Today, most patient records, and testing and reporting procedures, are automated and computerized, speeding up processes and reducing errors. Results are available online to physicians anywhere they can access a secure Internet connection, and more refinements and improvements are continually coming down the pike as companies enhance their offerings of laboratory information systems (LIS). A major element of this is connectivity and standardization, which allows the various systems to communicate with one another.

In the first quarter of this year, Orchard Software began offering a fully integrated Anatomic Pathology module to accompany its Orchard Harvest™ LIS, according to Curt Johnson, Orchard’s vice president of sales and marketing. Johnson says the Anatomic Pathology module is extremely beneficial to customers; and that while many accounts payable (AP) departments are still disadvantaged by paper audit trails and are unable to benefit from the LIS, the Orchard Harvest LIS Anatomic Pathology module has the advantage of rules-based decision-making and the integration of clinical data between departments. He says that in an era of shrinking budgets, health care providers want software that will allow them to expand capabilities and upgrade as needed.

The AP module is fully integrated into Harvest LIS and provides direct access to cytology, pathology, and clinical laboratory results, including all historical results. A single mouse click gives the pathologist immediate access to the patient’s entire clinical history, saving time and streamlining diagnosis. This direct integration and linking enhances communication between the clinical and AP departments, allowing customers to take advantage of a shared patient database and laboratory environment, while still providing a workflow that is unique to the Anatomic Pathology department.

The Harvest LIS AP module is designed to simplify case management. It employs a “worksheet” screen with templates that can be customized to follow individual laboratory procedures or any standardized protocol. Screen prompts ensure that all required information is included, and shortcuts permit the easy addition of free-form or preformatted text, new procedures, or any number of other important actions. The AP module’s multilevel sign-out procedures allow cases to be forwarded for review and final approval.

With the Harvest LIS AP module, evaluations, correlation studies, and many other management reports can be created without the need for special programming skills. Users can search by specimen, diagnosis, test result, or case number using the system’s data-mining capabilities. The completed reports can be printed on demand, or scheduled to print automatically at a more convenient time. Orchard has also released its newest enhancement, version 7.0.

CSS Laboratory Information Systems offers LIS systems primarily to independent reference, toxicology, and large group practice labs in both the billing and outreach areas. CSS Vice President James T. O’Neill says the current 8.0 version of CLS 2000 is compliant with the Health Information Portability and Accountability Act (HIPAA) and fully automates all areas of the lab, including sample processing, direct instrumentation interfacing, quality control and assurance, remote faxing and printing, HL7 records interfacing, and secure online lab report access. LIS modules can run independently and/or be seamlessly integrated on the same platform and database. All data from previous software versions can be transferred to the most recent version of the CLS-2000 Version 8.0, regardless of the client’s current version.

It also provides an integrated or stand-alone accounts receivable system, including electronic claims, automatic payment remitting, direct payment to more than 2,000 insurance companies, and client invoicing. It is also ANSI 4010 compliant, and it can link directly to other LIS and group physician practice-management systems.

For Psyche Systems Corp, the single focus has been on clinical and pathology labs, says Brian Keefe, director of product marketing, Clinical Systems. Psyche’s LabWeb LIS product is general lab software with such components as hematology, microbiology, and blood bank modules, as well as a shared database with Psyche’s robust WindoPath anatomic pathology system. Psyche’s software employs various tools and technologies, including Microsoft’s platform for deploying applications over the Internet.

LabWeb offers all the components of a modern LIS, plus hosting technology. It is user-friendly, and it can be accessed from anywhere using a secure Web browser, Keefe says. Psyche just released a new solution for cost-efficiently interfacing with many different types of electronic medical records (EMR) and practice-management systems that use Internet and HL7 standards for easier data sharing.

The Blood Bank transfusion module is for hospital labs that wouldn’t otherwise be able, for cost and complexity reasons, to justify obtaining such a system. The module is fully hosted on the Web, and it can be purchased as a stand-alone system that can interface to the existing LIS.

Specific Products for Targeted Customers
“Many of our customers need only specific functions in the blood bank and not all the bells and whistles,” Keefe says. Psyche Systems offers a basic system that includes inventory management and specimen tracking, and is ready for the ISBT 128 labeling system.

Psyche’s e.lixa system takes a modular, a la carte approach to buying software. It was designed specifically for labs that have made significant investments in their existing information systems, but have areas of functionality they would like to add or improve. Keefe says to obtain this kind of functionality, many labs would need to buy an entire LIS system, but e.lixa’s modular approach to management, reporting, and other tasks enables it to be added on to the lab’s current LIS. “It adds on seamlessly and improves the functionality of the current system for such things as distributing patient reports,” Keefe says. “Many legacy systems can’t perform certain functions, like adding graphs to reports for physician-driven customization and distribution options, but e.lixa allows users to get only this or any other function they need and add it to current systems. It’s completely Web-deployed, very affordable, and very stable. As a competitive business, the lab’s ability to offer personalized client service is key.”

According to John Selmyer, its president, and Greg Schallert, its software and support manager, Dawning Technologies Inc is one of a few companies in the new middleware niche. “Middleware is a hot topic,” Selmyer says. “There are many companies that claim expertise, but only a small number of vendors actually specialize in this area.” Dawning specializes in communication between lab instruments and lab information systems. The company is also starting to broaden its applications focus, which includes system-to-system connectivity for reference-lab connections and other applications.

The primary element of its middleware is JResultNet Interface Engine Software, a Java-based application that can run on a variety of platforms, including LIS servers or PCs. JResultNet acts as a complete interface manager controlling all connections. It supports multiple-host system connections for clients with multiple locations and LISs and the need to track data records accordingly.

An embedded version of JResultNet runs on the Dawning JavaLin interface. “We are unique in that we have a hardware element in our product mix,” Selmyer adds. Most other vendors are software-only producers who need hardware platforms, such as terminal servers and PCs for instrument connectivity. Dawning’s JavaLin interface is a small-footprint intelligent device that connects to a lab analyzer, and communicates with the LIS over the network, providing all the capabilities of JResultNet in a small device.

The Middleware Process
According to Selmyer, specimen IDs and test orders are communicated to instruments, which communicate back with results—the time frame can vary. When a clinician wants certain tests performed on a patient, he or she enters the test orders into the system, which are delivered to the LIS as “pending.” When samples are taken and delivered to the lab, sessioning matches samples with tests, and bar codes are attached to the samples. When the specimens are checked into the lab, they are assigned IDs to show which draw is for which patient, and they are tracked through the lab process. The information is delivered to automated testing stations, and results are communicated by JavaLin to the analyzer. As specimens are scanned, IDs extracted from the database tell technicians which tests should be done. Once analysis is finished, all relevant information is uploaded back to the LIS through a middleware interface, Selmyer says. Optimally, human error is eliminated, and reformatting is done along the way so the interface is better. JavaLin facilitates this, he says.

The market also drives software development at Aspyra; and Jay Abrajano, product manager, Information Systems Solutions, says patient safety and satisfaction, and decreased budgets, are high on the list of concerns. “There is increased interest in outreach programs and CPOE,” Abrajano says. Because of concerns with Medicare cutbacks and reimbursement, facilities want to increase revenue; and labs are looking to attract lab testing from outside physician’s groups and clinics. “That means software vendors have to provide outreach solutions. Aspyra’s Web Gateway product is Internet-accessible and allows physicians to perform order entry as well as have immediate access to their results on a secure site,” he says.

Aspyra recognizes the significant role that Lean/Six Sigma principles play in today’s laboratory environment. Therefore, the company has optimized tools and features in its LIS, CyberLAB, to complement the needs of a Lean/Six Sigma program. The software streamlines operations by eliminating unnecessary steps and allowing the most efficient workflows from order entry, collections, processing, and accessing results. For example, decision-support tools in the LIS have been expanded with auto-verification functions. Based on user-defined rules available in the system, it becomes unnecessary to review every test result, since a large majority of these falls into the normal range. This allows the laboratorian to focus on abnormals while decreasing turnaround time. In addition, since more and more facilities are becoming hot zones, Aspyra’s wireless mobile collection device, CyberMATE, can further increase efficiency and productivity and reduce errors.

Antek HealthWare’s LIS includes many features to enhance communications, says Vice President of Operations Jim Kasoff. These include automatic faxing, e-mail, and secure printing of results to physicians. “We are most proud of our ability to seamlessly provide bidirectional HL7 interfaces to EMRs, practice-management systems, reference labs, and hospital information systems,” he says.

Antek’s DAQreporter provides physicians secure access to patient results from any remote location to Antek’s server. Physicians can securely access new- or prior-patient results with high-level encryption by simply accessing a PC with an Internet connection. Advanced insurance filtering is another example of enhanced communication that ties in with HL7 interfaces. This addresses situations where labs send out blood work to a reference lab that is not authorized by the patient’s insurance; the system automatically refers the sample to an authorized lab, sends the order to that reference lab, prints requisitions and labels, and electronically receives the results.

The management-review module provides a dynamic tool for lab managers to review workflow and track samples in a variety of ways (such as pending requisitions, samples not received, flagged tests, etc). It also supports batch entry of samples received from other locations. This is especially useful for larger laboratories or those that support multiple sites. LabDAQ also interfaces with hundreds of analyzers, a core functionality of any LIS, Kasoff says.

Bryan Jones, senior systems analyst at Clinical Software Solutions, says his company’s CSSWIN LIS software supports all the common interfaces for analyzers and other lab instruments, but it includes microbiology in the basic lab package—something most other LIS systems don’t do. In addition, Clinical Software Solutions offers customization so the product will fit customers’ systems. CSSWIN is Windows®-based, but support for Web and client-environment platforms is also offered.

The Clin1 Suite is an EMR system, including modules for nursing, radiology, pharmacy, medical transcription, enterprise scheduling, and order communication. “We want to support ancillary services within the hospital, and integrate with billing systems, transcription, and medical records, as well as other ancillary departments, to take clinical personnel out of the data-entry business by using electronic transmission and reusing data as much as possible,” Jones says.

Looking Ahead
Psyche Systems’ Keefe says the labs’ unique needs determine the kind of software that is developed. An example is in the push for EMRs and middleware. “Interfaces are costly for labs, so we’ve looked at EMR standardization to reduce costs. It’s an alternative to the traditional HL7 interface, which has to be written individually. We’re trying to push this into the marketplace,” he says.

Psyche Systems is also developing a microbiology software package to improve infection-control reporting. The product will roll out within the next 12 months. Also, the company’s software for specimen processing and tracking is currently in development.

Abrajano notes that image capturing is playing a bigger role in diagnosis in such areas as pathology, urinalysis, and hematology. Images are increasingly being incorporated into LIS systems. “We’re looking at putting scattergrams and access to urinalysis images directly into the lab system for future software development,” he says. “We have merged with a PACS company and are looking at incorporating PACS into LIS technology.” In addition, the LIS will increasingly encompass genomics and proteomics, Abrajano says.

Selmyer says middleware has become much more intelligent. “We no longer recognize data in one format. Instead, we restructure it and send it along. Significant decision-making is now done on the interface level. We can move closer to auto-verification procedures and the process by which results produced by labs can be examined and analyzed all the way back to the patient’s bedside, without human intervention if possible. We’re able to screen out any inconsistencies with other systems and tests. About 80% of data will be automatically delivered back to the patients’ bedsides without human intervention. This is not exclusive to middleware; it’s a function of LIS as well, but middleware facilitates it enormously,” Selmyer says.

“The health care software and information-system industry will continue to improve its integration capabilities in its quest for the single electronic patient record. Instead of dedicated point-to-point connectivity, the Internet may become a more efficient method of allowing systems to communicate. The needs of the health care industry are so broad and expansive that it is too much for any one integrated vendor to handle,” Orchard’s Johnson says.

“As genetic/molecular testing matures, the interrelation between the main lab and anatomic pathology will become more important,” Johnson says. “An integrated clinical information system with a single database shared by both departments will be necessary, and companies like Orchard Software, which is moving its products in that direction, will be positioned to meet the new needs of the molecular diagnostic industry.”

Antek HealthWare is now alpha testing three new modules with high-end administrative features. All three administration modules will enhance the overall operation of the LIS and are included in the pending introduction of LabDAQ Prism. Prism is designed to address the needs of larger clinics and hospitals. The first is for the IT department to allow network administrators to monitor LabDAQ systems. The simple network management protocol confirms that the backup systems are working, monitors available disk space, and shows error messages and who’s logged on. The administrative module can create internal user-defined calendars, e-mails, and task lists, as well as staff schedules, reminders, routine maintenance, and logs.

Another module for lab managers and administrators is a workflow-analysis module that resembles a car dashboard. This provides customizable views of critical laboratory operations in real time. How much work is scheduled this hour? How many staffers are needed per shift? Workflow is analyzed on the spot. “With so much work and not enough time, this puts the entire picture at the administrator’s fingertips,” Kasoff says.

In addition, the practice-management system can be stand-alone or integrated with LabDAQ. It also provides such features as claims processing, appointment scheduling, and electronic remittance advice, Kasoff says.

As lab and medical records personnel struggle with HIPAA compliance, Clinical Software Solutions is helping to meet and exceed HIPAA requirements by using technology, including biometrics and RFID, for user authentication, access control, and tracking.

Improvements to EMR capabilities will offer instantaneous access to patient records, bypassing the old HL7 requirements, Jones says. “Our focus will increasingly be on improving access to clinical information through the use of alternative portable devices such as tablets, PDAs, cell phones, and thin clients.”

Abrajano says the move toward standardization will continue in many areas, including patient and provider identifiers, diagnosis codes, and communication protocols and formats between systems. It will be challenging to accomplish standardization with all the programs, vendors, and health care organizations in the industry. The winner will be the standard that gains the most acceptance and is adopted by the market and agencies. And ultimately, health care and patients will benefit.

Gary Tufel is a contributing writer for Clinical Lab Products.