Innovation in the LIS: Implications for Design, Procurement and Management

Transcription

1 Innovation in the LIS: Implications for Design, Procurement and Management Ulysses J. Balis, M.D. Director, Division of Pathology Informatics & Director, Pathology Informatics Fellowship Program Department of Pathology University of Michigan Pathology Informatics 2012 Meeting: October 9, 2012 Chicago Illinois

2 An Evolving Tension: EHR vs. LIS Thesis Statement: The contemporary stand-alone LIS model is being challenged by the reality of fullyintegrated primary vendor EHR solutions, which promise to provide functional equivalence of the stand-alone LIS with the added benefits of: Simplified enterprise complexity Simplified deployment logistics Reduced total cost of ownership Simplified long-term stewardship of both software, hardware and data Enhanced patient safety Simplified Meaningful Use certification Justification: If the pathology -owned LIS can be justified as the correct place to house data and workflow in the overall enterprise data model, Pathology will be allowed to continue in its role of being elector and steward of such systems

3 Key LIS Innovation Areas to Consider Enterprise Data Models and Support for High Dimensional Data Shared Stewardship of Knowledge Management Systems Reverse federation in support of personalized medicine (bidirectional data feeds) Intrinsic support for customized workflow Workflow Engines Transition to zero knowledge interfaces (XML) LIS interoperability Digital Pathology Workflow

4 Lee Hood, IOM February 27, 2012

5 Challenge: Evolving the contemporary LIS will be critical to staying current with the anticipated deluge of knowledge management challenges facing the clinical laboratory Population(s) From: Athey and Omenn, 2010

6 The Clinical Laboratory Information System holds the potential to be the Information Commons for all aspects of P4-assoicated patient data.

7 George Poste, IOM Feb. 28, 2012

8 Lee Hood IOM February 27, 2012

9 Five Education and Training View Omics Enhanced William S. Dalton; Moffitt Cancer Center; IOM Feb. 27, 2012

10 D. Wall, CBMI, HMS Whole Genome Mapping and Variant Annotation Pipeline: an EHR or LIS functional component? Genome Mapping and Raw Output Pre-Processing Standardization, Annotation, and Summary of Results Map Algorithm 1 Output Result 1 Output Custom Conversion Script Standardized Variant Output File Input Mapping Algorithms Pre-Processed Variant Data Map Algorithm 2 Output Result 2 Output Custom Conversion Script Pre- Processed Data Custom Conversion Script Mapping & Annotation Summary Report Annotate Variants and Analyze Quality and Coverage Finalized Variant Output Files (HGVS)

11 From WGA to Clinical Annotation: Possible LIS workflow Paired-end WGA workup sequencing ordered RNA-seq Validation (FISH, RT- PCR, Sanger) Database Oncogene/Tumor Suppressor Detection Amplified CNV Over-expressed Deleterious, LOH Variants Identified Validation Gene Expression FDA Approved On-Label FDA Approved Off-Label Clinical Trial Underway Treatment Plan Prepared Medical Impact Report Generated D. Wall, CBMI, HMS, Athey & Omenn

12 Campus Systems IT SERCUIRTY IT Security Global Presence of an LIS-centric world view at the enterprise level:: Education, Research, & Patient Care Brian Athey & ECRIT 1/11/11 Admissions Comprehensive Clinical Assessment Exam Clinical Scheduling & Grading System Education Curriculum Eval. System Ctools/Saki 3 Visiting Student Application Service(VSAS) M-Pathways Education Knowledge Repository Research Pre, Post- Award Research Administration Systems Click Commerce (IRB) ethority (billing) Collexis Next-Gen Sequencing Bioinformatics Research Proteomics Core Metabolomics Facilities/ Omics Tissue Biorepositories ULAM RedCAP Research BioDBX Data Management Velos Systems OpenClinica Registries Populations Research & Quality Metrics Data Demographics Marts Individuals Diseases Others Clinical Quality Analysis Metrics Database Reporting (CAD) & Peer Others Review Research Research Data Warehouse HSDW Administration Enterprise Federated Data Warehouse CAD Data Warehouse Historical SPORES i2b2 Data HIPAA/IRB Services (Honest Broker, DE-ID Consent Management, ) Service-Oriented Information Bus CareLink/ Eclipsys Pharmacy Pathology Radiology HIM/ Documentation Biomedical Engineering Common Identifier Services (Patient, Provider, Research, Specimens, External Mappings) Vocabulary & Terminology Mapping Services (ICD-9/10 SNOMED, IMO, cadsr,...) Messaging Bus, ETL & External Collaboration Services (SOA, cagrid, SHRINE,...) CDR Ambulatory Emergency Med. Patient Care Systems Legacy+/Epic EHR Revenue Cycle Scheduling Others Epic Clarity IT IT Security Portals / Providers, Payors, P. Health Databases / HIEs / NHIN Health Sciences Library Resources NIH-Specific & External Data Resources (PubMed, GenBank, KEGG, GO, etc.) Bioinformatics and Systems Biology Workbenches High Performance Cloud Computing & Data Storage Reporting Visualization Analysis & Data Mining Data Sharing with External Collaborators cabig TCGA International Industry: Pharma/ I2b2/ Biotech CTSAs SHRINE

13 Campus Systems IT SERCUIRTY IT Security Global Presence of an LIS-centric world view at the enterprise level:: Education, Research, & Patient Care Education Admissions Comprehensive Clinical Assessment Exam Clinical Scheduling Curriculum Evaluation System CTools/Sakai 3 M-Pathways Others Education Knowledge Repository Research Research Core Administration Facilities/ Omics Systems Research Pre, Post- Award Click Commerce (IRB) ethority (billing) Collexis Research Administration Data Warehouse Next-Gen Sequencing Bioinformatics Proteomics Metabolomics Tissue Biorepositories ULAM SPORES Research Research & Data Quality Metrics Management Data Marts Systems RedCAP BioDBX Velos OpenClinica Registries Research Data Warehouse Populations Individuals Diseases Demographics Others Historical Data HIPAA/IRB Services (Honest Broker, De-ID Consent Management, ) Biomedical Engineering Common Identifier Services (Patient, Provider, Research, Specimens, External Mappings) Vocabulary & Terminology Mapping Services (ICD-9/10 SNOMED, IMO, cadsr,...) Messaging Bus, ETL & External Collaboration Services (SOA, cagrid, SHRINE,...) i2b2 CAD Quality Metrics Reporting & Peer Review CIDSS Analytics & Reporting Tools Others HSDW Patient Care Systems Legacy + Epic Epic EHR CareLink/ Eclipsys Pharmacy Pathology Radiology Centricity Documentation HIM CDR Ambulatory Emergency Med. Revenue Cycle Scheduling Others Epic Clarity Brian Athey & ECRIT 1/11/11 IT IT Security Portals / Providers, Payors, P. Health Databases / HIEs / NHIN Health Sciences Library Resources NIH-Specific & External Data Resources (PubMed, GenBank, KEGG, GO, etc.) Bioinformatics and Systems Biology Workbenches High Performance Cloud Computing & Data Storage Reporting Visualization Analysis & Data Mining Data Sharing with External Collaborators cabig TCGA International Industry: Pharma/ I2b2/ Biotech CTSAs SHRINE

14 Concept: Reverse Federation Not only does the LIS serve the greater EHR connectivity ecosystem, so to should the greater plurality of EHR repositories serve the LIS and its emerging workflow needs, in the capacity of decision support data feeds assisting in report generation. Increasingly essential for: Molecular reporting Personalized medicine Synoptic cancer checklist reporting of correlation of histopathology staging in concert with clinical stage and longitudinal reporting (AJCC Cancer Staging Manual, 7 th edition and later )

15 Concept: Complex data & Thiopurine Metabolite testing: The emergence of Encoded Data from primary lab test data

16 Comparing MLA to 6-TGN

17 Summary The future LIS will leverage: Enterprise Data Models and Support for High Dimensional Data Shared Stewardship of Knowledge Management Systems Reverse federation in support of personalized medicine (bi-directional data feeds) Intrinsic support for customized workflow Workflow Engines Transition to zero knowledge interfaces (XML) LIS interoperability Digital Pathology Workflow