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What LIS companies serve labs in resource-poor countries?

I would presume there are several LIS companies that would be willing to serve these types of labs but I am not aware of a definitive list of these companies. My company recently placed a system in Malawi, Africa in a pediatric AIDS clinic. In this particular scenario, the laboratory was funded by the University of North Carolina. The University collaborated with the Kamuzu Central Hospital of the Malawi Ministry of Health in Lilongwe, Malawi Africa to provide laboratory services for HIV testing. The UNC project mission was to identify innovative, culturally acceptable, and relatively inexpensive methods of reducing the risk of HIV and STD transmission through research; strengthen the local research through training and technology transfers; and to improve patient care for people living with HIV and AIDS.



Unfortunately, most of the labs that are run in resource-poor countries are not well funded. They are typically small office laboratories and these smaller labs typically purchase manual or semi-automated analyzers that are not capable of interfacing. This means they are relying on the tapes and paper printed from the analyzer to get the results out. While these labs are still primarily manual, with limited automation (LIS as a lower priority), there are usually a limited number of larger labs that are funded by the government that do require an LIS for quality assurance compliance and data interoperability.

I have been just put in charge of getting an LIS system in out student health center laboratory. We will be using Pyramid EHR in the near future. I need some help to get me started in this process.

The first step is to select an LIS that has experience interfacing with the PYRAMED EHR. Since the EHR is uniquely designed specifically for university student healthcare centers, it is important that the vendor have proven success with the specific interface. I would imagine this step would significantly limit your choices. While selecting the analyzers for your center is an important step early in the process, the analyzer selection will have very little bearing on the interface between your EHR and LIS. Most LISs should be able to interface to the analyzers you choose.

Most LIS vendors will tell you if they have interfaced to your specific EMR/HER, and can provide references as well. As healthcare moves toward becoming more interoperable, your vendors’ experience with developing and implementing interfaces will have a significant impact on your overall investment in your LIS. If you can find an affordable product with superior product support and a vendor with experience, you will be on the right path for a smooth implementation process.

What is the best way to implement auto-verification?

For several years, autoverification has been discussed extensively in journal articles, during continuing education presentations, and at professional meetings. By definition, autoverification is a process that employs a user-defined set of rules to assess test results for release, without individual review by a qualified laboratorian. Autoverification can improve turnaround time (TAT) for test results, reduce test result errors and enhance workflow in the lab, which can provide a significant benefit as labs struggle to do more with fewer resources.



In reviewing the literature, the consensus seems to be that the process of implementation can be quite challenging, but appropriate planning can minimize the pain. There are several good references now available that provide guidelines for developing an implementation plan. (See below)



Once you decide on project leader and team your laboratory staff will need to understand that this is a tool for them (and not a replacement), and will allow them to focus on more difficult samples and results. They can clarify specific situations, or exceptions, that will need to be included in the rules. Once the rules are developed, they will also be involved in validating the rules. You will also want to discuss the plan with your LIS coordinator, and with a support person from your LIS vendor (who will hopefully have experience with autoverification and can offer insight into the process).



Then you need to decide where to start. While the Chemistry section of the lab might appear to offer the most benefit initially, it is also likely to be the most difficult. Consider a section like Urinalysis, which has only one sample type and fewer tests to define, but typically has a high volume.



Next, and most important, you need to define your rules, or criteria for autoverification. The

variables may include:

Will you verify only values that are within the reference range, or all values except criticals?
Will you require that there be no instrument errors or flags?
Will results be accepted if there are flags on control samples?
Will delta checks be considered on certain analytes?
Will you require that the verification be dependent on the results of other tests within the same run?


Once the rules have been defined, they will need to be tested. The LIS coordinator and your vendor representative should provide guidance through implementing the testing. You will probably find that some rules need refinement or modification, based on the results of your testing. In general, the more planning that has gone into the selection and definition of the rules, the easier the testing process will be.



The successful implementation in one area will serve as an impetus to move forward in other areas, following the same process.



Before going live, it is a good idea to write a policy for autoverification, which describes your criteria for determining which test results can be auto-released versus those that must be held for review. The policy should also describe how the autoverification process is tested, and at what interval.



References:

1. Clinical and Laboratory Standards Institute (CLSI). Autoverification of Clinical Laboratory Test Results, Approved Guidelines (AUTO 10-A) Wayne, PA: Clinical and Laboratory Standards Institute, 2006

2. College of American Pathologists. Laboratory General Checklist. Northfield, IL: College of American Pathologists, 2006

3. Autoverification of Test Results, How to avoid mistakes and Improve Efficiency in Your Lab; J. Johnson MT(ASCP)SH & D. Stelmach MT(ASCVP), MS

Clinical Laboratory News (Volume 33, Number 9, September 20074

I am looking for a LIS system that will work in a veterinary diagnostic laboratory. We perform many of the same assays used in humans labs (using many of the same intstruments such as a Cobas c501 chemistry analyzer and a CellDyne hematology analyzer). The major difference is that we are dealing with many different species and distinct reference ranges. Is there a LIS system that is flexible enough to handle this?

Yes, there are several LIS systems that are flexible enough to work well in a veterinary diagnostic laboratory. As a matter of fact my company has an LIS that is often adapted to veterinary laboratories. I am not aware of any surveys listing LIS systems specifically for veterinary diagnostic laboratories. One way to find these systems might be to refer to a listing of LIS systems for the clinical lab (such as the annual survey published in the November issue of CAP Today). The next step is to review the system features and select the vendors based on the functionality you desire. Once you get in touch with the vendor, it should be fairly easy to see which system might work for you.



As you stated, the major consideration is whether the LIS can support multiple reference ranges for different species, or special populations, as well as for gender and age. Another consideration is whether the animal/patient identification fields can support the name of the owner, as well as the name of the animal. Both the animal and owner name fields should searchable for each lookup. Finally, since most animals do not have their own medical records number, the system should be able to generate a unique animal ID at the time of registration. Beyond that, it will be a matter of determining what other functions are most important to you, so that you can make a decision as to which system will best fit the needs of your laboratory.

Question: what are the cons and pros of lab information system?

With proper design, operation and implementation, integrating a LIS in your laboratory can provide many benefits. In order to answer your question I am making the assumption you are referring to a laboratory running a fairly large number of tests in the disciplines of chemistry and hematology.

In virtually any clinical laboratory setting, automation with an LIS can:
· Significantly improve turnaround time via improved workflow automation
· Support automated analyzer interfaces (including calculations)
· Reduce errors via positive sample and patient ID with bar-coded samples. This, leads to improved patient safety and risk management
· Provide long term storage of patient data, which allows for access to cumulative and graphic result reporting for viewing trends over time
· Provide remote ordering and web based results reporting
· Support standing orders
· Assist with decision support automation
· Provide management tools to assist with controlling the tracking of test utilization and expenses.
· Provide integration to 3rd party software systems for data sharing (i.e., interfaces to electronic health record systems/HIS systems, reference laboratories and state agencies).

The LIS should be able to provide tools to aid with all regulatory compliance. This includes:
· Consolidated result reporting, which will improve the result review process for the practitioner and produce CLIA and JACHO compliant result reports
· Quality control functionality (including West Guard Rules)
· HIPAA security


As for the cons, this is a bit more difficult to answer. I suppose if you were running a low volume waived lab with no plans to purchase an EMR, it might not make financial sense to have an LIS as an LIS could be excessive in this situation. An important consideration before implementing the LIS is the added responsibility of requiring that each result be properly validated before implementing in production. In addition, the patient data output (demographic, panels, tests, results, reference ranges, flags, etc…) must be validated prior to dissemination. If clinical lab personnel do not validate the data, inaccurate information may be unknowingly distributed from the LIS by way of printer, fax, e-mail or export to EMR/HIS.

While implementation of an LIS adds an additional layer of responsibility to your laboratory, ultimately the benefits far out weigh the cost and effort. If you do decided to move forward with an LIS, I recommend careful planning before implementation, as well as thorough testing prior to reporting patient results in order to ensure a successful transition.