Walter H. Henricks, M.D. Director, Center for Pathology Informatics Cleveland Clinic

1. Practical Survival Tactics for Pathology Data Management in the Era of the Electronic Medical Record APIII 2006 August 16, 2006 Walter H. Henricks, M.D. Director, Center for Pathology Informatics Cleveland Clinic

2. Agenda • Electronic Medical Record systems (EMRs) • Features • Forces driving adoption • Status of adoption • Pathology data management in the era of the EMR • Requirements • Opportunities • Experience and case studies • Administrative tactics and approaches

3. Electronic Medical Records Systems Terminology • EMR – Electronic Medical Record • EHR – Electronic Health Record • CPR – Computer-based Patient Record. • No consensus; terms used interchangeably • EMR/EHR – Patient-centered, comprehensive electronic system for healthcare delivery processes and documentation

4. EMR/EHR – Core Functions (IOM) • Health information and data • Results management • Order Entry/Order management = CPOE (computerized physician/provider order entry) • Decision support • Electronic communication and connectivity • Patient support • Administrative processes • Reporting and population health management Key Capabilities of an Electronic Health Record System – IOM, 2003 http://www.iom.edu/?id=14391

5. EMR Relationship to Departmental Systems EMR + CPOE Clinician users Other departmental systems Interfaces Orders, results Laboratory information system (LIS) Radiology information system Pharmacy information system

6. EMR and CPOE – Forces Driving Adoption • Quality, effectiveness, and efficiency of patient care • Patient safety • Data-driven accountability in healthcare • Demonstrable clinical outcomes • Pay-for-performance • Financial incentives; billing accuracy • Federal government • Data standards • Framework for national EHR • Funding

7. EMR and CPOE – Forces Driving Adoption • Physician acceptance • Technology use • Standardization and standards in medical care • Market forces – vendor growth opportunities • Technology advances • Handheld • Wireless

8. Organizations Encouraging EMR Adoption • Institute of Medicine (IOM) • Employer-driven coalitions • Leapfrog Group • Bridges to Excellence • Professional societies • American College of Physicians • American Academy of Family Practitioners

9. Organizations Encouraging EMR Adoption • Federal and state governments • NCQA – National Committee for Quality Assurance • AHRQ – Agency for Healthcare Research and Quality • CCHIT – Certification Commission for Healthcare Information Technology

10. U.S. Government - DHHS • ONCHIT: www.hhs.gov/healthit • Goal: Interoperable nationwide electronic health records in 10 years • National Coordinator for Health Information Technology appointed 2004

11. Recent U.S. DHHS Actions Regarding EMR/EHRs (http://www.hhs.gov/healthit/) • Awarded contracts ($18M) for prototype nationwide health information network (NHIN) for sharing of health information • Appointed American Health Information Community (AHIC), a federally-chartered commission charged with advising the Secretary on how to make health information digital and interoperable • Listed 80 federal Health IT initiatives, >$900M www.hhs.gov/healthit/federalprojectlist.html#intitiativestable

12. Reported Benefits of EMR/CPOE • Reduced medication errors • Reduced medication turnaround times • Improved medication selection • Eliminated transcription errors • Decreased length of stay • Decreased costs • Increased compliance with preventive care guidelines Tierney WM et al, 1993; Sittig DF and Stead WW, 1994; Chin HL and Wallace P, 1999; Bates DW et al, 2001; Hwang J et al 2002; Mekhjian HS, et al, 2002; Doolan DF et al, 2003; Galanter WL et al. 2005

13. Status of EMR Deployment Only 12% have no plans for EMR 17th Annual HIMSS Leadership Survey (n=205 CIOs) (sponsored by ACS Healthcare Solutions)

14. Status of EMR/CPOE Deployment • Surveys of medical groups reveal EHR adoption of 14-30% in ambulatory settings. Simon JS et al, 2005; Gans D et al, 2005; Burt CW et al, 2005 • Leapfrog Group data indicate 5.6% of respondents have implemented CPOE www.leapfroggroup.com, accessed 5/30/06

15. Agenda • Electronic Medical Record systems (EMRs) • Features • Forces driving adoption • Status of adoption • Pathology data management in the era of the EMR • Requirements • Opportunities • Experience and case studies • Administrative tactics and approaches

16. Reported Benefits of EMR/CPOE for Laboratory Testing • Shorter laboratory result reporting times • Better access to laboratory results • Decreased overall lab test orders • Decreased redundant lab test orders • Decreased STAT lab orders • Reduced inappropriate testing Bates DW et al, 1999; Solomon DH et al, 1999; van Wijk MAM et al, 2001; Hwang J et al 2002; Mekhjian HS, et al, 2002; Doolan DF et al, 2003; Chen P et al, 2003; Rosenbloom et al, 2005

17. EMR Relationship to Departmental Systems EMR + CPOE Clinician users Other departmental systems Interfaces Orders, results Laboratory information system (LIS) Radiology information system Pharmacy information system

18. I don’t understand this lab report in my EMR. The lab screwed it up. I need to call the lab. Our results are reported in EMR, and we have no control over it; the doc’s have to talk to IT if they have a problem

19. EMR and Pathology/Laboratory Medicine – Lab Reports Questions to assess: • Are the lab data in the EMR a true copy of the lab database? • Is the display of lab results adequate for appropriate clinical decision making? • CAP Laboratory General checklist question GEN.48500 requires periodic verification of data transmitted from the LIS to other computer systems (phase II)

20. CLIA Requirement for Results Transmission • 42 CFR 493.1291(a) The laboratory must have adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following:…(2) Results and patient-specific data electronically reported to network or interfaced systems

21. Mini-Case Studies – Evaluation of Lab Report Display • Result types more complex than CBCs • Molecular tests • Coagulation • Electrophoresis • AP • Microbiology • Blood Bank • Alternate views of laboratory results that are available to clinicians; display functions in EMR that are not publicized or widely known

22. EMR and Pathology/Laboratory Medicine Evaluation of Lab Reports in EMR • Areas meriting particular attention: • Cumulative result display format and organization • Reference range handling • Interpretive reports (text and numbers) • Result comments and footnotes • Abnormal result flags • Addenda and amended reports • Formatting of results printed from EMR system • Other methods of results distribution: • Personal Digital Assistants (PDAs) • E-mail

23. Surgical Pathology Report in EMR • Line breaks may be different from original in APLIS • Sequence of fields may be altered • PDF-based interface may be an option to preserve format

24. Integration Requirements for Laboratory Results in Health System EMR • Integrating results from multiple laboratories into single EMR presents additional challenges: • Same test performed in different labs may have different methodologies that may affect interpretation and reference ranges • Identification of performing lab is important so clinicians know whom to contact • 42 CFR 493.1291(c) The test report must indicate the following:…(c)(2) The name and address of the laboratory location where the test was performed.

25. Implications for laboratories of poor CPOE process design:

26. CPOE and Pathology/Laboratory Medicine • Implications for laboratories of poor POE process design: • Incorrect or incomplete orders • Increased phone calls • Frustration with lab testing process • Compliance problems • Pitfalls – future, duplicate, and canceled orders

27. EMR-Laboratory Case Study • Phone call from angry internist: “Why is the laboratory repeatedly canceling the lipid screens that I order?”

28. EMR-Laboratory Case Study • Personal order sets (or preference lists) in EMR/CPOE system allow MDs to find easily tests that they commonly order • MDs received error messages when ordering certain lab tests from their personal order sets • MDs perceived that lab canceled their orders • The tests had actually been discontinued and de-activated in the EMR main database, but the EMR program did not update MDs’ personal order sets and screens, which showed the old test choices

29. CPOE and Pathology/Laboratory Medicine • The computer screen is now the requisition • Clinical information is critical for correct interpretations and diagnoses on specimens • Systems must be designed to provide necessary clinical information to the laboratory

30. EMR-based Test Ordering • Some tests, particularly genetic tests, require unique information with the requisition, e.g. demographics. • Germline molecular analyses need be performed only once per patient. • Opportunities for labs include: • Ensure that required data are captured during on-line requisition entry • Determine how such data will get to the lab • Validate choices for drop-down lists in EMR order-entry • Define tests for alerts to prevent redundant genetic testing

31. CF test req question drop down

32. Anatomic Pathology Order Entry Data Requirements • Multiple specimens, and each specimen (part) may have: • An organ of origin • A site within that organ • Additional description relevant to that part, e.g. “esophagus, 35 cm, nodule” • Clinical information applicable to entire case is necessary • e.g. “History of Barrett’s; rule out dysplasia” • Pap smears have specific requirements, e.g. LMP, previous treatment history

33. Anatomic Pathology Order Entry Interface Requires Mapping to Part Type in AP LIS • Order entry screens in EMR could be designed with drop down lists that map to Part Types Part Type in LIS dictionary Free text descriptive data, part-specific Histology protocols mapped to Part Type

34. Handling of Outside Reference Laboratory Reports in EMRAKA the Not-Entirely-Electronic Medical Record • Paper reports from outside reference laboratories present a challenge in the EMR era • Clinicians require access sendout test reports, and laboratories are responsible for getting these results to clinicians • Simple results can be manually entered into LIS, then sent to EMR • Many such reports are long and complex and may have charts, tables, graphs. • Document imaging may be a solution

35. Considerations for Scanning Outside Lab Reports into EMR • Imaging system – require means of integrating document imaging system with EMR • Indexing method – by patient, date, report type, etc. • Access in EMR – how will the clinicians know the result exists, and how do they access it? • Multiple page reports • QA of scanning process – image acceptability; no cut-offs • Corrected/amended report handling • Identity of scanning person; audit trail

36. Document Imaging System - Indexing

37. Elimination of Printed Laboratory Reports • EMR offers opportunity to cease paper report distribution • Reduction of clutter and waste • Clinicians’ desire not to receive redundant paper • Improved use of lab resources • Phased-in approach may have advantages in complex environments

38. Elimination of Printed Laboratory ReportsCleveland Clinic • Phased-in approach • AP and CP reports • 99.6% reduction in median monthly reports • 99.5% reduction in printed pages • 89% of physicians no longer receiving printed reports • Annualized savings of >$44K consumables and 0.4 FTE time

39. Assumptions About Pathology Data We Have Experienced Related to EMRs • All reference ranges for a given test (e.g. PSA) are the same across different labs • All test codes in the lab’s systems are mapped to LOINC • We can apply display filters to text results that do not have abnormal flags, e.g. “show only abnormal Pap smears”

40. Tactics for Working with EMR Staff • Build ties to EMR administrators with oversight of pathology data handling – they won’t look for you • Engage interested physicians and work with them to influence EMR changes • Provide specific examples and explanation of problems when they arise

41. Tactics for Working with EMR Staff • Use every opportunity to demonstrate value to EMR IT staff of having lab subject matter experts • Prevent problems • Resolve issues • Improve systems • Keep track of your lab’s efforts related to pathology data in EM (e.g. troubleshooting, implementation) to build your case over time for greater influence and involvement • Avoid finger-pointing and focus on collaboration (if possible)

42. Measures to Increase Involvement and Influence in EMR Processes Related to Pathology • Participate in EMR selection process • Contribute to RFP development • Attend vendor demonstrations • Assist with use cases for evaluation and testing • Offer to design structure of test groupings (“tree”) in cumulative result display (e.g. Chemistry, Heme) • Take over maintenance of lab data master files in EMR system • Coordination of new result components • Updating of test definitions • Ensuring correct mappings and battery component groupings

43. Far Side Ginger

44. Summary of Potential Tactics to Improve Pathology Data Management in EMR • Validate display of more complex tests in EMR, e.g., molecular, coag, micro, blood bank • Define surgical pathology order entry with mapping to part types defined in APLIS • Utilize interface engine for data translations when needed for EMR – e.g. performing lab location

45. Summary of Potential Tactics to Improve Pathology Data Management in EMR • Develop list of germline molecular tests that merit alerts to prevent duplicative testing • Consider PDF-based interface to preserve formatting of pathology reports • Investigate document imaging for incorporation of send out reports into EMR • Cease distribution of printed reports (pilot)

46. Pathology Data Management in EMRSummary • The electronic medical record is the physician’s “portal” to pathology data and laboratory processes • Laboratories must raise institutional awareness of pathology information handling issues related to the EMR