Process for Integrating Results from Pharmacogenomic Testing into an Electronic Health Record
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1 Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd Versin 1.0 Use Case Prepared by: Cmmnwealth f Virginia Health Infrmatin Technlgy Standards Advisry Cmmittee (HITSAC) Genmics Wrking Grup Develped in Partnership with Centers fr Disease Cntrl and Preventin Divisin f Labratry Prgrams, Standards, and Services, Inva Health System, Inva Translatinal Medicine Institute & the HL7 Clinical Genmics Wrking Grup September 23, 2014 Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 1 f 12
2 Table f Cntents General Infrmatin...3 Pharmacgenmic Test Result Plavix Gentype Test...5 Integrating Results frm Pharmacgenmic Testing int the Electrnic Health Recrd...6 Appendix A: ITMI Plavix Gentype Test Result Specificatin...X Appendix B: Inva Health System/EPIC Electrnic Health System Specificatin.. X Appendix C: Summary f Applicable Health IT Standards..... X Appendix D: Pharmacgenmic Test Result-EHR Integratin Transactin Wrkflw...X Appendix E: Pharmacgenmic Test Result-EHR Integratin Data Flw...X Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 2 f 12
3 General Infrmatin 1. Use Case ID HITSAC Genmics Wrking Grup Use Case #3 (HITSACGWG3) 2. Use Case Title Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd 3. Abstract The HITSAC Genmics Wrking Grup Use Case #2 defines the prcess fr integrating results frm pharmacgenmic testing int a patient s electrnic health recrd. 4. Descriptin Pharmacgenmics explres the rle f genetics in drug respnse, fcusing in particular n the influence f genetic variatin n drug respnse in patients by crrelating gene expressin r single-nucletide plymrphisms with drug absrptin, distributin, metablism and eliminatin and drug receptr target effects. Pharmacgenmics cncentrates n single drug-gene interactins and encmpasses a mre genme-wide assciatin apprach, incrprating genmics and prtemics while explring the effects f multiple genes n drug respnse. Results frm pharmacgenmic testing require a designated lcatin, standardized structure and nmenclature and dedicated persistence within the electrnic health recrd (EHR). Unlike ther labratry tests, such as fr chlesterl r glucse level, results frm pharmacgenmic testing d nt change. Therefre, pharmacgenmic test results must remain with the patient and be clearly discverable by healthcare prviders t infrm apprpriate pharmaclgical treatment. Specific requirements fr pharmacgenmic test results returned t the EHR are as fllws: A clinical reprt with the results described in narrative frm Actins and recmmendatins signed ff by the certified clinical and r mlecular geneticists Understandable infrmatin fr bth clinician and patient A discrete result f the allele variatin fr the specific lci being tested Allws fr interperability and data sharing based n a standard set understandable acrss the genetic cmmunity Enables alerts bth active and passive t be generated based n the results Prvides fr statistical and utcmes-based reprting frm the results Supprts future reprting and alerts based n discvery f validated drug/gene interactins A discrete, mre descriptive result f the test in the cntext f the test rder Prvides fr statistical and utcmes-based reprting fr nn-genetic purpses Gives clear indicatin result interpretatin in the cntext f patient pint f care Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 3 f 12
4 The Inva Translatinal Medicine Institute (ITMI) is a research center established by Inva Health System, t cnduct genmic research and translate findings int a clinical setting t imprve quality f patient care. ITMI has implemented a pharmacgenmic testing prtcl fr Clpidgrel (Plavix, CYP2C19), a secnd-generatin thienpyridine that inhibits platelet aggregatin and has been designed fr treatment f patients with crnary artery disease, acute crnary syndrmes (ACS), and/r after percutaneus crnary interventins (PCI). ITMI has named the test Plavix Gentype Test and perfrms the test using a kit apprved by the U.S. Fd and Drug Administratin (FDA). The interpretatin f the Plavix Gentype Test has been standardized n the assay and ITMI s Luminex labratry equipment. ITMI initiated its implementatin f the clinical genetic/genmics tests n these standard set FDA apprved pharmacgenmics tests, as these tests have been validated and are mstly reimbursable. As the testing prgresses, ITMI will implement genetic panels, targeting specific genetic markers fr cnditins such as cancer r supplements t standard tests such as newbrn screening. The fllwing use case has been develped by the Cmmnwealth f Virginia s HITSAC Genmics Wrking Grup (HITSAC-GWG) t define the prcess fr integrating results frm pharmacgenmic testing int a patient s electrnic health recrd. The use case leverages the wrkflw, testing prtcls and reprting capability currently being implemented by Inva/ITMI as the Plavix Gentype Test. The ITMI Plavix Gentype Test specificatin has been prvided in Appendix A. Specificatins and requirements fr integratin f pharmacgenmic test results int Inva s EPIC EHR have been prvided in Appendix B. The use case has been cnstrained t fcus n reprting f pharmacgenmic test results the Plavix Gentype Test within the Inva Health System labratry and EHR envirnment. Future use cases identified by the HITSAC-GWG will cncentrate n generalizing frm the Inva/ITMI-centric system t pharmacgenmic tests cnducted n ther labratry and EHR platfrms. 5. Stakehlders Inva/ITMI Pharmacgenmic Labratry Testing ITMI Labratry Sftware ITMI Labratry Staff Inva Health System Electrnic Health Recrd (EHR) System Inva EHR System (EPIC) Inva Clinical Staff 6. Definitins Pharmacgenmic Test: A labratry test that measures the influence f genetic variatin n drug respnse in patients. Electrnic Health Recrd (EHR): A digital versin f a patient's medical chart structured based n the Health Level 7 (HL7) Clinical Dcument Architecture (CDA) and Cntinuity f Care Dcument (CCD) Standards. Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 4 f 12
5 7. Versin Cntrl The fllwing table cntains a histry f revisins t this publicatin. Versin Date Revisin Descriptin Cntact 1.0 9/23/2014 Initial Use Case Dcument Je Grubbs Identifying Changes in This Dcument See the latest entry in the revisin table abve Vertical lines in the left margin indicate the paragraph has changes r additins. Specific changes in wrding are nted using italics and underlines; with italics nly indicating new/added language and italics that is underlined indicating language that has changed. The fllwing examples demnstrate hw the reader may identify updates and changes: Example with N Change The text is the same. The text is the same. Example with Revisin The text is the same. A wrding change, update r clarificatin is made in this text. Example f New Text This text is new. Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 5 f 12
6 Pharmacgenmic Test Result Plavix Gentype Test 1. Plavix Gentype Test Descriptin Nte: The ITMI Plavix Gentype Test specificatin has been prvided in Appendix A. The ITMI Plavix Gentype Test XXXXXXX [ADDITIONAL INFORMATION FOR THIS SECTION WILL BE PROVIDED BY ITMI/Aarn Black] 2. Alignment with Existing Health IT Standards The prcess fr integrating pharmacgenmic test results int an electrnic health recrd has been develped t align with the fllwing health IT standards, as required by the Cmmnwealth f Virginia: ID TITLE VERSION NOTES [ADDITIONAL INFORMATION FOR THIS SECTION WILL BE PROVIDED BY ITMI/Aarn Black] Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 6 f 12
7 Integrating Results frm Pharmacgenmic Testing int the Electrnic Health Recrd Nte: Diagrams f the wrk flw and data flw f the integratin f the ITMI Plavix Gentype Test results int Inva s EPIC EHR system have been prvided in this dcument as Appendix D and Appendix E. 1.0 Precnditins A set f cnditins that must be met befre the activities described in the use case can begin. 1. The Inva/ITMI has cnducted the Plavix Gentype Test. 2. The result frm the ITMI Plavix Gentype Test has been transmitted t the patient s EHR in Inva s EPIC EHR system. 3. The ITMI Plavix Gentype Test result has been integrated int the patient s EHR in Inva s EPIC EHR system. 2.0 Pst Cnditin A set f cnditins that must be met after the activities described in the use case have been cmpleted. The received ITMI Plavix Gentype Test becmes integrated int the patient s EHR in Inva s EPIC EHR system. 3.0 Pririty Describes the imprtance and sequence f the use case in the verall activities f the cancer registry. This is a high-pririty use case and the HITSAC Genmics Wrking Grup decided it shuld be develped first. 4.0 Frequency f Use Describes hw ften the activities in the use case take place. The activities in this use case will take place each time a new r resubmitted ITMI Plavix Gentype Test result becmes transmitted int the patient s EHR in Inva s EPIC EHR system. 5.0 Inva Health System EHR System EPIC Specificatins Describes the specificatins required fr integratin with Inva Health System s EPIC EHR System. XXXX. [ADDITIONAL INFORMATION FOR THIS SECTION WILL BE PROVIDED BY ITMI/Aarn Black] Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 7 f 12
8 6.0 Transactin Wrkflw Describes the specific steps in the wrkflw taken t integrate the results frm the ITMI Plavix Gentype Test int the Inva EPIC EHR system. 6.1 Order test in EPIC 6.2 SOFT registers test in LIS 6.3 EPIC sends a ntificatin t SOFT t cllect bispecimen 6.4 SOFT cllects bispecimen 6.5 If test is external, the fllwing steps ccur: 6.5a. ITMI ships bispecimen t vendr 6.5b. Vendr prcesses the bispecimen 6.5c. Vendr analyzes the bispecimen 6.5d. Vendr sends results t SOFT 6.5e. ITMI reviews and stres results 6.5f. SOFT reviews and stres results 6.5g. SOFT sends results t EPIC 6.5h. EPIC assciates results with MRN 6.5i. EPIC stres results 6.5j. EPIC recrds billing If the test is nt external, the wrkflw cntinues 6.6 ITMI prcesses bispecimen 6.7 ITMI cllects wrkflw data and tracks wrkflws 6.8 ITMI analyzes bispecimen 6.9 ITMI reviews and stres results 6.10 SOFT reviews and stres results 6.11 SOFT sends results t EPIC 6.12 EPIC assciates results with MRN 6.13 EPIC stres results 6.14 EPIC recrds billing Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 8 f 12
9 7.0 Exceptins Nne. 8.0 Includes Nne. 9.0 Special Requirements Nne Assumptins 1. The ITMI has implemented the Plavix Gentype Test. 2. The ITMI Plavix Gentype Test results are in electrnic frmat. 3. The ITMI Plavix Gentype Test results are encrypted pursuant t Cmmnwealth f Virginia standards. 4. The cllectin, management and transmittal f the ITMI Plavix Gentype Test results cmply with applicable law Pilt Prject Recmmendatin The findings frm this use case will be used t frame a pilt prject t test the prcess fr integrating pharmacgenmic test results int a patient s electrnic health recrd. The prpsed pilt prject has been dcumented in the white paper, HITSAC Genmics Wrking Grup Pilt Prject Recmmendatin: Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd. The purpse f the pilt prject will be t develp and implement a prcess t supprt integratin f pharmacgenmic test results int a patient s EHR t enhance quality f patient care References 1. XXXX. 2. XXXX. 3. XXXX. 4. XXXX. [ADDITIONAL INFORMATION FOR THIS SECTION WILL BE PROVIDED BY ITMI/Aarn Black] NOTE: FULL SET OF APPENDICES WILL BE ADDED IN PRODUCTION VERSION Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 9 f 12
10 Appendix D: Pharmacgenmic Test Result-EHR Integratin Transactin Wrkflw Diagram Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 10 f 12
11 Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 11 f 12
12 Prcess fr Integrating Results frm Pharmacgenmic Testing int an Electrnic Health Recrd v.1.0 Page 12 f 12
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