APIII Advanced Pathology Informatics LIS Implementation

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APIII Advanced Pathology InformaticsLIS
Implementation

• Kathy M. Davis, B.S.,MT(ASCP)
• Sunday, September 09, 2007

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So Whats the Next Step?

• Your project team has been initiated
• Project stakeholders have been identified
• The leadership at the institution and within your
  department has embraced and endorsed the project
• The RFP and selection process has been completed
• Contract negotiations have been completed and the
  contract has been signed
• Youre ready to begin the LIS implementation

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Overview

• Glossary of Terms
• Project Management
• The Challenges
• The Process
• Summary

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Glossary of Terms

• Business analyst database support and process
  flow
• Programmer analyst database and report queries
  interface expert
• Network engineer connectivity
• System manager system administration
• IT support trained informatics staff who
  support the LIS may be laboratory staff or
  central hospital staff
• Laboratory specialist medical technologist who
  works in the laboratory and has IT
  responsibilities

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Project Management
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Project Management

• A project has a set of objectives with a starting
  point, an ending point, and a budget
• Adopt a standard of project management and adhere
  to those standards of managing scope, time, cost,
  quality, risk, and customer satisfaction
• Project management has the capacity to consume
  ones available resources in the absence of some
  refinements
• Adopting a practical approach to project
  management is advised

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Team Work
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The Project Manager

• Key individual with leadership qualities,
  communication skills, and organizational skills
• Respected at the institution with a track record
  of previous successes
• Advantageous to find individuals with in depth
  knowledge and experience with laboratory
  information system management
• Often the job of the LIS manager or a key
  business analyst with domain expertise

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Project Manager Role

• Ensure top level commitment and support from
  leadership within the organization and from
  leadership within the department
• Ensure departmental resources are available to
  the project
• In house vs. contractors
• Temporary back fill for current work to enable
  current staff to work on the implementation
• Will require resources from many individual teams
  across the organization
• Communicating within and across the boundaries is
  often more challenging than the technical aspects
  of the project

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Project Manager Role

• Politics and pressures from those above, below,
  and the equals
• Personnel issues that are inherent with change
• Vendor interactions
• Communication channel with the vendor
• Escalation procedures
• Co-development relationships
• Change / version control
• Problem tracking and resolution

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Emotional Reactions to Change

• What? This just wont work in our area because
• Why? What will the new system do that our
  current system doesnt?
• Not again how many changes can we tolerate
  around here? Whats next?
• Hopefully, Ill be retired by then

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Managing Expectations

• Enlist the support of the laboratory specialists
  and clinicians at the beginning of the project
• Include these users on site visits and in
  discussions with the vendor
• Require labs and clinicians to provide a list of
  required functions and features
• Facilitate dialog between the site and the vendor
  to help manage expectations
• Current functionality
• Functionality required before go live
• Functionality required post go live with time
  frame
• Critical functional requirements must be in
  contract

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The Politics of the Implementation

• Lab managers and chief technologists have their
  own agendas
• Hospital administration and high level leadership
  may be puzzled by the lengthy the implementation
  process
• Bench technologists are being scrutinized for
  productivity and may show little interest in the
  disruption of learning another new process
• All organizations experience those who may
  attempt to sabotage the process, along with the
  nitpickers and the slackers

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Resource Requirements

• Project manager
• Institutional and departmental administrative
  leadership
• LIS IT Support Staff or Central IT Support Staff
• Business analysts
• Programmer analysts
• Networking engineers
• System managers
• Laboratory specialists

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More Resource Requirements

• Support staff from other institutional systems
  that are interfaced to the LIS
• Admission, Transfer, Discharge (patient
  management systems)
• Clinical Order Entry systems
• Clinical Data Repositories
• Electronic Medical Record Systems
• Laboratory outreach systems
• Specialized laboratory application management
  systems
• Work room
• Workstations where team works together building
  the database
• Web space for project status reports

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LIS System Environments

• Production environment
• Certification environment
• Test environment
• Development environment

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Project Management Tools

• Site developed project charter or scope document
• Problem Statement
• Objectives and goals of the project
• Scope and deliverables of the project
• Project approach
• Project team
• Project schedule (high-level)
• Project summary budget, costs benefit
• Project assumptions/risks (optional)
• Signoff section

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The Project Plan

• Site works with vendor to customize the project
  plan to reflect the required tasks and time line
• May create a visual project plan broken down by
  weekly required tasks that will be used by the
  project team organizes and simplifies
  presentation of required tasks
• Time line must include hours for unanticipated
  events and external dependencies
• Periodic adjustments of the project plan will be
  required to reflect reality

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Project Documentation

• Project Scope or Charter
• Project Plan
• Project status reports and documentation of
  vendor discussion items
• Project validation and testing documentation
• Training checklist
• Technical system management documentation
• End user documentation
• Project go live checklist
• Acceptance / Go Live sign off form

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Learn From the Mistakes of Others

• Each LIS vendor has strengths and weaknesses with
  implementation processes
• Consider the advice of colleagues who have
  already experienced the implementation process of
  the vendor
• Find out what project management tools were used
  at other institutions

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The Challenges
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Implementations then

• In 1982, the University of Michigan Medical
  Center installed Cerner Classic which is still up
  and running today
• At that time we installed a core package for
  general lab, blood bank, microbiology, and
  anatomic pathology, including cytology
• 15 instrument interfaces (including 4 Coulters
  and 2 SMAC IIs)
• 1 Admission, Transfer, Discharge Interface
• Machine room consisted of 2 VAX 8700 CPUs and 8
  256K disk drives

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Today

• We still have all the core modules, but have
  added on support for Flow Cytometry, Molecular
  Diagnostics, HLA Tissue Typing, and Cytogenetics
• 34 instrument interfaces including two robotics
  interfaces
• Orders / results interface to 11 regional
  hospitals
• CPOE electronic orders / results interface
• Positive Patient ID system
• Laboratory Web Portal system
• Flow Cytometry system
• Rals Glucometer system
• Benetec pre-natal screening system
• Statlia
• Imaging systems
• 3 interface engines
• 80 servers in our machine room

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Interface Integration
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Legacy Data

• Data cross load from legacy systems to the new
  LIS
• Vendors differ in approach and support for cross
  loaded data
• Data stored as discrete assays vs. data stored as
  blobs
• May be a very time consuming process
• Careful consideration of which data and how much
  of it should be cross loaded is essential
• Consider requirements vs. preferences

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The Process
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The Core Build Team

• Form core team of database builders
• Include representatives from each lab area and
  the IT support area
• Keep the initial team relatively small
• Vendor system management training
• On site vs. vendor site training
• Business workflow analysis current state vs.
  future state analysis
• Identify space and work together during initial
  building so questions and problems can be
  immediately noted and shared
• Standardized core tables system reference
  nomenclature

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Test Plans

• Expect vendor to provide baseline test plans
• Expect to modify test plans to reflect site
  specific functionality
• May need to create customized test plans
• Test plans are essential to ensure consistency
  between versions of software and are required by
  CAP and other accrediting agencies

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Issues Tracking

• Keeping records of issues is key to the success
  of any project
• Most vendors provide an issues tracking solution
• Built in escalation processes
• Built in historical tasks
• Built in knowledge base
• Tools on the market that can be purchased
• Excel spreadsheets or Access Databases
• Mutually agreed upon process between site and
  vendor
• All IT issues should be triaged by the sites IT
  support analysts before reported to vendor

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Training

• Train the trainer approach
• Training environments
• Physical space for classroom style training
• Training documentation and checklists
• On-line training modules
• Vendor supplied / supplemented
• Site supplied
• Just on time

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Unit Testing

• Reference tables, applications, interfaces
• Vendors should provide canned test scripts or
  guidelines for each application
• Modifications to those plans may be required to
  reflect the configuration at your institution
• Use of standardized scripts used during the LIS
  selection process should be used to ensure
  promised application functionality

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Integrated Testing

• Testing upstream to downstream processes
  including all interfaces
• Critical to the success of the project
• Requires resources from other departments at the
  institution so strong project management and
  communication skills are essential
• Test plans will be required
• Automated tools may be helpful

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Load Testing

• Validate that the system can deliver the required
  response time to meet the institutional
  requirements
• Automated tools vs. manual methods
• Can require vendor to produce performance
  statistics

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System Freeze

• Stop making changes to system configuration and
  back end code
• Critical to stabilize the environment before
  integrated testing and validation begins
• May have multiple system freeze phases of the
  projects
• Expect feedback from the end users and hold your
  ground

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Final System Validation

• Validation plans must be in place for each
  application and interface
• Input and output data must be captured, retained,
  and organized according to regulatory agency
  requirements
• All issues must be documented
• Signature required of the testing team with
  administrative sign offs

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Reasons for LIS Implementation Failures

• Lack of top down leadership support
• Mismatch between team size and project scope
• Lack of planning
• Contract
• Project management
• Failure to communicate
• Failure to manage expectations
• Lack of issues tracking and escalation procedures
• Lack of required skills on the part of the vendor
  and the site
• Lack of troubleshooting ownership

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Reasons for Implementation Success

• Communication and good project management
• Horizontal integration of LIS team into
  laboratories
• Vertical integration of the LIS system into the
  existing systems at the site
• Strong on-site IT support team who learns the
  secrets of system troubleshooting from the vendor
  and who maintains that skill set

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Summary

• LIS implementations are a big deal
• Support from top leadership is essential
• Project management required
• Vendor relationships matter
• Team approach crucial
• Standardized testing and validation processes are
  required
• In depth knowledge of the product and the support
  requirements are critical

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Thank You

• Kathy M. Davis
• kuzina_at_umich.edu
• 734-936-6744