Mastering Institutional Biospecimen Management

Transcription

1 Mastering Institutional Biospecimen Management Background: Background: Ms. Meliones is a management consultant who recently implemented an institutionally sponsored, enterprise-wide research biobanking system for one of the founding and leading CTSA academic medical centers. Ms. Meliones and her company s clients have included Duke University, The University of North Carolina and Brigham & Women s University, in addition to Fortune 500 technology, professional services and performance management organizations. Her technology solutions have won the Balanced Scorecard Collaborative Best Practices Award, the Computer World Honors, A Search for New Hero s Award and been featured in Harvard Business Review. Part 1 in the November 2015 issue covered the Business Case including current challenges, major drivers, stakeholder engagement, requirements specification, solution selection, business plan and funding. Part 2 in the 2 part series below covers Implementation & Ongoing Management including contract management, solution development and implementation, phased roll-out, tiered support & ongoing management (enhancement/operation) and impact assessment/conclusion. Successful funding of a compelling business case to build a centralized system for institutional biobanking will reduce costs, provide greater functionally and establish a broad support foundation for the organization. Now that important stakeholders are engaged in the initiative and the major business components of the project are complete including; identifying current challenges, agreeing on major drivers, specifying requirements, selecting the solution and securing funding, the technical aspects of the initiative come to the forefront. The second component involves negotiating the contract, implementing the system, rolling out the solution and establishing the ongoing management and support functions to maintain continuous improvement. Based on a recently completed biobanking solution implementation project with a leading academic medical center, some important learnings will be shared related to the second step in implementing the solution for the improvement of an academic biobanking system. Implementation and ongoing management of the solution for an institutional biobanking system encompasses five major components. 1) Contract Management is an important aspect of an institutional system and has widespread implications on cost containment, customization risk and successful ongoing management of the solution. Whether an internal or third party system is selected, a comprehensive contract must be agreed with the system provider. Having the Procurement Department involved during development of the RFP to insure data security and standard

2 contract terms were confirmed as part of the vendor proposal submission paves the way for a faster contract negotiation cycle as the vendor is pre-cleared for contracts. Vendors typically use standard contracts that must be carefully reviewed by procurement, the technical team and the business team to insure the functional, operational and ongoing support expectations are clearly defined. It is common practice to bind the vendor s RFP response/proposal as an exhibit in the contract to lock in their commitments. License fees for institutional systems are typically based on number of concurrent users, often by type of user (named vs. unnamed) and can be significant. For the case study we completed a comprehensive user analysis incorporating potential future functionality (shared services and LIMS) and negotiated an enterprise license, saving several million in fees. Customization costs can be significant and must be tightly analyzed and controlled. A very comprehensive RFP and review cycle will allow the specification and costing of most gaps up front. It is highly recommended that the billing rate and projected costs for customization are negotiated with the initial contract and refined with a Statement of Work thereafter. Support expectations and response times should be negotiated and documented. Stipulation of vendor project staff can also be negotiated during the contract process including the project manager, business analyst and technical lead. If implementation and roll-out are highly dependent on the vendor, performance clauses should also be considered. Contract terms and cost negotiations in the case study were completed by the management consultant leading the project in conjunction with legal review by Procurement. 2) Solution Development & implementation is driven by the project manager with the product manager overseeing fulfillment of the technical and functional requirements. The detailed project plan is defined and executed including installation of the servers, base software, network communications, monitoring tools and access security. This component typically draws on institutional resources that specialize in these areas. To reduce risk and provide seamless transitions, access security should be integrated with current authentication practices of the organization. In the case study the physical system was leased from the technology infrastructure department who maintains, monitors and operates the equipment whereas the informatics group manages, maintains and monitors the vendor software. Sizing the system is accomplished together with the vendor and business owner to gauge the capacity needed based on the implementation plan and demands of the particular solution. The case study deployed the full system configuration rather than add components during the roll-out cycles to minimize risk. A minimum of three systems must be deployed and maintained to support Production, Quality Assurance and Development. Often there is a fourth system to support training and demonstrations. The case study actually managed as many as six environments to support roll-out of shared resources functionality being implemented on the same solution concurrently with biobanking. The case study fulfilled the Project Management Office review and approval process to make sure all technical aspects were consistent with organizational standards prior to implementation. Upon completion of this component the environments and solution are implemented into production.

3 3) Phased Rollout is the longest aspect of the implementation effort and involves implementing biobanks in the new solution. If the system was specified and deployed as a true institutional system fulfilling >90% of the requirements across the portfolio of biobanks, there should be limited customization necessary for each biobank to go live. However, there will be unique operational practices for some biobanks that must be specified and much time will be spent configuring each biobank, and mapping and converting data from historical systems to the new solution. Generally one or two less complex biobanks are implemented initially to establish the implementation steps and stabilize the solution. Roll-out strategies include simple one biobank at a time, grouping several together in waves (by common attributes or based on schedule constraints. A detailed implementation plan is developed with slight variations based on type of bank or complexity and used as a template for each biobank. Several biobanks are generally in various stages of implementation at any one time and are supported by business analysts with the project manager tracking progress across the entire initiative. The typical elapsed duration to implement a biobank in an institutional system is 3-6 months depending on complexity, customization, data conversion and resource allocation. A high level implementation and roll-out status report that provides status info for each standard project phase within each wave as well as tracks risk is provided below. Note the project phase completion percentages are fed by the detailed project plans. Example High Level Implementation & Roll-out Status Report 4) Tiered Support is the operational aspect of the implementation, training and production support efforts. Support for the institutional system is typically spread over four organizations with all issues submitted through a central ticketing or help function and dispersed to the

4 appropriate owner. A central technology group handles tier 1 support including general access, password and communication issues. Individual biobanks address issues and inquiries related to their own operations. A central office specifically to support biobanks provides best practices, compliance and operational support as well as presents demonstrations and resolves any implementation scheduling and resource allocation issues. Finally a product support or informatics group supports tier 2 and 3 issue resolution, manages implementations and conducts training. The central office and solution support functions can be combined into a product support group function if the organizational structure and skill sets are conducive to this. Below is an example of the support functions within each area and how support is accessed. Example Tiered Support Program Institutional Biobank System Operational Support Structure Central System Support Biobank Central Biobank Office Access: Phone, Service Ticket Tier 1 support - Password - Network - Account Access Access: Phone, Service Ticket All Biobank specific issues - Storage - Fee's, quotes - Facilities - Services - Sharing - Retrieval Access: Service Ticket - Implementation order - Demonstrations - Best Practices - Compliance - Billing, invoicing issues - Rates - Reconciliation Solution Support Services Access: Service Ticket - Implementation - Requirements specification - Data conversion - Quality & compliance testing - Train biobank staff Tier 2 & 3 support - Program functionality - Bug resolution - Documentation 5) Ongoing Management & Enhancement of the institutional biobank solution encompasses governance, operations oversight and management of the product life cycle to ensure the solution fulfills the agreed upon goals and objectives long term. The governance committee should consist of key senior leadership able to maintain the institutional funding commitment, confirm priorities and provide strategic direction for the solution. Operational oversight is critical to insure the system is functioning up to standards and fulfills the service commitments and expectations. The product manager is responsible for gathering performance statistics, issue management information and user group feedback. Periodically, typically quarterly, the business owner compares this information against requirements, contract terms and service commitments and addresses outstanding issues or shortcomings. Finally, the product manager should define a rolling three year plan for the product life cycle including projected costs and estimated timeline for major enhancements, upgrades and additional service lines (LIMS, shared resources, etc.). A process for submission, approval and implementation of

5 enhancement requests will feed into the product life cycle management process to refine the contents for each cycle. Once in place appropriate governance, carful operational oversight and strategic product life cycle management will enable organizations to achieve the greatest return on their investment in an institutional biobanking system.