Integrated equipment and software solutions

Automation and workflow integration, says Dako’s Dennis E. Chenoweth, will dramatically impact the anatomic pathology laboratory.

The practice of anatomic pathology plays a critical role in healthcare delivery worldwide. In spite of this, the essential practices within the anatomic pathology laboratory haven’t changed fundamentally for several decades. When considered from a global perspective, the majority of anatomic pathology laboratories continue to utilize labor intensive workflow procedures that are organized as discrete processes, with both tissue staining procedures and patient record keeping being performed manually. As a result, the quality of tissue staining may vary; records may contain inaccuracies and inter-observer differences of interpretation are widely reported.

Change drivers
Integration of laboratory workflow through use of automated equipment and application of contemporary information technology is now providing the means to significantly improve the practice of anatomic pathology. The drivers for these changes have been fairly consistent. First, the typical anatomic pathology laboratory is now faced with the dilemma of attempting to provide an increasing amount of service while receiving less reimbursement.

Second, these difficulties are further compounded by a growing shortage of trained laboratory personnel. This problem is further compounded by the fact that both oncologists and their patients are requesting answers sooner. Thus it is common to find laboratories that are being asked to handle an increased volume while simultaneously reducing turnaround time and employing fewer people.

A third factor is the growing need to apply manufacturing quality principles and comply with quality initiatives that are being implemented by both regulatory and professional organizations. As a consequence, pathologists and their primary suppliers have been working together to identify opportunities for process improvements and introduce test methods that will provide greater consistency of tissue staining and interpretation. The introduction of automated tissue processors, slide staining platforms and image analysis systems are all examples of new systems that are aimed at addressing these needs.

The final factor that is driving change within the anatomic pathology laboratory is the need to provide accurate laboratory and medical records in this increasingly complex environment. Because laboratory workflow is fragmented, most patient-related data entry is done multiple times. Each separate instance represents an unfortunate opportunity for error. These types of problems will be accentuated as anatomic pathology laboratories are required to comply with the electronic medical records initiatives that must be fully implemented within the next few years.

New technologies
These needs can be addressed by the introduction of new technologies that can be roughly grouped into the following categories:

• systems that reduce overall laboratory costs in an era of declining reimbursements;
• process improvements that enable compliance with quality initiatives and improvement of quality to provide more consistent and reproducible results;
• introduction of information systems that improve the accuracy of diagnostic results and patient records.

High throughput automated platforms will be utilized to perform individual processes such as tissue embedding, routine staining and specialty staining. These systems will provide more consistent results and higher throughput while being much less labor intensive that the current manual methods. The individual instruments will be linked by data management software to enable data sharing and effective integration of workflow within the laboratory. As a result, overall labor costs will be significantly reduced and the total cost per slide or per reportable result will be correspondingly reduced.

These types of integrated equipment and software solutions will greatly improve workflow by increasing the visibility of each component of the process. For example, it will be possible for a pathologist or laboratory manager to utilize these systems to track the progress of any sample in the laboratory, monitor test status, order new tests, diagnose instrument performance and order additional inventory at any time. Furthermore, digital image analysis systems will permit the pathologist to view slides and make accurate diagnoses while at remote locations and be able to share these images with the primary care physician while consulting.

All of the improvements envisioned here are currently being developed and it is expected that they will be introduced in the near term. As a result, anatomic pathologists will be well positioned to respond to the demands they face today and improve the services they will be asked to provide. These dramatic changes are expected to contribute greatly to cancer diagnostics and patient care.

Dennis Chenoweth began his career in the private sector as a Vice President at Baxter healthcare and subsequently spent more than 20 years in industry. He served as a Corporate Vice President for the Pathology Group and of Business Development at Dako prior to his retirement in July 2007.