Journal:Laboratory information system – Where are we today?

Full article title	Laboratory information system – Where are we today?
Journal	Journal of Medical Biochemistry
Author(s)	Lukić, Vera
Author affiliation(s)	Railway Healthcare Institute (Belgrade, Serbia)
Primary contact	Email: veralukic dot lab at gmail com
Year published	2017
Volume and issue	36 (3)
Page(s)	220–224
DOI	10.1515/jomb-2017-0021
ISSN	1452-8266
Distribution license	Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported
Website	https://www.degruyter.com/view/j/jomb.2017.36.issue-3/jomb-2017-0021/jomb-2017-0021.xml
Download	https://www.degruyter.com/downloadpdf/j/jomb.2017.36.issue-3/jomb-2017-0021/jomb-2017-0021.xml (PDF)

Wider implementation of laboratory information systems (LIS) in clinical laboratories in Serbia was initiated 10 years ago. The first LIS in the Railway Health Care Institute was implemented nine years ago. Before the LIS was initiated, manual admission procedures limited daily output of patients. Moreover, manual entering of patient data and ordering tests on analyzers was problematic and time-consuming. After completing tests, laboratory personnel had to write results in a patient register (with potential errors) and provide invoices for health insurance organizations. The first LIS brought forward some advantages with regards to these obstacles, but it also showed various weaknesses. These can be summarized as rigidity of the system and inability to fulfill user expectation. After four years of use, we replaced this system with another LIS. Hence, the main aim of this paper is to evaluate the advantages of using LIS in the Railway Health Care Institute's laboratory and also to discuss further possibilities for its application. After implementing an LIS, the admission process has proven to be much faster. The LIS enables electronic requests, barcoded specimens prevents identification errors, a bidirectional interface replaces redundant data entry steps, QC data are transferred automatically, results are electronically validated and automatically archived in the database, billing information is transferred electronically, and more. We also use some advanced options, like delta check, an HIL feature, quality indicators and various types of reports. All steps in total testing process are drastically improved after the implementation of an LIS, which had a positive impact on the quality of issued laboratory results. However, we expect development of new features in the future, for example auto-verification and inventory management. Using Railway Health Care Institute's laboratory as an example, we show that it is crucial that laboratory specialists have the main role in defining the desirable characteristics of an LIS which the institution aims to buy. This paper suggests that the main features of an LIS should be system flexibility and the capability of adjusting it to user needs and requests.

Keywords: laboratory information system, flexibility, advanced options

Background

A laboratory information system is software which receives, processes and stores information generated by the laboratory workflow. It automates the workflow of all information related to the total testing process. Wider implementation of LIS in Serbia has gained momentum in the last 10 years. It is expected that the LIS facilitates communication between laboratory and clinicians and enables faster delivery of patient reports. The main aim of this paper is to evaluate advantages which the laboratory of the Railway Health Care Institute experienced with the implementation of an LIS, as well as to point out at some advanced options and possible further use of its features.

Workflow before LIS

In the last few decades medical laboratories have experienced dramatic transformation due to the automation and development of information technology. This transformation can be presented by example of the laboratory department in the Railway Health Care Institute. In the early 2000s, the Institute purchased high-capacity automated analyzers for hematology, clinical chemistry and immunochemistry. This represented a huge breakthrough at the time. However, from today’s point of view, there were significant imperfections and slowdowns in the working process. Here we point out how some tasks wasted most of our time. In spite of using high-quality laboratory equipment, there were still too many manual procedures. Registration of patients was slow due to admission desk procedures, which required writing by hand all patient data, as well as writing receipts for paid analyses. The admission desk represented a "bottleneck" which limited the daily number of patients in spite of the huge throughput capabilities of analyzers. Following that, all ordered tests were locally entered on analyzers. Thus, after obtaining results, patient reports were printed from each analyzer on individual slips of paper, resulting in different slips being attached in order to produce a final report for the patient. This form of report was visually unacceptable and rather difficult to read due to different fonts and formats. After that, all results were rewritten by hand in paper protocols for permanent storage. During the afternoon shift, staff again went through all data and made invoices for health insurance organizations. Tubes were manually marked with IDs, as well as sample cups, and samples were aliquoted from tubes to cups. These actions represented a weak point for identification error, caused by personnel fatigue or lack of concentration. The results were then reviewed by a clinical chemistry specialist in printed form, without access to previous results. Progressively, we recognized an emerging need for the implementation of a laboratory information system in our everyday practice.

Implementation of LIS

The first LIS was installed in our laboratory in 2008. It brought some advantages in terms of acceleration of admission procedures, but it did not fulfill our expectations. In the meantime, the laboratory purchased the latest generation of analyzers, which caused additional inadequacy with the LIS: it did not tap into the analyzers’ possibilities and did not allow them to achieve their maximum performance. Moreover, the LIS did not have the capability of adjusting to user needs. Its rigidity did not allow for further improvements, and it began to impede the efficiency of the laboratory. That made us aware that we had to acquire a new LIS.

Replacing existing LIS with new one

Although research literature implies that laboratories only change their LIS every 10 to 20 years because due to being an enormous undertaking, the laboratory of the Railway Health Care Institute had to do that four years after the first installation. We defined a clear list of requirements for the new LIS in order to avoid previously experienced obstacles. Our requirements were specific about each desired feature and function for each step of the total testing process, from preanalytical to postanalytical phase. The following was crucial when choosing the appropriate LIS: laboratory specialists had to be deeply involved in the selection process, and particularly in direct discussion of each and every feature of the LIS with the vendor, or, even better, with the software developer. In the summer of 2012, simultaneously with the integration of the clinical chemistry and immunochemistry modules, the installation of a new LIS was completed. Here we present some of the benefits of using the new LIS.

First, the ability to interface with a hospital information system (HIS) enables the use of electronic test requests and eliminates paper request forms, which drastically accelerates admission desk procedures. Electronic requesting improves the quality of communication between laboratory and clinicians. Moreover, the LIS performs automated printing of receipts and bills for analyses, which patients pay at the admission desk. Printing of patient’s informed consent for venipuncture is also automated. By entering a patient’s information and test orders into the LIS, the system can then generate an electronic invoice for health insurance organizations, without any further need for additional actions of admission personnel. Complete electronic registration of patients is printed at the end of the day, meaning that personnel are not required to manually write paper registers in order to be in accordance with regulatory legislation.

All samples are signed with barcode labels, so we use primary tubes for test analyses. Additionally, we ended the time-consuming and error-prone sample aliquoting to sample cups. Operators of laboratory analyzers are now fully concentrated on the analytical phase, because local test ordering on analyzers is replaced by automated order transfer from the LIS. Moreover, the LIS has a bidirectional interface with all analyzers, so there is no need for entering orders into analyzers manually, nor retyping results from the analyzer into the LIS. After test completion, results are transmitted to the LIS and made available to biochemists for review and verification. For the few analyses which have to be manually performed (urine sediment, FOBT), manual test result entry is facilitated by configured drop-down lists with offered values for each parameter. This makes result input much faster and also prevents typing errors, which were very frequent in the previous LIS, and a reason for recall of reports during review.

The verification screen offers plenty of data. On the top of the screen there are demographic data about patient and his/her diagnosis. Then there is a current report with highlighted results which fall outside of the reference range. When the cursor is positioned on any measured parameter, three previous results for that parameter are displayed at the bottom of the screen. With a simple button press, we can see all results for that parameter from all previous reports for that patient, which can be displayed not only numerically but also graphically. The user can define delta check rules, and there will be a pop-up window warning if the rules are violated. Also, we have configured critical values for some tests. If a critical value is obtained for some patient, there will be a red color alarm in the LIS, which is visible to all logged-in users regardless of the part of the program they are currently using. The system enables entering the time of communication of critical values to the doctor, monitors turnaround time (TAT) and stores reports about all communicated critical values. In printed form, any critical value is also specially marked. During verification, a clinical chemistry specialist can also see results of quality control for each parameter.

Just as in patient results, all quality control values are automatically transmitted to the LIS as QC files. Transfer of control values does not need any additional operator action, for example ordering directly from the LIS or manual input of obtained values. The LIS calculates running mean and standard deviation and generates Levey-Jennings graphs which can be seen from the verification screen. Also, we can see all values of repeated measurements on the verification screen, and we can choose which of them will be reported. On this screen we can also make comments for the doctor or patient. These comments may be configured as typical, which occur frequently, but they can also be typed in as free-form text. Moreover, we can make some technical comments which are visible just for laboratory personnel. After validation is complete, reports are ready for printing or e-mailing. Also, validated results are automatically sent to an electronic health record and are immediately available for the doctor.

When the patient is admitted to the laboratory as an emergency case, the LIS generates color-inversed barcode labels for samples, and they are clearly visible to all participants in the laboratory testing process. Analyzers recognize such labeled samples as "stat," and they are specially marked on the verification screen to be treated as priority through the entire testing process, respecting turnaround time. For all patients, priority or regular ones, the LIS maintains precise evidence of the time each step in the testing process is performed, so TAT for each patient is easily obtained from the LIS. The LIS also offers a wide spectrum of reports about the laboratory tests performed. Reporting data can be grouped by analyzers, time intervals, diagnosis, reference range, sex, doctor, and more. Additionally, it offers a variety of financial reports.

Access to the LIS is permitted only to authorized staff with a personal password. The system continuously creates a log of all actions in the system, identified by user, and all employees are aware that reports of all actions (with user names and exact time of performing actions) are periodically reviewed. Finally, the LIS keeps a log of communication details with analyzers (ordering time, measuring time, time of results transmission). All these logs enable maximum traceability of results throughout the laboratory.

Advanced options

The LIS offers some advanced options, where some of them were developed or upgraded in the laboratory of the Railway Health Care Institute to respond to our requests and needs. For example, it features serum indices, verification rules, quality indicators, and inventory management.

The quality of laboratory results is highly dependent on sample quality, and that is why reliable detection of the presences of interferents is one of the crucial preanalytical steps used to decrease the number of laboratory errors. Visual estimation of hemolysis, icterus and lipemia is unreliable and time consuming, so it should be replaced by automated measuring of serum indices. The Railway Health Care Institute's laboratory is one of the first in Serbia to implement systematic automated sample interference testing, which means that all serum tubes are being tested for hemolysis, icterus and lipemia (HIL test) on a clinical chemistry analyzer. Achieving this kind of systematic approach is not possible without the support of an LIS. Our LIS offers the possibility for a user to define which analyte requires testing for one or more of these interferents. In such a way, the LIS alone orders an HIL test from the analyzer without any action of admission staff, or the analyzer operator. Results of serum indices are automatically transmitted from the analyzer to LIS and are available to clinical chemistry specialists for evaluation and decision making. Furthermore, we have configured some rules related to serum indices, such that the LIS generates pop-up windows which prevent verification if some interferent is present in a concentration which can significantly affect some of the tests which are performed for that patient. This approach has enhanced systematic and objective detecting of the presence of interferents in patient samples, as well as adequate further management of such samples and results. These approaches provide high-quality reports and additional safety for our patients.

Aside from HIL indices, rules of verification can be configured in relation to some other laboratory situations; for example, an LIS alert can warn and prevent the release of LDL calculated by Friedwald formula, if triglycerides are higher than 4.5 mmol/L. Hence, the LIS enables an auto-verification feature that builds up on rules and algorithms for verification. We have made some trial steps, but this is huge, delicate and challenging work. We expect that auto-verification is the future of our laboratory, and it will enable biochemists to stay focused on those results which require professional attention and additional evaluation.

The LIS can also facilitate monitoring of quality indicators in medical laboratories. The identification and use of effective quality indicators in all phases of the total testing process is an essential requirement for laboratory accreditation, and for a valuable risk management strategy. Most laboratory specialists are aware that quality indicators are very important for quality of laboratory results. But, paradoxically, participation in available quality indicator programs is limited. We are aware that this is a difficult and demanding task. Nevertheless, the LIS can help us with this, enabling recording of a large number of quality indicators, and for some of them this is an automated process. For example: hemolysis in serum greater than 0.5 g/L of free hemoglobin, exceeded turnaround time for emergency requests, and exceeded time for communication of critical results. Our laboratory participated in the IFCC project "Model of quality indicators," and this has been facilitated mostly thanks to our LIS. Reports about absolute and relative frequency in defined time intervals are easily available for all recorded indicators.

An electronic stock management system is a feature we are still developing in our laboratory. It is conceptualized as an inventory management module through the LIS. When completed, it would enable monitoring of stock status for each article in the laboratory and monitoring of the expiry dates. Furthermore, it would facilitate ordering of inventory to prevent shortage, but also prevent overstock of any item in the laboratory. Thus, we expect that this feature will optimize inventory management and ensure product availability.

Staff satisfaction

Research literature shows that during implementation of new technology procedures 20 percent of employees support change, 60 percent are unsure of change and 20 percent dislike change. However, the situation was completely different with the implementation of a new LIS in our laboratory. One-hundred percent of employees demonstrated readiness for change, due to daily improvements. Manual tasks were either reduced or completely eliminated at all positions by the introduction of the new LIS, which increased the pace of all procedures. Thus, all employees experienced benefits in their daily practice.

Conclusion: Benefits of LIS implementation

The implementation of a quality laboratory information system points out some of the benefits for the laboratory: increased pace of patient admission, prevention of sample identification errors, prevention of test translation errors, permanent results storage in electronic form, prevention of billing errors, improved time savings and better staff organization. It should be emphasized that readily accesible data available to biochemists during verification improves the quality of reported data and patient safety. Cutting out the manual entry of patient data and hand writing of test results, as well as the repetitive job of aliquoting samples, has enabled better redistribution of working tasks between the employees. This implies a step forward towards optimization of the total testing process.

Finally, it is very important to highlight the key feature of a good LIS: its flexibility, i.e., its ability of adjust to user needs and integrate with other systems (analyzers, HIS). The laboratory is a dynamic structure and a rigid LIS can limit its development. Hence, quality and close cooperation between software developers and laboratory specialists is necessary. It is very important that biochemists define desirable LIS characteristics and suggest continuous changes which the laboratory needs. The biochemist as a user of the information system has to define needs and expectations from the LIS clearly and precisely. Future successful applications of an LIS highly depends on the care with which details are specified. Moreover, it is necessary to engage staff to cooperate during the test period for each LIS change, but also notice and report potential problems. Only an approach which implies patient and continuous collaborative work of biochemists and software developers can create an ideal LIS that meets particular laboratory needs. Thus, it holds potential to provide a stimulating environment for further development and success.

Conflict of interest statement

The authors stated that they have no conflicts of interest regarding the publication of this article.

Notes

This presentation is faithful to the original, with only a few minor changes to presentation, including the addition of PMCID and DOI when they were missing from the original reference. Grammar and spelling were updated for readability and should not constitute "sufficient new creativity to be copyrightable"; no other modifications were made in accordance with the "no derivatives" portion of the distribution license.