Clarient, Inc., a GE Healthcare company and ACORN Research LLC announced their strategic collaboration around molecular testing of tumor samples. The agreement will establish a standardized testing protocol across the ACORN network of oncology community practices and hospitals with treatment guidelines and clinical trial opportunities. These processes have the potential to improve oncology treatment and research that aim to deliver targeted treatments based on the specific genetic markers for each patient. The collaboration will establish a system for the collection of a broad array of tumor-specific biomarker data at the time of the patient’s initial cancer diagnosis. Clarient’s cancer diagnostics, combined with ACORN’s oncology network and advanced bioinformatics platform, will enable the patient’s medical team to better determine the effective treatment regimen for the patient’s tumor-specific biomarker profile. 

Courtesy of CAP Statline

Earlier this week HHS Secretary Kathleen Sebelius announced that hospitals and eligible providers who attested to Stage 1 of the agency’s “Meaningful Use” EHR incentive program in 2011 would not have to meet Stage 2 criteria until 2014, rather than 2013. The delay is to allow faster and easier adoption of health information (IT) criteria outlined in Stage 2.

This delay was first proposed in March by the Office of the National Coordinator for Health Information Technology’s HIT Policy Committee’s workgroup on Meaningful Use.

CAP’s Advocacy efforts related to Meaningful Use can be found on the “Comments to Regulatory Agencies” Web site under “Health Information Technology.” For more information on the CMS Meaningful Use EHR Incentive Program, visit the agency’s Web site.

CAP Concerns

The CAP continues to be concerned about numerous aspects of the Meaningful Use program, as outlined in Stage 2 criteria comments submitted over the summer. Specifically, because the rule is targeted toward office-based physicians—especially primary care providers—pathologists will face penalties for mandates that they cannot comply with for a number of reasons, including their scope-of-practice, typical interactions with patients (not usually face-to-face), and their use of laboratory information systems instead of certified EHRs.

The College is addressing some of these concerns through the Office of the National Coordinator’s (ONC) HIT Policy Committee’s Meaningful Use Workgroup Specialty Subgroup. At a recent hearing, the Subgroup appeared to be inclined to recommend that ONC and/or CMS deal with specialists’ challenges, such as certain certification issues, either through exemptions or other means. Looking ahead, the group also indicated that for proposed Stage 3 criteria, it may recommend a requirement that test results are sent back to the referring physician. This specialist subgroup is planning on moving these and other recommendations to the larger Meaningful Use Workgroup for consideration. All positive developments to be sure, although the ONC and CMS have ultimate authority for the program.

Preparing your lab for March 1, 2012 when proposed changes
take effect for code-stacked claims in Medicare’s J1 region

LIVE EVENT December 20th

YOUR PRESENTERS:

Elaine K. Jeter, M.D., Pathologist and Medical Director, Palmetto GBA

Mike Barlow, Vice President, Palmetto GBA

Robert L. Michel (Moderator), is Editor-In-Chief of The Dark Report and DarkDaily.com

Click Here to Read The Presenters Bios

____________________________________________________________________________

Is the era of code stacking about to end? The clock is certainly ticking for molecular diagnostic tests. Effective March 1, 2012, one of Medicare’s larger carriers is proposing new processes that will affect claims for molecular diagnostic tests (MDT) and laboratory-developed tests (LDT).

This milestone development has the potential to affect every laboratory that uses code stacks when submitting claims for MDTs and LDTs. In recent weeks, Palmetto GBA has published two proposed local-coverage determinations (LCD) that would change how code stacks are used for MDTs and LDTs, starting in the J1 region.

Palmetto GBA also released details about a proposed new “Molecular Diagnostics Services Program” or MolDx for short. MolDx will also launch on March 1, 2012, and to comply, labs would need to register every MDT and LDT, then submit clinical and scientific material for each test. This information would be evaluated by a special review panel, after which Palmetto GBA would make a coverage determination for each test.

By special arrangement, this audio conference on Tuesday, December 20, 2011 will feature Palmetto’s Medical Director, Elaine Jeter, M.D. and Vice President Mike Barlow. You and your lab team can get first-hand information about why these proposals were put forth, along with specific details about how Palmetto GBA plans to implement the two proposed LCDs and MolDx.

For pathology groups and clinical labs moving forward with molecular diagnostics testing, this is a “must-attend” event. You’ll get the knowledge you need to ensure that your lab’s MDT and LDT claims comply with the proposed changes. Not only will you hear directly from the Palmetto GBA executives tasked with addressing the issues triggered by the growing number of code-stacked claims, you’ll also get answers to your specific questions when we open up the phone lines to Q&A from the audience.

This high-value, low-cost audio conference will help you and your entire staff develop a strategic plan to respond to the proposed new processes involving molecular diagnostic tests and LDTs. It’s information you can’t get from any other source, so be sure you register today to guarantee your place at this important event!

For one low price-just $195 (through 12/9/11; $245 thereafter) you and your entire team can take part in this fast-paced, insightful audio conference. Best of all, you’ll be able to connect personally with our speakers when we open up the phone lines for live Q&A.

Here’s just some of what you’ll learn during this in-depth 90-minute audio conference:

• Why do code stacked claims cause problems for health insurers?
• How do the two proposed local coverage determinations (LCD) address code-stacking issues?
• Can my lab expect to be paid if it submits code-stacked molecular test claims after March 1, 2012?
• What is the purpose of the molecular test registry?
• How will the clinical and scientific material in support of my lab’s tests be evaluated?
• Why do I need a “Z-Code” for each of my lab’s molecular diagnostic tests and LDTs?
• Will there be flexibility in the timelines?

…and much more!

How to Register Now:

1. Online
2. Call toll free: 800-560-6363.

Your audio conference registration includes:

• A site license to attend the conference (invite as many people as you can fit around your speakerphone at no extra charge)
• A downloadable PowerPoint presentations from our speaker
• A full transcript emailed to you soon after the conference
• The opportunity to connect directly with the speaker during the audience Q&A session

Register Now! Or for more information, call us toll-free at 800-560-6363

ACCENT® Continuing Education Credit
The American Association of Clinical Chemistry (AACC) designates this program for a maximum of 1.5 ACCENT® credit hours towards the AACC Clinical Chemist’s Recognition Award. AACC is an approved provider of continuing education for clinical laboratory scientists in the states of California, Florida, Louisiana, Montana, Nevada, North Dakota, Rhode Island, and West Virginia.

PathXL Simulator: Prebuilt Simulations for Pathology Training

14th December 2011, 4pmGMT /11amEST /8amPST /5pmCET

PathXL Simulator is a comprehensive set of training modules designed for early stage training by residents in Pathology and Biomedical Scientists.

Customers include Thames and Medway Training Schools, Liverpool Training School, South West Deanery Training School and the RCPA (Royal College of Pathologists of Australia) and Astra Zeneca.

Guest Speakers:

Professor Chris Womack, Astra Zeneca

Dr Jim Diamond, PathXL

Click here to register

Why Attend?

• Learn about PathXL Simulator and modules available
• Listen to other users experiences
• Join a Q&A session

Modules available

Breast Cytopathology (PAP)

Breast Cytopathology (Giemsa)

Breast Histopathology

Cervical Histopathology

Neuropathology

Prostate Cancer

Urine Cytopathology

Salivary Gland Tumours

Skin Squamous Malignancy

Skin Melanocytic Lesions

Colon Polyp

Bowel Polyp

The SkyLight: An iPhone Adapter For Your Microscope, Now On Kickstarter

BY JOE WHITE on Tue December 06th, 2011 Kickstartermicroscope SkyLight The SkyLight

A new project has recently appeared on Kickstarter called “The SkyLight.” This clever accessory, which can be yours for a pledge of $60 or more, connects your iPhone to a microscope and allows users to scrutinize fuzzy, microscopic beings on a 3.5 inch screen.

As outlined over at the product’s Kickstarter webpage:

The SkyLight is a sleek, minimalist adapter that connects smartphones to microscopes. The smartphone camera can then capture photos and videos for uploading, e-mailing, and sharing on the web and social media sites, as well as real-time viewing on the smartphone screen or via video-conferencing software. The SkyLight is the first of its kind, as there is no other available device that attaches any smartphone to any microscope. The SkyLight’s universal compatibility allows previously owned technology (microscopes) to be upgraded to the digital age with the use of a widely available technology (smartphones) – good for global health, science classes, and anyone else!

It’s an impressive accessory, and something we like the look of. To get your own SkyLight simply make a Kickstarter pledge of $60 or more – anything under this will only get you a postcard or print.

Below, we’ve included some images of The SkyLight. For more information on the product (including the option of backing the project), head over to Kickstarter. You can also visit The SkyLight’s official webpage for additional images and information.

[via Cult of Mac]

Invitation for TMA webinar

You are kindly invited to attend the following webinar, where you can get a comprehensive insight into Automated, database-linked creation and analysis of digital TMA slides using 3DHISTECH systems presented by Dr. Tibor Krenacs, PhD at the 1^st Department of Pathology & Experimental Cancer Research, Semmelweis University!

Date: 13^th of December, 2011. 

This event requires registration!

To register for the online event:

1.a. If you choose the first session, please click here.

1.b. If you prefer the second session, please click here.

2. Click "Register".

3. On the registration form, enter your information and then click "Submit". 

Program of the TMA Webinar:

-  Introduction to Tissue Microarray (TMA) technique

-  Database-linked automated creation of TMA

-  Whole slide digitalization of brightfield and multichannel fluorescence TMA

    samples

-  Software supported scoring and analysis of TMA results on digital slides

-  TMA Workflow summary

Please join the TMA Webinar of 3DHISTECH Ltd. presented by Dr. Krenács Tibor, Phd.

With recent news of the FDA classifying whole slide scanning systems as Class 3 devices and therefore requiring pre-market approval (PMA), I would propose an idea to my fellow pathologists and our professional college, the College of American Pathologists (CAP) to have a supporting role in these endeavors.

For the sake of argument, let's take 16,000 as the number of members of CAP.  If conservatively, 10% of its members contributed, say 2,000 cases to the organization, the CAP would have at its disposal over 3 million pathology cases.  For members, this may constitute a few days, week or month of accessions depending on the size of the laboratory operation.  Members would select accessions beginning the first week of December 2008 until enough cases were collected from that particular laboratory/group to contribute to the CAP.  This would likely require some cost to recut the cases and perhaps not all cases may be suitable from the standpoint of having enough diagnostic tissue, blocks sent to another institution and not returned, etc...Members of committees often contribute cases, control material and cytology slides for purposes of proficiency testing and validation.  This would involve more folks and create I think for the first time in CAP's history a slide repository from a cross section of laboratories across the country representing a wide variety of specimens, cases, tissue types, part types and slides.

Manufacturers and software companies can then make "withdrawals" from the slide bank, for say, 90 days to conduct studies evaluating glass slide versus digital diagnosis.  Someone may ask for 10,000 breast cases, 15,000 GI cases or a subset of gynecologic specimens for a specific intended use they are going to submit a PMA for.  Random number generators can be used to "shuffle" the cases selected for a particular request.

The CAP would could create a revenue stream as companies are charged processing and handling fees for the withdrawals or loans.  The cost of the "CAP Center for Slide Excellence" in terms of housing and cataloging millions of slides would be one factor for the CAP to consider among many others.

Vendors that do not return material in a timely fashion or in its original condition are charged according to pre-defined fees and may potentially risk being excluded from the priveledge of using the slide bank.

Pathologists in-turn perhaps are provided some form of renumeration for the time and effort to collect the slides and manage handling to the CAP slide bank.  Anonymous brief clinical histories and the referring diagnosis will be submitted along with the slides.  Although the referring diagnosis is I think of least importance here as seperate individuals and/or panels will establish the "ground truth" diagnosis the additional seperate microscope and digital reads are compared with.

In addition to costs for CAP and what likely revenue this could garner as well as the actual need for this product and service may be overstated in this simplified proposal.

Larger vendors that have access to large medical centers and universities may already have this kind of access with current clients or established beta partners.  Smaller vendors may have a greater need to access of a library of this type and could benefit from the diversity of cases that would be submitted from pathologists willing to contribute.  

This product and service would be open to anyone with the need to perform studies on the level of a PMA study but could also include other validation studies, proficiency testing, GME and CME material.  

No scanning of any shape or form would be done within the slide bank.  The slide bank is just that - a collection of slides that are loaned as substrate to be used on the specific device, platform, open system, closed system, etc... of the company or individuals making the request.

While this concept is not unique, as tissue banks and university laboratories may have for-profit ventures where tissue slices, cores or TMAs are made or clinical trials and supporting services are managed, care will have to be exercised by all parties to insure patient privacy and cost vs. expense are managed and exercised in a professional manner.

For the CAP and its pathologists members, we can assist industry colleagues recognizing the quality of material produced by CAP members and recognition by the CAP for offering this type of product and service on behalf of inventors and innovators.  Manufacturers are served by cost effective access to a large selection of cases as part of their investment in the PMA process.

I welcome your comments to this proposal

Not anything related to digital pathology. Taken from Chicago Tribune.

It is possible the president in 2024 might be 22 now.  Playing Xbox right now.

Let's hope the Bulls have 6 more championships by then but I kind of doubt it.

Medicare running out of money could be a bad thing, particularly since I will still need it as a source of income and a plan I have been paying into and will continue to for years and will need long after it is gone.

As much as any Chicagoan would like to see the Olympics in our hometown I think it is more likely Medicare could run out of money by then.

And who will be the Bears quarterback then?  Where is he right now? Let's hope playing Pop Warner football in Mississippi, Louisiana or Western PA. Some good ones have come out of there.

If former Gov. Rod Blagojevich reports to prison as scheduled Feb. 16, he could be released in early 2024, after serving the required 85 percent of his 14-year sentence imposed Wednesday. Here's a look at some other news expected that year:

• The U.S. will elect a new president. If Barack Obama is re-elected in 2012 and is succeeded by another two-term president, the commander in chief chosen in 2024 will be our nation's 46th, and could be as young as 22 right now.

• Bulls guard Derrick Rose could be finishing the 2023-24 season at 35, an age whenMichael Jordan played his last game for the team and by which he had amassed sixNBA championships.

• If still alive, former Presidents Jimmy Carter and George H.W. Bush will turn 100, as will actresses Doris Day and Lauren Bacall, former New York City Mayor Ed Kochand businessman Lee Iacocca.

• "Saved by the Bell" actors Mark-Paul Gosselaar, Tiffani Thiessen and Lark Voorhies would turn 50.

• A total solar eclipse will occur April 8. The area around Carbondale will make news for experiencing two such eclipses within seven years, the other occurring Aug. 21, 2017.

• The Medicare hospital insurance fund is projected to run out of money, according to a report issued this year by Medicare trustees.

• Fifty-year observances will take place recognizing President Richard Nixon's resignation, Hank Aaron's breaking of Babe Ruth's home run record, the first printing ofPeople magazine and the invention of Rubik's Cube.

• The Summer Olympics will take place, in a city to be determined. If the International Olympic Committee holds to form, that decision will be announced in 2017. Could it be … Chicago?

November 30, 2011 in GenomeWeb – Clinical Sequencing News
By Julia Karow <mailto:jkarow@genomeweb.com>

Baylor College of Medicine's Cancer Genetics Laboratory is about to launch a sequencing-based test on the Ion Torrent PGM that uses the firm's Ion AmpliSeq Cancer Panel to target mutations in 46 cancer genes.
The lab is among the first in the country to use targeted next-gen sequencing in a clinical setting for cancer. Washington University School of Medicine's Genomics and Pathology Services Laboratory recently introduced a similar test on the Illumina HiSeq, targeting 28 cancer genes (CSN 11/22/2011 <http://www.genomeweb.com/sequencing/wash-u-med-school-offers-28-gene-cancer-dx-panel-hiseq-through-clia-lab> ).
Baylor's test, which the CLIA- and CAP-certified CGL will start offering in December, targets 739 mutations in 46 commonly mutated cancer genes. It will be priced under $2,000, and its turnaround time will be around seven to 10 days, although it is possible to complete the test within a day or two, according to Marilyn Li, the lab's director and a professor of molecular and human genetics at Baylor.

While Baylor will offer the test on a research basis, it can be ordered by both basic researchers and doctors. "It's truly a research tool at this point in time," said Condie Carmack, the lab's general manager. And while insurance will not initially pay for it, the CGL will look into whether the test could be reimbursable. The panel could replace, at a lower cost, existing tests that sequence small numbers of genes, he said.
Initially, the test will be based on the Ion AmpliSeq Cancer Panel that Ion Torrent launched for the PGM in October (CSN 10/12/2011 <http://www.genomeweb.com/sequencing/life-tech-launches-cancer-panel-amplicon-sequencing-kit-ion-pgm-plans-510k-filin> ). That panel uses single-tube PCR to amplify 190 amplicons in 46 cancer genes from 10 nanograms of DNA in 3.5 hours, according to the company, and can detect mutations down to a frequency of 5 percent.

According to Li, the coverage for the targeted mutations varies between less than 100x to close to 10,000x, with an average coverage of about 2,000x.So far, the CGL has not had problems with homopolymer regions, which the PGM is said to have trouble with. "We are aware that it could be a problem [but] it does not seem to be an issue with this AmpliSeq product," Carmack said.
Ion Torrent selected the genes for the panel after seeking input from several cancer researchers, including the Baylor team. It includes somatic mutations in genes commonly mutated in cancer as well as germline mutations found in inherited forms of the disease.The reason CGL chose the Ion Torrent platform for the test is its quick turnaround time and low cost per run. At the moment, the lab has two Ion Torrent sequencers that share one Ion Server, but it considering purchasing "a couple" more PGMs.

 
The Illumina MiSeq did not exist at the time they were developing the test, according to Carmack, and while the lab also has a HiSeq, its turnaround time was too slow and its throughput too large. "We really wanted something quick, inexpensive, and compact," he said.
Another advantage of the Ion Torrent panel is that it can be customized, and in future versions of the test, the CGL plans to add or omit genes or to sequence some genes with greater depth. "That is very appealing to a lot of researchers, as well as to clinical trials," Li said. According to Ion Torrent, AmpliSeq custom panels can include "hundreds of genes" or DNA regions up to 500 kilobases in size.
Initially, the test will run on the Ion 314 chip, though CGL is considering moving it over to the higher-throughput 316 or 318 chips. This would allow them to deepen the coverage, add more genes to the panel, or multiplex samples.
While the lab is currently not using the Ion OneTouch to prepare samples for the PGM, it already has the instrument in house and is planning to test it.

Focusing on the 'Clinically Useful'
There are several reason why CGL opted for a targeted cancer gene panel, rather than analyzing whole cancer exomes or genomes, Li said.
For one, the mutations targeted by the panel are interpretable, whereas large-scale sequencing yields many variants that "may not be clinically useful," and confirming them all takes a long time. "That doesn't meet the need of cancer diagnosis," she said. In addition, the cost of targeted sequencing is still much lower than that of whole-exome or whole-genome sequencing, and the turnaround time is shorter.
Also, because the test is less complex than exome or genome sequencing, it was easier to implement it in the clinical lab, she said. Lab technicians were able to achieve the same results as the R&D lab relatively easily.
For whole-exome or whole-genome sequencing for cancer to become practical in a clinical setting, she said, its cost will have to come down to that of a single-gene test, and the data analysis will need to be able to extract relevant results quickly.

Another Baylor lab, however, is already forging ahead with clinical whole-exome sequencing, albeit for inherited diseases rather than cancer. Earlier this month, Baylor announced the opening of the CLIA-certified Whole Genome Laboratory, which offers a whole-exome sequencing test for the diagnosis of genetic disorders, with plans to move to whole-genome sequencing in the future (IS 11/16/2011 <http://www.genomeweb.com/sequencing/baylor-whole-genome-laboratory-launches-clinical-exome-sequencing-test> ). Like the CGL, the WGL is affiliated with Baylor's department of molecular and human genetics and its Medical Genetics Laboratory, but it also closely collaborates with the Human Genome Sequencing Center.

There are some types of mutations that the CGL's current cancer panel, which focuses on point mutations and small insertions and deletions, cannot detect — for example, translocations, copy number variants, or epigenetic changes. "There is no one technology that is going to cover it all," Li said. But CGL is hopeful that further improvements of the Ion Torrent platform will enable it to analyze both copy number variants and translocations.
The cancer panel is only one of more than 135 tests the CGL offers, including sequencing of single genes, deletion and duplication testing, chromosome analysis, FISH, and chromosomal microarray analysis.
Many of these tests, which target mutations found in inherited cancers, were already offered by Baylor's Medical Genetics Laboratory, from which the CGL split off about a year ago. "We are moving them over under the CGL banner and expanding our content in somatic and acquired cancers," Carmack said. The reason CGL was founded as a separate entity is that its focus on both non-inherited and inherited forms of cancer required special expertise in cancer genetics, he explained.

The CGL — a joint project of the department of molecular and human genetics, the department of medicine's hematology and oncology division, the department of pathology, the Dan L. Duncan Cancer Center at BCM, and the Texas Children's Hospital Pathology Laboratory — still works closely with the MGL, which shares the same location, about a mile and a half from the main Baylor campus.
Besides molecular testing for guiding patient treatment and prognosis, the CGL offers clinical trial services to companies and conducts research to discover new cancer genes, markers, and tests for them, both on its own and in collaboration with industry.

Earlier this week at RSNA, the tradeshow of tradeshows and the single best week for cab drivers in the city of Chicago, Agfa HealthCare announced a combined pathology and radiology PACS solution building on their radiology experience and backbone.  

Little curious they would choose to do this at a radiology show rather than say at say, USCAP or one of the dedicated pathology informatics/digital pathology meetings and not clear to me from this press release if they have built their own scanner for pathology slides or using someone else's device.  I suspect the latter. Either way -- cool news piece with another player in the digital pathology space with shared pathology/radiology diagnostic imaging at a big operation with 1,600 teaching beds.  

Now the large radiology vendors such as GE, Philips and Afga in this space, who will be the next company with extensive radiology PACS and image acquisition/management to enter the digital pathology market?

And will this help drive a convergence towards Departments of Diagnostic Medicine/Imaging? And if that does happen wouldn't pathologists be better positioned and suited to be the gatekeepers of the images as a percentage of volume of information from those images?

One of the most popular posts I have written is now nearly 3 years old entitled Departments of Diagnostic Medicine? I think because of the picture of the cast of House, still a good show and one of my personal favorites.  I wasn't warm to the idea then but coming around to the idea this may happen with digital pathology scanners, radiology image/management experience and combined collective intelligence of radiologists and pathologist to use synergistic technologies for diagnosis, staging and progonosis.  

System now in hospital trial leverages company’s PACS, informatics, image storage and distribution expertise with new digital pathology solution

• Press release
• Mortsel, Belgium/Greenville, SC
• November 29, 2011 04:00

• Solution currently implemented for clinical review at the La Pitié-Salpêtrière teaching hospital in Paris, France.
• Solution links new, pathology slide scanning device with dedicated analytical workstation to enhance data sharing of radiology and pathology images. 
• A critical step towards improved productivity and enhanced quality assurance in pathology for university hospitals and large clinics.

(RSNA 2011, Booth #8350) Agfa HealthCare announces today that it has successfully implemented a comprehensive solution that, for the first time, integrates digital pathology with X-ray imaging and informatics through its IMPAX Picture Archiving and Communication System (PACS) platform. This solution, revealed at the 97th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), is currently in clinical review at the La Pitié-Salpêtrière hospital, a 1600-bed Paris teaching hospital. It includes a high-throughput, whole slide scanning device coupled with dedicated workstations used by pathologists to view digital pathology images that support more confident diagnosis through specific clinical applications.

Several weeks ago on the family's annual pilgrimage to the pediatrician's office for the flu shot a friend of mine called me and asked if I was near a computer and if I could look at something online with him.  

Never one to be too far from my laptop or willing to see a nice digital image of pathology slides I mentioned I could in a few minutes while waiting our turn at the pediatrician's office for the flu shot. 

So, armed with laptop, my personal Mifi 2200 card and a few minutes, I was able to view in real time the effect of changing the gamma on some scanned cytology slides.  

The value of Pathology 2.0 - digital pathology combined with other taken for granted technologies that provides the world at your fingertips - anytime, anywhere collaboration in a few minutes between a cellular phone call and waiting for the flu shot.  

The question here of course is whether, if this were a "real" case, could I review the images and make an opinion based upon the images presented to me standing, waiting in a doctor's office. 

Technically, I am in a doctor's office, or at least the waiting area.  A real doctor.  One that sees actual patients in their entirety - mainly their right or left arm this particular clinic, rather than just representative slices of their tissues.

The short answer - for primary diagnosis (let's for the sake of argument leave out "H&E" from these words) based on guidance from the FDA and CLIA earlier this month appears to be no.  As a consult, I think the guidance is this use case is reasonable and presents less potential risk and potentially huge benefit not otherwise possible as an intended use. 

"Hey, I have an interesting case I would like to show you - are you near a computer?"  

"Sure, let me just turn off the football game, go into my home office with my radiology-grade monitor I actually picked up on eBay from a teleradiologist and review the case with you." 

Anyways, I was able to view crisp, clear images quickly and accurately, outside of my office and was comfortable with the images being representative of the glass slide.

If we don't control the environments we conduct these practices in, regulatory efforts will tell us how to conduct them (enter CLIA '88).  

Recall the history of CLIA - beginning in 1987, a series of newspaper and magazine articles were published on the quality of laboratory testing. Also, simultaneously television programs were aired concerning the number of laboratories that were not subject to either federal or state regulations. Congress held hearings in 1988 and heard testimony from “victims” of faulty laboratory testing. Specific concerns were raised about the validity of cholesterol screening and the accuracy of Pap smear results.

Section 4064 of the Omnibus Budget Reconciliation Act of 1987 [OBRA-87 - Public Law 100-203], enacted on December 22, 1987 amended Section 1861(s)(11) to require physician offices that performed more than 5000 tests per year to meet regulations. Laboratory testing in both physicians’ offices (POLs) and rural health clinics that did not accept and perform tests on referral specimens would not be subject to these revisions because both the Medicare and CLIA statues [Section 1861(s)(11) of the Act and section 351(I) of the PHS Act] respectively precluded the regulation at that time of POLs and RHC that performed tests only for their own patients.

On October 31, 1988, Congress enacted Public Law 100-578 in response to the congressional hearings. PL 100-578 greatly revised the authority (PHS Act) for the regulation of laboratories.

This law revised section 353 of the PHS Act (42 U.S.C. 263a) amending CLIA-67 by expanding the Department of HHS’s authority from regulation of laboratories that only accepted and tested specimens in interstate commerce to the regulation of any laboratory that tested specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.

Then on December 19, 1989, Congress enacted OBRA-89 (Public Law 101-239). Section 6141 removed the provision under section 4064 of OBRA-87, which would now require certification of all laboratories performing tests. In addition, it required laboratories participating in the Medicare/Medicaid programs to comply with CLIA-88 requirements.

On February 28, 1992, the final regulations for CLIA-88 were published with an implementation date of September 1, 1992. Sections of the CLIA requirements were to be phased in allowing previously non-regulated laboratories to become accustomed to the regulations. The regulations adding Provider-Performed Microscopy Procedures (PPMP) were published on March 24, 1995. Work is currently in progress with the CDC and CMS to develop final CLIA regulations, which will reflect all comments received since the September 1, 1992, Federal Register publication and the development of new technologies.

On April 24, 2003, the revised CLIA regulations went into effect. 

Anyways, the question here for consideration when viewing images remotely, outside a defined laboratory is what defines a laboratory or doctor's office.  Would a quiet, controlled setting with adequate technical resources to perform the test (in this case -- review the slide) be sufficient?

Of course most of us recognize that while you could do this on a boat, at the beach or on a golf cart, reasonable pathologists would not do this.  They might take blood bank or toxicology calls but not review images.  Most practicing pathologists have been called away from meetings, outdoor activities, dinners, movies, shows, etc... to do just this.  It's not that they are technically unable to do it, it is just that they have it done it yet.  Physicians don't take night and weekend call from their offices.  It kind of defeats the purpose of being "on call". Even before cellular devices and remote access to hospital network applications. 

Congratulations to the award winners and travel award recipients. Great turnout for this meeting complete with CME and attendees from 17 countries.  

An unprecedented number of digital pathology professionals attended the 7th annual Pathology Visions Conference earlier this month. The Digital Pathology Association (DPA) gathering in San Diego featured more than 50 presenters and 42 educational sessions. Participants from 30 states, 17 countries, and 174 organizations left with a greater understanding of the cutting-edge applications of digital pathology. For those unable to attend the conference and who want to earn CME credits, two of the conference presentations, the keynote address and regulatory panel discussion, are now available online.

Fernandez to complement the Ventana growing leadership team focused on advancing the standard of cancer patient care

Tucson, 21 November 2011. -- Ventana Medical Systems, Inc.(Ventana), a member of the Roche Group, announced today the appointment of Gerardo (Jerry) Fernandez, M.D., to the position of Medical Director, Ventana Digital Pathology, based in Sunnyvale, CA. Fernandez was most recently Vice President, Pathology of Aureon Biosciences where he also served as VP, Research & Development. Prior to this, Fernandez was an attending Pathologist at Genzyme Genetics and at several hospitals including St. Lukes-Roosevelt Hospital Center and Beth Israel Medical Center.

"Jerry brings considerable experience in quantitative digital imaging and is an outstanding complement to our growing leadership team," said Mara G. Aspinall, President of Ventana. Aspinall herself joined Roche in September, 2011. She was most recently Founder, President, and CEO of On-Q-ity, a start-up diagnostics company focused on circulating tumor cell technology and formerly President of Genzyme Genetics and President of Genzyme Pharmaceuticals. "In line with our mission to improve the lives of all patients afflicted with cancer, Jerry will be working closely across Ventana and Roche organizations with a focus on enabling our customers to deliver the highest standards of patient care through the most advanced digital pathology technologies and solutions available.”

Steve Burnell, VP, Ventana Digital Pathology, commented, "Digital pathology is transforming the practice of pathology in ways that will significantly impact healthcare delivery globally. Innovation in digital technologies is empowering pathologists and clinicians worldwide with tools for more efficient, repeatable, and accurate diagnoses and increasing patient access to skilled pathologists and sub-specialties. VENTANA next-generation, digital pathology solutions fully leverage our unique strengths in high quality staining platforms, assays, and innovative workflow solutions to deliver a complete end-to-end solution for pathology. In his new role, Jerry will help further shape and accelerate our digital pathology vision and commitment to personalized healthcare as a key interface and resource to the Ventana and Roche product development teams and the external medical and scientific communities.” VENTANA advanced workflow and digital pathology products include the VANTAGE workflow solution, the iScan Coreo Au slide scanner and VIRTUOSO software for image management functionality from acquisition through reporting. The VENTANA iScan HT slide scanner, launching soon, will also be integrated with VIRTUOSO.

Fernandez holds a Doctorate of Medicine from Drexel University, Philadelphia, PA and a bachelor’s degree in natural science and mathematics from Bennington College, Bennington, VT. He begins his new role in November, 2011.

The VENTANA iScan HT is for research use only. Not for use in diagnostic procedures. Ventana products are for in vitro diagnostic use for specific applications and are research use only for other applications.

About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. (“VMSI”) (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA solutions are used in clinical histology and drug development research laboratories worldwide. The company’s “Smart Systems” – intuitive, integrated staining and workflow management platforms that optimize laboratory efficiencies to reduce errors – support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI is driving personalized medicine through accelerated drug discovery and the development of “companion diagnostics” to identify the patients most likely to respond favorably to specific therapies. Visit http://www.ventana.com to learn more.

VENTANA, the VENTANA logo, VANTAGE, iScan, and VIRTUOSO are trademarks of Roche.

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