Digital Pathology Blog

What is your disaster recovery plan?

I was recently asked a question about digital pathology I had never given much thought to.

The question came out of a discussion relating to storage needs for digital pathology, particularly in a full adoption mode for 100% sign-out.  There are matters of capacity, live versus archival, storage time, redundancy, backups, etc...

A colleague of mine recently had his external 1 TB hard drive "crash".  Every powerpoint lecture, reams of research data, manuscripts, personal files & 25,000 mp3 files were thought to be lost.  He neglected to backup any of it obviously.  A commercial service restored the disk with everything but the music files.  We all know this happens routinely.  He did this only recently due to some constraints on enterprise servers and personal storage available on the institutional network and issues with file loss on shared folders with larger capacity.

A clock starts ticking the day you first use such a device that overtime will determine when some mechanical or software function will fail and loss is inevitable, in my opinion.  It has happened to me twice, both after about 3 years of use with varying sized drives and manufacturers.  Both times mirror drives caused no loss of any data.

In pathology we are careful to track what and how much tissue was collected, how may blocks are made, slides from those blocks, stains, recuts, slides sent-out, etc...

As we discuss storage needs and requirements for digital pathology we will have to think about similar issues and disaster recovery plans.

It made me think - what is our disaster recovery plan for stored tissue, wax blocks & glass slides?

I can't recall ever seeing a procedure or policy to address this issue at any institution. 

In case of fire, flood or hurricane what do you do?  What is your lab/institution's policy?

This hospital can trace its roots back to a tornado devastating the town.  The images can always be re-created assuming the real raw data is there to be had.

Thoughts on HIMMS meeting

Attended the HIMMS meeting in Chicago a few weeks ago. Ole Eichorn over at The Daily Scan has a very nice report as well (with better pictures).  Enjoyed Ole's talk (one of the few related specifically to specialty of pathology).  Lot of interest among hospital IT folks about capacity, bandwidth, security, archiving image needs and compatibility between different systems as well as DICOM compliance for whole slide images in pathology.  From my perspective, they seem to understand this is technology they may need to support in their institutions and were asking very pertinent questions. 

No discusion about image resolution for clinical use, images being too large to manage or ability to serve images.  Discussion much more focused on understanding what needs to be done to support the technology.

Telemedicine was a large part of the program including the number and scale of exhibitor booths.

Can you imagine having mimes at the next USCAP meeting?

 

Harris Corporation had a booth and demonstrated their technology to move whole slide images and view them rapidly over satellite communication with BioImagene slides.  Very fast viewing of whole slide images without any tiling or pixelation with satellite communication from remote serve.

     

Apollo PACS (who have recently re-designed their website) exhibited at the meeting as well as dozens of other PACS companies.  I spoke with several and asked about what they were doing considering whole slide images in pathology.  Most had no idea what I was talking about, what a pathology slide was and what whole slide scanning or digital pathology involves.  Despite that they all said the same thing, "If it is DICOM, we can do it." 

All in all, the highlight of the meeting for me was hearing Dr. Jerry Linenger speak who gave one of the closing keynotes (Alan Greenspan gave the other).  Picked up one of Dr. Linenger's books since ("Off the Planet") and recommend if space travel interests you.

The Anxiety of the Biopsy from NY Times Health Blog

Came across this post from NY Times Health blog this week.  Couple of thoughts:

Biopsies required to fix for certain time should need for certain IHC (i.e. HER2) required.  Formal guidelines coming on ER/PR as well just as we know have ASCO/CAP guidelines for HER2 testing.  Despite the time requirement, processing can and often occurs in 1 day and can be signed out the following day.  I would gather most laboratories will complete majority of sign-outs in one day.  We do it routinely here otherwise get calls from clinicians by mid-day asking for results.  Of course some require additional levels, review, consultation and/or IHC but the exception, not the rule.  2.5 day turn around time seems excessive.  5 days for 73 of 126 women not to have a result seems protracted. I would have hoped the patients' clinician explained reason for delay but this did not seem to occur either. 

Nonetheless, in the laboratory industry the goals are to have high diagnostic accuracy, rapid turnaround time and cost control; said another way, you can have it right, fast or cheap, pick any two.  If given a choice, I gather all of us would choose the right answer in a timely fashion at a reasonable cost. Nonetheless, it sometimes takes a little longer to ensure the right answer & may involve more tests increasing costs.  Having been on both sides of this equation I would rather have the right answer even if it costs more and takes longer.  I wonder what happens to cortisol levels with misdiagnoses and inappropriate, unnecessary or unindicated therapy...

Post and abstract from paper published below.

Waiting days for the results of a breast biopsy appears to affect stress hormone levels just as much as finding out you have cancer does, a new study shows.

Harvard researchers tracked 126 women who were undergoing breast biopsy, monitoring their levels of the stress hormone cortisol while they waited.

One of the most surprising findings, researchers said, was how long many women had to wait before receiving their results. While the average wait time was 2.5 days, many women had to wait five days or longer. By the fifth day, 37 women learned their biopsy was benign, 16 learned they had cancer and 73 still did not have a result, according to the report, which appeared in the medical journal Radiology. Most of the women who did not have a diagnosis had not received any information or explanation for the delay.

Women who were still uncertain about their diagnosis had abnormal cortisol levels that were “essentially indistinguishable’’ from the cortisol profiles of the women who were told they had cancer. And women without a diagnosis had significantly worse cortisol profiles compared to women who had received benign test results.

“If you talk to any woman who has had a biopsy who has had to wait for results, she will tell you it’s a horrible roller coaster,’’ said Dr. Elvira V. Lang, associate professor of radiology at Harvard Medical School and Beth Israel Deaconess Medical Center. “Even when patients hear they have a cancer, they can start doing something. But if you hang in there for five days and you still don’t know what direction it goes, it’s just very stressful.’’

The concern, Dr. Lang said, is that cortisol levels can influence wound healing and immune response, raising a woman’s potential health risks if she ultimately needs to be treated for cancer. And the stress and anxiety of waiting also affects the quality of life of a woman, her family and her ability to function well at work, she said.

Dr. Lang said the research should spur hospitals to focus not only on speeding up test results, but on improving communication and possibly offering psychological services to women who are waiting for a diagnosis. The study was funded by the Department of Defense breast cancer research program. Dr. Lang has a financial interest in a consulting firm that trains medical personnel how to improve communication with patients.

“We have to work much faster to get results to women,’’ Dr. Lang said. “You want to keep stressors as profound as this as short as possible.’’

Large-Core Breast Biopsy: Abnormal Salivary Cortisol Profiles Associated with Uncertainty of Diagnosis

Elvira V. Lang, MD, FSIR, FSCEH, Kevin S. Berbaum, PhD, and Susan K. Lutgendorf, PhD

From the Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA 02115 (E.V.L.); and Departments of Radiology (K.S.B.) and Psychology (S.K.L.), University of Iowa, Iowa City, Iowa. Received June 19, 2008; revision requested July 22; revision received July 31; accepted August 27; final version accepted September 16. Supported by the U.S. Army Research and Materiel Command DAMD 17-01-01. E-mail: elang@bidmc.harvard.edu.

Purpose: To determine whether uncertainty of the diagnosis after large-core breast biopsy (LCBB) adversely affects biochemical stress levels.

Materials and Methods: This study was institutional review board approved and HIPAA compliant, and all patients gave written informed consent. One hundred fifty women aged 18–86 years collected four salivary cortisol samples per day for 5 days after LCBB. t Tests were used to compare diurnal cortisol slopes among three groups: patients who did not have a final diagnosis (uncertain group), patients who knew they had cancer (known malignant group), and patients who knew they had benign disease (known benign group).

Results: Women learned their diagnosis on days 1–6 (mean, day 2.4) after LCBB. Analysis was truncated at day 5, when the data from a sufficient number of patients from each group were available for meaningful analysis: 16 patients from the known malignant group, 37 from the known benign group, and 73 from the uncertain group, which totaled 126 patients. The mean cortisol slope for the women with an uncertain diagnosis (–0.092 ln [µg/dL]/hr; 95% confidence interval [CI]: –0.113 ln [µg/dL]/hr, –0.072 ln [µg/dL]/hr) was significantly flatter (less desirable) than that for the women who learned that they had benign disease (–0.154 ln [µg/dL]/hr; 95% CI: –0.197 ln [µg/dL]/hr, –0.111 ln [µg/dL]/hr; P = .014) but not significantly different from that for the women who learned that they had malignant disease (–0.110 ln [µg/dL]/hr; 95% CI: –0.147 ln [µg/dL]/hr, –0.073 ln [µg/dL]/hr; P = .421).

Conclusion: Uncertainty about the final diagnosis after LCBB is associated with substantial biochemical distress, which may have adverse effects on immune defense and wound healing. Results indicate the need for more rapid communication of biopsy results.

© RSNA, 2009

A Doctor Takes His Cut

Medicare frauds are nothing new and I can't say I am too surprised about this one featured on "American Greed" on CNBC. A Mohs surgeon in Sarasota, FL milked millions out of Medicare for thousands of "skin cancer" surgeries.  During the investigation experts claimed nearly 2000 slides prepared by this physician were "unreadable". 

Check out CNBC.com for an overview on the story and American Greed Episode #21 for the full version.

Digital pathology to benefit from Middle East oncology clinics

UPMC and its partnership with Omnyx recently announced the formation of 25 oncology clinics over the next 10 years in the start of a global healthcare business they may expand elsewhere.

Part of this initiative includes Omnyx as part of the project.  Oncology care has at its center, pathology and this use of digital pathology will help further validate the technology, field and use.

This venture offers proven premium clinical services with UPMC, GE Healthcare's experience in global healthcare and IT support, combining key elements essential in the successful implementation and use of digital pathology.  

In doing so, UPMC and its partners will be able to provide "subspecialty care as far forward as possible," and help to elevate the standard of care for the affected patients.

Full story below.   

Oncology specialists take care of in-patient and specialised treatment at the hubs, while outpatient care is offered at more than 30 satellite centres.

UPMC has awarded $300 million contract to Alcatel-Lucent for the development of an IP network project to provide improved communication. It has set up a start-up with GE Healthcare with an investment of $40m for developing and marketing digital pathology systems.

Other major projects include a $367m project for developing IT infrastructure.

Twenty-five oncology clinics will be opened over a 10-year period in the Middle East and Europe by the University of Pittsburgh Medical Centre (UPMC), a global healthcare business.

And UPMC is considering establishing centres in other countries as it seeks to tackle cancer and raise the global standard of healthcare.

"We are in the process of identifying the countries in Europe and the Middle East where we will set up 25 oncology centres," Simona Abbro, UPMC's International Marketing Director, told Emirates Business.

"We see a greater need for treatment facilities for the increasing number of cancer patients in the region. We estimate that one out of three people gets cancer in Europe against the ratio of one in 20 that was seen 20 years ago." The centres will offer advanced diagnosis and radiotherapy treatment in patients' homes.

"We find that most cancer patients wait for months to get advanced treatment," added Abbro.

"To address this problem we are setting up oncology centres with a focus on developed and developing nations. Countries such as Germany, Turkey, Greece, South Korea and Qatar are under consideration.

"We have entered into an agreement with GE Healthcare, which would as a strategic supplier provide medical equipment for our global initiative. We are also actively forging long-term partnerships with global majors from the technology and healthcare sectors."

Full story: UPMC to set up 25 oncology clinics

 

Storing Whole Slide Images in DICOM

Ole Eichhorn, CTO of Aperio and a member of DICOM WG 26 has kindly posted this update following their recent meeting at CAP '08.  This group is charged with addressing the issues related to storage of digital pathology images in DICOM.  This group is making significant progress toward this shared goal among numerous vendor colleagues and users alike.  His summary below summarizes the challenging and interesting issues related to this, the progress made to date and active proposal which is gaining support for a common standard.  The group's efforts in this endeavor will help to further advance digital pathology technologies for all of us.  Look for more positive direction and deliverables to follow and thank you to Ole for the guest post bringing us up to date on their efforts.

"A key challenge in any new field is inter-operability between vendors.  At first there are no standards, so each vendor creates their own, perhaps leveraging standards from other fields, but after a while customers demand inter-operability, and the vendors themselves benefit from this due to faster adoption and more flexible response to customer needs.  In digital pathology, a key standards area has been storing and retrieving digital slides, also known as whole slide images (to distinguish them from photomicrographs, digital images of a single microscope field.

Most digital pathology vendors have chosen an existing imaging standard like TIFF (tagged image file format) or JFIF (JPEG file interchange format) for storing digital slides, but the need for a single standard is becoming stronger.  At the same time, digital pathology is moving from education and research applications into the clinical market, where there is already a strong standard for digital images called DICOM (digital imaging communications in medicine), used for disciplines like radiology and cardiology.  Large hospitals and pathology labs inevitably ask “can I store digital slides using DICOM” when they investigate adopting digital pathology.  They have substantial investments in large computer systems called PACS (picture archive and communication systems) which implement DICOM.

There are two problems with storing digital slides using DICOM, they’re both interesting.  First, digital slides are too big, and second, pathologists access their slide images differently to the way their radiologist colleagues access their images.

As regards size, some math; a typical 20mm x 15mm tissue sample scanned at 20X (or .5 micron/pixel) results in an image of 40,000 x 30,000 pixels, or 3.6GB of data, which is compressed to a file size of about 200MB; a more extreme sample of 25mm x 25mm scanned at 40X (or .25 micron/pixel) results in an image of 100,000 x 100,000 pixels, or 30GB of data, which is compressed to a file size of about 1.5GB.  The DICOM medical imaging standard presently does not accommodate such large images; both the pixel dimensions and the object size exceed the maximum values supported.

As you know, pathologists pan through slides, zooming in and out often.  A typical diagnosis involves a great deal of inspection at 4X, with occasional zooming to 10X, 20X, or 40X to inspect small regions at higher magnification.  In contrast radiologists view an entire X-ray or MRI all at once, at full resolution (and they may have other needs such as rotating the point of view).  For this reason present DICOM viewers are not efficient for pathologists to use in diagnosing digital slides.  The DICOM standard must provide for sub-regions of the large image to be accessed randomly (to support panning), at varying resolutions (to support zooming).  Currently the DICOM standard only allows integral access to an entire image.

The DICOM standard is administered by NEMA (National Electronics Manufacturer’s Association), and NEMA establishes working groups to develop supplements to the standard whenever new needs arise.  NEMA Working Group 26, of which I am a member, has the charter to address storage of digital pathology images in DICOM.  This working group has already developed a supplement which provides an expanded specimen model for pathology, and is now working on another supplement to store whole slide images in DICOM.

The active proposal has the enthusiastic support of all the digital pathology vendors who are members of Working Group 26, including Aperio, Bacus, Bioimagene, Dako, DMetrix, Hamamatsu, Olympus, Omnyx, and Zeiss, as well as the PACS vendors such as GE and Philips.  This proposal encapsulates a digital slide as a conceptual pyramid of images, at various resolutions, each of which may be broken into one or more rectangular tiles.  Each tile of each image in the pyramid is stored as a separate image in a DICOM series. The following diagram illustrates:

This works around the key limitations of DICOM quite nicely.  Because only individual tiles are stored, the size of the overall image object is no longer material, only that each tile be within the pixel dimension and object size limits of DICOM.  And because individual tiles are addressable as separate images, using defined DICOM protocols, random access to sub-regions of the pyramid is supported (for panning).  Having multiple levels in the pyramid at several resolutions supports the need to access images at varying resolutions (for zooming).

The proposed supplement is vender-neutral and does provide substantial scope for individual vendors to optimize their implementations, which is important for the early days of a new field.  Advances in access mechanisms, image formats, compression types, etc. may well occur, and easily can be incorporated into the scheme.  The supplement also supports JPEG2000 image objects and JPIP access to those objects as a proper subset, for vendors who wish to make use of that access mechanism.

The state of this effort is that the proposal has been made and discussed, and approved.  The next step is to convert the proposal into the formal language of a DICOM supplement, and then work with NEMA Working Group 6, the standing committee which oversees all supplements to the DICOM standard, to get this supplement approved and incorporated.  After that individual digital pathology vendors will begin implementing the standard, fostering inter-operability among themselves, and PACS vendors will adopt the new standard into their systems, and begin deploying it to their large hospital and lab customers."

Issue of "automatic" special stains for GI biopsies

I came across this discussion on a pathologist bulletin board recently.  The original post and responses are from May and I have again scrubbed the names (when used) to protect the innocent. 

What I like about this post is the fact it was started by a pathologist working in a GI POD lab.  This remains a topic of discussion in pathology practice, although their days may be numbered. 

Nevertheless, previous posts on this topic remain one of the most visited pages on this blog and I think this small discussion, largely by pathologists, highlights the issues.  One concern that all of us deal with and we could argue that there is no financial disincentive not to, is the topic of "automatic" special stains in GI biopsies.  Personally, I have not worked anywhere that does this routinely, largely for the reasons below, but realize several labs do, including specialty POD labs, academic and private groups alike.  The other issue of course is the self-referral business and doing more biopsies perhaps than would normally be indicated. 

Questioner:

I'm working in-house for a gastroenterology group as an "independent contractor" pathologist. Before my arrival at the GI office, its pathology operation had been set up by a consultant to maximize income.

I have some ethical and possibly legal/regulatory concerns. First is the matter of whether or not the gastroenterologists might be performing excessive numbers of biopsies, given their financial interest-- but this is something over which I clearly have no control.

Of more direct concern to me is the protocol of default performance of special stains on all gastric and esophageal biopsies. Billing for the special stains is "automatic" from the time of specimen accession. Some of these stains I consider so pointless that I just sign them out as "non-contributory".

Questions for Discussion: 1. Do other GI practices also perform specials routinely, regardless of clinical context or H&E findings? 2. Is the automatic performance of special stains best classified as "standard practice", "outlier", or "egregious"? 3. Is the GI group at risk? If so, what are the specific risks, including their odds and magnitudes? 4. Even though I am neither ordering the special stains nor cashing the checks from the patients or insurers, am I at risk?

Response #1 of 4:

Interesting questions. I can't comment at all on the legal "at risk" issues, but I do know that ordering some stains "up front" on GI biopsies is a pretty common practice in my area of the US. Although I agree that the special stains are often not helpful, it has been advocated by some experts (Montgomery in Biopsy Interpretation of GI Tract Mucosa, for example, recommends upfront ordering of Alcian Blue/PAS for upper GI biopsies although she says it is not essential - see page 1). We don't get these stains upfront at my county hospital, but many of our local private hospital pathologists do, so I don't think you are in the "egregious" category...

Response #2 of 4:

Special stains that are not required (noncontributory), but billed, are fraudulent. If you already see the H. pylori with H&E, why the histochemistry? If you already see the specialized intestinal metaplasia, why the histochemistry? If the special stain is not even appropriate (cluster of squames, ulcer bed, obvious carcinoma...) it is totally inappropriate to bill for it.

The G/I pathology in office ancillary services exception to Stark Medicare exception is already under scrutiny by the OIG (in part due to pod labs and specifically the Uropath lawsuit and because of the obvious financial incentive to biopsy once and bill twice) and likely is a cul-de-sac. I suggest you peruse / subscribe to Endoeconomics http://www.endocenters.com/endoeconomics.html

The spring 2008 issue suggests that this self referral scheme is not going to be around much longer. Your "colleagues" are already "in," so they will ride this scheme (including you) as long as they can. Speak openly and honestly with your G/I client and lay out your concerns. Tell them in writing that you want to be able to cancel the charge for special stains if it was performed, but non-contributory. If they are worthy of your regard as professionals, they will be amenable to addressing your concerns. If they are not, you should distance yourself from these scoundrels and report them to the OIG for Medicare fraud (and collect your whistle-blower reward) with specific examples that you happen to have handy from systematic inappropriate charges to Medicare patients.

Endoscopists are under compensation assault so they are rapacious. Don't compromise yourself to offset their financial woes. Do not be part of what is WRONG with American Medicine.

Response #3 of 4:

[Anonymous], a superb answer. The difference between right and wrong is often very clear indeed and if you want to sleep at night...

Response #4 of 4:

A local GI group has an in-house path lab. The members don't seem sleepy, but are currently doing a prospective study to determine whether or not their biopsy rates have increased since instituting in-house billing. What they'll do if the results show an increase,(I'd bet on it,) will be interesting. One of their members still argues about the necessity of 6-7 minute cecum-rectum times.

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Standards in Digital Pathology and Telepathology

I get many questions concerning the use of telepathology and standards.  In short, there aren't many standards per se, this site I came across recently talks about the development of such and groups that are working in this area with updated documents - http://www.conganat.org/digital/index.htm.

In addition, there are some proposed clinical guidelines produced by the special interest group for telepathology for the American Telemedicine Association - http://dpig.upmc.com/ata/guideline.htm.

To my knowledge the clinical guidelines are still in a "draft" format but provide an outline for telepathology consultation and clinical practice guidelines that are analagous to traditional consultation.