StartUp America Challenge. Improvements to Information Structure Data Standards, Quality & Interoperability. Part 3 FINAL PROJECT PLAN

Transcription

1 StartUp America Challenge Improvements to Information Structure Data Standards, Quality & Interoperability Part 3 FINAL PROJECT PLAN Lyndia A. Hayden Northwestern University MED 407, Winter 2012

2 StartUp America Challenge: Part 3 2 Scope In 2011, the Institute of Medicine published Health IT and Patient Safety: Building Safer Systems for Better Care. The report identified the information structure problem as a productive area that required further research and questioned how health IT can be used to create meaningful representations of clinical data and knowledge. Adhering to standards and maintaining systems that are interoperable will facilitate the use of meaningful clinical data on a national level. The Scope of this proposal will identify how improvements in information structure through the use of data standards with standard development organizations promotes consistency, quality and the key elements to interoperability among disparate systems. The Scope of this proposal is a conceptual design for an application that acts as a national data repository (NDR) for the various fields, acronyms and terminologies that are encountered in an electronic health record (EHR). The NDR is a web-based utility tool that is built on a Software as a Service (SaaS) platform. It performs data mining to align to existing data standards so that various healthcare organizations, such as regional health information organizations (RHIO), health information exchanges (HIE) and the national health information exchange (NHIN), can receive semantic data from hospitals, private medical practices, imaging centers and laboratories with minimal test errors. Below is a description of the 4-step process (Diagram 1): Step 1: The data is sent from the client facility (i.e. hospital, medical practice, image center, laboratories) through a choice of vendors who have proven track records of transferring protected health information (PHI) via a secured File Transfer Protocol (FTP). Two such vendors are Iron Key and FTP Worldwide.

3 StartUp America Challenge: Part 3 3 Step 2: The data is received from the FTP vendor in the NDR and identified for the specific facility. The extraction, transformation and loading (ETL) process occurs to prepare the data for analysis against the data warehouse. Step 3: The data warehouse stores the existing data standards, nomenclature and terminology that is used in the healthcare industry and will be used to exchange data with the RHIOs, HIE, and the NDHIN. Step 4: The data is mined and reports are generated to identify gaps where corrective actions are necessary to achieve interoperability. Diagram 1 The NDR stores the data in a warehouse that acts as a repository. The information in the warehouse is a collection of information received from the existing standards organizations that are widely used in the healthcare industry: American National Standards Institute (ANSI) - oversees the creation, promulgation and use of standards across sectors in the U.S.; member of ISO Health Level Seven (HL7) ANSI standard that is a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information

4 StartUp America Challenge: Part 3 4 Digital Imaging and Communications in Medicine (DICOM) standards that allows digital imaging technologies to interact seamlessly; managed by Medical Imaging & Technology Alliance International Health Terminology Standards Development Organization (IHTDO) - develops and promotes use of SNOMED CT, a clinical terminology and is considered to be the most comprehensive, multilingual healthcare terminology in the world. Integrating the Healthcare Enterprise (IHE) - promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical need in support of optimal patient care. National Drug Code (NDC) requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs for commercial distribution according to The Drug Listing Act of 1972; updated twice a month. Unified Medical Language System (UMLS) library by the U.S. National Library of Medicine that integrates and distributes key terminology, classification and coding standards Current Procedural Terminology (CPT4) medical nomenclature developed by the American Medical Association that is used to report medical procedures and services under public and private health insurance programs International Classification of Diseases (ICD9/ICD10) international standard diagnostic classification of diseases developed by the World Health Organization Logical Observation Identifiers Names and Codes (LOINC) - A universal code system for identifying laboratory and clinical observations Although the referenced standards organizations are widely used, instances will inevitably occur where the standards do not meet the needs of all facilities or the facilities preferred to use proprietary nomenclature and terminology. These instances create a risk that delays interoperability and further validates the purpose of the NDR to align the facilities with the standards.

5 StartUp America Challenge: Part 3 5 Objectives Breakdown Structure The transformation of healthcare depends on interoperability. When interoperability is commonplace, patients, clinicians, managers and researchers will enjoy secure access to the right information at the right time and at the right place, leading to better patient outcomes and fewer mistakes (T. Benson, 2010). IT applications should guide data acquisition in a way that data are placed in a meaningful context from the beginning, so that they are ready for reuse in different contexts without the need to manually index or transform the data (R. Lenz et al, 2005). The objective of the NDR is to facilitate interoperability by performing a service to collect key elements of health data for a client, compare the data to existing data standards, perform analysis and associations based on the standards, and produce a report for the client to take corrective action in order to achieve interoperability with other healthcare facilities. As an added value, the NDR can consult with the client to build the necessary resolution plans. The output from the NDR service, coupled with the benefit of exchanging the data with RHIOs, HIEs and the NHIN, will enable clinicians to focus on the value of the outcome and offer comprehensive treatment plans to the patients based on the collection of accurate, semantic data. The NDR concept aligns with the following benefits of interoperability outlined in a report by the Center for Information Technology Leadership (CITL, 2004): Interoperability between outpatient providers and independent laboratories improves clinical care by providing clinicians better access to longitudinal test results and eliminates errors associates with verbal reporting results. Interoperability between outpatient providers and radiology centers improves patient safety by alerting both the provider and the radiologist to test contraindications; improves coordination of care and reduces redundant tests.

6 StartUp America Challenge: Part 3 6 Interoperability between outpatient providers and pharmacies improves clinical care by enabling complete medication lists, thereby reducing duplicate therapy, drug interactions, other adverse drug events and medication abuse. Interoperability between providers reduces fragmentation of care and improves quality of the referral process by giving clinicians patient-specific information to provide effective consultations. Interoperability between providers and public health departments earlier recognition of disease outbreaks to facilitate biosurveillance, identification of warning signs and trends from multiple sources. Below is the work breakdown structure of the objectives in a high-level project plan for a medium physician practice, which averages 6 months. The projections are estimates based on collaborative efforts for all parties involved.

7 StartUp America Challenge: Part 3 7 Resource Requirements The timeframe of the project is dependent on the amount of data, the availability of the client s staff, the expectations of the client and the client s budget. Below are projected durations and costs if all parties are fully engaged and committed to following the project schedule. All projects are assigned to a Project Manager and Analyst. The number of Analysts assigned depends on the client s budget and timeline. It is advised that an IT staff member be dedicated to the project and that clinicians from their respective departments who are familiar with the systems and relevant data fields be available at least 25% of the time for the duration of the project. It is the client s responsibility to manage internal priorities that conflict with the project. The decision to use the services of NDR offers a cost-efficient solution that provides oversight and subject matter expertise, characteristics that the average healthcare organization does not have or cannot commit on a full-time basis. As a result, the coordination efforts would take significantly longer. The time and money saved factors into the overall operating expenses that impact healthcare costs.

8 StartUp America Challenge: Part 3 8 Risk Management The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, resulted in the Department of Health and Human Services announcing the final rule on Meaningful Use Stage 1 for Medicare and Medicaid on July 13, The focus of Stage 1 is to increase adoption and implementation of electronic health records by The focus of Stage 2 (rule not final yet) will be on patient accessibility to their healthcare record and electronic health information exchange between providers beginning in Interoperability is a critical component in Meaningful Use Stage 2. Although the timeline for Stage 2 is in two years, healthcare organizations must be vigilant in raising awareness because there are intricate and complex aspects to using standards and cross referencing terminologies across systems. Each healthcare organization should develop a compliance plan to minimize the risk of not meeting interoperability. The Compliance Plan should list the designated Compliance Officer, the Compliance Committee members, policies and procedures, communication guidelines, plans for training and education, rules for auditing and monitoring as well as disciplinary guidelines. The champions for the NDR project should be able to refer to the Compliance Plan, Compliance Officer and Compliance Committee members as an escalation point if internal project team members do not cooperate as expected to achieve the project goals.

9 StartUp America Challenge: Part 3 9 Ethical Guidance Transferring PHI data is processed through a variety of methods encryption, Virtual Private Network (VPN), Electronic Data Interchange (EDI) and FTP. Nonetheless, the NDR process through a third party may pose an ethical dilemma. Ethics in healthcare is an important topic because patient lives are at stake. The privacy aspect in PHI adds another layer of concern if the information is divulged to the wrong recipient(s). The recommended strategy is a Business Associate Agreement (BAA) with the NDR and FTP vendors. The Health Insurance Portability Act (HIPAA) has a boiler template BAA that vendors are familiar with since Legal Counsel for the healthcare facility should add additional language, where appropriate. In addition, the FTP password should follow the guidelines for a combination of mixed case letters, punctuation marks, symbols and numbers. Stakeholders Roles Stakeholders are the key individuals who are impacted by or as a result of key decisions. Each stakeholder has a specific role. In addition, Department Champions must be identified to support and assist in the implementation of the proposed solution. Meetings must be scheduled with representatives of each group to discuss the proposed solution and gain buy-in. Communication to the stakeholders is important. When stakeholders believe they are included in the decision-making process, the flow of information and the adoption rate is higher. In addition, if the correct stakeholders are involved in the process, it validates that issues and concerns have been raised and that impacts have or will be addressed accordingly. It is for this reason that two

10 StartUp America Challenge: Part 3 10 additional stakeholders have been added. The Beacon Community Cooperative Program (Beacon) and Strategic Health IT Advanced Research Project (SHARP) are grantees of the Office of the National Coordinator for HIT. Both of these programs are at the forefront of health IT and would be able to provide valuable feedback of the proposal and conceptual design. Below are a list of key stakeholders and the responsibilities: Stakeholder Obama Administration Office of the National Coordinator for HIT (ONC), U.S. Department of Health and Human Services Clinicians (i.e. Physicians, Nurses, Pharmacists) Vendors (i.e. EMR, Lab) IT Standards Development Organizations Insurance Companies Health Information Exchanges ONC Grantees - Beacon & SHARP Responsibility Approval of proposal, plan and key decisions. Co-Approvers of proposal, plan and key decisions. Coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. Work collaboratively with vendors, standards development organizations and insurance companies to define data acronyms and terminology. Provide software solutions that are interoperable based on defined acronyms and terminology. Build in clinical field associations based on standards. Configure and test HIT standards. Develop HIT standards. Work collaboratively with clinicians, vendors and insurance companies to mutually agree on definitions. Continuous resolution of gaps and overlaps in HIT standards. Define HIT data standards collaboratively with vendors, clinicians and standards development organizations. Collaboratively develop the network standards, services and policies. Provide feedback on proposal and conceptual design; provide test data for NDR process during pilot phase Evidence-based medicine depends on scientific data that is accurate and consistent. The NDR proposal advances the transition to a patient-centered, evidence-based health care environment through the promotion of standards, quality and interoperability. If the information structure is improved, the data is passing through internal and external systems in a consistent manner, thereby benefiting the patient and the clinician.

11 StartUp America Challenge: Part 3 11 References Benson, T. (2010). Principles of Health Interoperability, HL7 and SNOMED. Center for Information Technology Leadership (2004). The Value of Healthcare Information Exchange and Interoperability. Fenton, S., Giannangelo, K., Kallem, C., Scichilone, R. (February 2007). Data Standards, Data Quality, and Interoperability. Journal of AHIMA 78, no.2: Retrieved from bok1_ FTP Worldwide Secure FTP of PHI: Retrieved from Halamka, J. (2006). Harmonizing Healthcare Data Standards. HIMSS. Retrieved from Institute of Medicine (2011). Health IT and Patient Safety: Building Safer Systems for Better Care (Chapter 7). Board of Healthcare Services, Institute of Medicine, Washington, D.C.: National Academy Press. Iron Key Secure FTP of PHI: Retrieved from healthcare?ik_s=google&ik_t=paidsearch&ik_k=ftp%20hipaa&ik_v=hipaa- Text&ik_c=Healthcare_USA_Search&ik_ad=TRUE Lenz, R., Beyer, M., Kuhn, Klaus (December 2005). Semantic Integration in Healthcare Networks. International Journal of Medical Informatics 76 (2007) Patterson, Leigh-Ann, HIPAA Business Associates Agreements: Knowing When and How to Enter into Them. Nixon Peabody LLP. Retrieved from