What's the buzz on anatomic pathology?

April 1, 2010
Tumor classification transcends tissue of origin

Pathologists, oncologists, and pharmaceutical
companies will recognize that individualizing oncologic therapy requires
technology agnostic identification of biologically homogenous tumor
classes. The work-up of new cancer diagnoses will include morphology,
immunohistochemistry, gene-expression measurement, and detection of
mutations and translocations in DNA that are carefully selected to
identify groups of patients highly enriched for response to
therapeutics. These histologic and molecular classes will transcend the
tissue of origin of the tumor and lead to more rationally designed
clinical trials, resulting in higher response rates and clearer choices
for patients. Personalized medicine in oncology will be recognized as
the domain of pathologists — who are situated perfectly to interpret
this complex and diverse classification data.

Doug Ross, MD, PhD
Chief Scientific Officer
Maker of
Insight DX Pulmotype and

Insourcing and outreach impact revenue

While numerous issues impact anatomic pathology, two directly impact revenue. Growth of physician insourcing of histology labs: With increasing federal regulations associated with purchasing services from an outside entity, physicians are investigating the in-office histology laboratory as a means to increase revenue and efficiency, and cut the "apron strings” pathologists have with hospitals. Cost, regulations, and payor reimbursement will be important factors in this model. Growth of hospital laboratory-outreach programs: Many hospital laboratories are developing laboratory-outreach programs to enhance hospital revenue and remain players in their geographic areas. Various regulations will play an important part in developing such programs.

Bob Weathers

Specialty Vice President
Pathology and Laboratory Medicine
McKesson Revenue Management Solutions
Provider of Revenue Cycle Management,
Access Management, and
Enterprise Revenue Management

Reducing healthcare costs

Emerging technologies such as molecular testing, pattern recognition, computer-aided diagnosis, and whole- slide digital imaging are tools pathologists will utilize more effectively to augment their main tool — the microscope. In an effort to reduce the cost of healthcare and, at the same time, provide better patient care, hospitals are consolidating and/or divesting their pathology and outreach services while the industry focuses on the effective utilization of the electronic medical record. Additionally, advances in tissue-processing technology and in specimen tracking will result in workflow enhancements with a Just-In-Time/LEAN-Six-Sigma mentality. These factors and others influence the way in which vendors are effectively utilizing their development resources.

Wally Soufi
Chief Executive Officer
Maker of NovoPath
Anatomic Pathology Software System

Critical foundation needed for new pathology applications

Digital-pathology applications and their integration into the laboratory information system (LIS) is, by far, the most talked about news item in anatomic-pathology (AP) information systems. Fundamental to their successful implementation, however, is the less glamorous — but absolutely critical — foundation of asset tracking and workflow management. Without the adequate LIS capabilities in place, digital pathology becomes the highly accurate, highly precise final step in a process otherwise laden with inefficiencies. Perhaps more laboratories will be able to justify the costs of a digital-pathology implementation, but
all laboratories will benefit from an LIS which manages workflow and builds a solid foundation for a future digital-pathology implementation.

Michael Mihalik
Vice President, Sales
PathView Systems
Maker of Progeny AP Information System

Alignment of pathologists and clinical labs

To maintain their market share and financial stability, pathologists are taking a more active role in the clinical-outreach labs at their affiliated hospitals, where they often serve as medical directors. This alignment of clinical-outreach programs with independent pathology practices provides opportunities for hospitals and pathologists through combined financial-reporting methodologies and trending in the referring physician markets. This, in turn, allows hospitals and pathology practices to make more informed business decisions regarding growth and client maintenance while leveraging their relationship in the community healthcare system.

Randal Sanderson
Vice President
Business Development
PSA, a MED3OOO company
Maker of PathLab Coding Solutions

Expansion of test offerings with pathology testing

The latest trend and movement in the clinical and anatomic-pathology lab is the expansion of test offerings. Many clinical labs are adding pathology testing, and many pathology labs are more tightly integrated with the clinical patient histories than ever before. This trend is due, in part, to two major business functions: 1) to increase services, reimbursements, and growth for the lab, and 2) to leverage efficiencies, IT infrastructure, lab space, and staff, and drive better patient care and outcomes. Laboratories will better accomplish these goals by implementing solutions that are truly seamlessly integrated for both the clinical and AP labs while offering the features, functionality, and workflow that are unique to each lab.

Lisa-Jean Clifford
Chief Executive Officer
Psyche Systems
Maker of WindoPath AP System

Value-added AP, cytology, and autopsy solution

Implementing a value-added AP solution that integrates with your hospital's LIS not only improves workflow and productivity but also improves your standard of patient care by providing a comprehensive report going across CP, AP, and genetics that is visible in PDF form on the hospital's electronic medical records (EMR). The amount of data and significant findings a pathologist is expected to report continues to increase. Digital pathology is an emerging technology that answers the ever-increasing expectations of the pathology lab. The continued pressure for labs to contain costs, the emphasis on clinical diagnostics and early diagnosis of disease, and the growth of molecular diagnostics are all factors affecting the AP environment today. LIS/AP providers on the forefront of clinical information must be able to respond to advances in the industry. Once digital pathology is integrated into the LIS, it is possible to share images and data with EMRs, setting the stage for more widespread adoption of digital-pathology systems. We have worked toward providing anatomic pathology, cytology, imaging, and autopsy information systems, which offer a total solution for AP labs, and also address the needs of today's progressive pathologist to ensure a tighter connection between the clinical LIS, genetics, and the AP information solution.

Gilbert Hakim
Founder and Chief Executive Officer
SCC Soft Computer
Maker of SoftPath

Interfacing path instrumentation and delivering reports to EMRs

The following trends in pathology are affecting information systems' use, and desired features. The overriding question is how quickly pathologists embrace the value of informatics and the codification of diagnosis for synoptic reporting and improved data mining. We already see the increased use of microscopes with the capability to capture and store digital images, and the use of digital imaging to formulate a diagnosis is on the horizon as well. With these advances in digital imaging for pathology comes an increased desire to annotate and include such images within the patient report. Requirements to improve and streamline the workflow of processing and reporting are increasing. Interfacing pathology instrumentation for positive sample identification is key to reducing errors and allowing the pathology laboratory to move away from the inefficiencies associated with batch processing. Also, we see the growth in molecular and genetic testing and how it is bringing together the disciplines of clinical and anatomic pathology for more sophisticated diagnoses and reporting. Finally, in addition to what is happening in the lab, as the penetration of EMR systems increases, delivering these reports to providers' EMRs will become more important.

Keith McKinney
Senior Marketing Product Manager
Orchard Software
Maker of Orchard Pathology
Diagnostic Information System

More flexibility in tissue processing

Throughout the years, the trend for tissue processing in histology laboratories went to floor-standing models using one or two process chambers. This kind of technology reveals significant disadvantages like the lack of flexibility and frequent technical problems caused by pumping hot paraffin. The user can typically run only one program of about 100 or 200 cassettes in parallel. Once the lab needs different programs or a higher capacity at the same time, it requires additional units. These disadvantages resulted in the development of our new bath system, which offers the capability of processing three different programs simultaneously and independently, with a total capacity of 660 cassettes. The user is able to run fast biopsies, normal and long-running processes at the same time, with only one instrument at half the cost The risk of losing biopsies due to pumping problems is eliminated since the system provides separate paraffin containers.

Michael E. Ott
Maker of TPC 15 Trio Tissue Processor

Web outreach reduces potential for errors

Web outreach is a mainstay in general clinical lab work. Likewise it will become an adjunct to AP and cytology lab work by offering direct access via secure Web connections (lab portals) for convenient, error-free ordering that precludes the possibility of pre-analytic transcription errors inherent in paper systems. Web outreach and the software behind it also helps technologists and pathologists manage the transportation, receipt, integrity, and examination of specimens along with maintaining demographic and clinical history data. Reporting of finalized results, interpretations, and diagnosis is convenient, fast, and free of potential post-analytical errors because the process is almost entirely electronic from end to end.

Andrew McLean
Marketing Representative
CSS West
Maker of WebOrdersView and WebResultsView

The advent of diagnostic workstations

Integrated diagnostic workstations are “the next big thing” for anatomic pathology labs. They will enable integrated and efficient management of whole slide images (virtual glass slides), gross pathology images, radiology images, LIS, EMRs, and decision support software for pathologists. The integrated diagnostic workstations effectively use digital-pathology software for a wide variety of applications, including case archiving and retrieval, image analysis, remote consultations, primary diagnosis, and real-time collaboration. Diagnostic workstations have been successfully used in other specialties, such as radiology and cardiology, to produce operational efficiencies and improve patient care. By bringing digital pathology together with other medical imaging and patient information, the integrated diagnostic workstations are poised to elevate pathologists to the role of diagnosticians at the center of patient care.

Ajit Singh, PhD
Chief Executive Officer
Provider of digital pathology solutions
Virtuoso and iScan scanners

Digital gross image standardization

Over the last several years, we have witnessed a progression in gross image capture from simple images of either interesting and unusual cases to a true “chain of custody” principle for the entire grossing process. Standardization and documentation, using high resolution images with annotation, measurement, audio and video enhancements is quickly becoming commonplace in many of today's grossing labs. The ability to integrate gross digital imaging systems with either a PACS system or directly with the LIS provides for a seamless capture and transfer of data for management and reporting activities. We see concepts like telepathology, radiology-pathology convergence, and diagnostic EMRs as future technologies driving the digital gross image to become an imperative in the future. Continued advancements in both still and motion digital-image capture, along with higher speed computer processing and miniaturization will offer new options for portability and true mobility of this evolving tool. Ultimately, this technology will contribute to a comprehensive report that patients can view and understand as a key component for making informed decisions about the treatment of their disease or health status.

Dave Sanford
General Manager
Milestone U.S.
Maker of MacroPATH D

Three-minute cryostat disinfection

Recent studies highlight the inadequacy of cryostat safety today due to infection risks. Cryostat safety requirements lag far behind all other areas of the laboratory where fresh tissue and sharps, such as needles or blades, are used. Cryostats cut fresh frozen tissue daily in clinical laboratories and are only required to be disinfected weekly due to the time-consuming process. Nowhere else in laboratories are healthcare workers required to use equipment that is contaminated from up to a week's worth of use. The focus on cryostat-disinfection methods is increasing as laboratory regulations become more stringent. Disinfection methods are evolving to provide users the protection they deserve in a time frame that is manageable in today's busy laboratory environment. The automated disinfection methods of the future will need to be fast enough to be used during daily workflow, safe enough to not pose additional safety risks, and able to completely disinfect the cutting chamber. Users deserve to be protected throughout every single day.

Tyler Liebig
Product Manager
Histology Instrumentation
Thermo Fisher Scientific
Maker of Thermo Scientific Cryostats

Web enables telepathology

What we have observed is an increase in the need for electronic imagers and applications that can work from multiple geographies over the Web. This trend has caused a significant increase in the demand to collaborate and share data between pathology groups and external/remote pathologists and allow remote users to review slide images, add their findings, and sign cases remotely. Some of our recent product enhancements cater precisely to this telepathology collaboration.

Rami Jaschek
Vice President of Technology
Maker of AutoLims

Sponsoring the digital pathology age

Being a Founding Gold Sponsor of the Digital Pathology Association (DPA), the advancement of digital-pathology applications and the automation of the pathology workflow enhances both speed-to-diagnosis and improved patient healthcare. We entered a collaborative effort with Massachusetts General Hospital and Partners HealthCare System to develop the next generation of AP-based LIS. We seamlessly connect with numerous standard lab-imaging interfaces in order to enhance utilization and flexibility.

Kelly Feist
Vice President of Marketing
Sunquest Information Systems
Provider of healthcare diagnostic information
technology and outreach solutions

Genetic testing comes to skin cancer

We recently completed a 500-sample validation study for our new genetic melanoma FISH test with 97% specificity and a 98% NPV. Melanoma has challenged pathologists for decades with a histological gray zone, and has become the most litigated area within the cancer-diagnostic arena. We were asked by the dermatopathology community to develop a test with high specificity (i.e., a very high negative predictive value) which would add a significant degree of confidence in determining a normal diagnosis. The addition of this new genetics test in the melanoma-testing algorithm is expected to save hundreds if not thousands of lives per year.

Bob Gasparini
President and Chief Scientific Officer
NeoGenomics Laboratories
Maker of MelanoSITE