Labs Over Direct: A Toolkit to Get Started

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1 Labs Over Direct: A Toolkit to Get Started April 10, 2013 Version P age

2 Table of Contents 1.0 Introduction Background on the State HIE Lab Summit and Pilot Program Meaningful Use Requirements Toolkit Overview Intended Audience Planning a Labs Over Direct Pilot Lab Pilot Planning Checklist Identify Pilot Partners Select a Pilot Scenario... 7 Scenario 1: Manual Unstructured... 7 Scenario 2: Partially Automated Unstructured... 7 Scenario 3: Automated Structured... 8 Scenario 4: Automated Structured Lab Results Interface (LRI) Lab Pilot Key Considerations Develop a User Story Populate the Pilot Canvas Operationalizing Pilots Overview Develop a Project Management Plan Plan Pilot Communications and Outreach Maintain Pilot Team Communications Marketing and Outreach Checklist Review Legal Checklist Vendor Management Checklist for the Implementation Guide for Delivery Notification in Direct Implementation and Testing Delivery Notification Test Scripts Pilot Evaluation and the Expansion of Services to Other Labs Summary of Lessons Learned From the Six Pilots P age

3 5.2 User Experience Documentation Expand Services to Other Labs Additional Resources Frequently Asked Questions Useful Links and Resources State HIE Lab Summit and Pilot Program Contact Information P age

4 1.0 Introduction 1.1 Background on the State HIE Lab Summit and Pilot Program In 2011, to address the concerns of the laboratory (lab) industry not moving to adopt Direct secure messaging (Direct) for reporting laboratory results and concerns regarding the impact of Direct on lab accreditation, ONC formed a workgroup including labs, accrediting agencies and Clinical Laboratory Improvement Amendments (CLIA) experts. The Direct Laboratory Reporting Workgroup members included ONC, LabCorp, Quest, Methodist Hospital, Pathology Inc., College of American Pathologists (CAP) and CLIA. The charge of the workgroup was to: Identify any regulatory and operational issues with Direct that prevent or limit adoption by clinical labs for transmitting the report of record to the final report destination Identify mitigation strategies for each of the issues For regulatory issues, work with ONC and CMS/CLIA to ensure that where appropriate, guidance is issued to accrediting agencies to enable the use of Direct for lab reporting As a next step, a subgroup of Direct Project s Implementation Geographies Workgroup was formed to develop an implementation guide detailing how to implement timely, predictable positive and negative acknowledgements of delivery within a Direct context. The Implementation Guide for Delivery Notification in Direct ( Delivery Notification IG ) is finalized and available on the Direct Project wiki. In May 2012, a small group of HIE leaders from Alaska, Florida, Guam, Hawaii, North Carolina and West Virginia met at the State HIE Lab Summit to leverage the work of the Direct Laboratory Reporting Workgroup to jump-start lab results reporting over Direct. The meeting format enabled state leaders and vendors to map out plans for delivering lab results to ambulatory providers leveraging Direct, as well as review the Delivery Notification IG with subject matter experts (SMEs). To date, Alaska and West Virginia have successfully tested their delivery notification functionality against the Direct Project Java Reference Implementation. These initial implementations serve as a catalyst for the wider scale deployment of Direct as a scalable, standardized and valuable means of HIE for lab transactions. 1.2 Meaningful Use Requirements In meaningful use stage 2 (MU2) and the 2014 edition of the certified electronic health record (EHR) technology (CEHRT) criteria, exchange and lab interoperability continue to be significant priorities. Based on certification and MU requirements: All providers will have Direct secure messaging functionality, with the ability to send and receive Direct messages Eligible providers and eligible hospitals will incorporate 55% of lab test results into their EHRs as structured data Eligible hospitals will send structured lab results to ambulatory providers (20% of electronic orders received) 4 Page

5 Direct secure messaging is a low-cost, secure, scalable, and standardized solution to help labs send test results to providers electronically where there are no existing point-to-point interfaces. Direct with the Delivery Notification IG is CLIA-compliant and can help labs stay competitive in an evolving marketplace. As such, the simple, cost-effective tools enabled through the Direct Project open standards and specifications are an appealing delivery mechanism for electronic lab results. 1.3 Toolkit Overview The toolkit is a how to guide, drawing from the experiences of the six lab pilots to help grantees better understand the key steps and sequences to get to production quickly and accelerate lab interoperability. The toolkit is broken down chronologically, from initiating pilot planning to evaluating lessons learned. We encourage you to use the templates, tools and resources in this toolkit which were developed primarily by the lab pilot teams and subject matter experts. 1.4 Intended Audience The toolkit and related resources have been developed to help HIE entities and labs lay the foundation for lab results reporting over Direct by starting with a pilot project to work to integrate Direct in lab workflow and lab systems, as well as address technical and legal questions. Starting with a pilot to work out kinks can enable a smoother transition to production, as well as expansion to other labs. 5 P age

6 2.0 Planning a Labs Over Direct Pilot 2.1 Lab Pilot Planning Checklist When initiating pilot planning there are a number of important steps that need to be taken to identify partners, define project goals and success criteria, select the appropriate scenario and flesh out a user story. It is estimated these activities, which are broken down further in the checklist, will take 1 to 2 months to complete. Lab Pilot Planning Checklist Identify pilot partners Laboratory Lab information system (LIS) vendor Health information services provider (HISP) vendor(s) EHR vendor Provider Other Convene partners and stakeholders to define goals, scenario, and user stories Initial work through pilot scenario options (see pg. 9) Develop user story (see pg. 11) Identify gaps and open questions Populate the pilot canvas (see pg. 12) Set tentative project timelines Confirm pilot team members and facilitate a pilot kick-off call Populate shared project management intranet or wiki with planning documents 2.2 Identify Pilot Partners Click here to access a copy of the Pilot Planning Checklist document. Work with key stakeholders and the Regional Extension Center (REC) to identify the right pilot partners as highlighted in the Lab Pilot Planning Checklist. We recommend targeting independent reference labs, hospital labs and ambulatory providers that do not have existing point-to-point interfaces. After the complete pilot team has been identified, maintain regular touch bases with all team members to ensure active participation and engagement in the project. See Section 3: Operationalizing Pilots for more details about communicating promising practices. 6 P age

7 2.3 Select a Pilot Scenario An initial work through of various architecture scenarios can help pilot partners understand the architecture options. The following four scenarios are intended as baseline use cases for describing lab results reporting using Direct. A variety of permutations of each scenario is possible based on technical, policy, and workflow considerations. Click here to access the Lab Results Reporting Scenarios with Direct. Scenario 1: Manual Unstructured In this first scenario, the lab end-user creates a Direct message and attaches a LIS-generated print image (i.e. PDF unstructured document) of the lab results in a desktop client or webmail portal. On the other side of the transaction, the provider end-user receives the Direct message with the PDF attachment in a desktop client or webmail portal and manually enters results into an EHR. Lab Edge Protocol SMTP w/ S/MIME or TLS HTTP w/ SSL/TLS HISP A Direct Backbone SMTP w/ S/MIME HISP B Edge Protocol SMTP w/ S/MIME or TLS HTTP w/ SSL/TLS Provider Scenario 2: Partially Automated Unstructured In this scenario, the LIS programmatically generates a print image (i.e. PDF unstructured document) of the results, creates a Direct message, attaches the results and sends to the HISP. On the other side of the transaction, the provider end-user receives the Direct message with the attached PDF document in a desktop client or webmail portal and manually enters results into an EHR. Lab Edge Protocol SMTP w/ S/MIME or TLS HISP A Direct Backbone SMTP w/ S/MIME HISP B Edge Protocol SMTP w/ S/MIME or TLS HTTP w/ SSL/TLS Provider 7 P age

8 Scenario 3: Automated Structured In the third scenario, the LIS programmatically generates a structured message (i.e. HL7) based on national standards and sends the message to the HISP. On the receiving end of the transaction, the ordering provider s EHR receives the message and stores structured data in the EHR. Lab Edge Protocol SMTP w/ S/MIME SOAP / XD HISP A Direct Backbone SMTP w/ S/MIME HISP B Edge Protocol SMTP w/ S/MIME SOAP / XD Provider Scenario 4: Automated Structured Lab Results Interface (LRI) In the fourth scenario, the LIS programmatically generates an LRI IG-compliant structured (i.e. HL7) message and sends to the HISP. On the other side of the transaction, the ordering provider s EHR receives an LRI-compliant message and automatically stores structured data in the EHR. Lab Edge Protocol SMTP w/ S/MIME SOAP / XD HISP A Direct Backbone SMTP w/ S/MIME HISP B Edge Protocol SMTP w/ S/MIME SOAP / XD Provider *Note: Edge protocols (e.g., SMTP, SOAP, HTTP, etc) are up to the discretion of the HISP and may come in many forms other than those listed in the scenarios. 2.4 Lab Pilot Key Considerations As your team is reviewing the architecture scenario options and identifies open gaps and questions, take into account the following key considerations: 8 P age

9 Technical Considerations Policy and Legal Considerations Workflow Considerations Business Considerations General Considerations Key Considerations Will the pilot pursue a single HISP or a multi-hisp model? What edge protocol(s) will be used? Will there be HIE involvement/ functionality (beyond Direct/HISP)? What message content standards, including the need for content translation/integration engine(s) (middleware), will be used? What are the state and federal requirements for CLIA compliance using Direct? Will the lab results be stored by the third-party HIE and/or reused for any purpose? If so, this may require additional contractual language. What agreements are required between pilot participants (i.e., Business Associate Agreement (BAA), Data Use Agreement (DUA), Service Level Agreement (SLA), etc.)? What are the workflow implications that technical and policy decisions have on lab, providers, HISP, accreditation status, other? What are the opportunities for workflow improvement? Does the selected model and design choice enable a viable long-term solution? Are there other general opportunities for improvement, questions or gap areas that need to be discussed? Office of the National Coordinator for HIT Pilot Team Responses *Tip: Your response should include a description of what data will be stored, how it will be stored, and why. Additionally, if patient consent is required please cover details of how consent will be established (data storage is not recommended for an initial pilot). *Tip: Access to PHI requires a BAA regardless of storage. *Tip: Your response should include a description of how your solution demonstrates sufficient scalability, provides acceptable return on investment (ROI) and meets the legal and regulatory requirements (if not, what needs to change). 2.5 Develop a User Story Click here to access a copy of the Key Considerations document. 9 P age

10 Work with your pilot team members to connect your lab pilot scenario with a real world user story that aligns with the everyday work of your pilot partners. Review your pilot scenario as you work to outline an appropriate user story. Examples of use cases may include, structured lab results delivery for a low-volume lab client, medical examiner s office or even a cc copy request by an ordering provider. Click here to access the User Story template and example. 2.5 Populate the Pilot Canvas Work with your pilot partners to populate the blank pilot canvas with your high-level project summary information, including major milestones, value proposition and open questions. 10 P age

11 West Virginia Key Partners Grantee team: WVHIN Lab representative: Grafton City Hospital Lab LIMS vendor(s): Orchard Software Practice or hospital representative: Grafton City Hospital, Preston Taylor Community Health Center, Premier Medical Group HISP vendor(s): Truven Health Analytics REC: WVRHITEC Key Milestones Orchard generates first PDF, creates a Direct message, attaches results and sends through WVDirect to Preston Taylor and Premier Medical. Preston Taylor and Premier Medical receive message through WVDirect web portal and manually re-enters information in to EHR or attaches PDF document. Key Resources Orchard technical team, Grafton City Hospital Lab, REC, technical support for Preston Taylor Community Health Center, Preston Taylor Operations Manager, Premier Medical Office Manager User Story Pilot Scenario Diagram Partially Automated, Unstructured Orchard programmatically generates pdf, creates Direct message, attaches message and sends to WVDirect.. Edge Protocol SMTP w/ S/MIME Scene 1: Patient visits Preston Taylor or Premier & lab tests are ordered from Grafton City Hospital using paper requisition form. Scene 2: Grafton receives paper order from the presenting patient, enters order into Orchard and includes WVDirect address as preferred result delivery method. Grafton completes tests and results are transmitted to Preston Taylor or Premier using WVDirect. Scene 3: Preston Taylor or Premier receives the results via WVDirect, manually enters info into EMR record or attaches PDF and triggers a notification to treating physician. Value Proposition Our goal is to support unconnected rural hospital labs to deliver structured lab results to ambulatory providers in their community as part of their clinical workflow. If EMR vendor is not available, value will still be seen on the lab delivery side. Legal Agreements WVDirect Subscription Agreement and BAA between WVHIN and Grafton City Hospital, and WVHIN and Preston Taylor Community Health Center and Premier Medical Group. Open Questions What will the CLIA requirements be to ensure Direct is compliant? What agreements are needed to ensure future participation in State HIE? How can EMR, LIS vendors be convinced to participate? How can providers in small communities find sufficient value to participate? Preston Taylor/Premier Medical receives Direct message w/ attached print image of results (e.g., PDF) in a webmail portal and manually re-enters results into EHR or attaches PDF. Grafton City Hospital Lab / Orchard WVDirect hosted by Truven Preston Taylor CHC/Premier Medical Group 8 Click here to access the blank pilot canvas and canvas examples. Team Name Major Milestones User Story Value Proposition Open Questions Pilot Partners Resources Legal Agreements Pilot Scenario Diagram P age

12 3.0 Operationalizing Pilots 3.1 Overview When transitioning a labs over Direct pilot from the planning stage to the testing and production stage, there are many steps that need to be taken to successfully operationalize it. In this section, we discuss the essential components of a functional project plan, legal considerations and the importance of communication to track progress. 3.2 Develop a Project Management Plan After collaborating with your pilot partners to identify high-level pilot objectives, the next step is to develop a clear project management plan that further details the scope, activities, resources, schedule, resources and risk analysis strategies. Clearly documenting this information before implementation will help to ensure accountability and transparency amongst pilot partners and stakeholders. Stage Planning Stage Completion Date Deliverables Assemble Pilot Team Define Scope / Objectives Insert Date Deliverable Completion Date Owner Status Notes Requirements Definition Deliverable Status Data Flow / Model(s) Complete Use Case Definition In Progress Insert Date Legal Agreements Late Design Lab(s) / LIM(s) HISP(s) Insert Date EHR(s) Build / Implement Lab(s) / LIM(s) HISP(s) Insert Date EHR(s) Integration / Testing / Acceptance Production / Metrics Lab-to-HISP HISP-to-Provider/EHR(s) End-to-End (Lab-to-Provider) Cross-Pilot Exchange Test End User Satisfaction Feedback Reporting on Usage / Volume Ongoing Recruit Additional Labs Recruit Additional Providers Click here to access a copy of the project management template. 12 P age

13 Click here to access a project management plan example from Alaska. Click here to access a project management plan example from West Virginia. 3.3 Plan Pilot Communications and Outreach Maintain Pilot Team Communications When completing the overall project plan, it is important to consider the various types of meetings needed to maintain engagement and communications with the pilot team members. Here are some suggested meeting types and the purpose of each. Description Attendees Frequency Duration Purpose Pilot Team Meeting Pilot Lead Check-ins SME Support Calls All pilot team members Bi-weekly 1-2 hours Review project management plan and progress reports from each actor Leverage SMEs to help troubleshoot issues, answer questions, and disseminate resources and strategies across all pilot participants Pilot leads Regularly minutes Quick touch base on progress and action items Identify questions and issues SME, specific team members As needed 30 minutes Leverage SMEs to provide targeted, 1:1 support for specific team members 13 P age

14 3.3.2 Marketing and Outreach Checklist Marketing and outreach tactics and strategies include all written, spoken, and electronic interaction with stakeholders and communities interested in participating in the pilot and/or enrolling for live services. Marketing and outreach activities are essential to your overall project plan. Consider using the following types of communications tools to share the goals and objectives, and progress updates on your pilot with all to all of your constituents. Click here for a marketing and outreach checklist document. Click here to access a state specific example of the Florida pilot team press release. 3.4 Review Legal Checklist Your pilot team will need to establish legal contracts, policies and procedures that support compliance with state and federal law. Certain triggers exist in any health care project involving patient information. The following list of questions will help you and your legal counsel evaluate the types of agreements, policies and procedure that need to be put in place before launching your labs over Direct pilot. For additional background, please find below an overview of the terminology, policies and agreement types most often required to deliver laboratory results from the performing laboratory to the final report destination using Direct. Use this primer to improve the understanding of the legal requirements 14 P age

15 associated with your pilot; however, please also recognize that this does not serve as legal advice, nor replace the counsel you should seek any time you enter into a legal contract. Click here to access the legal agreement definitions and checklist document. 3.5 Vendor Management A significant factor contributing to the success of a pilot is how well teams managed their vendor. Strong vendor management and oversight will help pilots mitigate risks during the period of performance. Click here to access the vendor management overview document. Click here to access a past Regional Meeting vendor management presentation. 15 P age

16 3.6 Checklist for the Implementation Guide for Delivery Notification in Direct In order to meet the requirements for Security/Trust Agent (STA)-to-STA exchange, a HISP/HIE must full support the specifications set forth in the Delivery Notification IG. Use the checklist below to ensure that all requirements are met. Click here to access the Checklist for Implementation Guide for Delivery Notification in Direct. 16 P age

17 4.0 Implementation and Testing 4.1 Delivery Notification Test Scripts Test scripts can be used to ensure that your implementation meets the requirements outlined in the Delivery Notification IG. The scripts each outline the situation description, prerequisites, steps, and expected results. This section describes seven detailed test cases for successful/positive and failed/negative notification delivery. There are other scenarios to consider, but these examples address the major use cases. Click here to access the complete set of delivery notification test scripts. 17 P age

18 5.0 Pilot Evaluation and the Expansion of Services to Other Labs 5.1 Summary of Lessons Learned From the Six Pilots As part of the State HIE Lab Summit and Pilot Program, we collected key takeaways and lessons learned from the six pilot teams, Alaska, Florida, Guam, Hawaii, North Carolina and West Virginia, which we have summarized below. We recommend using these lessons learned to help frame and guide your pilot efforts. Resource Allocations Ensure the allocation of resources from volunteers is adequate and builds momentum to keep the project a priority for the volunteers. Pilot Project Scope of Work Ensure that the scope of the efforts is within your existing contracting requirements. Project Management Principles Set firm deadlines and try to resist participant efforts to reschedule HIE work based on other internal priorities. Ensure that all required modifications to existing infrastructure and systems are identified early on so that no details due to procurement from third parties delays the project. This is difficult in projects establishing new ground, but it is essential to understand the existing capabilities and the path for reaching the endpoint. 5.2 User Experience Documentation Below we have included a document containing evaluation questions developed by the six pilot teams to assess pilot participant experience and iron out any kinks with the pilot testing prior to widespread rollout of these services. 18 P age

19 Click here to access the sample User Experience survey. 5.3 Expand Services to Other Labs Now that the pilot team has ironed out kinks and the project is in production, the next step is to expand the service offering to other labs. Consider leveraging the lab(s) and ambulatory provider(s) that participated in the pilot as champions to talk to their peers about the labs over Direct use case. Consider opportunities for lab orders through Direct, leveraging the work of the Standards & Interoperability (S&I) Framework. 19 P age

20 6.0 Additional Resources 6.1 Frequently Asked Questions Why should I start a labs Over Direct pilot? The delivery of lab results over Direct is fast, simple, secure, and cost-effective. As Direct is integrated into a greater number of EHRs for Stage 2 Meaningful Use, labs will be able to send results directly to a physician s EHR, saving time and resources. The use of Direct for labs is a secure, scalable, standardized and valuable means of health information exchange. What is CLIA, and what impact does it have on lab results delivery? The Clinical Laboratory Improvement Amendments were passed by Congress in These amendments established quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. There are currently over 225,000 labs registered with CLIA. The Division of Laboratory Services (DLS) is responsible for implementing the CLIA program. New York and Washington are the only two states exempt from CLIA as their regulations meet or exceed CLIA. To ensure that Direct was a viable option for CLIA certified labs, ONC formed a workgroup including labs, accrediting agencies, and CLIA. This group was tasked with identifying any regulatory or operational issues with Direct that would inhibit CLIA compliance. From there, the workgroup developed mitigation strategies and established guidance around the implementation of Direct for lab results delivery. What guidance is available on this subject? The Direct Project s Implementation Geographies Workgroup formed the Lab Reporting Over Direct subgroup to develop the Delivery Notification IG. This guide explains how to implement the necessary notifications within Direct. The guide also details how to request destination delivery notifications, what constitutes a delivery success or failed notification, and the responsibilities of each HISP during the exchange. What is delivery notification and why does it need to be implemented? Delivery notification in Direct is a method used by Security/Trust Agents (STA) to provide a high-level of assurance that a message has arrived at its destination. The delivery notification is needed because the delivery of lab results over Direct initially presented a risk because reliability and timeliness needed to be confirmed in order for labs to be CLIA-compliant. The guidance issued by the workgroup stated that STAs that receive a Direct message must acknowledge successful receipt and trust verification of a 20 P age

21 Direct message by sending a delivery notification with a processed disposition. The delivery notification ensures that the CLIA criteria are met and that the labs can remain CLIA-compliant. When is delivery notification applicable? Delivery notification is applicable in both single and multi-hisp environments. When more than one HISP is involved, delivery notification is critical since the sending HISP cannot always determine when delivery to the destination (via the receiving HISP) has succeeded or failed. However, even in a single HISP environment (when the sending and receiving parties use the same HISP or STA), the Implementation Guide states that the HISP or STA "SHALL notify or indicate back to the sender successful or failed delivery to the destination," and that the sender's HISP or STA "SHALL notify the sender of the successful or failed delivery of the original Direct message by delivering a positive or negative delivery notification message as defined in the Implementation Guide." Are there any potential security issues related to delivery notification? Delivery notification messages are only supposed to be sent after security and trust have been verified, and are themselves Direct secure messages. What is the difference between Delivery Notification and MDN? Always cite the Direct Delivery Notification IG and not just the message disposition notification (MDN). The MDN is part of the delivery notification implementation guide specification which also defines how to request an MDN, what events it should be used to report (e.g. success and failure of delivery to the edge system or mailbox) and what to do if the MDN (or the DSN) is not returned to the sending HISP/STA. Implementation of MDN alone, without implementing the full set of requirements in the Delivery Notification IG, does not meet the CLIA delivery requirements for lab results. What is the actual definition of delivered to final destination? Where the Delivering Notification IG is concerned, successful persistence into the recipient's mailbox would constitute successful delivery, and hence the generation of a positive delivery notification (i.e., dispatched MDN). Why should I use a MOU? The objective of the memorandum of understanding (MOU) is to define the responsibilities of the participants and in what situations the data can be used. This goes above and beyond BAA language. Does CLIA support Direct secure messaging as a transport for electronic reporting of laboratory results? CLIA s position is that Direct with the Delivery Notification IG for reporting lab results aligns with regulations and requirements. 21 P age

22 6.2 Useful Links and Resources Lab Interoperability Health Information Technology Research Center (HITRC) Page: Delivery Notification IG: +v1.0.pdf Direct CoP Use Case Repository: Direct Project: Direct Project Java Reference Implementation: and CSharp (.NET) Reference Implementation: 6.3 State HIE Lab Summit and Pilot Program Contact Information State HIE Lab Summit and Pilot Program participants and contact information for the team leads is included in the table below. Alaska Team Lead: Paul Cartland, Alaska Department of Health and Social Services Anchorage Neighborhood Health Clinic Fairbanks Memorial Hospital Alaska State Public Health Laboratories Orion Health Chemware Cognosante Providence Alaska Medical Center Florida Team Lead: Walt Culbertson, Agency for Health Care Administration Care360 Hawaii Team Lead: Greg Suenaga, Hawaii Health Information Exchange Clinical Laboratories of Hawaii, LLP Hawaii Beacon North Provider Medicity Wellogic North Carolina Team Lead: Keith Scott, North Carolina Health Information Exchange Orion Health 22 Page

23 IOS Health Systems Harris Corporation MedPlus, Inc. Quest Diagnostics Florida Health Management Associates Guam Team Lead: Ed Cruz, Office of the Governor of Guam Provider Diagnostic Laboratory Services ApeniMED Medicity Atlas Office of the National Coordinator for HIT Solstas Labs West Virginia Team Lead: Kathy Moore, West Virginia Health Information Network West Virginia Premier Medical Group West Virginia Preston Taylor Community Health Center Grafton City Hospital Orchard Software Corporation Truven Health Analytics (formerly Thomson Reuters) 23 P age

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