How to buy an LIS

Why do you want one?

An LIS to connect two waived devices to your EHR will vary in acquisition cost from a low of $4,000 to a high of $25,000. Annual operating costs will vary from $1000 to $5000. The $5000 choice will be very easy to use and will deliver results to your EHR. It will, however, be of no help if you acquire a non-waived device or need a third device. The $25,000 solution will be very complex, be expandable and have lots of features you will probably never use.

Begin your LIS acquisition adventure by listing the features you will need your LIS to support. This is a team support that should include all constituents and is greatly enhanced by someone who has experience and is on your team as either employee or consultant. Here is a list of popular features:

1. Accept orders from your EHR
2. Send orders to one, or more, reference labs
3. Accept results from lab devives in your office
4. Accept results from one, or more, reference labs
5. Send results back to your EHR
6. Generate specimen labels with or without barcode labels
7. Generate reports (you will need to list the ones you need)
8. Support billing function (you will need to define level required)
9. Support CLIA compliance

In order to generate this list you will need to first define your workflow and the roles the EHR and LIS will play. For example, which application is in charge of generating specimen labels and resolving exceptions? Do your lab devices use specimens with barcodes. Can the tests be staged by the LIS onto the lab device saving the lab tech the need to type information onto the device console?

Some Technical Terms

Getting lab results from most analyzers into the patient chart in your EHR is way more complex than connecting the device to the back of your EHR computer. Lab devices will output their results out of a computer port in the back of the device and send them via a cable that connects the lab device to your LIS computer or your Locan Area Network (LAN). This cable is almost always an RS232 or USB cable but newer devices can connect directly to your LAN. When the results data arrive at the LIS computer they will be converted into an HL7 message that can then be sent to the EHR. And this is a gross simplification the technical issues that must be resolved between the LIS workstation the lab devices connected, the local area network over which the LIS will send results to the EHR and the software at each end whose purpose it is to accept and receive HL7 messages.

Just because your lab device can output HL7 results does not mean that they will end up in the EHR patient chart. Designing and deploying a local area network at your practice that transfers patient and lab information to and from lab devices, reference labs and your EHR over your local area network in compliance with both patient privacy requirements and the competing needs of your EHR and LIS is not for the faint of heart or amateurs. Find a lab consultant with plenty of experience.

Lab Devices typically output their results using an international standard like (ASTM) if you are lucky or some proprietary format (which means the interface cost will be higher) that must then be converted into the HL7 international standard for conveying health information between computer systems. The HL7 standard is what the US government has selected for use by EHR systems which are certified.

If you are starting a new lab or just adding new devices always ask the salesperson if they will cover the cost to interface the analyzer to the LIS. In many cases (but not all) the manufacturer of the analyzer will cover the cost of the interface or provide free reagants. For most analyzers the manufacturer is motivated by the expectation of selling you reagants each month for many years.

Evaluating Products

If all you want to connect is a reference lab you are in luck. In most cases the reference lab will cover the cost to connect to your EHR. If you are connecting one or two waived devices the previous paragraph covers the key issues.

If, on the other hand, you will be operating a lab with one, or more moderately complex devices choosing an LIS will be a whole lot more complex. The first thing you should do is find a local Lab Consultant to help you make the right choice. It will probably cost you a $1000, but is likely to save you much more and significantly improve the likelihood that you will still have a lab a year later. The range in costs for a moderately complex lab with two, or three, lab devices will range from a low of $10,000 to a high of $30,000 and all systems will do what you need done. The $10,000 solution will only do what you need, but should allow you to add functions over time if you need them. The $30,000 system will have all the features you will ever need (and maybe some you will never need). Five year cost of ownership can range from a low of $20,000 to a high of $60,000.

Never buy an LIS without having first written down your required work flow. Once you have your work flow defined ask each vendor you are considering to show you how they deal with each required function. All vendors are happy to provide you with a web-based demo.

Never buy an LIS without having the person who will run the lab see the demo and be absolutely clear on how each function will work. If an LIS vendor cannot show you how their application performs each step of your required work flow you need to cross them off your list. Your LIS vendors will be happy to provide as many demos to as many members of staff as you would like. Don't let your providers tell you they are too busy to check the format of the LIS reports.

Get TEN references and call them. Make a spreadsheet listing all the functions that you know you will need. Ask each vendor to show you how they handle each function and then grade them (e.g. Poor, OK or Great).

In-house versus Cloud

A key decision you will make is whether you wish to have the LIS run independent of the Internet or not. In the past applications only ran on an in-house server to which PCs were connected. This required significant monthly costs to manage and maintain the network and equipment. With the emergence of complex and expensive requirements to protect Patient Health Information (PHI) there has been great incentive to deploy cloud-based solutions. For some the inability to hire qualified network employees has mandated a move to the cloud.

There are now LIS solutions that are totally cloud-based. These solutions allow you to run the LIS from ANY PC from ANYWHERE. This means that your Docs can connect with their smartphone to the LIS from her/his vacation in Bermuda and provide a consult if needed. If you are considering this option make sure your potential vendor provides you a written guarantee of HIPAA compliance for their solution. In general cloud-based solutions are fine. Besides HIPAA your primary concern should be what happens to communications with your analyzers when there are Internet interruptions (and there will be interruptions). Cloud-based solutions are best when the vendor provides a local PC that is directly connected to your analyzers and will keep running even if you lose internet connectivity.

New technolgies always bring with them tecnical challenges and mangement complexity. Note there are many new cloud-based options. With a younger firm you will have lower costs but higher risk of problems. A common problem with a new supplier is their inability to support new complex analyzers. Checking their references with labs with similar equipmwnt is critical. Your lab consultant can guide you thru the many technical choices/issues you will need to asses for your LIS vendor options. My best advice is to make sure the cloud software you are considering is hosted on one of the top three cloud platforms (Amazon, Google or Microsoft). Each of these will provide you with regulatory PHI compliance, superb service and competitive costs.

Hidden Costs

In the LIS business there is no end of ways in which well-intentioned professionals can misunderstand each other. For example, the EHR vendor tells you that their product is able to accept HL7 lab results messages. Does that mean you can connect your lab device to the EHR: No. Does that mean that if you buy an LIS that sends HL7 result messages to the EHR they will end up in the right patient chart: No. Does that mean that you will have to buy the "optional EHR HL7 Connector" they forgot to mention: Yes. There will still be an installation fee.

In more than 25% of LIS sales there are "surprises" after the LIS is purchased. Even after the buyer has been told the issues that this page addresses. A classic case is that the practice tells the EHR that they are buying an LIS and need the ability to deliver HL7 lab results. Somehow this frequently gets misunderstood by the EHR vendor as a request for connecting to a reference lab like LabCorp or Quest which is normally much more expensive that an LIS connection. Be sure you communicate in writing and get a response that confirms your understanding. The absolute best thing to do is to host a conference call where the EHR and LIS vendors review the work that will need to be done. In this way there is a clear communication of the technical issues and who will be responsible for what component of deployment. You can be sure they will both charge a fee.

Before you buy an LIS send your EHR vendor a letter or email that announces your intention to acquire an LIS and ask that the EHR respond by listing any fees that they may charge to connect orders and results HL7 processing to the EHR. Further request that they provide with you a date on which they would be prepared to work with the LIS supplier to connect and test the processing of orders and results.

In most, but not all, cases you will spend more with the LIS company in years two through five then when you acquired the LIS System. Have your vendor provide you with their fee schedule for:

1. Annual license fees
2. Support fees
3. Charges to switch a lab device model
4. Charges for a new additional lab device
5. Charges for application upgrades
6. Fee structure for new reports or screens
7. Fees if you move or if you add an additional location

Managing Installation

We have customers where it has taken almost two years to complete installation of the LIS. We have one customer that waited seven months for their EHR supplier to schedule technical staff to allow connection to their EHR.

All LIS installations involve at least three parties and frequently more. A partial cast of possible players are:

1. Your EHR
2. The LIS supplier
3. Your IT support person
4. One, or more, reference labs
5. A third-party provider of interface services to your EHR
6. Your lab consultant

For deployment of the LIS System to be both timely and successful you will need to assign a senior staff member to babysit the process. A critical component of managing is a weekly conference call where each group reports on how they did on their committments from last week and what they will complete in the coming week. The weekly meeting brings focus to what needs to be done and highlights how each player is meeting their committments.

All installations of an LIS for either a first-time lab or a connection to an EHR will have problems during the first couple of months. The level of problems will be a function of:

1. The EHR you picked
2. The LIS you picked
3. The Lab Devices you picked
4. The staff you picked
5. The complexity of your lab devices
6. A third-party provider of interface services to your EHR
7. Your lab consultant

There is an incredible amount of information that your staff will need to absorb and understand and for most deployments they are not going to get a couple of weeks off to train in a test environment that replicates the choices you have made. An EHR, complex new lab analyzer and a new LIS can tax even the most seasoned lab tech.

Count on there being problems. Make a plan that includes your staff and suppliers on how these problems will be resolved when they occur. The plan should include who to call for what type of problem and who is the backup. What expected resolution time will be and what is the escalation plan. The best measure of a supplier is not how they perform when things are going well, but rather how they perform when there are problems.