I am in the process of accomplishing one of my new years resolutions to become Black Belt certified in Lean Six Sigma. I am two thirds of the way done. I became certified as a Six Sigma Green Belt in April and Lean certified in June; both with a focus in healthcare.  I am currently in the process of taking my black belt course and working on a project for certification.  These days Lean Six Sigma methods are constantly running through my head and I have applied several methods to my consulting work.

The power of Post-It's and moveable whiteboards!

One of my favorite tools are Post-its and take anywhere, disposable white boards.  I use them on-site with clients and I also use them in my office, ALL over my office.  So in an ongoing effort to immerse myself more in Lean Six Sigma for the lab I turned to one the leaders of Lean Six Sigma in pathology, Henry Ford Hospital.

Dr. Mark Tuthill, Division Head of Pathology Informatics, was kind enough to give me a tour and WOW was I impressed.  Yes.. it was a big WOW! My last blog post was about creating WOWs instead of waiting for them to happen.  This is exactly what Henry Ford’s department for Pathology and Laboratory Medicine has done and continues to do, because striving to improve is never complete!  You know from the moment you enter the department you have walked into a remarkable place.  Placards are prominently displayed with powerful messages including:

Every Life Deserves World-Class Laboratory Service”

Lean Six Sigma is a management philosophy and their department is lead by prominent pathologist Dr. Richard Zarbo, who clearly embraces the power of Lean Six Sigma.  The entire department is involved and committed to continuous improvement; a fact that would make their founder, and the father of Lean, Henry Ford proud.

Here are some of my take-aways from my visit.

• Silence is golden! Dr. Tuthill brought to my attention, while standing in the gross lab, how quiet everything was. This quite and calm environment continued throughout the AP lab too.  The department has moved away from transcription and voice dictation and developed templates that integrate into their LIS.
• Process improvement takes time and really is continuous. This is a fundamental of Lean Six Sigma but was reinforced throughout my department tour.  White boards are all over to illustrate how new processes are mapped, monitored, and certain boards engage employees to document defects on an ongoing basis.  Defects, as defined in their publication “Effective Reduction of Process Defects and Waste In Surgical Pathology,” are forms of waste including flaws, imperfections, or deficiencies in specimen processing that required work to be delayed, stopped, or returned to the sender.  Here are some pictures of their whiteboards and process flow charts:

Gross Room: Process Flow Chart

Defect Tracking

• A very visual environment. Everything, and I mean EVERYTHING was labeled- even gauze.  The department loves 5S and Kanbans and you can tell.  You never have to question where something is, where it should go, or if there is more available.  It’s a straight forward concept but is your lab like that?
• A foundation for success! Henry Ford has been working hard to prepare their lab and department for their digital future over the past few years (while also reducing costs, improving patient safety, and laboratory efficiency). Their entire process is barcoded from accession to sign-out.  The laboratory uses barcode technology from General Data, and even assigns barcodes to requisition forms that are scanned to eliminate paper in the lab.  The gross lab is set up with a Milestone gross imaging system,  digital cameras are mounted on grossing tables and pathologists microscopes.  The cameras are then connected via a TWAIN interface to PathPacs, their middleware software by Apollo.  PathPacs is integrated with their Sunquest CoPath Plus LIS and allows the pathologist to choose and select images to be in the LIS and reports.

Can you guess their next step for their digital future? Digital Pathology!   With the foundation described above, a Lean Six Sigma culture, and a management team with vision I have no doubt that they will be successful.  Thank you Henry Ford Hospital for your level of excellence, you truly are a gold standard.

I attended Pathology Visions last week (more on that later…) which is organized by the Digital Pathology Association (DPA).  The DPA released on Tuesday two white papers; 1) Interoperability between Anatomic Pathology Laboratory Information Systems (APLIS) and Digital Pathology Systems and 2) Archival and Retrieval in Digital Pathology Systems.

The white papers are good and provide vendor neutral information to help the digital pathology industry and consumers.  Here are the abstracts and a few of my favorite points from each:

Archival and Retrieval in Digital Pathology Systems

This white paper frames the issues related to Archival and Retrieval of images and associated data as Anatomic Pathology laboratories adopt a digital imaging workflow in a research or clinical setting. This overview also includes a brief discussion of some of the solutions being developed and offered in digital pathology systems (DPS’s).

DPS’s start with creation of a whole slide image and provide an imaging workflow for pathologists by associating the images with a patient and case and furnishing the tools to review the cases digitally. Whole slide images (WSI) are very large and will drive the need for extensive storage and information life cycle management. Customers seek options for fast access to high quality and highly available data, when they use the DPS in a business critical application. Most importantly, since DPS’s are deployed in regulated environments, data reliability, privacy, and security need to be built into the solution and its management process.

Solutions that are being developed and deployed in digital pathology systems are also presented.

Favorite points:

• WSI are about 10x that of Radiology images.  The white paper talks about an average, compressed image size and the storage and network requirements needed to support a DPS for different size programs.
• The importance of data integrity, reliability, and audit trails for HIPAA, CLIA, and FDA compliance.
• An overview of Image Life Cycle Management (ILM) and important decision criteria.

Interoperability between Anatomic Pathology Laboratory Information Systems and Digital Pathology Systems

This white paper offers an overview of the current state of interoperability between Anatomical Pathology Laboratory Information Systems (APLIS’s) and Digital Pathology Systems (DPS’s). This overview also includes a brief discussion of future work that will impact interoperability.

Both systems rely on data from the other to efficiently deliver full digital imaging functionality to the healthcare provider. Anatomic Pathology (AP) departments and patients will benefit most from imaging workflow when there is a high degree of integration of Digital Pathology information within AP workflow. Implementations of such data sharing already exist via interfaces and standard communication protocols between APLIS’s and DPS’s, and work continues on these interface standards to improve the degree to which these systems can be used together.

The current state of interoperability provides Pathologists with access to images and image analysis data from within the APLIS or the DPS. This information is then available to the Patient Report.

Favorite points:

• In depth analysis and information about digital pathology and the AP Lab workflow
• Examples of current interoperability implementations between the APLIS and DPS
• Dealing with network and security issues for outside consultations
• The importance of barcodes
• Understanding the difference between compatibility and Interoperability

Below is an article I wrote for ADVANCE for Laboratory Professionals, Perspectives In Pathology.

Putting the Digital Pieces Together

By Amanda Lowe

Digital pathology is often described as the scanning of a glass slide into a whole slide image; yet, it is much more. It is so much more, in fact, that pathologists and laboratory professionals find themselves puzzled with how it will affect their future. As technology progresses, we must start to understand how to put the pieces of it together—from acquisition to integration to data management and interpretation.

Acquisition

Acquisition of a whole slide image from a glass slide is done on a slide scanner, which creates the image necessary for interpretation. Important elements of slide preparation and patient information can make the acquisition process simple or complex.

Slide preparation is a crucial and often overlooked element of digital pathology. Pathologists can handle slide artifacts such as folds and air bubbles under a microscope; slide scanners are not always as forgiving. Also, staining has to be perfected, not only for scanning but for accurate interpretation and use with image analysis software. Poor staining can result in tissue not being scanned, inaccurate image analysis data—and in the worst case—a wrong diagnosis.

Traditionally, when glass slides are prepared, they are manually matched with the patient paperwork (including patient history, requisition and gross review), then delivered to the pathologist. With digital pathology, the process looks different. You now have whole slide images that need to be reconciled to the digital patient paperwork, then delivered to the pathologist. The only way to do this is with a laboratory information system (LIS), electronic medical record (EMR) integration, and bar codes. Bar codes will reduce human error, save time on the constant need for verification and re-checks, and improve quality assurance by tracking all specimens throughout the histology process.

Integration

The LIS and often the EMR need to share information with the digital pathology software to create a pathology picture archiving and communication system (PACS) that consolidates all patient paperwork, gross images and whole slide images for interpretation. This is the most important but also the most difficult piece for labs to handle. The process can be costly and require collaboration of two or more vendors, which can be a frustrating and hard process to manage. However, it can be accomplished with a plan, a budget and someone to manage the project.

Data Management

Many hospitals do not have adequate IT resources or the expertise to handle their already stressed storage demands. Yet these whole slide images have to be stored somewhere. Unfortunately, most IT departments do not understand the fundamentals of digital pathology. Pathology leaders and their lab personnel must improve communication with their IT departments and take an active role in educating IT on the realistic needs of the department now and over the next five years. Hospitals have to prepare for the increase in lab data and pathology images that will soon be their future.

To estimate your whole slide image storage needs, divide the number of surgical slides your lab generates per year by 3,500 to get an estimate of terabytes needed annually; 3,500 is the average number of whole slide images per one terabyte.

Healthcare providers are required to save medical records for a specified time; for most, this is a minimum of seven years. Security is not optional, and HIPAA mandates backup and disaster recovery plans for patient records, including all medical images. The specialty of pathology will not be an exception to the rule.

Interpretation

One goal of digital pathology is to enhance the sign-out process for pathologists. Pathologists should be able to sit down at a computer monitor to sign out digital cases retrieved from a pathology PACS system. Easy access to archived cases for disease progression or comparison, rapid case sharing and consultations, data mining for decision support and image analysis will all help improve the diagnostic process.

Powered by the rapid and endless growing portfolio of image analysis algorithms, pathology will transition from a qualitative to a quantitative discipline. Digital pathology partnered with image analysis will create the infrastructure necessary so pathologists can confidently determine the severity of a disease and predict responses to a target therapy.

Digital pathology streamlines laboratory workflow, enhances the sign-out process, and can improve diagnostic outcomes and treatment responses for patients while at the same time forge a new foundation for the use of pathology data to drive translational research and higher standards of care.