Practical Considerations in Pathology Informatics Practice

1
Practical Considerations in Pathology Informatics
Practice

• Walter H. Henricks, M.D.
• Director, Laboratory Information Services
• The Cleveland Clinic Foundation
• henricw_at_ccf.org

2
Pathology Informatics Definition

• The theory and practice of computerized
  information management in anatomic and clinical
  pathology

3
Practical Considerations in Pathology Informatics
Practice

• Considerations for outreach programs
• Implications of migration to client/server, thin
  client, ASP
• Fundamental of project management and
  justification
• Importance of pathology informatics in
  institution-wide clinical information system
  initiatives

4
Challenges Facing Laboratories Relevant to
Pathology Informatics

• Shift in focus for hospital-based laboratories
• Consolidation and integration of services
• Revenue enhancement through outreach programs
• Delivery of services on a regional basis
• Need for hybrid hospital-reference laboratory
  systems that are able to support inpatient,
  outpatient, and outreach testing in
  geographically dispersed IDSs

5
Options for Integrating Laboratory Information
Systems

• LIS with multi-site functionality
• Interfaces between multiple LISs

6
Multi-Facility LISAdministrative Questions

• Who will perform various maintenance tasks?
• How will other support tasks (e.g. network
  trouble) be allocated?
• How will billing occur for tests that are ordered
  at remote site but performed in central lab?
• How will disagreements be mediated?

7
Multi-Facility LISAdministrative Questions
(contd.)

• What are other special requirements of individual
  sites?
• What is the envisioned degree of integration of
  lab operations?
• How will costs be allocated?

8
Multi-Facility LISPros and Cons

• Benefits
• Standardization of systems, data, definitions,
  etc.
• Simplified support and maintenance
• Anticipated long term cost savings
• Single repository for enterprise-wide lab data
• Drawbacks
• Significant operational and organizational change
  necessary
• High switching costs

9
Interface Legacy SystemsPros and Cons

• Benefits
• Less operational and organizational change
  required
• Applicable for higher volume outreach clients not
  part of IDS
• Drawbacks
• Technically challenging
• Different vendors, different timetables
• High programming/license costs
• Less integration and standardization achieved

10
Outreach Functionality RequirementsHybrid
Hospital-Reference Laboratory

• Systems for hybrid labs must meet hospital and
  outreach needs
• Patient-centric and client-centric views of
  information are necessary

11
Outreach Functionality RequirementsHybrid
Hospital-Reference Laboratory

• Patient-centric view
• Longitudinal orientation around patient stay
• Delivery of daily cumulative reports to chart
• Uniform report formats and requisitions
• Inquiry of lab results by patient name or ID
• Client-centric view
• Database fields for client ID codes to which
  client-specific parameters are linked
• Ability to view information filtered on client
  basis

12
Outreach Functionality RequirementsHybrid
Hospital-Reference Laboratory

• Multiple remote report distribution methods
• Remote printing, FAX, E-mail, Web, PDA, pager
• Multiple site report distribution
• Reports with all tests from single requisition
• Remote order entry and results inquiry
• Client-specific report formats
• Instrument-ready specimen barcode label printing
  at client sites
• LIS to LIS interfaces

13
Outreach Functionality RequirementsBilling/Financ
ial

• Billing options
• Client
• Insurance
• Patient
• Flexible fee schedules
• Medical necessity checking/Advanced Beneficiary
  Notice (ABN)
• Management reports by client, test, payer

14
Outreach Functionality RequirementsLogistics and
Client Services

• Specimen tracking
• Courier management
• Client Services module
• Help desk
• QA database
• On-line test directory
• Electronic document management

15
Electronic Document Management in Pathology - CCF

• Paper documents scanned and indexed into document
  imaging and database system
• requisitions, outside reports, release letters,
  billing instructions, others
• Immediate retrieval via network
• Improved client satisfaction (shorter hold times)
• Improved internal processes (AP and CP)
• gt17,000 documents scanned/month
• gt3300 imaged documents viewed
• Estimated 3.4 FTE savings

16
Laboratory Database Maintenance and Change Control

• Test maintenance information may reside in
  multiple sites
• LIS maintenance tables
• Financial systems
• On-line directories
• Printed handbooks
• Changes to test database affect multiple user
  groups having diverse needs and expectations

17
Laboratory Database Maintenance and Change Control

• User groups potentially affected by test database
  changes
• Laboratories
• Hospital clinicians
• Multi-facility LIS sites
• Interfaced sites
• Outreach clients
• Client Services
• Sales and Marketing
• Central IT/HIS

18
Laboratory Database Maintenance and Change Control

• Specific procedures are needed for consistent
• change control and coordination
• communication
• documentation

19
Practical Considerations in Pathology Informatics
Practice

• Considerations for outreach programs
• Implications of migration to client/server, thin
  client, ASP
• Fundamental of project management and
  justification
• Importance of pathology informatics in
  institution-wide clinical information system
  initiatives

20
LISs in the 2000s

• With increased flexibility comes increased
  complexity
• More options more decisions more maintenance
• Client/server environments are complex and
  require significant resources to implement and to
  support
• Cost estimates have ranged from 7,000 to
  14,000/year per seat

21
Legacy LIS
Terminal Server
Mini-mainframe

• Mainframe
• controls all functions and transactions
• holds database and all software
• Terminals
• are for data input and display

Dumb Terminals
22
Client/Server LIS
Fax server
PC clients
Print server
Image server

• Client/server architecture
• Database server holds database
• Other servers (agents, monitors) handle certain
  transactions - fax, print, interface
• PCs manage user interface
• Application software functions are distributed
  across all clients and servers

Database server
Interface server
23
Easily Overlooked or Underestimated Items in C/S
LIS Upgrades

• Hardware (PCs and servers)
• Adequacy to run LIS with acceptable response time
  in your environment
• Interfaces
• 5 - 30,000 each
• Database conversion
• Standard costs
• Customizations to cover all data elements
  desired

24
Easily Overlooked or Underestimated Items in C/S
LIS Upgrades (contd)

• Network
• Adequacy to handle load of new system
• Remote access
• Training, training, training
• Users and system managers
• Conversion to GUI user environment
• Customization requirements

25
Expertise RequirementsClient/Server LIS System
Support

• Database administration
• Network administration
• Server administration
• PC support and troubleshooting
• Specialty areas
• Web
• Voice
• Imaging

26
Thin Client Computing

• Thin client generically refers to the setting in
  which a device runs application software that is
  relatively simple and requires less computer
  power and resources to operate
• Thin client term is used loosely and applied to
  hardware and software
• Web browsers are often referred to as thin clients

27
Thin Client Architecture in LIS
Thin clients
Thin client server
Database server

• All application logic executes on thin client
  server
• Only keystrokes, mouse clicks, and screen
  updates travel the network between thin client
  and server

28
Thin Client Computing
www.citrix.com
29
Thin Client Computing for LIS Benefits Promised

• Easier administration standardized desktop
  controlled centrally
• Cross-platform (PC, Mac)
• Lower hardware requirements and costs
• Remote access
• Less network traffic

30
Thin Client Computing for LISPotential Drawbacks

• Hardware and license costs
• Single point of failure for all workstations
  connected to thin client server
• Effectiveness of vendors implementation of thin
  client
• Inability to do specialized functions on thin
  client stations imaging, voice

31
Client/Server LISwith Thin Client
Fax server
Web server
Image server
Fat and thin clients
Database server
Print server
Interface server
Thin client server
32
Application Service Provider (ASP) Model

• Contractual arrangement in which a provider
  delivers a software application or suite of
  services to a client over a network, usually the
  Internet outsourcing
• Hardware, software, security, upgrades entirely
  managed by vendor
• Fixed subscription fees, either per transaction
  or flat rate

33
ASP ModelEnvisioned Benefits

• Reduced up-front software costs
• Minimal capital hardware investment
• Predictable, stable costs
• Support functions provided by vendor
• IT expertise (personnel)
• Maintenance
• Upgrades
• Focus resources on primary business needs

34
ASP ModelConsiderations for Laboratories

• System security
• Privacy/Confidentiality/HIPAA
• Access
• Backup
• HIPAA compliance
• System reliability
• Availability/uptime
• Performance
• Fault tolerance

35
ASP ModelConsiderations for Laboratories
(contd.)

• Pricing scheme, including minimums
• Termination options
• Upgrade management
• Scheduling
• Right of refusal
• Site-specific functionality requirements
  (customizations)
• Interfaces
• Vendor solvency and commitment to product

36
ASP ModelService Level Agreement (SLA)

• Contract that defines the technical and business
  parameters of the relationship between ASP vendor
  and client
• Key terms
• Responsibility
• Performance
• Remediation
• Quantifiable metrics valuable, such as system
  uptime, performance

37
ASP - Questions to AskPutting the S in ASP

• Will you provide reference sites that can tell us
  about your technical and service capabilities?
• What level of system availability do you
  guarantee, and how do you measure it? What
  penalties will you accept?
• What are your provisions for security, data
  backup, and disaster recovery?

38
ASP - Questions to AskPutting the S in ASP

• What are the capabilities and certifications of
  your technical support employees?
• What are your hiring and training practices?
  What strategies do you have for retaining your
  technical people and their knowledge of our
  needs?
• What levels of personnel are at the hosting site?
  What hours? How quickly can we get access to
  the site?

39
ASP - Questions to AskPutting the S in ASP

• What plans have to made to add capacity, and how
  quickly will you provide it?
• What are your equipment repair capabilities,
  procedures, and time-frames, and what spare parts
  do you keep on-site?
• Will you assign a customer advocate and technical
  liaison to our account?
• Anthes GH, Computerworld, October 16, 2000

40
Practical Considerations in Pathology Informatics
Practice

• Considerations for outreach programs
• Implications of migration to client/server, thin
  client, ASP
• Fundamental of project management and
  justification
• Importance of pathology informatics in
  institution-wide clinical information system
  initiatives

41
Goals for Initiatives and Projects

• Improvement of care
• Cost Savings
• Integration - technical and organizational
• Friedman BA,1996
• Enhanced perceived value of informatics and
  laboratory services
• Elevitch FR,1995

42
Algorithm for Pathology Informatics Initiatives
PRIORITIES
Initiatives/ projects
Prerequisites?
No
Yes
Assessment
Justification - Return on investment -
Value definition
Implementation - Product selection - Contract
- Project management
43
Priorities for Projects

• Laboratory systems - replace, upgrade, enhance,
  optimize functionality, consolidate platforms
• Integration within organization - interface to
  electronic medical record, service distributed
  laboratory sites or other remote ambulatory care
  sites
• Integration with other organizations - link to
  outreach clients

44
Priorities for Projects(contd)

• Internet-based laboratory computing
• HIPAA/privacy/security
• Digital imaging
• Handheld computing
• Special projects for individual laboratory areas
  e.g. voice recognition
• Delivery of service directly to patients

45
Project Justification

• Organizations must decide in which projects to
  invest limited funds and time. These decisions
  are made on the basis of cost-benefit analysis
• Cost-benefit analysis is based, at least in part,
  on some type of financial projections to justify
  an investment

46
Project Justification - Return on Investment (ROI)

• Payback analysis - benefits divided by annual
  costs, expressed in years
• Time period at which benefits accrued are
  expected to equal the original investment
• Relatively crude measurement of return on
  investment
• No accounting for time value of money

47
Time Value of Money

• Time value of money - concept that money can earn
  interest in other investments over time so that a
  dollar invested in any project today cannot be
  considered to have the same value as a dollar
  returned in a year

48
Project Justification - ROI Analyses

• Discounted cash flow analyses - methods that take
  into account the time value of money
• Net present value - method which determines
  whether a project earns more than a desired rate
  of return
• Internal rate of return - method that finds the
  specific rate of return that is expected for a
  project

49
Project Justification Steps

• Assess all costs and benefits expected
• Consider these elements
• increased revenue
• decreased expenses
• protection of revenue
• cost avoidance
• productivity improvements

50
Project Justification Steps(contd)

• Expense decreases and avoided costs are probably
  easiest to quantify
• Examine workflow carefully and focus on process -
  flow charts that map out processes can help
  define costs and savings
• Quantify as much as possible - ROI on IT
  investment is about 60 measurable and 40
  immeasurable

51
Project JustificationAdditional Options

• Challenge your assumptions and consider best and
  worst case scenarios
• Ask vendor to include estimated ROI as part of
  RFP
• Examine experiences of other organizations

52
Project JustificationAdditional Considerations

• Part of the difficulty in cost justification for
  IT projects is that the benefits are intangible
  and/or impossible to quantify
• Some now believe that traditional cost-benefit
  analysis for strategic IT initiatives is
  unnecessary or not useful
• improved care and service are goals rather than
  cost savings
• strategic initiatives are necessary for business
  growth
• IT is intertwined in all aspects of the business
  such that it is difficult to assess value
  separately

53
Project JustificationKey Points to Convey
Regarding Pathology

• Preparation to handle increased complexity and
  volume of new testing
• Importance of pathology data in the medical
  record
• Value of pathology in medical decision making
• Cost-effectiveness of investment in pathology IT
• Need for inclusion of pathology testing in new
  multidisciplinary initiatives
• Becich MJ, AIMCL 2000

54
Fundamentals of Project Management

• Obtain senior management buy-in
• Assemble project team
• Identify specific tasks
• Identify dependencies (what must be done first?
  what can be done in parallel?)
• Assign responsibility and maintain accountability

55
Fundamentals of Project Management(contd)

• Set deadlines for tasks and milestones
• Monitor progress
• Use tools like Gantt charts (MS Project)
• Communicate, communicate, communicate
• Establish conflict resolution process - Executive
  Steering Committee
• Manage user expectations

56
Project ManagementCommon Reasons for IT Projects
to Fail

• Unfamiliarity with project requirements
• Fluctuating requirements and scope
• Inadequate specifications
• Poor communication within organization
• Overoptimism about functionality, timelines
• Insufficient buy-in and support

57
Project ManagementCommon Reasons for IT Projects
to Fail

• Insufficient testing
• Missing key components people, tools
• Unreasonable expectations regarding
• Schedule
• Personnel allocation
• Funding
• Scope

58
New View of Managing IT Projects

• successful project management today is less
  about the science of using Gantt charts, work
  breakdown structures, and critical-path
  methodology than about effective communications,
  trust, integrity, flexibility, rapid
  decision-making, problem solving, leadership, and
  customer satisfaction.
• Foote D, Computerworld, September, 2000

59
Practical Considerations in Pathology Informatics
Practice

• Considerations for outreach programs
• Implications of migration to client/server, thin
  client, ASP
• Fundamental of project management and
  justification
• Importance of pathology informatics in
  institution-wide clinical information system
  initiatives

60
EMR Relevance to Pathology

• The laboratory will in all likelihood be held
  responsible for all aspects of laboratory
  testing, from order entry through result
  distribution, whether or not it participated in
  development of all systems and procedures
  involved.

61
EMR Issues of Relevance to Pathology

• Stewardship of pathology data and integration
  into EMR
• Electronic order entry (POE)
• Structured pathology data for EMR
• Opportunity to be integral to success of
  institutions strategic project

62
EMR Relevance to PathologyStewardship of
Pathology Data

• Pathology/laboratory data comprise majority of
  data in current EMRs
• 70/70 rule Becich MJ, 2000
• 94 of Mayos EMR database is lab data
• Forsman R, 2000
• When pathology data are transferred to or
  replicated in another record, there are patient
  care and regulatory implications for the
  laboratory

63
EMR Relevance to PathologyStewardship of
Pathology Data

• Questions to assess
• Are the lab data in the EMR a true copy of the
  lab database (source of truth)?
• Is the display of lab results adequate (at least)
  to support appropriate clinical decision making?

64
EMR Relevance to PathologyStewardship of
Pathology Data

• CAP accreditation checklist
• Has the laboratory documented the accuracy and
  consistency of laboratory results (reference
  ranges and appropriate comments) across all
  computer interfaces with external systems (LISs,
  HISs, and others)? (Phase II)

65
EMR Relevance to PathologyStewardship of
Pathology Data

• Areas meriting particular attention
• Result comments
• Critical results flags
• Drug peak and trough identification and timing
• Addenda and amended reports, corrected results
• Other methods/systems of results distribution
• Additional clinical systems
• E-mail
• PDAs

66
EMR Relevance to Pathology Strategic
Opportunities

• EMRs are high stakes initiatives, and
  participation is an opportunity to be an integral
  part of the success of a strategic project
• Participation will set the groundwork for crucial
  roles in future efforts that will include
  enhanced decision support, guideline development,
  and other advanced EMR features
• Political power accrues to those subunits of an
  organization best able to solve the strategic
  problems of an organization Friedman, BA 1990

67
Practical Considerations in Pathology Informatics
Practice

• Considerations for outreach programs
• Implications of migration to client/server, thin
  client, ASP
• Fundamental of project management and
  justification
• Importance of pathology informatics in
  institution-wide clinical information system
  initiatives

68
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69
References

• Outreach and related
• Aller RD. Creating integrated regional
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• Friedman BA, Smith W. Integrating information
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  creation of a value-added network. Am J Clin
  Pathol 199399637-642.
• Henricks WH. Information system needs of
  clinical laboratories serving complex integrated
  delivery systems beyond Y2K. J Healthc Inf
  Manag 200014(3)55-67.

70
References

• Client/Server, thin client, and ASP
• Server-based Computing White Paper. Citrix
  Systems, Inc. Fort Lauderdale, FL, 1999.
  www.citrix.com
• TCO Total Cost of Ownership Analyst. White
  Paper. Gartner Consulting. Stamford, CT, 1997.
• Total Cost of Application Ownership. White Paper.
  The Tolly Group. Manasquam, NJ, 1999.
• Thomas JC. Leaving your legacy choosing a
  centralized for decentralized client/server
  architecture depends on your business objectives.
  Healthcare Informatics. 1998October123-124.
• Client/Server Software Architectures. Software
  Technology Review. Software Engineering
  Institute, Carnegie Mellon University,
  Pittsburgh, PA, 1997 (rev. 2000).
  www.sei.cmu.edu/str/descriptions/clientserver_body
  .html
• Thin clients behind the numbers. Byte. April
  1997. www.byte.com/art/9704/sec6/art3.htm

71
References

• Holohan M. Application Service Providers.
  Computerworld, September 11, 2000, p.70.
• Shand W. Service-Level Agreements.
  Computerworld January 22, 2001, p.53.
• Apicella M. Shaking hands is not enough.
  Infoworld April 30, 2001, p.49-50.
• Anthes GH. Asking the right questions up front
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  Computerworld October 16, 2000, p.80-81.
• www.whatis.com (An excellent web site that has an
  easy-to-use searchable dictionary of numerous
  computer-related terms, basic and advanced)

72
References

• Project justification, management ROI
• Abbott B. Software failure can lead to financial
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• Amatayakul M. Impact analysis valuing the
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• Multiple authors Whats IT worth? Special
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• Foote D. Managing projects with a new view.
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• Lewis B. Shepherding complex projects is hard
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• Books
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73
References

• Role in institution initiatives
• Becich MJ. Information management moving from
  test results to clinical information. Clin Lead
  Manage Rev 200014296-300.
• Forsman R. The eletronic medical record
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• Friedman BA. Informatics as a separate section
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