Cytology information systems

Oct. 18, 2013

Laboratory information systems have enabled many advances in the laboratory to support patient care. In the field of cytology a comprehensive laboratory information system can help cytotechs, cytologists, and laboratory owners efficiently meet the needs of the lab as a business, including streamlined workflows, regulatory compliance, and superior reporting capabilities. Additionally, the cytology LIS can be integrated to EMRs and outreach solutions as well as provide full lab automation through connections to instrumentation and physician offices, all supporting the reduction of human error and streamlining test order entry and results retrieval.

As early as 1983 software programs to assist in the production of large volumes of testing handled by cytology laboratories were developed to aid laboratory staff in providing accurate reports to physicians. Early systems included many of the features that are still standard today, among them reporting, data storage, and elementary data mining. During the past thirty years software has made significant leaps in capabilities; we now have the ability to tailor the software to support the unique workflow of individual laboratories with automated enhancements (barcode labeling, specimen tracking, automated and customized report delivery, reflex testing, billing system interfaces, and more), providing users with the resources necessary to focus on their primary functions: processing and resulting tests.

Workflow and cytology information systems

There are a host of cytology information systems that offer a variety of customizations to fit the cytology lab’s needs. The core of a good cytology LIS is the ability to apply case numbers to each case as laboratories enter orders and receive specimens (either through paper requisition or electronic orders) as the case is accessioned. The LIS will then be able to automatically produce labels for each specimen for tracking purposes throughout processing and storage.

Once the processing and staining have been completed, the cytotech can screen a given case and enter a diagnosis directly within the software, either by typing directly within the window or through voice recognition software. Whether the laboratory uses Image Guided screening or manual screening methods, the software should enable easy notation for each slide through keyboard macros (shortcuts) or voice recognition with feedback.  Some systems offer digitally spoken vocal feedback that lets the cytotech hear what data is being entered as it relates to each slide. Every possible descriptor should be coded from the slide reading to recommendations and diagnosis for easy data entry, allowing cytotechs and cytologists to focus more on the slides and less on the software used to capture the data.

Typically, negative cases will have a standard adequacy and category so that the case can be signed out by the cytotech and the report distributed to the client. A certain percentage of these normal cases will automatically be flagged out for rescreen based on any parameter the lab sets or the standard 10%. Some applications allow the lab to define rescreen rates per employee, supporting the evaluation and training of new employees or those that have been identified as having a need for retraining. Some labs or physicians are allowing patients direct access to negative results as provided by a progressive LIS vendor through secure web portal access.

Cases that are positive for abnormal cytology are sent to the pathologist flagged for review. The laboratory information system should allow the pathologist to edit or keep the diagnosis set by the cytotech and finalize a case, allowing for the report to be generated and delivered to the ordering physician.

For high-volume laboratories this workflow relies heavily on the LIS to organize cases by their needs, sending rescreens and abnormal cases to the appropriate parties and automatically routing finalized reports directly to clients.

Meeting regulatory needs

Well written laboratory software will ensure that users comply with relevant regulations as well. Laboratory information systems should adhere to guidelines set forth by government agencies such as CMS and FDA, as well as CAP and the CLIA guidelines. Good software logic looks at the workflow and allows users access only to what they are allowed to perform by the official regulations, and sets up unique, individual user accounts based upon access rights.

The cytology LIS can report on the CLIA’s maximum-slide-per-day limit so cytotechs know when they are approaching their daily limit, and will not allow them to exceed it.

Other efficiencies

A laboratory information system that is interfaced to laboratory equipment will reduce errata associated with manual data entry. The LIS can accept the data directly from the screening instrumentation, add it to the appropriate case, and flag for review by the cytotech. Abnormal case findings, as well as a percentage of normals as defined by the lab, can be automatically rescreened and flagged for review. Orders can also come directly from the LIS to the equipment, in a bi-directional interface.

If the LIS is integrated with an outreach module, orders from physicians can be directly placed via the Internet along with all pertinent patient information so that when the sample is collected the LIS has all the information necessary to rapidly process the test. Then the report can be delivered electronically back to physicians. The physicians, or their offices, will also have the ability to track the progress of the test via the secure login 24/7.

Reporting results

At the end of the day the final report to the ordering physician is the product of the cytology lab. The report indicates all the work done by the laboratory and the results of the tests ordered. Reports should be distributed to those who ordered them in the manner they want them—in the order they want to see the information, at the time they prefer, and through the delivery mechanism they choose (electronic, direct to an EMR, faxed, or printed directly within the physician’s office). Customized reporting is just one feature of a good cytology laboratory information system. But it is the final product that customers receive, and as such it gives customers a lasting impression of the service they are receiving. How it is perceived can be a major factor in maintaining a good relationship between the lab and its customers.

In addition to current reports for individual patients, the software should be able to look up patient history to provide a complete and accurate picture of patient health and how it relates to tests ordered. Archived cases should be searchable to provide helpful insights into patient health over long periods of time (five years, ten years, etc.).

To sum up, a well-written and -implemented LIS, tailored toward the specific workflows of a cytology lab, will allow for increased efficiencies, regulatory compliance, and a complete report on patient health. A system that is integrated with laboratory instrumentation will allow for automated processes and reduce errors associated with manual data entry of results. Errors are also reduced when the system allows for electronic order entry, barcode requisition, and sample scanning and reduces the amount of patient data that needs to be entered at sample collection/receipt. Given the rules-based nature of advanced information systems, regulatory compliance is built into laboratory software logic, freeing technicians to read slides and interpret results without worrying about compliance issues or monitoring rescreens; the software does that for them. Reports tailored to client preference, with the ability to provide a complete picture of the history as well as current results, provide physicians with the information necessary to treat their patients with the best possibility for positive outcomes.

Lisa-Jean Clifford is CEO of Massachusetts-based Psyche Systems Corporation. She has more than a dozen years experience in the healthcare high-tech field.