Building Blocks: Newborn Screening Health IT Implementation Guide and Toolkit

Section 5: Tools Reference Guide

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Summary

This section collects all the tools mentioned throughout the Building Blocks Guide and Toolkit. For each, we provide a description of the tool and an explanation of when to introduce and apply the tool. Where applicable, we offer publicly available templates and examples that the laboratory can use as a basis for its own project artifacts. The Building Blocks team has also developed certain resources, including an implementation workbook, a mapping document, and an example message, to help laboratories implement NBS data exchange; the list below identifies these resources and how to access them. In addition, several laboratories have graciously permitted us to reference examples of tools that they have developed internally.

CDC Unified Process

CDC created a framework and methodology known as the Unified Process to urge project managers to use best practices in the design and execution of their projects.[1] The templates, tools, and other resources that make up the framework enable project managers to adopt practices and processes that comply with good project management methodology and with Federal regulations and policies, including the Enterprise Performance Life Cycle (EPLC) framework. (Health and Human Services utilizes the EPLC in all its projects.)

CDC designed the UP framework specifically with informatics projects in mind, and the mission of the CDC in many respects mirrors that of Public Health Agencies and Laboratories. Therefore, while project management templates are available from many sources, the Building Blocks Toolkit provides multiple examples from the CDC UP.

None of the recommended tools or templates in this Section should be considered constrictive or authoritative. Often the laboratory will have a set of project management or other documents that should be used. The use of standard, consistent tools increases the efficiency and effectiveness of project management processes. The source of these artifacts is the decision of the project team, the laboratory and its partners.


[1] For more on the CDC Unified Process, visit https://www2.cdc.gov/cdcup/.

APHL Informatics Self-Assessment Toolkit

Description

The APHL Informatics Self-Assessment (SA) Toolkit is a web-based tool that the laboratory can use to assess its informatics maturity across 19 capability areas. Users can compare their laboratory’s capabilities to that of other, similar laboratories and to the national average. The laboratory can use the SA Tool to identify gaps in current informatics capabilities, which may help to determine the laboratory’s readiness to engage in a large-scale data exchange implementation project. The Tool also allows the laboratory to compare its capabilities over time to demonstrate the impact of development projects.

More Information:

APHL has published the Self-Assessment as both a pdf document and as a web-based tool. The web-based version lets registered users save their work and compare previous assessments; it also features robust visualization tools. Email informatics.support@aphl.org to set up an account.

Newborn Screening IT Systems Architectural Diagram

Description

The architectural diagram is a visual representation of the IT systems and infrastructure that will contribute to the technical solution. It depicts the process that the laboratory will use to receive, process, and deliver the message to the LIMS. The design should indicate the transport method and connection point, the integration engine and/or LIMS, and any other systems involved.

More Information:

See 1C: Identify a Health Data Exchange Technical Solution for a Sample technical architecture diagram.

Baby Steps Toward Defining the Message

Description

This document is a companion to Section 1D of the Building Blocks Guide. It describes the steps required for HL7 message definition and provides additional information on the tools and topics discussed in the Guide, including the Implementation Workbook and the Message Validation Template.

More Information:

The Building Blocks team developed the Baby Steps document as a companion to Section 1D of the Guide:https://www.newsteps.org/resources/baby-steps-toward-defining-hl7-message

Business Case

Description

A business case summarizes the justification for starting a new project. It defines the problem that the project is attempting to address and explains the proposed solution. The business case may include a basic cost benefit analysis; it may also review the pros and cons of alternative solutions. The business case is often the first project artifact to articulate and document the objectives of a project, and project sponsors may use the business case to authorize the initiative, or at a minimum to green light additional project planning.

More Information:

The CDC UP framework provides a useful template for creating a business case: https://www.newsteps.org/resources/cdc-business-case-template 

Change Management Tools

Description

Change management is a discipline that prepares organizations to adopt change. By equipping individuals and teams with the tools needed to be successful, organizational change management increases the success of projects. To successfully implement a project on the scale of electronic messaging, change needs to take place at the level of the individual employee, the organization, and the entire enterprise. Furthermore, these changes need to be managed carefully to maintain employee morale and adoption of the required changes.

More Information:

Multiple publicly available tools exist to help organizations with planning and executing successful change management. MITRE, a non-profit organization, has published an article on its website that offers a useful and informative introduction to change management:

https://www.mitre.org/publications/systems-engineering-guide/enterprise-engineering/transformation-planning-and-organizational-change

Communication Plan

Description

Managing many stakeholders can be complicated. A communication plan documents how and when the project team will reach out to different stakeholders, as well as whose responsibility it is to do the communicating. The Communication Plan may be included as part of the project management plan.

The project team should consider developing a communication plan concomitantly with the Stakeholder Matrix during the early planning stages. The team will refer to the Communication Plan continuously throughout the project lifecycle. The project manager may need to update the Communication Plan as stakeholders change and depending on the particular organizational structure of hospitals that are engaged.

More Information

The CDC UP framework provides a useful template for creating a change management plan. https://www.newsteps.org/resources/cdc-change-management-plan-template

Data Use Sharing and Reciprocal Support Agreement (DURSA)

Description

The Data Use and Reciprocal Support Agreement, a document developed by the NHIN Cooperative DURSA Workgroup in 2009, is a specific agreement signed by every participating National Health Information Network (NHIN). The DURSA can serve as a potential model for any multiparty trust agreement. The agreement lays out the responsibilities and expectations of each participant. Among other stipulations, the DURSA points out that all participants are Covered Entities as defined by HIPAA or Business Associates of Covered Entities, and are therefore protected by and must comply with HIPAA privacy rules. It stipulates that the data can only be used for specified purposes, and that each participant is responsible for maintaining a secure environment, and for obtaining necessary equipment and software. A DURSA may alleviate some of the concern that the laboratory or the hospital may feel about sharing data with external entities. In general, a DURSA documents the details of a data-sharing  relationship more thoroughly and more rigidly than a MOU.

More Information

In 2009, the National Health Information Network (NHIN) IT released a draft DURSA that would govern the exchange of health data on the NHIN. To access the draft: https://www.newsteps.org/resources/nhin-data-use-and-reciprocal-support-agreement-dursa

Example Budget

Description

It may be necessary during the initial planning phases for the laboratory to estimate the costs of the proposed implementation project. In many cases, it is extremely difficult to accurate calculate the true budget of the project because all of the costs may not be known at the outset. Moreover, the expenses associated with staff time, IT services, software, licensing, HIE connectivity, consultants, developers, etc., will differ for every laboratory. For some laboratories, the effective cost for certain services will be $0. Despite the inherent challenges, the Virginia DCLS has shared an example budget for the Virginia NBS implementation project that offers estimates of the time required from both the Division’s IT and laboratory teams.

More Information

The Virginia DCLS provided an example budget: https://www.newsteps.org/resources/virginia-example-budget-data-exchange-implementation

Example Message

Description

While each jurisdiction will create a unique HL7 profile for NBS messaging, it may be helpful for laboratories to review an example order and result message. The Building Blocks team has therefore developed an example of each type of message and populated the Message Validation Feedback Template to serve as a guide.

More Information

LOI Example Message: https://www.newsteps.org/resources/hl7-laboratory-order-result-interface-loi-lri-example-message-and-feedback-template

LRI Example Message: https://www.newsteps.org/resources/hl7-laboratory-order-result-interface-loi-lri-example-message-and-feedback-template

Populated LOI Message Validation Feedback Template: https://www.newsteps.org/resources/hl7-laboratory-order-result-interface-loi-lri-example-message-and-feedback-template

Populated LRI Message Validation Feedback Template: https://www.newsteps.org/resources/hl7-laboratory-order-result-interface-loi-lri-example-message-and-feedback-template

HL7 Validation Tool

Description

The National Institute of Standards and Technology (NIST) hosts several tools and utilities to support HL7 messaging. The laboratory and its testing partners can use the NIST Validation Tool to validate test messages against the HL7 V2 Lab Results Interface (LRI) Guide, Release 1 or Release 2. As of April 2017, the Lab Orders Interface (LOI) Guide had not yet been added to the NIST Validation Tool. Note that the NIST Tool validates messages against the general LRI Guide and does not test the conformance of newborn screening messages specifically.

More Information

The NIST HL7 V2 Resource Portal is available at http://hl7v2tools.nist.gov

Hospital Contacts Template

Description

A project roles template identifies the individuals who will perform each required role on the project. The same individual may perform several roles. The project manager may request that each hospital complete this template so that the team has a clear understanding of who is responsible for specific elements of the project.

More Information

The Building Blocks team developed a Hospital Contacts Template: https://www.newsteps.org/resources/data-exchange-hospital-contacts-template

IHE Quality Research and Public Health (QRPH) White Paper: Newborn Screening White Paper

Description

The Integrating the Healthcare Enterprise (IHE) QRPH White Paper presents use cases that describe the processes, personnel, and events involved in NBS activities throughout a workflow. It advocates for increased integration and electronic communication across the systems and agencies involved in NBS (e.g., EHRs, LIMS, and surveillance systems). It describes NBS workflows in US Public Health, as well as in France, Germany, and Austria.

More Information

The IHE QRPH White Paper: https://www.newsteps.org/resources/ihe-quality-research-and-public-health-qrph-white-paper-newborn-screening

Implementation Guides (LOI & LRI)

Description

The Laboratory Order Interface (LOI) and Laboratory Results Interface (LRI) are HL7 Implementation Guides for creating a HL7 Version 2.5.1 OML^O21 message for laboratory test orders and results, respectively. HL7 Workgroups have created cohesive LRI and LRI Guides specific to the NBS reporting requirements. As of August 2017, these draft profiles are being balloted, with final publication anticipated in late August or early September. These profiles will be of significant value to laboratories that are implementing NBS orders and results.

More Information

The ballot versions of both Guides are on the HL7 ballot web site. Note that you will need to create a free HL7 account to download these documents.

Implementation Profile

Description

An Implementation Profile is a specification that further constrains the HL7 Implementation Guide based on the requirements of your system interface. The laboratory’s IT staff and its messaging partners will need this profile to properly implement the data exchange and to generate a HL7 message that is structurally and syntactically valid. The Implementation Profile should present clear, precise requirements for data format and semantics. The Profile will serve as the gold standard against which the content and structure of test cases are validated.

More Information

The Wisconsin Public Health Laboratory has provided an example implementation profile:

Implementation Workbooks (LOI and LRI)

Description

This template merges information from the various sources that define the message format and associated standard codes. It serves as the worksheet to perform gap analysis (existing data vs. requested data) and map to the local data elements. It also serves as the underlying structure for the integration engine, provides mapping from local to standardized data elements, and links to the bound value set for vocabulary validation.

More Information

Building Blocks developed an Implementation Workbook for the LOI order message and the LRI result message: https://www.newsteps.org/resources/hl7-loi-and-lri-implementation-workbooks

Hospital Informational Package

Description

The laboratory will need a package of information to distribute to hospitals to help them understand the project and implement NBS electronic data exchange. This package should contain 1) material that introduces them to the project at a high, non-technical level; 2) partnership documents, such as a data use agreement or a memorandum of understanding (MOU), to formalize the relationship between the hospital and the laboratory, and 3) technical information about how to create and validate the messages, cut over to production, and discontinue the legacy feed(s).

More Information

The Virginia DCLS developed a comprehensive guide for its hospital partners and has posted it to the agency website for easy access: https://dgs.virginia.gov/division-of-consolidated-laboratory-services/resources/nbs-data-exchange/

Mapping Workbooks

Description

In most instances, both the sender and the receiver will need to map standard codes that are used in the HL7 message to local codes used by the native system (i.e., the EHR or LIMS). A mapping workbook that lists out all the required and optional data elements in the message will facilitate the review and collection of this information. The technical team will then be able to use the mapping workbook to populate lookup tables and update system code as necessary to generate the message.

More Information

Building Blocks developed a Mapping Workbook for the LOI order message and the LRI result message: https://www.newsteps.org/resources/hl7-loi-and-lri-standard-codes-mapping-workbooks

Memorandum of Understanding (MOU)

Description

A MOU establishes a partnership between two or more entities. While it is not legally binding, a MOU, it is stronger than an unwritten, so-called “gentleman’s agreement.” Its intention is to confirm that all parties have a common understanding of the terms of the partnership. The laboratory may choose to execute a MOU with its data exchange partners or other stakeholders.

More Information

The CDC UP framework provides a useful template for creating a memorandum of understanding between two or more parties: https://www.newsteps.org/resources/cdc-memorandum-understanding-mou-template

Message Flow Diagram

Description

A message flow diagram is a visual representation of the how the message will travel from the sender’s systems to the receiver’s systems. In this case, it may depict the flow of the message as it is received by and processed by the laboratory’s messaging engine and is then delivered to the LIMS.

It is important to create a message flow diagram early in the planning process so that all stakeholders understand the process that is being considered, and IT leaders can explain the level of effort involved in setting up the data exchange process. Technical architects will rely on and modify the message flow diagram as they implement the technical solution. The project manager may also use the diagram while in planning and discussion with external partners, including HIE and hospital leadership.

More Information

The Michigan and Wisconsin Public Health Laboratories have provided examples of Message Flow Diagrams.

MI example: 

WI example: 

Message Validation Feedback Template

Description

This template documents suggested system updates that would address issues encountered during validation. This template will assist in tracking the issue and resolution or business decision that has been taken because of the issue.

More Information

The Building Blocks team developed a Message Validation Feedback Template: https://www.newsteps.org/resources/hl7-message-validation-feedback-template

Message Validation Template

Description

Testers can use these templates during validation to compare the expected value for each data element against the actual content of the message. The LOI and LRI templates are populated with data for the Virginia DCLS order and result message in order to demonstrate how laboratories can utilize this tool. It is expected that the laboratory will replace this data to reflect its own message values.

More Information

The Building Blocks team developed a Message Validation Template for the LOI order message and the LRI result message. As further guidance, the Building Blocks team has populated a copy of each template with an example message: https://www.newsteps.org/resources/hl7-message-validation-template

Newborn Screening Coding and Terminology Guide

Description

The National Library of Medicine (NLM) has defined codes specifically for Newborn screening test panels. Users can peruse or download tables of the codes and value standards that are relevant for recording and transmitting the newborn tests and the conditions for which they screen. This Guide is a valuable resource for the Vocab SMEs at both the laboratory and hospital as they map local to standard codes for the NBS order and result messages.

More Information

The LOINC Panel for NBS is available through the NLM website: https://newbornscreeningcodes.nlm.nih.gov.

Partner Assessment

Description

Early in the engagement, the laboratory will need to assess whether the hospital hospital’s systems and setup possesses the minimum technical capabilities to implement this data exchange. The assessment should inquire about any upcoming large-scale upgrades or releases that may affect the proposed timeline. If applicable, the assessment should ask if the hospital is prepared to work with a third-party vendor. The assessment is also an opportunity for the laboratory to gauge the hospital’s overall commitment and interest, collect information about the hospital’s EHR, understand, IT structure and process, and identify important points of contact. The laboratory may require the hospital complete and return the assessment, or the laboratory may choose to use the assessment as a script to guide the initial call with the hospital.

More Information

The Building Blocks team developed a partner assessment tool that laboratories can modify:

PHII Communications Toolkit

The Public Health Informatics Institute (PHII) recently released the PHII Communications Toolkit, which provides recommendations for how to present and discuss informatics concepts to non-technical audiences. The project team may consider incorporating some of these communication strategies in the discussions with stakeholders.

The full text of the PHII report and toolkit are available at http://phii.org/informatics-communication-toolkit/introduction.

Project Charter

Description

The project charter provides a high-level overview of the entire project. It states the objectives of the project, the justification or business need, timeline and resources required, and the critical success factors. In many ways, the project charter builds on the business case. The charter is often one of the first artifacts that the project team drafts and may be used to confirm that stakeholders understand and commit to the project.

More Information

The CDC UP framework provides a useful template for creating a project charter: https://www.newsteps.org/resources/cdc-project-charter-template

Project Management Plan

Description

The Project Management (PM) Plan is a document (or set of documents) that helps the team guide the project through its lifecycle, from planning through execution and close-out. It details the project objectives, scope and schedule, and documents the intended approach to managing various elements of the project. By clearly outlining the process for tracking milestones, mitigating risks, or approving changes, the PM Plan instills a formal management approach to project activities.

More Information

The CDC UP framework provides a useful template for creating both a project management plan and a project management plan “lite” for short time, straight forward initiatives: https://www.newsteps.org/resources/cdc-project-management-templates

Project Schedule

Description

The project schedule documents the planned timeline of milestones and activities. The schedule may be based on target milestone dates, individualized tasks, or the anticipated completion date of specific project deliverables. Typically, the project schedule includes start and end dates and identifies dependencies. For example, the team cannot start Task 2 until Task 1 has been completed. The project manager can choose to display a schedule in a variety of visual formats, such as a table, a timeline, a calendar, or a Gantt chart.

A project schedule is an essential tool to think through the activities that need to be completed (and in what order) to accomplish the goals of the project. In addition, the schedule can incorporate external factors, such as vacations, holidays or system upgrades that may affect the overall project timeline. Moreover, the project team will be able to assess the impact of delays on the project by revising dates in the schedule. It is highly recommended that the project team put together a project schedule early in the planning process and update it continually over the course of the project.

More Information

The CDC UP framework provides useful templates for creating a project schedule: https://www.newsteps.org/resources/cdc-project-schedule-templates

Risk Management Plan

Description

Every project is subject to uncertainty. The risk management plan itemizes known factors that may have a positive or negative impact on the project. It estimates the likelihood of the risk occurring, as well as the impact it may have on the project. While some risks are beyond the control of the project team, the risk management plan lays out a strategy for managing these risks and mitigating their impact. The risk management plan often presents this information in a tabular format; it generally forms a part of the project management plan.

More Information

Many simple risk management templates exist. Most can be adapted for a project regardless of the project’s focus area. For example, a 2014 conference presentation on electric furnace rebuilding presents a useful and free example of a risk management plan: https://soroakoaace2014.wordpress.com/.

Requirements Documents

Description

Careful and clear documentation of the requirements needed to implement electronic messaging is vital. The requirements define what is needed to the work of the electronic messaging. These requirements can help prioritize the work to be done and can be referenced in the scope of work of a contractor or vendor.

The requirements should define the “what” not the “how” of the system updates, and should be actionable by the system developer.

More Information

A 2006 article in Scientific Computing, an online computer technology magazine, provides a useful overview of how to define system requirements: https://www.newsteps.org/resources/effectively-defining-lims-system-requirements

The Public Health Informatics Institute (PHII) has also published an article on documenting requirements: https://www.newsteps.org/resources/phii-defining-and-validating-system-requirements-guide

Smart HL7 Viewer

Description

SmartHL7 is a "brand" for a set of HL7 tools developed by a software design programmer in Australia. The tools are designed for those working with HL7 standard and protocol. The Message Viewer is a tool for casual inspection of HL7 messages. (NOTE: Developer does not claim the tool to be standard-compliant.)

More Information

The SmartHL7 viewer is a non-commercial tool that can be downloaded according to the terms and conditions outlined on the website. To learn more visit: http://smarthl7.com/tools.html

Stakeholder Matrix

Description

A stakeholder matrix is a tool that allows the project manager to classify the people involved in a project. Typically, this information is presented in a tabular format that maps stakeholders to the amount of influence and impact each has over the project and lays out the strategy for engaging them. The stakeholder matrix facilitates and documents the stakeholder analysis that occurs early in the project planning phase, and should be updated regularly throughout the project lifecycle.

More Information

The CDC UP framework provides a useful template for performing a stakeholder analysis: https://www.newsteps.org/resources/cdc-stakeholder-analysis-template

Test Plan

Description

Creating a test plan is essential to ensuring that system changes are properly tested. By planning out the testing phase, the team can provide the resources and time needed to test and document system functionality before the system is put into production.

More Information

The Office of the National Coordinator (ONC) has posted a testing plan template to the healthit.gov website that can be used for any health IT system testing activities: https://www.newsteps.org/resources/ehr-system-testing-plan

Value Set Companion Guide

Description

This document, distributed by HL7, defines detailed value sets for each field of the LOI and LRI Implementation Guides where a coded value is required. These values are expected to apply to the message profile unless the laboratory has specifically decided and documented otherwise. The values in this Companion Guide, paired with the codes in the LOINC Panel for NBS, will provide the laboratory with standard codes for the majority of concepts relevant for NBS orders and results.

More Information

The Value Set Companion Guide is available for download on the HL7 website: https://www.newsteps.org/resources/hl7-laboratory-order-result-interface-loi-lri-implementation-guides-may-2018

Workflow Assessment Tools

Description

Workflow assessments provide the basis for determining what changes will need to take place to accommodate the change in process. Documenting an “as-is” and “to-be” workflow shows the existing and future processes and can be used to demonstrate the tasks needed to achieve the new workflow.

More Information

The Public Health Informatics Institute (PHII) has developed a diverse toolkit to assist with setting up an EHR-based surveillance program; the toolkit includes tools to understand and accomplish workflow. To access the toolkit, visit: http://www.phii.org/ehrtoolkit.

Resources in Section 5: Tools Reference Guide