The repair person shall also, prior to departure, provide the visited site with written documentation of 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 due to the facilities staffing. 5.3 Service is to include, at no charge, all labor, travel, and parts necessary to make repairs. 5.4 Requests for services will be through primary contractor. 5.5 The vendor shall provide instrument support service sufficient to provide assistance with troubleshooting and repair of the analyzer. The vendor may list their service options available. Or the following service option may be available: 24 hours/day, 7 days/week basis for hospitals. The support service shall follow-up all down calls within 1 hour. The FSR at all times shall keep the facility informed of the time line for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the field service engineer arrives. 5.6 The vendor shall pay for the laboratory testing at a reference facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the facility/clinic for a total of more than 24 hours. The cost incurred from the reference facility testing, packaging and shipping will be applied to the invoice in the form of a credit or deduction. Downtime for each incident shall start from the time the facility/clinic makes a bona fide attempt to contact the vendor s designated representative until the analyzer is returned to 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 has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting facility site, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the vendor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory will result in default 5.7 Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing and will pay for shipping for volume adjustments should additional supplies be required. Vendor will also pay shipping costs on any emergency order or supplies. 5.8 The vendor must provide replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results. 5.9 The vendor s technical service representatives must comply with each facility s requirements for onsite vendor representatives. This may require a low risk background investigation by federal authorities paid for by the vendor. 5.10 A preventative maintenance schedule to include a minimum of two scheduled preventative maintenance visits per year for vendor providing services. 5.11 Vendor is to state how supplies / reagents are shipped with respect to temperature variations. 5.12 Vendor shall provide data concerning the amount of bio-hazardous waste generated, to include an analysis of the waste determinations. TRAINING AND PROCEDURES: 6.1 Vendor must provide all education/training on site during installations or update to the equipment. Training will include staff on all shifts. Training must include basic operation, interpretation and reporting of results, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site. 6.2 Provide initial in-depth training for two key operators at each site and annual training for one VA equipment operator. Key operator training is to include all costs 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 MSDSs (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Vendor must provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility. 7. VALUE-ADDED CHARACTERISTICS: These characteristics are not mandatory, but will be considered as value-added in the Best-Value Determination. Value added characteristics may include, but are not limited to: a. Footprint of system (large capability in a small instrument), with the ability to expand analyzer capacity if the increased utilization of media is sustained. b. User Friendliness: I) must provide software and/or supporting instrumentation required to maintain, or improve levels of date retrieval, which may be used for epidemiology, or cost-decreasing measures; II) ease in handling: simple bottle management, ability to place bottles anywhere, ability to identify and trouble-shoot misplaced or unidentified bottles, and/or to resolve bottle errors; III) a system that will alert user of expired media. c. Ability to manage data and compile reports to include but not limited to blood culture contamination rates, contamination rates by collector, ward, etc. d. Software system that will monitor the blood culture volumes, with the ability to generate reports for bottles that are of inadequate or overfilled blood volumes. e. Include electronic operating manuals and troubleshooting guide as well as a preventive maintenance guide and log. f. Vendor shall state what steps they are taking to conserve natural resources that will enable their customers to become more energy efficient, environmentally friendly, and competitive. 8. OTHER TERMS AND CONDITIONS: 8.1 Unless otherwise agreed upon by both parties, Terms and Conditions of this contract will be determined by the vendor s current Federal Supply Schedule contract with the General Services Administration or VA National Contract Center. 8.2 All pricing shall be based on and shall not exceed the vendor s most current FSS contract pricing for supplies offered. 8.3 A post award conference shall be held to discuss the guidelines for implementation. 9.PAST PERFORMANCE / TECHNICAL EXCELLENCE: 9.1 The vendor shall provide four references: two VA (not within VISN 5) and two from the private sector. References to include the address, telephone number, and contact person s name which can validate past experience within the last three (3) years regarding: Quality of Service (to include timeliness of service, documentation (service report), communication of work/repair at time of service, does service repair/fix the problem on the first site visit or does service have to return to repair/fix the problem again, are parts/tools available when service is performed or is service delayed due to ordering replacement parts, and technical support including method validation. Ability of vendor to supply accurate data for annual contract renewal by required time frames and timeliness of billing reconciliation. Customer satisfaction: meets or exceeds turn-around with negligible downtime. 9.2 The vendor shall supply the national average of service calls per analyzer per year. 9.3 The vendor shall list reagent recalls/bulletins within the last five years. The vendor shall list any product unavailability due to manufacturing issues within the last five years. 9.4 The vendor may list the number of new tests/features introduced within the last 3 years or any technology updates. 9.5 The proposed equipment shall have at least one-year proven experience and be available on the Federal Supply Schedule. 9.6 Vendor shall provide 5 year history of recall on machines and reagents. Attachment 1: Test Volumes- Hershel Woody Williams VAMC (October 1, 2018-September 30, 2019) Annual test volume: Aerobic Bottles- 3372 Anaerobic Bottles- 3348