Laboratory Information Systems (LIS) have enabled many advances within the laboratory environment for the support of patient care. In the field of pathology/cytology, a comprehensive LIS can help cytotechnologists, pathologists, and laboratory owners efficiently meet the needs of the lab as a business. Examples include a more streamlined workflow, greater regulatory compliance, and superior reporting capabilities. Internal efficiencies often include instrument interfacing to assist with the automation of order placement and the retrieval of results back into the LIS. Externally, the LIS can be integrated with Electronic Medical Record (EMR) systems and web-based outreach solutions with each being linked to a physician office, clinic, or hospital system. The incorporation of these internal and external solutions results not only in greater efficiency, but also in the reduction of human error (by restructuring the ways in which tests are ordered, and in which results are entered and received by the ordering physician).
As early as 1983, software programs that assist with the production of large volumes of testing within this specialized field were developed to aid laboratory staff in providing accurate reports to physicians. Early systems included many of the features that are still standard today, including report distribution, data storage, and elementary data mining. Today, orders can feature the capability to support the modern requirements and unique workflows of individual laboratories, with automated enhancements that include: Bar code labeling, specimen tracking, automated and customized report delivery, reflex testing, billing system interfaces, custom report formatting, and electronic order entry, just to name a few. This provides laboratory personnel with the resources necessary to focus on what they do best: Testing specimens.
All inbound lab orders must be reconciled with a matching specimen, using the proper identifiers. Once this process has been completed, the orders are accessioned. Accessioning can occur either by entering the data manually, or by finding the orders placed electronically; the latter is considered to be far more convenient due to the enhanced automation. Then a “case” number is assigned, which follows the case through the diagnosis and to the final report. Each order is considered a unique case. Labels may be generated at this time, as necessary.
Specimens are able to be processed with greater ease and, depending on the specimen types and order type, the specimen processing follows its own specific workflow. Once processed and stained according to the specimen requirements, a cytotechnologist and/or pathologist will screen the case for any abnormalities, then enter a diagnosis directly into the software.
Within the industry, there are a few methods for diagnostic entry: (1) typing directly into the LIS; (2) using voice recognition software; and (3) working with pre-defined library items that contain canned text for standard verbiage use (i.e. The Bethesda System). One of the most common workflows includes the processing of a Pap test/smear. A Pap is obtained at the physician’s office using a non-invasive screening method for cervical cancer and infectious disease. The specimen is preserved in a vial and transferred to a single slide for screening, staining, and evaluating. When a Pap case is negative, a cytotechnologist will sign out the case and the report will be distributed to the submitting physician’s office. A standard 10 percent of these negative Pap cases will automatically be flagged for a quality review rescreen per CAP and CLIA compliance. The laboratory may also increase this percentage, if desired, for new employee evaluation or retraining purposes. Some labs and physicians allow their patients direct access to negative results through secure web portal access.
Cases that are positive for cellular abnormality should be flagged for review and sent to a pathologist for final diagnosis. LIS software should allow the pathologist to edit, add additional testing procedures, or keep the original diagnosis set by the cytotechnologist.
For high volume laboratories this workflow relies heavily on the LIS to organize cases by individual needs, sending rescreens and abnormal cases to the appropriate parties, and automatically routing finalized reports directly to their client’s offices.
Another common laboratory workflow is that which is used for histology specimens obtained from surgical specimens. The first requirement is the preliminary assessment of the whole specimen, which includes the documentation of a gross description, as well as the indication and preparation of specimen pieces of special interest (to be further diagnosed microscopically). Based on the specimen type and procedures ordered, the histotechnologist will be able to cut the wax-embedded specimen using a microtome. The specimen is then stained according to the pathologist’s findings during the gross evaluation, using the clinical information provided by the ordering physician.
Software to meet regulatory needs
Anatomic pathology software allows users to comply with certain regulations. An LIS adheres to guidelines set forth by regulatory bodies and industry associations such as Centers for Medicare & Medicaid Services (CMS), College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA) guidelines. Technologists rely on the efficient adherence to these regulatory aspects to maintain compliance without undue stress and worry, which contributes to the best practices found in the industry.
Best practice efficiencies
LIS software can be interfaced to laboratory equipment, which can help reduce errors associated with manual data entry.
In these scenarios, LIS software accepts the data (results) directly from the instrumentation, adds it to the appropriate case, and in some instances advances cases to the next step. Orders can also come directly from the LIS to the equipment, as in the case of bi-directional interfaces.
If the LIS can be integrated with a web-based outreach module, physician orders can be directly placed, along with all pertinent patient information. When the sample is collected, the LIS already has all the information necessary to rapidly process the test. Then the report can be delivered back to the physician, electronically. The physician, or their office staff, will also have the ability to track the progress of the test 24/7 via the secure login.
The key to this entire process is the final report, because the ordering physician’s report is the final product of the laboratory. The report represents all the work done by the laboratory and presents the results of the tests ordered. Because of their importance, reports should be distributed to those who ordered them in the manner in which they want to receive and view them. This includes the order in which they want to see the information, as well as the delivery mechanism of their choice (electronic, direct to an EMR, facsimile, or printed directly within the physician’s office). Highly customized report formatting is just one of the features LIS should provide.
In conclusion, a well-written and implemented LIS tailored toward the specific workflows of various laboratories will allow for increased efficiencies, assistance with regulatory compliance, and a complete report on patient health. A system that is integrated with laboratory instrumentation will allow for automated processes and will reduce the types of errors that are associated with manual data entry. Errors are also reduced when the system allows for electronic order entry, barcode requisition, and sample scanning, thus minimizing the amount of patient data that needs to be manually entered. Given the rules-based nature of advanced information systems, regulatory compliance is built into the laboratory software logic, freeing technicians to do what they do best, which is reading slides and interpreting results, without worrying about compliance issues or monitoring rescreens. Reports tailored to client preferences, with the capability to provide a complete picture of their history as well as the current results, allow physicians to treat their patients with the highest possibility for positive outcomes.