The tender seeks proposals for the provision of coagulation
reagents, instruments, equipment, maintenance, training, and support for a Roche **** Total Laboratory Automation (TLA) system at Madigan Army Medical Center. The contractor will be responsible for furnishing maintenance, services, repairs, and parts to maintain the systems in optimal operating condition. The contract includes detailed specifications for the analyzers,
reagents, maintenance, training, and data management system. Method validation will be conducted in accordance with established protocols. The contractor must provide a qualified technical service representative with specific experience and knowledge of method validation. The contractor will also provide initial onsite operator training to all technicians assigned to the government site. The analyzer system must be capable of interfacing with the military hospital computer system (MHS Genesis). The contractor must have an established driver compatible for interfacing the analyzer with the IM. The interface between IM and the analyzer shall be bidirectional. The data management system shall have a comprehensive, fully integrated quality control (QC) software module that stores and evaluates quality control results. The application shall validate QC results by checking them against user-selected rules and automatically alert the operator when a rule violation has occurred. The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of onboard
reagents and control materials. The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage. The data management system must use Microsoft Windows 10 that includes the most current version with all the security updates. All contractor systems that communicate with Department of Defense (DOD) systems shall interconnect through established virtual private network (VPN) business-to-business (B2B) gateway. The contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. The contractor shall comply with DOD guidance regarding allowable ports, protocols and risk mitigation strategies and will provide, maintain and configure VPN concentrator that complies with DOD security standards. All costs for VPN hardware and software shall be incurred by the contractor. The contractor shall initiate, maintain, and document personnel security investigations appropriate to the business associate representatives responsibilities and required access to MEDCOM sensitive information (SI) as determined by the site chief information officer. The contractor shall validate that systems authenticate users through the use of the common access card (CAC) or CAC alternative as a part of a two-factor authentication mechanism on the business partner side of the VPN. The contractor shall also identify the exact location from which remote operational control will take place from, the encryption that will be used, and how the vendors technical users will maintain secure logon. The contractor shall provide an up-to-date operating system that includes all software patches and updates for all programs installed on the operating system. The operating system and all the programs on the operating system must stay up to date with all software patches and updates throughout its lifecycle. The contractor shall include all costs to achieve the initial authority to operate (ATO) and maintain it during the lifecycle. The contractor shall pass prevalidation technical screening vulnerability scans utilizing Nessus, security content automation protocol (SCAP) scans, and security technical implementation guides (STIGs) checklists within 6 months of the contract award. Appendix 1 provide