How to Develop an Interface Gap Analysis Document

Tip 10 in the Interoperability Tip Series

In the previous tip, we covered specifications. Another key requirements or scoping document you’ll need is a gap analysis. In this tip, we discuss how to develop an interface gap analysis document.

Many analysts develop their own gap analysis templates in Microsoft Word or Excel. To fill in templates, they look at messages, run queries when they can, and manually document their findings. This can be a fairly onerous process if they’re basing the analysis on real-world messages (as opposed to doing a simple vendor spec walk-through). Another option is to take advantage of software that automates the gap analysis process.

Whatever your approach, you want answers to the following questions so you can identify gaps related to messages:

  1. Does the destination system handle all of the message types from the sending system?
  2. Are there any differences between the message structures in each system?  If so, what are they?
  3. Are there any mandatory data elements on one side that are optional on the other?  If so, what are they?
  4. Do both systems use the same code sets? Are they the same values?  Which values do I need to map?
  5. Do both systems specify the same maximum length of characters for data fields?
  6. What z-segments are in use?
  7. Is the data semantically consistent? In other words, does the meaning or significance of an element always match across both systems?
  8. What are the requirements for encryption or de-identification, usage restrictions, and HIPAA compliance related to confidential information?

 
In the next tip, we’ll explain why you need a gap analysis.

Download the HL7 Survival Guide

Download the HL7 Survival Guide

How to Develop an HL7 Interface Specification

Tip 9 in the Interoperability Tip Series

how-to-develop-hl7-interface-specificationIn Tip 8, we explained what an HL7 interface specification should include. In this tip, learn how to develop an HL7 interface specification, which you’ll need for each interface you develop.

(A quick note about terms. There is no standard term for a spec. Some people call them a profile, conformance profile, schema. We use the term profile or HL7 profile in our software. We use the terms specification, conformance profile, and profile interchangeably in the tip series.)

To build a specification, you have several options.

Messaging Workbench available via HL7 International (look for a file name that includes “MWB release”) is open-source software designed to build conformance profiles. But keep in mind, with Messaging Workbench you need to build out individual profiles for each message type. If you define 10 message types for an interface, you’ll be building 10 separate profiles. You’ll also have to read through messages to get the information you need.

You can also develop templates in Excel or Word and then populate them manually. Or you can take advantage of functionality in Caristix software that automatically creates profiles from HL7 messages. In our world, a profile corresponds to the spec for a source or destination system, with however many message types you need.

Regardless of how you develop a profile, you need to do it. The problem is that there’s no industry-standard template available. That’s why we’ve developed this HL7 profile template kit and made it available to you for download. With it, you can avoid the time and effort to set one up, and make sure you clearly and concisely communicate what your integration environment expects in terms of data exchange. Feel free to download the template and tweak it to suit your needs.

[caristixbtn style=”orange” text=”Download The Kit” url=”https://hl7-offers.caristix.com/hl7-profile-kit/” blank=”1″]

Why Leaders Should Require Project-Specific Interface Specifications

  • Profiles or specs gets analysts, developers, internal customers, vendors, and consultants on the same page.
  • Populating a profile identifies risks before interface development.
  • A profile also serves as a list of requirements.
  • Develop an accurate list, and your team eliminates time spent on coding, testing, and on trial and error during go-live.
  • A profile makes it possible to easily generate your gap analysis report as well as test and validation plan.

The Dangers of a Missing HL7 Interface Specification

Without an interface spec outlining your requirements, you’ll be stuck implementing a generic interface.

Let’s say you work for a health system. If your organization is like most, your clinical resources are already stretched thin – and the last thing you can afford is to dedicate those resources to testing. But that’s what you’ll find yourself doing if you go with a generic spec. After all, your interface will likely be buggy when it goes live because your true requirements weren’t gathered up-front. As a result, you’ll find yourself bogged down with extensive troubleshooting after go-live, especially when you run into issues with clinical workflows because the interface doesn’t work as expected and clinicians report a lack of data, orders, lab results, and/or medication as a result.

On the vendor side, you don’t want to be putting your clients through this. They’ll turn to other organizations that can eliminate this pain.

Download the HL7 Survival Guide

Download the HL7 Survival Guide

Resources for CDA, CCD, and Consolidated CDA Documents

In our discussions with vendors and providers on these new standards, we’ve seen a wide range of learning curves. Some people are just getting started, while others are knee-deep in live exchange. What are the tools and resources that are out there? This blog post gives you a handy list  of resources for CDA, CCD and consolidated CDA documents to get started.

Start with HL7 International

HL7 International is the standards developing organization for healthcare data exchange and integration. They provide the fundamental resources you’ll need to implement CDA. One good place to start is the Implementation Guide for CDA R2 CCD.

Another great resource is Keith Boone’s healthcare standards blog, Motorcycle Guy. Keith blogs extensively on how healthcare data standards are developed, and he provides insight into how to implement CDA. In fact, he wrote the book on CDA. Check out his “Great Stuff” column for a list of CDA-related tools.

Meaningful Use Stage 2 Requirements

Go to the source for Meaningful Use Stage 2 requirements.

High-Level Intros

EHR vendor Practice Fusion has two solid introductory articles (first article, second article) on developing the clinical exchange documents to meet MU2. If you’re an analyst or developer, you may already be familiar with the content. But keep in mind that these are good for sharing with people who don’t need the technical implementation details , but who need to understand the why and how of the big picture.

If you need a high-level introduction to Meaningful Use itself, check out out this video from EHR vendor Hello Health.

SMART C-CDA Scorecard

This consolidated CDA tool was developed by Smart Platforms, an ONC-funded project that aims to create a platform architecture for medical apps – one analogy might be iPhone apps or the Salesforce AppExchange. They see CDA as a key component of the architecture. The Scorecard helps you evaluate the quality of the clinical summaries relative to Meaningful Use Stage 2 requirements and the consolidated CDA specification.

Also check out the blog posts on the Smart Platforms site. Start with the C-CDA posts here: http://smartplatforms.org/interoperability/

Frameworks and Tools

Don’t forget about the S&I framework and NIST tools. These are essential for understanding how your work is going to meet MU2 and CDA requirements. A bonus: CDA Guideline Validation from NIST.

What Caristix is Working On

We see a need to address gap analysis in order to ensure that best practices are followed, and the structure and content meet standards. David Kreda and Joshua Mandel on the Smart Platforms site summarized the issues well; here’s an excerpt:

  • material ambiguities in the C-CDA specification
  • accidental misinterpretations of the C-CDA specification
  • lack of authoritative “best practice” examples for C-CDA generation
  • errors generated by certification itself, i.e., vendors are incentivised to produce documents that set off no warnings in the official validator (rather than documents that correctly convey the underlying data)
  • data coding errors that reflect specific mapping and translation decisions that hospitals and providers may make independent of EHR vendors

Other Resources

What other CDA, CCD and consolidated CDA document resources should we list? Leave a suggestion in the comments below.

What Should An HL7 Interface Specification Include?

Tip 8 in the Interoperability Tip Series

Profile EditorCritical Elements in an HL7 Interface Specification

These are critical elements a developer needs to create a interface that works (almost) out of the box with minimal testing. The more accurate the HL7 interface specification, the faster it’ll be implemented – and the less costly the work will be.

1. Interface name
How do you refer to your interface in your integration environment? Some organizations manage thousands of interfaces. If you’ve got 10 or 20 interfaces, no big deal. But if you’ve got thousands, devise a naming system for easy name recognition and tracking.

2. Source or destination system name and version
System versions (and even product names) change over time. Make sure you’ve got a way to track this in your spec.

3. Message types used in the interface
A message type is essentially a trigger event, such as patient admission, lab request, lab results available, new appointment, etc. How you use and implement events is completely up to you – it depends on your system and hospital workflow. Each of the HL7 v2.x reference specifications contain hundreds of trigger events. Just focus on the ones you need for your interface.

4. Message definitions including segments, fields, data types
You need a list of the segments, fields, and data types used in each message type.

5. Segment and field attributes
These are optionality, repeatability, data type associated with a field, field length, tables associated with field.

6. Z-segments
Custom segments, if a vendor or your facility uses them.

7. Data types
Apart from a list of data types, you will also need attributes and customizations.

8. HL7 tables with field and data type content
Within your HL7 interface specification, you need the real-world data or code sets that are actually implemented – such as gender, race, and lab codes – not what the standard provides. Otherwise you’ll find yourself wasting lots of time trying to figure out what’s really going on in your system, especially when data such as lab codes change over time. You can solve this problem by keeping track of the actual data and code sets used, along with where and how they’re used, and the meaning of the information.

9. Specialized interoperability challenges
Without getting all necessary information upfront, your challenges around interoperability become greater and more insurmountable. Consider lab interoperability and the example of Logical Observation Identifier Names and Codes (LOINC) codes – the LOINC dictionary contains more than 42,000 codes and some codes mean similar things. That means two systems exchanging data could refer to that data differently – leading to confusion and information-exchange problems. Read more about addressing the challenges of lab interoperability in this Clinical Innovation and Technology article: Lab Interoperability Plays Catch Up.

Download the HL7 Survival Guide

Download the HL7 Survival Guide

Gap Analysis and CCD Document Specification

Bridging the Gaps

CCD document specification gap analysis

In a previous post on CCD, C-CDA, and CDA, we compared HL7 v2 messaging to CCD development. This week’s article is about the biggest roadblock with CCD document specification: gap analysis.

What is Gap Analysis?

Simply put, gap analysis is about understanding the differences in the data between two systems. The output of a gap analysis process is a list of all the differences between two systems charted in a requirements document. With HL7 v2 messaging, many organizations create their own gap analysis templates and include items such as field mapping tables, the development work involved with bridging a gap, and an issue tracker. To fill in the template, they do a spec cross-walk, look at messages with text or HL7 editors, run queries using messaging tools, and manually document their findings. Some use Caristix software to automate this process.

What about the CCD Document Specification and Gap Analysis?

You’ll need to apply the same process with CCD document specifications and messages. The manual gap analysis process can be onerous with HL7 v2.x messaging. That doesn’t change with CCD.

Gap Analysis Questions

With CCD document specifications, you’ll need to answer the following questions during the gap analysis process:

  • Built into the standard is the ability for both source and destination systems to handle all tags. How does each system handle extra tags built for special needs?
  • Are the systems using the same version of the standard? The standard is evolving, so systems might be on different versions.
  • Are there any differences between the format or structure in each system? If so, what are they?
  • Are there any optional data elements that are required in one system?
  • Do both systems use the same content? They may use the same code sets, but they may be using slightly different sets of constraints. For instance, take LOINC or SNOMED. It’s all well and good to say these are specified in the standard, but these are vast data sets. Is there a perfect match in all fields/tags? You need to check during gap analysis.
  • What about data attributes like length or optionality?
  • Is there any custom information that must be documented or explained?
  • Is the data semantically consistent? In other words, does the data mean the same thing in both systems?

Why You Need to Do the Gap Analysis

The gap analysis is a critical requirements document. Without one, you won’t uncover your systems’ unique needs before development, so testing and validation will drag on. Every single difference or customization will require extra time, money, and effort to troubleshoot and resolve. The result cascades into extended go-lives, more expensive maintenance, and unhappy end-users.

Our two cents: do the gap analysis. It’ll save time, money, and headaches down the road.

Are You Using These Interfacing Project Assets?

Tip 7 in the Interoperability Tip Series

interfacing-project-assetsCommunicating These Needs to Leadership

These are the most important assets you’ll need when you’re working on creating new interfaces or converting existing ones from one system to another. You’ll need to create them manually, or automate this work via interface lifecycle software.

Why These Assets?

Besides making sure that you have complete requirements so that you can accurately scope a project, you need to make sure you have all the parts and piece lined up and built into your project planning to prevent unforeseen roadblocks. These are the interfacing artifacts or assets that a project requires. Know what they are and what you need to do to get them in place to keep your project on track.

Interfacing Project Assets

HL7 conformance profiles (also known as profiles or interface specifications). HL7 profiles should at a minimum provide a list of messages, segments (including z-segments), fields, data types, and typical code sets or data.

Gap analysis between systems to connect. Big picture: gap analysis sets the scope of the interfacing project. Nitty-gritty: make sure you have field mapping tables. Read more about gap analysis in this Caristix white paper.

Test scenarios. Vendors typically provide you with a boilerplate validation guide to ensure the interface works as expected. But your team needs to ensure that your organization’s clinical workflows are covered. For example, let’s say you have a duplicate patient record in the system. Some hospitals are going to perform a merge to get rid of the duplicate; others are going to ignore it; and yet another batch might delete one of the duplicates. But the boilerplate guide might just say to merge. So create your own.

Test system. Make sure you can document test results and don’t sign off on acceptance criteria unless your clinical workflows are covered.

Message samples and test messages. Critical for testing prior to go-live as well as post-go-live for troubleshooting.

Process and workflow maps. This rounds out your view of your interfacing ecosystem. Complement the message structure and content details from HL7 profiles with good process and workflow maps for future interfacing asset management.

What other interfacing project assets do you use? Let us know in the comments.

Download the HL7 Survival Guide

Download the HL7 Survival Guide

 

HL7v2 to CCD

Confused? Start with What You Know

CCD-HL7-get-startedOver the past few months, we’ve heard a lot from our hospital-based customers about CCD and C-CDA readiness. There’s more urgency with Meaningful Use Stage 2 deadlines, even with the extension.

But the funny thing is: hardly anyone ever says, darn, but this is confusing.

Sometimes people express their frustration. “What the heck are those regulators doing? Why are they pushing more stuff at us, when we’re barely able to keep up as it is?”

Others bury their heads in the sand. “We’ll get to it. It can’t be that hard. Just go download a few Implementation Guides and we’ll get it done.”

And few and far between, there are the rare people who say, “This is hard. This is confusing. How do we start?” This post is for those folks who find it confusing. Here are some suggestions for getting started.

For starters, you’re an interface expert – either an analyst or developer. You’ve already got an extensive body of knowledge in HL7 v2.x messaging.

How do you add CCD to your toolkit? Simple. Start with what you know: HL7 v2.x. Here are some answers to the questions we’ve often come across.

With HL7 2.x interfacing, scoping and validation is a big part of the work. Will this volume of work be reduced with CCD?

No. And here’s why. CCD, which is based on Clinical Document Architecture (CDA), is an evolving standard and it parses a number of discrete elements. And as an implementer (either as a vendor or a provider), you can define or tweak your own templates.

Sure, there are specific templates that are prescribed by Meaningful Use. And these are publicly available, with a full set of schemas (which define the structure or format), content, and of course use cases.

The validation or conformance templates are also available, so it’s easy to define the rules they have to conform to.

The danger here is that implementers still have to meet their organization’s own needs, therefore they will need to define custom formats – similar to z-segment in HL7 v2.x. They’ll meet their immediate needs.

If the CCD spec or schema is more constrained, shouldn’t the interoperability work be easier?

You would expect that to be the case. The CCD specification is more constrained than the HL7 v2.x standard from a structure or format point of view. But keep in mind that the CCD spec (because it is based on on XML) is huge. And the content is varied. One analyst said, “it’s all over the map. I have no idea where to start.” So the idea of creating profiles – what Caristix Workgroup software enables — is attractive, since it facilitates the gap analysis process. (More on gap analysis and CCD next week.)

How do I manage custom elements and variations?

Documentation is important. An XML schema, while complete, is hard to read and represent easily. They are self-referring. You’re going to scroll a lot. Our goal, with our profile approach, is to makes this process easier. Coming soon: another article on the biggest roadblock with CCD: gap analysis.

Stay tuned. Tell us: What else would you like us to cover? Leave a comment.

The Good, The Bad, and The Ugly: Interoperability, Negotiation, and Culture

Tip 6 in the Interoperability Tip Series

interoperability-due-diligenceThis tip is for hospital or provider analysts and team leads.

You’ve got a firm grasp of the technical ins and outs of system and application interfacing. Because you’ve got the background, you know that contractual and cultural issues can affect your team’s ability to deliver on time and on budget. 

Make sure these issues are on the table with your leadership, ideally during negotiation before a deal is signed. Your leadership will thank you for thinking ahead — focusing on the good and avoiding the bad and the ugly. Use your operational expertise to avoid expensive problems down the road.

6 Points for Due Diligence

Is your leadership aware of these points?

1. Negotiating an Interface
When a hospital buys a clinical system, interoperability and HL7 are usually not addressed during the negotiation. The vendor’s sales rep often glosses over the requirements and simply mentions the “thousands of interfaces they’ve got in a library.” The problem is that analysts like you get pulled into the project after the contract has been executed only to discover it’s challenging to interface with the new system – but you’re stuck with making it work. Approach your manager before the negotiation phase and ask to be involved. By highlighting the issues that can arise when interoperability and HL7 are not addressed during the vendor negotiation, you can help avoid lots of project complications and will set you and your manager up for a smoother, more successful project.

2. Black-box Syndrome
In this scenario, the vendor keeps control of the project and interface, leaving you to pay for any tweaks or additional needs going forward, including documentation. Just as painful is the fact that the knowledge walks out the door when the vendor implementation team or consultants leave. How do you ensure this doesn’t happen? Ask for documentation specific to your site, including the interface specification, as part of the contract. This should detail which systems are linked/interfaced, which messages are exchanged, and which message formats are used, at a minimum.

3. Vendor Lock-in
Some interface vendors or consultants introduce their own intellectual property into the interface. In such cases, your organization has license to use the interface, but not full ownership of the interface, which means you need to pay the vendor on an ongoing basis for any required changes or updates you’d like to see. We’ve come across situations where providers are stuck paying five figure fees for gaining access to their own interfaces and data.

4. Who Drives the Interface Specification?
In the past, the clinical technology vendor would drive the spec and customers had to conform to the requirements. Nowadays, the opposite approach is increasingly common: the hospital drives the spec and vendors must conform. While this approach is more expensive initially, down the road it makes the process smoother for the hospital, especially as hospitals are increasingly part of HIEs and merge to form large hospital groups or IDNs. This is good for hospitals and providers but you need the right infrastructure (i.e., the right HL7 software and integration engine, configured to meet your organization’s needs) and culture to support this approach, whether you handle interface implementation in house or outsource it.

5. Supporting Technology
A good integration engine is a great building block, as we mentioned in Chapter 2 of the HL7 Survival Guide. But you also need supporting technology and a culture that help you – and anyone else who gets involved at any time – manage and update the engine and interfaces over time. Look for software and technology that simplify the process of generating, updating, and managing specifications, requirements, test scenarios and other documentation associated with your engine and data exchange work. You’ll also want a repository that provides a central location for anyone with permission to access the documentation. A detail that may seem nit-picky at the beginning of a project just might be the essential connectivity information you need a year later, when an interface goes down at 5 pm and you are the Tier 3 support on call.

6. Culture
Your organization’s culture and approach can make or break a consulting engagement or in-house project. Ideally you want to drive the show with consultants. Set clear expectations. Control deliverables by coming to clear agreement as to their definition and due dates. Use your project documentation from Point 5 above to ensure clarity and accountability throughout the interface lifecycle. Ensure a structured methodology is used to test and validate the interface. And clearly define your acceptance criteria for the project.

How to Use Caristix Software to Get Answers

Laying the foundation for interoperability, these are the questions that Caristix Workgroup software organizes for analysts and developers. By creating specs automatically from messages, the software helps analysts provide answers with little to no manual work, while enabling developers to get interfaces into production faster. We think it’s a win-win for both vendors and providers.

Download the HL7 Survival Guide

Download the HL7 Survival Guide

What is One-Hour Interoperability?

The Status Quo

This is the world interface analysts, developers, and quality testers work in:

  • 2 weeks to get a list of code values for a single field
  • 1 week to get a list of custom field formats like lab order codes
  • 20 hours to code a schema in an engine from a spec in Excel
  • 9 days on gap analysis
  • 30 days to test a 10-minute code change
  • 8 versions of a spec before it’s baked enough for development

Productivity with Caristix

With our software, especially with the new version that just came out, you can move these numbers dramatically:

  • 15 minutes to get code values for all fields
  • 15 minutes to get a list of custom field formats
  • 1 minute to generate a schema for an engine
  • A half-day on gap analysis
  • 10 minutes of automated validation to test a 10-minute code change
  • 1 version of a spec before it’s baked enough for development

So, yes, we’re paying attention to all those things that get in the way of interoperability.  We are removing roadblocks. We’re helping interfacing teams become more productive and get interfaces into production much faster than before, with fewer manual steps than before.

But we’re aiming higher.

Vision: One-Hour Interoperability

one-hour-interoperabilityThe vision we have for interfacing and interoperability is much bolder. We aim to build interoperability technology that makes analysts and developers so productive, they’ll deliver One-Hour Interoperability. Not weeks. Not days. A single hour.

With One-Hour Interoperability, a team will gather requirements, then configure, test, validate and take in the interface live, glitch-free, in an hour. A bold vision? Absolutely. And that’s where we are taking our customers.

You’ll find the building blocks of One-Hour Interoperability in the Caristix v3.0 release. We’ve made gap analysis simpler and easier to use, cutting hours off scoping mapping tables. Remove noise with filters. Capture just the gaps that are relevant to developers. Clearly designate inbound and outbound systems. Easily build transformation tables. Use the matching filter to spot differences in product versions. Highlight data differences with message comparison.

We’re working on a CDA product, so that everything you do today for traditional HL7 v2.x interfacing, you’ll be able to do for CDA. EHR implementation, Meaningful Use, and related deliverables all happen on time…and on budget.

Learn more about what we’re doing with CDA and the other building blocks. You’ll get the latest in our newsletter. Sign up here.

Laying the Foundation for Interoperability

Tip 5 in the Interoperability Tip Series

9 Critical Questions You Need to Ask Your Clinical System and Interface Vendors

Like our last two tips, this week’s tip is geared to hospital teams asking their vendors the right questions. Vendors who are on the ball will have the answers at their fingertips.

Why Should Health System Leadership Care About This?

foundation for interoperabilityThese lay the foundation for interoperability. They are the basic format and content scoping questions that kick off each and every interfacing project. Your teams will work with your vendors to answer these questions for every system they work with. Your managers will be tracking answers, and the quality of the information they get will impact risk, timelines, and costs.

1.    “Who provides the hardware, if any?”

When you implement a new EHR or clinical system, validate it doesn’t need extra hardware for data exchange. You want to find out about hidden costs.  

2.    “What standard does your system use for data exchange? HL7? Which HL7 2.x version are you using?”

These questions lay the groundwork for the next one.

3.    “Can you supply a list of customizations you made to the HL7 v2.x standard you are using?”

While most vendors will claim they deviated very little from the standard, you will probably find they deviated in several ways (custom messages, Z-segments, customized data types, customized code sets, etc). The longer the list of customizations, the longer and more risky the project.

4.    “Within your HL7 2.x based interface, can you tell me which elements and values are configurable?”

You need the details. If they can’t provide details on configurability, you might be facing a longer test cycle than anticipated. Trial-and-error interface validation can slow down implementation. 

5.    “When you send us the interface spec for sign-off, do we get a fully documented list of gaps and exceptions for specific data values and data elements?”

You want a full list, or you’ll be facing a lengthy validation process, waiting for super-users and clinical testers to flag bugs in the test system.   

6.    “Will you provide a list of the interface customizations you create for us?”

No interface specification works perfectly out of the box; it has to be customized to your environment. Keep this list for troubleshooting and maintenance, or risk extra downtime. 

7.    “How do you document changes and upgrades throughout the lifecycle of the interface? Do you automatically provide us with updated documentation?”

If there’s anything worse than missing documentation, it’s partial or out-of-date documentation. What you get at go-live will not be usable two years out. Make sure the responsibility for documentation updates is clearly spelled out. 

8.    “Does the interface you built contain any intellectual property?

This is crucial! Validate if a license will apply to the code and you will own the interface – or if the vendor will own it. If the vendor owns it, you might need to pay big bucks in licensing fees if you ever need to access that feed. 

9.    “How guaranteed is message delivery? Does each message get an “acknowledge” (ACK) or “no acknowledge” (NACK) reply?”

This is part of the HL7 standard and is an important piece of the message delivery process as you cannot guarantee the message was delivered without it.

How to Use Caristix Software to Get Answers

Laying the foundation for interoperability, these are the questions that Caristix Workgroup software organizes for analysts and developers. By creating specs automatically from messages, the software helps vendors provide answers with little to no manual work, while enabling provider teams to get interfaces into production faster. We think it’s a win-win for both vendors and providers.

Download the HL7 Survival Guide

Download the HL7 Survival Guide