Lab Soft News

Cytopathology Imaging Presented at ASC Annual Meeting

A previous blog addressed the issue of the adoption curve for digital imaging in pathology and made reference to a 2005 article in CAP Today which presented the results of a survey of attitudes about the topic among pathologists. The article noted that cytopathology ranked quite low in terms of the integration of images into reports.

Patty Anderson, manager of national accounts for Olympus America has played a vital leadership role in this area by working with the cytopathology personnel to create enthusiasm and interest for imaging. Her activities culminated in a panel luncheon entitled New Horizons in Digital Imaging at the American Society of Cytopathology (ASC) annual meeting on November 5, 2005, in San Diego. Here is a list of the educational objectives underlying that panel presentation:

To understand the strategic direction and goals for pathology oriented digital image transmission and storage in the near future

To understand the goals of the Association for Pathology Informatics (API) in the development of a Data Exchange Specification for digital images in pathology as part of the Lab Digital Imaging Project (LDIP)

To understand the value of a digital image in enhancing the communication between pathologist, clinician, and patient

To understand DICOM and PACS and how pathology can take advantage of these technologies for image capture in their practices

To provide information about the benefits of image capture in pathology reporting, education, competency assessment, and proficiency testing

To understand how digital imaging may be used in the recertification and proficiency testing of cytology professionals, using capture and storage, network based assessment testing, and virtual screening

Barbara Guidos of the ASCP also participated in the planning and presentation of the ASC panel.  Her special interest is the use of imaging in cytopathology education, recertification, and proficiency testing. 

The panel luncheon was so enthusiastically received by the members of the ASC that Patty is already planing an expanded version of it at the nest annual meeting.  Efforts are also underway to establish pilot cytopathology imaging projects at large medical centers to demonstrate the value of this technology.

Abbott Diagnostics Announces Relationship with Omnilab

In a previous blog, the relationship between Abbott and P.G.P., a Belgian lab software company, was mentioned in relationship to Abbott's Accelerator Decision Manager.

Abbott also announced in January of this year, a middleware relationship with an Italian lab software company, Omnilab, for a Glasgow site. Here is a quotation from the Omnilab press release:

Omnilab has been selected by Abbott Diagnostics as the supplier for a seven-year tender to provide a software application to interface the pre-analitycal instrumentations and the diagnostics analyzers instruments to the Laboratory Information System in the Greater Glasgow Health Board (GGHB) community.

Reference Labs in the Lab Software Business

There is a relatively long history of commercial reference labs participating in the lab software market.  For example, Specialty Laboratories, recently acquired by Ameripath, developed a lab portal product called Outreach Express which it has decided to sunset. Specialty still offers a separate lab portal product called DataPassportMD to those hospitals that send their lab specimens to Specialty. Jack Redding, who was the point person for software sales at Specialty, now works for Labtest Systems, one of the leading vendors of lab portal software.

Along similar lines, LabCorp announced in February, 2005 a relationship with Medicity, a provider of web-based clinical computer applications. The two companies plan to offer an on-demand lab test ordering and results as part of Medicity's hospital portal product.

Quest acquired MedPlus in April, 2001. Two of MedPlus' products are ChartMaxx, an electronic medical record, and eMaxx, a physician portal. The eMaxx product has now merged with Care360 to form a system that enables physicians to view medication histories for their patients, check pharmacy plan eligibility and formulary information, and write prescriptions electronically in addition to test ordering and test results retrieval. The precursor to eMaxx was one of the earliest lab portal products in the market which was called LabPortal. In April, 2003, Quest had acquired American Medical Laboratories and an affiliated company of AML, LabPortal.

Bio-Reference Clinical Laboratories has a software product which entered the market as CareEvolve but has now "evolved" into a lab portal product called LabEvolve, which supports lab outreach order-entry and results-reporting. The software business unit of BRLI is still called CareEvolve.

All of this activity clearly suggests that the major national reference labs view software, most particularly lab portal software, as strategic for their core business.  This makes perfect sense in the outreach market when the lab's software product has the ability to facilitate order-entry and results-reporting (and other outreach support functionalities) from physicians' offices. 

Reinventing Direct Access Testing (DAT)

BioPhysical Corp. recently launched a direct access testing (DAT) product in the Texas market unlike any other available at this time. It's called the BioPhysical 250 which is a mega-panel of 250 different biomarkers that is being offered direct to consumers. Here is the link on the BioPhysical web site which displays a sample report listing the entire set of biomarkers comprising the panel.  I am a member of the BioPhysical Medical Advisory Board.

The founder of BioPhysical is Mark Chandler who also started Luminex which pioneered the use of patented multi-analyte profiling (MAP)technology to measure analytes based on flow cytometry, microspheres, lasers, digital signal processing, and traditional chemistry methods.  This approach permits the measurement of multiple analytes in a single serum sample with minimal reagent use. Chandler is also the founding director of Rules Based Medicine which is a reference lab that provides MAP analysis for the pharmaceutical industry in support of basic research and clinical trials.  Rules Based Medicine performs approximately 65% of the tests comprising the BioPhysical 250 panel.

Previous DAT ventures have offered routine sets of lab tests to consumers similar to the typical hospital screening panels. Here are the DAT panels offered by Results Direct, which is an established DAT provider in Spokane, Washington. In many ways, the test offered by BioPhysial appears to be a forerunner of the broad health screening panel of the future based on advances in proteomic biomarkers.

New Design and Format for CAP Web Site

Check out the newly redesigned CAP web site here. For a sample of some of the valuable content on the site, click on the Reference Resources and Publications tab at the top. Then click on the Outcome Templates in the Practice Resources list in the upper left portion of the page. The Introductions at the top of the page describe these Outcome Templates in the following way:

The patient outcome templates are an education-based, information toolset to help guide pathologists in leading outcome measurement studies in their local institutions. Each patient outcome template consists of downloadable files containing the following components:

Pathologist Summary: Two to three pages of text summarizing the disease, its prevalence and morbidity and mortality data.
References: A list of appropriate citations from the medical literature.

The following disease templates are provided:

Cystic Fibrosis: Improving Health Outcomes Through Detection of Carrier Status
D-dimer as an Element of Clinical Algorithms for the Evaluation of Deep Vein Thrombosis and Pulmonary Embolus in the Emergency Room Setting
Hemoglobin A1c: Improving Diabetic Outcomes
Hereditary Hemochromatosis
Identifying and Managing Acute Transfusion Reactions
Improving Outcomes in Established Coronary Artery Disease LDL Cholesterol
Oral Anticoagulation in Atrial Fibrillation To Prevent Stroke Indicators

Public Health Informatics Update

This blog on public health informatics was triggered by a recent press release that Science Applications International (SAIC) has been awarded a $27.6 million contract to support the CDC in the design, development and implementation of the National Electronic Disease Surveillance System (NEDSS) Program Area Modules (PAMs) and CDC Area Modules (CAMs). The NEDSS project is CDC's public health initiative to provide a standards-based, integrated approach to disease surveillance in state and local public health departments.  A key objective for NEDSS is to improve the nation's ability to identify and track emerging infectious diseases, investigate outbreaks, and to monitor disease trends. The PAMs are disease specific and designed to run at health departments nationwide, with or without the NEDSS Base System.  Modules for tuberculosis, varicella, and lead poisoning will be the first PAMs released by the CDC. CAMs are designed to reside at the CDC as part of the CDC external Web presence. Bold face emphasis is mine.

So here we have a contract between the CDC and SAIC for software to be developed and deployed in the various state health departments (PAMs) and at the CDC (CAMs). Pressure for such a nation-wide public health surveillance system has obviously been on the front-burner since 9/11 because of the need for early detection of bioterrorism.  Needless to say, there has been, and will continue to be, pressure on hospital and reference labs to become more closely linked and integrated into such a national system. The first signs of a bioterrorism attack may well be detected in hospital emergency departments, perhaps by syndromic surveillance computer programs. Germane to this, check out syndromic.org. Mandatory infectious disease electronic reporting to state public health labs and authorities will undoubtedly occupy more and more of our time and energy in the months ahead.

CSC has also collaborated with the CDC in the past to develop and build-out of NEDSS.  Here is a cut-and-paste from the CSC web site about this topic (emphasis mine):

The NEDSS initiative was officially born in 1998. Late in 2000, CDC contracted with CSC to lead development of a NEDSS-compatible Base System to be offered to state health departments and eventually to other organizations. The NEDSS Base System (NBS) enables data entry via the Web, electronic interchange of laboratory data, and an integrated data repository for data pertaining to multiple diseases. An important part of the NEDSS initiative is the propagation of standards for public health information systems, including a push to use industry data standards whenever possible. These standards mean that many systems, not just the Base System (whose use by states is optional), will interface with NEDSS.

More on this very juicy and relevant topic later.

Fleury Diagnostics: A Brazilian Lab Powerhouse

I want to call your attention to Fleury Diagnostics which started in 1926 in Sao Paulo, Brazil, as a clinical laboratory and evolved into a multi-specialty diagnostic enterprise. Here is the Fleury web site.

Fleury offers more than 2,000 different types of diagnostic tests, in addition to CP and AP. These include nuclear medicine, radiology, cardiology, neurology, otorhynolaringology, urology, pneumology, endoscopies, bronchoscopies, hysteroscopies, and tests in fetal medicine. Fleury has a staff of 270 physicians and a total of 1,600 employees.

Lab test ordering in Brazil is different than in the U.S. The physician initiates the test order but the patient decides which lab to submit the requisition to. Test results are delivered back to the patient and not to the physician.  As a result, many Brazilian labs tend to be very consumer-oriented. Fleury, for example, prides itself on limiting the wait-time for a customer to have a blood specimen drawn to a few minutes.

Rogerio Rabelo, MD, PhD, MBA, is the Director of New Business for Fleury and a frequent lecturer at U.S. lab meetings, particularly on ISO standards. He presented a lecture on this topic at the AACC annual meeting last July. Here is the AACC conference brochure for 2005.

Below is a summary of his presentation at the IQLM 2005 conference from the Medscape web page. Bold face emphasis is mine. Here also is the link to the proceedings of the IQLM 2005 conference at which he spoke for those who want a quick review of lab quality issues.

Approaching quality improvement from a systems perspective also showed promise. Rogerio Rabelo, MD, PhD, MBA, described how Fleury Diagnostics, a privately owned, full-service, high-volume laboratory in São Paulo, Brazil, developed an integrated management system using the international quality management and environmental management standards ISO 9001 and ISO 14001, respectively. The benefits included process standardization for more efficiency and effective management, better control over documents and records, cost reduction, continual improvement as measured by a dynamic set of indicators, and compliance with environmental requirements and pollution control. Quality indicators were merged with other business and customer satisfaction indicators to create a balanced score card for ongoing measurement against goals.

New Test for Diagnosing Carcinoma of Unknown Primary (CUP)

Here is an announcement from Quest Diagnostics regarding a new test for the diagnosis of carcinomas of unknown primary (CUP). I have emphasized key phrases of interest with bold face.

The new test for Cancer of Unknown Primary will significantly reduce the amount of time it takes for pathologists and oncologists to assess CUP patients.  Currently, without a true diagnostic for CUP, evaluating CUP patients using conventional diagnostic approaches based on imaging, biopsy, endoscopic and laboratory tests is a slow and costly process, typically taking several weeks or months and yielding limited success - identifying only 25% of
primary cancers.  With the new CUP test, test results are available to physicians within two weeks.

The new CUP test uses gene expression profiling of biopsy tissue to determine the primary tumor site. Using the patient's biopsy specimen, gene expression profiles are generated for 92 genes using PCR methodology.  The patient's gene expression profiles are compared to an in-house reference database comprising gene expression profiles from 39 known tumor types.  Based on this comparison, the most likely site of origin is determined. Study results indicate that the test provides 82% sensitivity for identifying the site of origin in cancer of unknown primary and 99% specificity.

There are many interesting comments that could be made about this item -- I will kick off the discussion with a few of my initial impressions:

• CUP is very rare. Only 2-4 percent of cancer patients, according to the NCI, have a primary which is never identified. If this test is successful, this percentage should decrease even more.
• The gold standard for tumor diagnosis presently is morphologic observation of the lesion with an H&E stained slide. In almost all cases, this approach is hard to match in terms of accuracy, cost, and rapid turn-around-time. 
• The Quest CUP examination seems to be an ideal test to determine a diagnosis when a skilled surgical pathologist is unable to come up with one and/or the hunt for the primary using the sophisticated imaging modalities available in radiology draws a blank.
• Clearly informatics plays a crucial role in the development of the CUP test, both in the gene expression profiling of the tumor tissue as well as in the comparison of the tumor profile to the in-house reference database of 39 known tumor types.
• I have a question about when a pathologist or oncologist submits tissue for this test.  It seems to me that this should be a last resort and only after all other attempts to identify a primary have been unsuccessful.  In such a setting, a two-week wait, to get a definitive result, seems reasonable. The test should obviously not be ordered in parallel with other efforts to find the primary which may yield positive results within the two-week test turnaround-time.

Developing an Enterprise Storage Strategy

The Waterloo Institute for Health Informatics Research (WIHIR) is located at the University of Waterloo in Ontario, Canada.  The founding director is Dominic Covvey who has been a thought leader in healthcare informatics, both in the U.s. and Canada, for many years.

WIHIR released a report on November 29, 2004 entitled:  Storage in the Digital Healthcare Enterprise.  Here is a link to the report in PDF format.  Below is an excerpt from the document listing ten prerequisites for the development of a strategy for data storage in a healthcare setting.  I was particularly impressed by the fourth point which I have emphasized in bold face. However, the entire document deserves your attention. I will comment on some of the other points in subsequent blogs.

1. The enterprise must define business rules that derive from privacy legislation and regulation related to the stewardship of health data.

2. The storage strategy must deliver protection from hardware obsolescence and allow on demand growth in a heterogeneous hardware environment with no vendor lock-in.

3. The storage solution must be interoperable – accessible and usable by any imaging modality, application or IT system in the healthcare organization. This will require data and messaging standards.

4. Departmental applications must not be permitted to dictate the storage strategy for the healthcare enterprise. Vendors of data intensive applications (e.g., PACS) must be prevented from imposing a departmental storage strategy through proprietary interfaces or standards.

5. The storage strategy must be based on open standards and the organization must ensure that technological solutions comply with key standards.

6. The storage strategy must address fixed content (e.g., images, lab data, doctors notes, signals) and variable content (i.e., data that change based on interaction) data storage over a multi-year time span.

7. The storage strategy must ensure that an organization has the means to secure permanent
control over its data and track its use (e.g., copying, access, alteration).

8. The enterprise storage strategy must be embodied in all RFPs, and all vendor-proposed
solutions must conform to the strategy.

9. Smooth evolution from current solution to future solutions must be possible and planned.

10. The organization must address non-technical factors such as re-engineering, human resources restructuring, staff education and training, and the management of change, ensuring they are included in the enterprise storage strategy.

This fourth point is highly relevant in relation to the development of imaging in pathology. Clearly, in most hospital settings, PACS is the dominant system with a storage capability of terabytes of data generated in radiology.  One of the ways for imaging to gain some traction in pathology would be the deployment of enterprise image servers in hospitals that could store images from departments other then radiology such as pathology, cardiology, and gastroenterology. 

With the deployment of such a "generic" image servers, JPG images created in pathology could  be stored on a PACS using a DICOM wrapper. Frankly speaking, I have been surprised by the paucity of discussion about the development of such enterprise image servers on the web.  A Google search using this term turned up little of interest and no references to global PACS corporations such as GE Healthcare, Siemens, and Phillips. However, I have heard that an announcement will be coming soon from one of the majors (if not all of them) about the development of such a product.

CAP Foundation Informatics Training Awards for 2006

CAP Foundation Advanced Training Grants in Informatics
Elective rotation training grants to support learning advanced sciences, techniques, and technologies in informatics.  Grants may be up to $2,000/month and can be awarded for training opportunities of multiple days up to 3 months.  (For pathology residents and fellows in training)
Deadline: First Friday in January, May, and October

CAP Foundation Grant for Telepathology
Grants to further developments in and use of telepathology and information technology for the practice of pathology. (Funding by Olympus America)  (For pathology residents, fellows in training, and pathologists in their first five years of practice)
Deadline: February 1, 2006

CAP Foundation/API Informatics Award 
Residents learn how new and improved information technology is developed in a business environment.  (Funding by McKesson)   (For pathology residents fellows in training).
Deadline: March 17, 2006

Conference Travel Awards for Informatics (for pathology residents  fellows in training)
Deadlines: June 1, 2006 – To attend Eleventh National Conference on Advancing Practice, Instruction and Innovation through Informatics (APIII)
July 14, 2006 - To attend Cerner Health Conference
Dec 1, 2006 -- To attend 2007 LabInfoTech Summit, Las Vegas

Informatics Scholarship (for pathology residents and fellows in training)
Learn about new software developments and information technology.
Deadline: June 7 -- (Funding by IMPAC)

Research Grants (or pathology residents and fellows in training)
CAP Foundation Scholars Research Program funds proposals for translational research in pathology.  Projects may range from 6 months to 1 year.  Funding amount up to $25,000 for year-long projects.
Deadline: First Friday in October

Browse the CAP Foundation web page for more information.