Clarification of Comments about the U.C. Berkeley Genetic Testing Program

Joe Plandowski has emailed me to correct a portion of my blog note of yesterday (see: UC Berkeley "Adjusts" Its Freshman Genetic Testing Program). Here is his comment:

Also, all labs other than research labs in this country that test patient specimens and release those test results to physicians or patients, where allowed by the state, must be CLIA registered. Last time I looked, there were about 180,000 CLIA registered labs. Of that total, about 110,000 such labs are in physician office practices. Commercial labs occupy about 5,000 of the total and hospitals have about 8,000 of the registered labs. There are more CLIA lab registrations for hospital labs than there are hospitals because some hospitals have multiple registrations (ex - Cleveland Clinic has 4 CLIA registrations).

Joe is correct. I conflated the two separate issues of (1) CLIA certification of labs and (2) the release of test results directly to a patient, the latter being  controlled by state regulations. Here is a brief summary of the CLIA regulations (see: Clinical Laboratory Improvement Amendments).

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.The objective of the CLIA program is to ensure quality laboratory testing.

So, here are the salient take-home points:

• Research labs are not required to be CLIA certified, presumably because they are not pursuing the diagnosis of disease in humans. Some research labs obviously do perform tests on humans, as in the case of drug trials, but these tests are part of a project and the results are not released to the subjects.
• CLIA regulations are quality-driven and apply to those labs performing tests on humans for the diagnosis of disease. Physicians order their tests from such labs.
• As emphasized by Joe above, there are a set of states where individuals can directly order lab tests and receive lab results. California is not one of them. The ASCP has determined that direct-access-testing (DAT) is allowed in some form in 34 states.  In all the rest of them, the tests are ordered by a physician and the results are returned to that physician. Only the ordering physician can release test results to the patient.

Last Day to Get Epocrates Essentials for Free for Medical Students

To kick off the new school year Epocrates is giving all U.S. medical students a free copy of its popular Epocrates Essentials suite which typically costs $159. Today is the last day of the offer so do it now before the clock strikes midnight and you turn into a pumpkin. Compared to the Epocrates Rx, which has always been free, this version includes an infectious disease treatment guide, alternative (herbal) medicines, disease monographs and diagnostic and laboratory tests. This version of Epocrates is available for the iPhone/iPod touch, Palm, Blackberry, and Windows Mobile. Link: Free Epocrates Essentials for Med Students... Product page: Epocrates Essentials... Michael
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Private Donations Rescue Medical Technology Program at the U. of Hawaii

We are facing a major shortage of medical technologists in this country (see: Comments on the Medical Technologist Shortage; The Continuing Shortage of Medical Technologists: a Challenge for Hospital Labs). They constitute an absolutely essential component of the clinical labs. They are the front line troops who perform nearly all of the essential tasks including most new test development. Many medical schools and universities have walked away from their medical technology programs because they can be complex to organize and manage and faculty members may be difficult to recruit. Now comes the news that the University of Hawaii will once again admit students to its medical technology baccalaureate degree program (see: UH to admit medical technology students again). Below are the details:

Donations are enabling the University of Hawaii to once again admit students to its medical technology baccalaureate degree program. Clinical Laboratories of Hawaii and Diagnostic Laboratory Services saved the program with $100,000 in donations to the university. The money is allowing the John A. Burns School of Medicine to support a full-time faculty member for the next two years. State budget cuts forced the school's Medical Technology Department to stop admitting new baccalaureate students last summer.The university since sought private support for the program.

As we all know, many states like Hawaii are in severe financial stress and are thus cutting back on allocations to their state university programs. For various reasons, med tech programs seem to be particularly vulnerable to cutbacks and closure. I think that part of the problem is that the essential role of this group of healthcare professionals is not well understood by politicians and the various higher education officials. It's telling with regard to the University of Hawaii that: (1) the funding of only one faculty member for two years was sufficient to resurrect the program; and (2) the money was obtained from two local commercial reference labs. Of course, these labs have a significant vested interest in such a program, often hiring the graduates for their labs.

Guest Article: Top 10 tips for successfully using speech recognition in EHRs and healthcare apps

Moving away from paper is an automation journey that is both challenging as well as rewarding and choosing the right data entry technology is certainly one of the biggest challenges. Choose the right data entry mechanism and your journey is smooth; choose unwisely, and you’re in for a great deal of pain. There is no right mechanism for everyone so you’ll need to go through the various options with great care. One of my favorite data entry techniques is speech recognition (something I use for dictating blogs and writing articles) so I invited Nick van Terheyden, MD, Chief Medical Information Officer (Clinical Language Understanding) from Nuance Healthcare to offer tips and tricks that can help simplify and ease the move towards electronic records using speech recognition. In addition to spending several years as a medical practitioner, Dr. van Terheyden was also behind the development of an electronic health record in the early 1990’s and later became a business leader in one of the first speech recognition Internet companies so he knows his stuff. He’s a very interesting physician and you can follow him on Twitter @drnic1 and on his blog, Voice of the Doctor. Here’s what Dr. van Terheyden had to say about how to maximize speech recognition in EHRs as well as some pitfalls to avoid:

1. Have the right hardware installed – while technology has improved and Moore’s law remains in effect doubling the number transistors (and hence power) of the chip. But doubling the power in the laboratory and store doesn’t translate into doubling of power of the desktops in a clinical setting that may have been installed several years ago and are now underpowered for current applications. In fact for many the hardware is woefully inadequate and nothing will kill the value proposition than the dreaded hourglass cursor or worse repetitive delays and even crashes. Speech technology requires processing power and memory – make them available. Buying the low cost home computer from CostCo or Best Buy that features an older processor such as the older Intel Celeron. This is especially true for the Netbooks that just don’t have enough processing power or memory to meet the need. Much better to buy a higher end business machine with an Intel Pentium4 or AMD Athlon 64 chip with at least 1 Gb of RAM and preferable more.
2. Intelligent application Coexistence – putting a speech recognition application on the same desktop as any graphic intensive application that creates 3-D models out of 2-D input (such as Vital Images Vitrea, Tera-Recon Aquarius or Barco’s Voxar 3D) is asking for trouble. Both these application need powerful processors and lots of memory. If both are installed they’ll be competing and likely neither will work well and frustrate users. Same applies to other processor and memory intensive applications such as video editing and processing applications or heavy data query/reporting tools.
3. Use good quality microphones and sound recording equipment. Buying the cheapest microphone and expecting to get good results from speech recognition is similar to using the cheapest quality meats and food ingredients and expecting a 5 star dish worthy of placement in an Iron chef competition. If you want good results you need good quality audio. Most vendors have a recommended list of recording devices – find a range of choices and offer them to your users. Most of the modern Plantronic headsets are firm favorites with Speech recognition users including myself. The DSP 300 offers wireless connection, and the Audio 310 offers a flexible wired connection with straight audio jacks and a handy USB adaptor for computers that have no audio jacks built in. But for those looking for low profile connections the RevoLabs RF:xTag offers a device that clips on to your lapel for almost invisible recording capability. Bonus Tip: Assemble the full collection of styles and types of devices and keep them on hand available for users to view and test to determine personal suitability. One colleague has a suitcase filled with the various types of devices that is he takes to show colleagues the choices and help them settle on the most appropriate choice for them in their clinical setting
4. Environmental Considerations. Think about the clinical environment – a busy and noisy setting may need a different approach for capturing audio. But there are basic actions – a radio playing loudly in the background is unlikely to help a speech recognition solution return accurate results. While the staff may want to have the radio playing this may not be the best choice if it interferes with the effectiveness of the technology. Bonus Tip: There has been some work that suggests that better than a quiet environment is an environment populated with White Noise – in troublesome areas introducing some white noise generators (assuming hey are acceptable to patients and staff) may help improve accuracy and the overall acceptance and usefulness of a speech solution.
5. Create a Standard and Replicate. Once you have found the ideal configuration(s) using both technical specifications, local circumstances and requirements and some inevitable trial and error get several users to try the configuration to make sure this meets the broadest range of needs. Then rinse, lather and repeat. Take this configuration and replicate it faithfully throughout the facility, clinic or enterprise. So if you have found that Computer A, with a specific motherboard, memory size and type, hard drive, graphics and audio add options buy the identical set up and replicate the exact configuration down to the operating system version, software and even patches. This might sound daunting but this is exactly what corporate and enterprise IT system support centers do. They create one standard and then create an exact image of the drive and copy this to all the other machines (purchasing the necessary licenses for the number of installations created). This can be done with tools designed for this purpose for large numbers of machines or simply by following an identical setup procedure for each new machine. Once you have a working environment don’t be in a rush to update software components with the latest versions or patches before you test to make sure updates don’t break your working configuration.
6. Anticipate Resistance. Expect resistance – resistance is part of life and best faced directly with a clear understanding of the reasons. Some of this arises from the prejudice based on historical bad experiences with technology that was implemented either before it was ready or without the right environment and support. Set up opportunities for everyone to see the technology in use and try it for themselves. Clinicians successfully using the solution in use in a there own clinical setting is most helpful in overcoming the resistance
7. Quick Portable Guides. Develop a Short Guide/Cheat Sheet of Commands and tools and Techniques – taking a leaf out of the Apple playbook and simplify the experience. Overwhelming already frazzled clinicians with hours of training is unlikely to lead to success. Identify the key pain points of clinical documentation that can be helped using speech recognition and dictation, accepting that for some clinicians using speech may not be suitable for them at this time or in their particular circumstance and focus on delivering success here. This may not include all the features and short cuts available when using a speech recognition solution but early success is more important than using every element available in a solution.
8. Preparation. Prepare, prepare and prepare some more – Once you have identified good targets offer a simple path to adoption that does not entail long user training sessions. Capitalize on the built in tools available in speech recognition products that jump-start the building of a customized profile. Pre load with previous reports for that user, carry out minimal audio enrollment and test the profile for effectiveness. At the elbow training is most helpful here to get a critical mass of users up to speed and using the solution effectively. Once you have the critical mass or early adopter super-users this group will help the late adopters when they elect to transition to using he technology (and this move will be driven in large part when they see their colleagues being successful using the technology)
9. Horses for Courses. Some users will use the most basic features for simple typing replacement. Dictating into a box and seeing the results appear and being able to complete a document immediately may be enough. Mixed with some use of the keyboard and other documentation tools may be enough to keep some clinicians happy. Others may make use of templates, an the ability to customize standard content for different patient interactions. And there will be some who make extensive use of the features including all of the above as well as command and control to navigate applications, sign documents, display results and automate complex tasks. Accept the variation and be prepared to support all levels of usage –success is measured by each doctor not by a standard set by a group or department. If a doctor feels successful then he is
10. Identify champion(s). More often than not facilities are full of existing users who have speech recognition in use in a range of circumstances. These individuals are often well connected to the industry and other power users through online forums and conferences. Identify them early and make them a apart of the process and implementation baring in mind that if you are asking them to give up clinical time they need to offset this lost income in some way – many contribute excess hours and time to projects to of goodwill and passion but finding ways to compensate them is likely to create a stronger more long lasting supporter

Digitizing medical records is not so much a destination but a journey and one that we must all take. There are challenges and achieving success is not entirely dependent on speech recognition technology but where it does make sense getting the best from the technology will go a long way to easing the strain everyone feels with change. The benefits are clear the question you must ask yourself as a physician is can you afford not to go digital and more importantly can your patients.

Also, if you’re looking for EHRs and other software don’t forget that you can get free medical software advice on HITSphere.com.

The Future of Healthcare and the Four P's: Preventive, Predictive, Personalized, Participatory

I have posted a number of previous notes on the topics of preventive, predictive, personalized, and participatory medicine (see: Preventive and Predictive Medicine as Components of the Healthcare Continuum; Some Encouraging News About New Federal Funding for Preventive Medicine Initiatives; Wellness, Preventive Medicine, and the Classic Disease Model; The Need for a Preventive Medicine Infrastructure in the U.S.; A Key Link Between Predictive and Preventive Medicine; Further Consideration of the Definition for Personalized Medicine; Recruiting Office Patients into a Participatory Model of Healthcare Delivery; "Participatory Medicine" and Its Relationship to Clinical Lab Testing). There are more but you get the idea.

Putting it all together, they together constitute a blueprint for the healthcare development arc in the near term. Tony Killeen, who blogs over at iPathology, makes reference to a recent lecture by Leroy Hood about P4 Medicine (see: P4 Medicine: Predictive Preventive Personalized and Participatory). Below is an excerpt from his note:

One "deals" with the enormous amount of data that will be accessible to us using information technology, but Tony already knows this. I think the question that he is really asking here is how the IT tools that will be at the disposal of both physicians and patients will be integrated into healthcare delivery. What's most revolutionary about the Four P's is the last one -- participatory. The truly unique aspect of this formula will be the nearly unfettered access by patients to the same information about their health status as the healthcare professionals (see: Should Patients Be "Allowed" to Read Their Medical Records?; Paging Dr. Google! We Are Waiting for a Second Opinion.; Teaching Consumers to Say "No" to Physicians' Recommendations). The most engaged of them will become key partners in the quest for continuing wellness.

Coming Soon: Piezoelectronics at Nanoscale

McGill University scientists have developed a way to place electric charges onto quantum dots (particles sized Cadmium Selenide quantum dots can be used in a wide range of technological applications. Solar power is one area that has been explored, but this new discovery has paved way for other nanoscale device applications for these dots. This discovery offers a way of controlling the speed and switching time of nanoelectronic devices, and possibly even developing nanoscale power supplies, whereby a small compression would produce a large voltage. "The piezoelectric effect has never been manipulated at this scale before, so the range of possible applications is very exciting," explained Pooja Tyagi, a PhD researcher in Professor Patanjali Kambhampati's laboratory. "For example, the vibrations of a material can be analyzed to calculate the pressure of the solvent they are in. With further development and research, maybe we could measure blood pressure non-invasively by injecting the dots, shining a laser on them, and analyzing their vibration to determine the pressure." Tyagi notes that Cadium Selenide is a toxic metal, and so one of the hurdles to overcome with regard to this particular example would be finding a replacement material. More from McGill: Good Vibrations: new atom-scale products on horizon... Abstract in NANO Letters: Controlling Piezoelectric Response in Semiconductor Quantum Dots via Impulsive Charge Localization... Michael
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Important Deadline Approaching for the Pathology Informatics 2010 Conference in Boston

The Pathology Informatics 2010 conference will take place on 19-22 September at the Westin Copley Place Hotel in Boston. It's an amalgam of three previous pathology informatics conferences: (1) APIII, held for 14 years, mainly in Pittsburgh; (2) Lab InfoTech Summit, presented for six years in Lab Vegas; and (3) AIMCL with a 21 year tenure in Ann Arbor.

A key date is approaching for those interested in registering for this conference -- August 27. This marks the deadline for the reduced conference registration fee for the event and also for making a reservation at the Copley. A block of rooms have been set aside at the hotel by the conference organizers for registrants at a special price but there is no guarantee that rooms will be available after this date. On-line registration is available at the conference web site as well as details about how to reserve a room at the hotel.

Early indications are that the conference will provide a very valuable educational experience for registrants. A record has been set this year for the number of scientific presentations on the basis of abstract submissions (see: New Record Set for Scientific Abstract Submissions to Pathology Informatics 2010). In addition, a record number of exhibitors, 41, will be demonstrating their products in the large exhibitor ballroom. Forty-eight faculty members will participate in three workshops, three separate content tracks, and three plenary sessions.

Providence Health Links Labs, EHRs

Providence Health & Services in Portland, Ore., will integrate its laboratory and diagnostic imaging applications to the GE Centricity electronic health records software used by 800 affiliated physicians in the state.

New Record Set for Scientific Abstract Submissions to Pathology Informatics 2010

Pathology Informatics 2010 will take place on September 19-22, 2010, at the Westin Copley Place Hotel in Boston. This conference has been formed from a merger of APIII, held primarily in Pittsburgh for the past 14 years, and Lab InfoTech Summit/AIMCL that were presented in Las Vegas/Ann Arbor for the past 27 years.

AIMCL has always included scientific sessions and e-posters in its programming. The former are 15-minute oral presentations selected on the basis of submitted abstracts. E-posters, as the name implies, are lecture-demo's using PCs as a substitute for the standard physical posters presented at many medical conferences.

A new record has been established for scientific abstract and e-poster submissions for this year's conference with 60 of the former and 24 of the latter. In order to accommodate these 60 abstract presentations, the conference organizers have expanded the number of available conference rooms to five. The sessions will run in parallel on Monday and Tuesday mornings, September 20 and 21, from 7:30-9:00 a.m.

Nanocorrosion Identified as Cause of Failure of Medical Device Coatings

Diamond-like carbon (DLC) coatings are commonly used in medical implants to greatly improve their resistance to environmental factors. Though impressively strong and impermeable, DLC will often break off from the implants to become a nuisance within the body. Now scientists at Empa, a Swiss research institution, have discovered why that happens and what can be done to prevent the chipping. "When two materials are placed in contact with each other, the result is a reaction layer at the interface between them, which is only several atomic layers thick. Thus a new material is formed, which we investigated now for the first time", explains Roland Hauert of Empa's "Nanoscale Materials Science" laboratory. His team showed that the so far barely considered reaction layer, which is not always completely corrosion resistant, is responsible for the detachment of the DLC layer. On the one hand, stress corrosion cracking occurred in the reaction layer. The mechanical load in conjunction with the penetration of body fluids led to slow-growing cracks, which in turn caused the DLC substrate to detach little by little. In other cases, crevice corrosion was responsible for the damage. Over time, an aggressive, acidic medium develops in fine crevices and slowly dissolves the reaction layer or the additional adhesive layer, likewise leading to detachment. But the Empa team didn't stop there; together with their industry partners Synthes and Ionbond, they developed a corrosion-resistant intermediate layer at the interface to the DLC layer. What's more, the researchers also developed a process that can determine a crack's growth rate under conditions similar to those experienced in the human body as well as the dissolution rate of the reaction layer in cases of crevice corrosion. Full story from Empa: Nanocorrosion causes implants to fail...... Michael
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LabCorp Collaborates with Clearstone in Support of Global Clinical Trials

Contract research organizations (CROs) such as Covance and Charles River, particularly those with expertise in clinical and anatomic pathology, have been in the forefront of efforts to develop global networks for collaborative work and information exchange (see: A Look at the World's Largest Central Laboratory Network; Covance's Execution of a Global Virtual Clinical Lab; Charles River Acquires Molecular Imaging Company; Status and Challenges of Offshore Clinical Trials). They are also leading the way in the adoption of digital pathology for their veterinary pathologists (see: Veterinary Pathologists Adopting Digital Pathology Faster than MDs). These networks allow for archiving of digital image files in central global locations plus collaborative efforts across multiple sites in the analysis and interpretation of digital images. These clinical trial and research networks will be important models for the future exchange of scientific and medical data, which will be of increasing importance as healthcare transitions to a more global model.

The CRO market is particularly attractive now for clinical and pathology reference labs because Big Pharma is withdrawing from its drug-development and clinical trial efforts, turfing them instead to the rapidly growing CROs (see: CROs Continue to Prosper; Benefits of Big Pharma Outsourcing). This retrenchment is one facet of Big Pharma's cost-cutting efforts and disappointment with its new drug pipeline. A recent press release indicates that LabCorp has seen the handwriting on the wall and is collaborating with privately held Clearstone Central Laboratories in order to quickly establish its own global network (see: LabCorp Establishes Global Clinical Trials Collaboration with Clearstone Central Labs). Below is an excerpt from it:

Here's how Clearstone describes itself on its web page:

Obviously, a physical global network is only one part of the success equation. A second key element, as noted in this excerpt, is Clearstone's clinical trials management software, APOLLO CLPM, that is part of the deal for LabCorp. As you can imagine, managing complex clinical trials across multiple physical locations is a complex endeavor and requires direction from some higher-level "guiding hand." Here is a description of the APOLLO CLPM, also from the Clearstone web site:

APOLLO CLPM is a secured globally accessible web based, 21 CFR part 11 validated application. Designed and developed by subject matter experts of every applied discipline integral to the system. Built on an Oracle database, the APOLLO CLPM system is a truly singular database that replaces multiple legacy systems and sub-systems, helping to drive improvements in efficiency and quality across the central laboratory business Apollo provides for global standardization of requisitions, reports, kits, barcode labels, as well as scientific information, and improves the accuracy and speed of sample reception and processing.

Paper: Patel et al. (2009) Clinical complexity and medical education

The following item about a paper from last year was posted by Rakesh Biswas on the COMPLEXITY-PRIMARY-CARE list. After Rakesh's comments I have included a quotation.

The paper in question by Patel, et al. will be an important reference for me, even though the definition of domain and discipline remains problematic. (A glossary for the health career model will follow on the new site.)

Suddenly, the passing of time is also clear given that:

Shortcliffe, E.H. (et al.) Ed. (1990) A History of Medical Informatics, Wokingham, Addison-Wesley Publishing Co.

- appeared twenty years ago. Ten years ago I cited Shortcliffe et al..

Twenty years! How long is that in technology / internet terms?

The bold text below is my emphasis:

From: Rakesh Biswas
To: COMPLEXITY-PRIMARY-CARE@JISCMAIL.AC.UK
Sent: Thu, 12 August, 2010 16:41:06
Subject: Clinical complexity and medical education

As our society progresses in the accumulation of knowledge and as the complexity of this knowledge increases, it becomes more important to determine how to structure education to provide individuals with the most comprehensive base of knowledge without sacrificing either depth and complexity or broadness of material.

Human beings have an extraordinary capacity for storing large volumes of organized information in memory. How does one apply such detailed knowledge to practical, real-world problems and situations?

What is the optimal mode of learning that will promote flexibility and transfer of general knowledge across domains during problem-solving?

For more, see the article by Dr Patel whose focus area is Medical Cognition (how doctors think and develop their so called expertise).

Regards,
Rakesh

Here is a quote from the paper:
Much of the early research in the study of reasoning in domains such as medicine was carried out in laboratory or experimental settings. There has been a shift in more recent years toward examining cognitive issues in naturalistic medical settings, such as medical teams in intensive care units [2], anesthesiologists working in surgery[89], nurses providing emergency telephone triage [90], and reasoning with technology by patients [91] in the health care system. This research was informed by work in the area of dynamic decision-making [92], complex problem-solving [93], human factors [94,95], and cognitive engineering [44]. Naturalistic studies reshaped researchers’ views of human thinking, as expressed in ‘‘situativity” theory’s terms (as described in Section 2.1.4) [23–26], by shifting the onus of cognition from being the unique province of the individual to being distributed across social and technological contexts. p.186.

Whilst as Rakesh points out Dr. Patel's focus is medical cognition, then through the health career model it would appear my interest is nursing cognition. As per the legacy of models of nursing - which did recognize the patient through the concept of patiency (Stevens, 1979) - we realise that now all disciplines must demand much more of their respective models in the 21st century.

Patel, V.L., et al. (2009) Cognitive and learning sciences in biomedical and health instructional design: A review with lessons for biomedical informatics education, Journal of Biomedical Informatics, 42, 176–197.
doi:10.1016/j.jbi.2008.12.002

Stevens, B.J. (1979) Nursing Theory: Analysis, Application, Evaluation. Boston: Little, Brown and Company.
Read more [Hodges' Model: Welcome to the Quad]

Free Epocrates Essentials for Medical Students

Epocrates, one of the most well known medical programs for mobile devices, is offering its Essentials version for free to medical students for a limited time (normally $159). Compared to the Epocrates Rx, which has always been free, this version includes an infectious disease treatment guide, alternative (herbal) medicines, disease monographs and diagnostic and laboratory tests. This version of Epocrates is available for the iPhone/iPod touch, Palm, Blackberry, and Windows Mobile. Although you have to study medicine in the United States to be eligible, there doesn't seem to be any check for this during registration. The offer stands until August 31st. Link: Free Epocrates Essentials for Medical Students... (hat tip: iMedicalapps)... Wouter Stomp
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PathologyLinks: A Comprehensive Gateway to a Host of Resources

I have just discovered PathologyLinks (Eric's Links) by way of a referral to Lab Soft News. It's a compilation of approximately 230 separate links (there were so many that I lost count) with relevance for the practice of pathology and categorized in the following way:

• Surgical Pathology (general)
• Subspecialty Surgical Pathology     
• Cytopathology
• Autopsy
• Histology
• Anatomy & Physiology
• Microscopes and Microscopy
• History of Pathology
• Other Pathology Resources
• Bioinformatics
• Internet Research

Eric turns out to be Eric K. Morgen, M.D., an AP resident in the Department of Lab Medicine and Pathobiology at the University of Toronto. This meta-site is obviously a labor of love for Eric -- great work. We can all derive benefit from his efforts. I could spend a couple of days and still not adequately scan all of material to which these links lead.

I can't pass up a brief comment on the use of the term pathobiology for the University of Toronto department in which Eric is a trainee. The Wictionary defines the term in the following way: The branch of biology that deals with pathology with greater emphasis on the biological than on the medical aspects. The specialty of pathology focuses on abnormal biology, which is to say the broad spectrum of disease. It's understood that one cannot understand the abnormal unless one has a grasp of the normal states from which the abnormal is derived.

For the name of a department with a strong bench research component, the use of the term pathobiology seems to make good sense. However and for the clinical side of the department with the job of focusing on the diagnosis of disease, I am not sure that the name is completely apt. I could be all wet here -- a Google search shows about 13 million hits for the term so perhaps it is currently in vogue and I just plain missed the shift.

15 – Free and Open source LIMS : Laboratory information management system programs and projects

MIT Researchers Use Raman Spectroscopy for Noninvasive Blood Glucose Measurements

Researchers at MIT's Spectroscopy Laboratory have announced that they are currently working on a Raman spectroscopy machine which can measure blood glucose without a blood sample. The machine sends infrared light through the skin to determine glucose levels in the interstitial fluid. In a paper published in the July 15 issue of Analytical Chemistry, the researchers described their algorithm for determining blood glucose levels based on the interstitial concentration. From MIT's press release: Researchers in the Spectroscopy Lab have been developing this technology for about 15 years. One of the major obstacles they have faced is that near-infrared light penetrates only about half a millimeter below the skin, so it measures the amount of glucose in the fluid that bathes skin cells (known as interstitial fluid), not the amount in the blood. To overcome this, the team came up with an algorithm that relates the two concentrations, allowing them to predict blood glucose levels from the glucose concentration in interstitial fluid. However, this calibration becomes more difficult immediately after the patient eats or drinks something sugary, because blood glucose soars rapidly, while it takes five to 10 minutes to see a corresponding surge in the interstitial fluid glucose levels. Therefore, interstitial fluid measurements do not give an accurate picture of what's happening in the bloodstream. To address that lag time, Barman and Kong developed a new calibration method, called Dynamic Concentration Correction (DCC), which incorporates the rate at which glucose diffuses from the blood into the interstitial fluid. In a study of 10 healthy volunteers, the researchers used DCC-calibrated Raman spectroscopy to significantly boost the accuracy of blood glucose measurements - an average improvement of 15 percent, and up to 30 percent in some subjects. Press release: Shining a light - literally - on diabetes... Abstract of the researchers' paper: Accurate Spectroscopic Calibration for Noninvasive Glucose Monitoring by Modeling the Physiological Glucose Dynamics... Smit
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More Information about Epic's Beaker LIS and Its Sibling

We are gradually acquiring more information about the status of Epic's LIS, which is called Beaker (see:Introducing the Epic Laboratory Information System (LIS); It's Called Beaker.; An Update on Epic's LIS, Called Beaker, from HIStalk). Now we have a submitted comment from HIStalk that the Sisters of Mercy Health System may be taking the plunge with Beaker in two of their hospitals (see: News 8/6/10). Below is the comment:

From PrettyKitty: “Re: Epic Beaker LIS. After a four-year project rolling out Epic to 10 of their hospitals and replacing existing systems in an effort to standardize, Sisters of Mercy Health System is developing Epic’s Beaker lab application for their next two hospitals to be implemented in the second quarter of 2011. They had been retaining and integrating the previous lab systems — Cerner and Meditech — but have been told that Beaker is ready. They are in the selection process for a Blood Bank system since Epic will not offer that.”

It turns out that Beaker is Epic's "best-of-breed" LIS but it also has an AP-LIS sibling:

Beaker Clinical Laboratory Information System supports inpatient and ambulatory laboratory workflows, combining best-of-breed LIS functionality with the benefits of enterprise-wide integration. With Epic's Web-based OutReach application, external submitters to your reference laboratory can enter orders and receive results online.

Anatomic Pathology Laboratory Beaker for Anatomic Pathology supports the needs of surgical pathology and cytology labs. Barcode enabled workflows help promote safe practices, while dedicated pathologist, cytotech, and histotech worklists help guide cases through the lab. Integration with Beaker Clinical laboratory provides one click access to the patient's history and synoptic reporting allows for efficient data mining.

So we have the BCLIS and APLBAP. Although I think that the name Beaker is a shade too precious for my taste, I think that it's a whole lot better than the name that the Epic name-mavens came up with for the RIS:

Radiant Radiology Information System combines tools for rules-based scheduling, documentation, results communication, chart/film tracking and detailed statistical reporting in a unified system that is fully integrated with our clinical systems. Radiant allows clients to link images and reports with a single system that can be accessed simultaneously by multiple users in multiple departments.

I thought that radiant was a term reserved for Miss America pageants and astrophysicists. Perhaps the alternative name of Radiation Information System was already taken.

An Update on Epic's LIS, Called Beaker, from HIStalk

I raised the topic of Epic's LIS, Beaker, in a recent note (see: Introducing the Epic Laboratory Information System (LIS); It's Called Beaker). Now comes another unverified piece of news about the product from a comment in HIStalk (see: News 8/4/10), I present it in its entirety:

From LISales: “Re: Epic Beaker LIS. Word on the street is that they have one SMALL site using the system within the Wisconsin area, but nothing major yet. I’ve also heard that they are beefing up the development team while including the licensing right to the module within ALL of their enterprise licensing agreements. Also heard is that the functionality is being somewhat oversold compared to actual capability with no desire to develop certain aspects of a full-scale laboratory’s needs, Blood Bank to name but one.” Unverified [by HIStalk].

One word of caution here: this comment was submitted by someone with the nom de plume of LISsales, suggesting perhaps that he or she is involved with sales of a competing LIS product. However, the comment contains at least a grain of truth. It's a common practice for major EMR vendors such as Epic to shrink-wrap an inadequate LIS, or one early in development, with the sought-after EMR in the contract. This is probably even more prevalent these days with many CIOs seeking an enterprise rather than a best-of-breed solution (see: Are You an Enterprise or Best-of-Breed CIO? Access to Cash May Make the Difference.).

This EMR + LIS packaging may be offered for no additional licensing fees as a come-on. The company will then obtain their LIS margin "on the come" with the yearly support fees for the total system. Of course, there is also some padding in the up-front licensing fees. The net result of all of this is that pressure is applied on the lab leadership to join the crowd in the support of the "enterprise solution" from a single vendor. This is fine in theory but the pursuit of such a solution should not penalize the lab personnel who are required to work with a suboptimal LIS.

You may suggest at this point that the position of Epic with their immature Beaker LIS product is no different than any of the current best-of-breed LISs like SCC or Sunquest or Cerner. All of these products at one time or another had a small installed client base and worked with their beta clients to improve their product. Fair enough! In my mind, here's the difference with this Epic scenario. For Epic, their LIS will always be a subservient feeder system for their EMR and never a best-of-breed system. The LIS has always been more than a reporting system for the labs -- it optimizes lab workflows and also provide critical quality control functions. A "good enough" LIS will never suffice and that's why most lab professionals endorse the best-of-breed approach.

Another key point needs to be raised here. I believe that medical diagnostics, composed primarily of in-vitro diagnostics (IVD), pathology, and radiology, has been operating on a different IT development curve than hospital and office EMRs for a number of years. This will eventually result in two separate but inter-connected medical information networks: the clinical EMR and the diagnostic EMR. The reason for this dichotomy is that clinical EMRs (hospital plus physician office systems) will never be able to adequately manage, report, and store the increasingly complex data ( textual, numerical, and image) generated in the diagnostic services. Even the specialized LIS vendors are having trouble satisfying the information processing requirements of molecular diagnostics. Aa another example of this complexity, vendors are having difficult merging RISs and PACS systems. This clinical/diagnostic dichotomy will never be recognized, or even fully understood, by Epic executives.

OpenELIS : Free , Open source , Web based Enterprise Laboratory Information management System – LIMS

Definiens Tissue Studio 2.0 Digital Pathology Image Analysis Software

A few years behind radiology, the field of pathology is now slowly making the move to a digital working environment. One of the new tools helpful in automating some of the laborious tasks involved in pathological research is Definiens Tissue Studio, a digital pathology image analysis program for biomarker translational research. The program uses a "learn-by-example" principle, where it learns from example digital histopathology images with features identified by the user in order to automate measurement in other images. It can quantify localized biomarker expression as well as more than 50 morphological features within pre-defined regions of interest on a cell-by-cell basis and within sub-cellular compartments. The software can handle whole virtual slides as well as tissue micro arrays. The new 2.0 version adds full immunofluorescence support, improved nucleus detection for bright field images, customized “tuning” of Definiens Composer technology along with faster performance. Although it is aimed at research environments, we can see these kind of tools making headway into the clinical environment in the future as well, e.g. for quantifying Her2/neu expression in breast cancer. Press release: Definiens Tissue Studio 2.0 Supports Tumor Profiling, Multiplexing and Biomarker Translational Research... Product page: Tissue Studio...... Wouter Stomp
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Image Analsysis Using an iPhone Camera; Comparisons with Digital Pathology

I still haven't gotten used to the idea that I have a camera in my pocket at all time -- my smart phone. If and when I get my head around this idea, I will be confronted with a new capability. I can use this camera to better understand the world around me. This concept was explained in a recent article from which I quote below (see: Seeing the World Around You Through Your Phone):

This discussion of Goggles and Layar provides a suitable segue to the idea of image search and interpretation in digital pathology (see: Technologies and Tools to Search Images with Images; "Eminence-Based" Surgical Pathology and the Digital Pathology Department). A pathologist selects a field of interest from a current case and asks the computer to search an image database and find identical, diagnosed images. The computer then provides diagnostic and therapeutic suggestions for the case in question. Similar image analysis technology has already gained a foothold with the use of algorithms to score immunohistochemistry (IHC) stained tissue (see: Putting Some Numbers to Digital Pathology Adoption Trends by Pathologists). Regarding the use of such computer algorithms, there is common agreement that this is only a tool to assist a pathologists in interpreting a stained slide and that he or she is the final arbiter of the results.

Regarding image search in surgical pathology, I think that such an approach to diagnostic interpretation will soon become a widely accepted practice, again as a tool to assist the pathologist in the interpretation of a case. What we now lack, however, is a curated histopathology image database. By this I mean an database of pathologic images that have been reviewed and vetted by experts as to the diagnoses used to tag them. If you perform a Google search for the terms pathology, image, and archive today, you get 278,000 hits.  Who's to know which of these archives provide universally reliable diagnoses linked to the images. Once such a curated database is created, the next step would be to link it to reliable clinical databases, allowing queries about optimum treatment for patients with the lesion under study across time.

Membrane Created for Controlling Passage of Gas Using Light

Researchers from Rochester University have created a hard plastic membrane, full of tiny holes, that can go between being permeable and impermeable to gas by shining light of different wavelengths. The holes in the membrane are filled with liquid crystals and a light reactive dye. When blue light is shined onto the dye, it lines up and the liquid crystals follow suit, creating a passage. When ultraviolet light is applied, the dye crinkles and so do the liquid crystals, blocking the hole. We can imagine drug dispensing devices that are stuck on or under the skin that can be easily switched on and off using a pocket light. Creating the membrane is a multi-step process. First, a circular hard plastic chip is bombarded with a beam of neutrons to make the tiny, evenly spaced holes that are about one-hundredth of a millimeter in diameter. The chip is then dipped in a solution of liquid crystals and dye, and the mixture fills the holes through capillary action. The final product is spun in a centrifuge to remove the excess liquid crystals from the surface. Controlling a membrane's permeability with light is preferable to controlling it with heat or electricity - two readily used alternative methods - for several reasons, Glowacki [Eric Glowacki, a graduate student at the University's Laboratory for Laser Energetics] said. For starters, light can operate remotely. Instead of attaching electrical lines to the membrane, a lamp or a laser can be directed at the membrane from a distance. This could allow engineers to make much smaller, simpler setups. Another advantage is that the color of the light illuminating the membrane can be changed precisely and almost instantaneously. Other methods, like heating and cooling, take a relatively long time and repeated heating and cooling can damage the membrane. Also, light does not have the potential to ignite a gas, which could be a crucial benefit when working with hydrocarbons or other flammable gases. Lastly, the amount of light energy needed to switch the membrane on and off is miniscule. Press release: Purple Light Means Go, Ultraviolet Light Means Stop ... (hat tip: io9)... Michael
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RODS Open source Java Real-time Outbreak and Disease Surveillance for public health

Gold Standard Diagnostics Unveils EIA Platform

Gold Standard Diagnostics, Inc., a small company out of Davis, CA, just unveiled their Thunderbolt Automated Diagnostics Platform. The Thunderbolt is primarily an Enzyme Immunoassay (EIA) diagnostics tool, though it can be configured to perform chemiluminescence as well as multiplexing. Picture it as a customizable box with a fully programmable EIA processor that handles your samples and lets you customize it as you like. It seems like this is panning out to be Gold Standard Diagnostic's flagship product and they're keen to start showing it off. From the press release: The ThunderBolt platform will provide laboratory customers with a single hardware solution that can utilize multiple diagnostics technologies such as EIA, chemiluminescence and multiplexing. The inaugural product of the ThunderBolt platform is an EIA (enzyme immunoassay) processor, with a completely open software design capable of programming virtually any EIA test. EIA tests are widely used to detect and quantify substances such as peptides, proteins, antibodies and hormones, and to diagnose diseases and conditions including infections, cancer, metabolic disorders, allergies and autoimmune diseases. In a single, easily configured run, the flexible ThunderBolt EIA processor can process multiple microtiter plates, while also running up to eight different simultaneous assays. With an onboard reader, the fully automated EIA processor offers a true “walkaway” solution for labs of any size. The compact design takes up less than half the workspace of similar EIA automated processors on the market. Cost-effective operation makes the ThunderBolt suitable for larger clinical laboratories, while it also provides the customizable capabilities needed in hospital or research laboratories. Press release: Gold Standard Diagnostics Introduces the ThunderBolt Automated Diagnostics Platform... Product page: GSD Thunderbolt...... Sean Duffy www.medgadget.com
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Bika : Free , Open source LIMS – Laboratory Information Management System for Windows , Linux and Mac OSX

Test Pilot

Vermont makes a good laboratory for testing all kinds of efficiency strategies.

ESP : Free – Open source EMR analysis and Disease reporting

Introducing the Epic Laboratory Information System (LIS); It's Called Beaker.

In response to yesterday's note, Infopathic provided us with a key piece of intelligence via a comment -- the status of Epic's LIS:

The Epic solution for EMR has has indeed been judged to be superior. And for those searching for a superior LIS, one with a seamless integration to this EMR would be epic! or, at least...superior. A recent peek into the EPIC LIS entry - Beaker, reveals that the search is far from over. This LIS newcomer is certainly not ready for prime time. Whereas several basic workfolows are in place and appear to be well designed, in my humble opinion, the Beaker is half-empty as a product for large, complex health systems. The search goes on...

How quaint! The name "beaker" sounds to me like it was the product of a coffee klatch attended by creative, marketing types who had never stepped into a modern clinical lab. You will see high powered automated analyzers, chips, and DNA but nary a beaker. Infopathic's information may be true with some support from the Epic web site:

Beaker Clinical Laboratory Information System supports inpatient and ambulatory laboratory workflows, combining best-of-breed LIS functionality with the benefits of enterprise-wide integration. With Epic's Web-based OutReach application, external submitters to your reference laboratory can enter orders and receive results online.

Here are some more details about Epic's OutReach:

OutReach works with the Beaker Clinical Laboratory System to help build strong relationships with external providers that receive laboratory or diagnostic services from your organization. Intuitive order entry features allow users to send orders to your facility securely over the Internet rather than through staff-intensive telephone, fax or paper-based methods. Decision support and results communication features support users during the order entry process and help route test results appropriately. Integration with our Beaker Clinical Laboratory System allows your users to carry out specimen collection and shipping management tasks online.

Perhaps apocryphal, I have been told the story of the head of pathology informatics in a large academic medical center that had just signed a contract with Epic. He was told by the CIO: "You will, of course, install the Epic LIS." He, like all lab types, has a very practical streak. He said: "Let me see it and test it. If I can't poke it, tickle it, run it through it's paces, it simply won't 't do. We also need to benchmark it against its competitors in the market." He was a best-of-breed kind of guy because he understood that his job was totally dependent on running a reliable, comprehensive, and functional LIS (see: Are You an Enterprise or Best-of-Breed CIO? Access to Cash May Make the Difference.).

I yield to no one in terms of my admiration of EMRs. Patient care is complex. You need to post the results of physical exams. You need to post progress notes. You need to order meds. Building an LIS is a different sort of enterprise, requiring different knowledge and skills. A typical set of labs and LIS in a large hospital offers a menu of a thousand or more tests and performs millions of them a year and stores many more. A lab report can be a sentence long or multiple pages and can contain complex tables, images, or text. The blood bank module tracks an inventory of thousands of blood products. A simple computer error in the blood bank can kill a patient. I am also a strong advocate of the best-of-breed theory as it applies to LISs. An "enterprise, integrated  lab solution" may sound good during a power lunch and may be the favorite approach of the CIO but may not be good enough to get all the lab work done.

Philips Taps Dako's Image Analysis Expertise for Next-Gen Digital Pathology Solutions

Royal Philips Electronics has announced a partnership with Danish company Dako, in which the companies will work together to develop new digital pathology solutions. Philips plans to develop a slide scanner with integrated image analysis software to be provided by Dako. The companies will initially be working towards a breast cancer test, and plan to eventually expand functionality to prostate and colon cancers. From the announcement: Currently, anatomic pathology workflows to examine tissue samples are based on the microscope, through which pathologists examine tissue sections mounted on glass slides and treated with different stains. The staining enhances the contrast between, or reveals the presence of, cellular and molecular components such as cell nuclei or specific proteins. Accurate interpretation of the results is critical to the diagnosis and staging of each individual patient's disease and requires a great deal of skill and experience. Digitizing the images that pathologists normally view through a microscope may enable the introduction of objective and quantitative image analysis tools. Press release: Philips and Dako join forces in digital pathology...... Smit
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Instrumentation Laboratory's Neonatal Bilirubin Assay Gets FDA Clearance

Bedford, Massachusetts-based Instrumentation Laboratory has announced FDA clearance for a new assay which can measure bilirubin concentration (tBili) in newborn babies. Bilirubin is naturally produced in newborns as fetal blood cells are broken down, but abnormally high concentrations can result in permanent brain damage. The tBili assay will be performed using the company's GEM Premier 4000 analyzer, which will provide results in 90 seconds. From the press release: tBili assays performed on the GEM Premier 4000 are not affected by moderate turbidity or hemolysis, ensuring accuracy. Additionally, from a single whole blood sample, a full range of analytes can be measured, including Blood Gas, Electrolytes, Glucose, Lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status. Press release: Instrumentation Laboratory Receives FDA Clearance for New Automated Total Bilirubin Assay on GEM Premier 4000 Critical Care Analyzer... Product page: GEM Premier 4000...... Smit
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links for 2010-07-27

LOINC, a Universal Standard for Identifying Laboratory Observations: A 5-Year Update -- McDonald et al. 49 (4): 624 -- Clinical Chemistry 'The Logical Observation Identifier Names and Codes (LOINC®) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems.' (tags: HL7 LOINC cielodev) The Web Robots Pages This document represents a consensus on 30 June 1994 on the robots mailing list (robots-request@nexor.co.uk), between the majority of robot authors and other people with an interest in robots. It has also been open for discussion on the Technical World Wide Web mailing list (www-talk@info.cern.ch). This document is based on a previous working draft... Hunscher
Read more [FutureHIT]

links for 2010-07-27

LOINC, a Universal Standard for Identifying Laboratory Observations: A 5-Year Update -- McDonald et al. 49 (4): 624 -- Clinical Chemistry 'The Logical Observation Identifier Names and Codes (LOINC®) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems.' (tags: HL7 LOINC cielodev) The Web Robots Pages This document represents a consensus on 30 June 1994 on the robots mailing list (robots-request@nexor.co.uk), between the majority of robot authors and other people with an interest in robots. It has also been open for discussion on the Technical World Wide Web mailing list (www-talk@info.cern.ch). This document is based on a previous working draft... Hunscher
Read more [FutureHIT]

links for 2010-07-27

LOINC, a Universal Standard for Identifying Laboratory Observations: A 5-Year Update -- McDonald et al. 49 (4): 624 -- Clinical Chemistry 'The Logical Observation Identifier Names and Codes (LOINC®) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems.' (tags: HL7 LOINC cielodev) The Web Robots Pages This document represents a consensus on 30 June 1994 on the robots mailing list (robots-request@nexor.co.uk), between the majority of robot authors and other people with an interest in robots. It has also been open for discussion on the Technical World Wide Web mailing list (www-talk@info.cern.ch). This document is based on a previous working draft... Hunscher
Read more [FutureHIT]

links for 2010-07-27

• LOINC, a Universal Standard for Identifying Laboratory Observations: A 5-Year Update -- McDonald et al. 49 (4): 624 -- Clinical Chemistry 'The Logical Observation Identifier Names and Codes (LOINC®) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems.' (tags: HL7 LOINC cielodev)
• The Web Robots Pages This document represents a consensus on 30 June 1994 on the robots mailing list (robots-request@nexor.co.uk), between the majority of robot authors and other people with an interest in robots. It has also been open for discussion on the Technical World Wide Web mailing list (www-talk@info.cern.ch). This document is based on a previous working draft under the same title. (tags: cielo robots.txt seo search reference howto)

Patent Awarded for Processing Pathology Slides

The U.S. Patent and Trademark Office issued a patent to Aperio Technologies for its digital pathology system.

Philips Enters the Still Embryonic U.S. Digital Pathology Market

Philips may be a force to contend with in the increasingly competitive U.S. digital pathology market. The company first unveiled its "work-in-progress" slide scanner and image management system at the USCAP conference last March in Washington, D.C. (see: Philips to unveil breakthrough in digital pathology). Their prototype system has been initially positioned for research but will then transition to clinical use after FDA approval. More recent news is that the company signed an agreement to integrate some of Dako's image analysis applications into Philips'  digital pathology solutions. Company officials have emphasized that anatomic pathology is an essential element in virtually every cancer diagnosis and that demand in this cancer market is increasing.  Philips will also participate in the Pathology Informatics 2010 conference to be held in Boston on 19-22 September, 2010.

I had the opportunity to recently speak with Steve Klink, Director of Communications for Phillips Research, and Jose Castanon, Marketing Director of Philips Digital, about digital pathology in the U.S. They both describe digital pathology as an embryonic market with the overriding demands from customers for rapid slide scanning and image management. They maintain that their equipment will be able to deliver one-minute total handling time per slide. They did agree with me, however, that this may not be absolutely required in all settings if and when slide scanning is performed the night before image interpretation by pathologists.

Both were in agreement that the early adopters of their system will include high-volume reference labs as well as academic departments. The latter may be under pressure to deploy this new technology because of the preferences of residents and fellows applying to their programs (see: Putting Some Numbers to Digital Pathology Adoption Trends by Pathologists). For early adopters, the return-on-investment (ROI) for systems is still not totally comparable to older histopathology techniques but the desire to become an early adopter and master this new technology may outweigh these financial issues. I asked whether they were considering an up-front capital purchase or the rental, taxi-meter approach for their system. They indicated that both approaches are required in the U.S. market.

Because pathology surgical pathology images are not "digital from birth" as they are in radiology, the business case for digital pathology is harder to make than in radiology. Like radiologists, however, pathologists will be forced to retrain with this new technology and also make major changes to histology workflow and report generation. Harking back to the early days of LISs, these new workflow requirements are not tightly integrated into the image storage and retrieval support systems. Hence, the digital pathology vendors like Philips will need to serve as advisers to customers about the optimal deployment of the products that they are selling.

Novel Time-Resolved Fluorescence for Cheap and Reliable Diagnostics at Point of Care

Cambridge Consultants (Cambridge, MA) and XenBio Fluidics (San Diego, CA) just announced a new platform that may bring rapid diagnostic testing to the bedside. Some details from the press release: The new immunoassay platform is based on a novel time-resolved florescence (TRF) label and low-cost portable detection technology, providing the precision, accuracy and sub-pM sensitivity expected of a clinical laboratory in a cost effective near-patient setting, better enabling earlier diagnosis and the detection of a wider range of biomarkers. Cambridge Consultants' platform is based on the combination of a TRF reader and label that achieve high sensitivity by using a temporal, rather than spectral separation of excitation and detection light. At the core of the new platform is an innovative TRF label that offers far greater levels of sensitivity compared to existing gold labels. The new label, when integrated with Cambridge Consultants' sophisticated detection unit, can deliver over four orders of magnitude improved sensitivity compared to gold labels. Using an NT-proBNP assay, Cambridge Consultants has demonstrated that the new platform is capable of detecting the biomarker in concentrations of less than 1pM and under certain conditions as low as 0.01pM. Cambridge Consultants and XenBio's new platform can be applied to a number of substrates, arrays and planar surfaces as well as being capable of being retrofitted to a range of existing lateral flow assays. As a result new tests can quickly be brought to market. Press release: Development opens potential for earlier detection and treatment of major diseases...... Michael
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Large Pathology Informatics Teaching Archive Now Available On-Line

Recently updated on the Pathology Informatics 2010 home page is an archive of the lectures presented at Lab InfoTech Summit (LITS) from 2004-2009 and at APIII from 1996-2009. Access to the LITS lectures is simple -- from the archive index, you only need to click on the year and you will be shown the lecture titles and the name of the presenter for that year. You then have the choice of viewing or listening to the lectures or both. To access the APIII lectures, click on the year and then schedule. Scroll down the schedule and note that for most of the lectures, and adjacent to the names of the faculty members, are labels: [View Presentation] or [View PDF]. Click on these and you are in business. Also now available for viewing or download on the conference home page is the PI-2010 brochure as a PDF file. This was mailed a couple of weeks ago. If you did not receive a copy or want to see it again, click on the caption underneath the brochure icon in the right hand column.

BYOMD: Bring Your Own MD When Hospitalized

As a physician, I have often been drawn into situations by family and friends in which I have served as an informal medical consultant about care and treatment issues. This has usually involved only telephone calls but, for immediate members of the family, hospital visits were commonly involved. On some occasions, I engaged in discussions with the treating physicians. On a small number of occasions, some of these conversations grew heated regarding the type and quality of care being given. One incident in particular stands out in my mind when a family member was clearly expressing a choice which was ignored by the treating physician who was interested. and insistent, on performing a procedure. He backed off reluctantly when I told him that my family member did not want the procedure and had been clearly stating that preference (see: Teaching Consumers to Say "No" to Physicians' Recommendations).

I am sure that my experience is not unusual. In my opinion, it is essential that family members provide close oversight over all aspects of healthcare delivery to avoid errors and improve the quality of care in their families. One blogger is referring to this phenomenon as Bring Your Own Physician (BYOMD). A recent article discussed the phenomenon (see: Going to the hospital? BYOMD):

I fully understand that many families do not have ready access to a doctor friend or other skilled healthcare professional to provide advice when and where it is needed. I can also say with assurance that advice from family members about the care of hospital patients is frequently not appreciated by overworked hospital doctors and nurses. My only advice in these situations is to be courteous but firm when possible errors are spotted. This not only requires close surveillance by family members but, in many cases, some knowledge about the nature of the disease being treated as well as hospital procedures. Some of this knowledge can be obtain with deliberation and caution using quality web sites (see: Paging Dr. Google! We Are Waiting for a Second Opinion).

First Functional Bioreactor-Grown Artificial Lungs Perform Well in Rat Model

Following up on a recent study by a Yale team that has shown effective gas exchange in transplanted bioengineered rat lungs, researchers from Harvard Medical School and Boston University now claim to have created the world's first functional bioartificial lung. Harvard Bioscience, a Holliston, Massachusetts company has proudly announced to have provided the bioreactor in which the lungs were grown. Some details of the study from an abstract in Nature Medicine: We decellularized lungs by detergent perfusion and yielded scaffolds with acellular vasculature, airways and alveoli. To regenerate gas exchange tissue, we seeded scaffolds with epithelial and endothelial cells. To establish function, we perfused and ventilated cell-seeded constructs in a bioreactor simulating the physiologic environment of developing lung. By day 5, constructs could be perfused with blood and ventilated using physiologic pressures, and they generated gas exchange comparable to that of isolated native lungs. To show in vivo function, we transplanted regenerated lungs into orthotopic position. After transplantation, constructs were perfused by the recipient's circulation and ventilated by means of the recipient's airway and respiratory muscles, and they provided gas exchange in vivo for up to 6 h after extubation. Press release: Harvard Bioscience Novel Bioreactor Helps Grow First Functional Lung for Successful Transplant in Collaboration With Dr. Harald Ott and Massachusetts General Hospital ... Abstract in Nature Medicine: Regeneration and orthotopic transplantation of a bioartificial lung Flashback: Engineered Mouse Lungs Function Well in Laboratory Study... Michael
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Webcast of the FDA Public Meeting on Laboratory Developed Tests (LDTs)

This two-day meeting focusing on laboratory developed tests (LDTs) is now being webcast real-time. Background information about this public meeting is also available at the FDA web site.
Read more [Lab Soft News]

Lockheed Martin Moving Forward with Army Exoskeleton Tests

The US Army has given a contract to Lockheed Martin to test its HULC Exoskeleton in the Natick testing facility in Massachusetts. As the embedded video below shows, the HULC assists soldiers movement through terrain and in picking up heavy things. Similar technology from other manufacturers (like Rex) emphasize the medical uses of such a system, particularly for elder care and allowing wheelchair-bound patients to walk, but that's not what Lockheed is doing. The purpose of the testing is to: ... evaluate how the HULC affects Soldiers' performance. Additionally, biomechanical testing will measure the energy expended by a Soldier when using the HULC. The laboratory testing will also assess how quickly users learn to use the HULC system when carrying various loads and moving at various speeds. The contract includes options for field trials to test the system's utility in operational environments. This tech is many years out from operational use. A large issue, and a possible reason for the rockin soundtrack in the video, is that the systems tend to be quite loud. Something soldiers, and the medical community, try to avoid. Press release from Lockheed Martin: U.S. Army Natick Soldier Center Awards Lockheed Martin Contract To Perform HULC™ User Testing... Project page: HULC un-tethered, hydraulic-powered anthropomorphic exoskeleton... More from Wired: Army Tests 'HULC' Super-Strength Gear, No Gamma Rays Allowed...... Dan Buckland
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Sernova's Cell Pouch System Showing Promise in Diabetes Treatment

Sernova, a London, Ontario company, has announced positive results from an animal study testing the safety and efficacy of the company's Cell Pouch System for treatment of diabetes. The details of the study, which involved porcine diabetes model, will be presented in August at the International Conference of the Transplant Society in Vancouver, British Columbia. Some of the major findings of the study released by Sernova: Long-term insulin independence was successfully achieved with significantly fewer islets than the current standard of care, requiring only about 10% of insulin-producing islets normally used for the Edmonton Protocol. Animals in the study achieved long-term glucose normalization throughout the course of the study. Standard laboratory tests demonstrated transplanted islets produced insulin and responded similarly to non-diabetic animals to provide control of glucose. No adverse events related to the Cell Pouch System(TM) occurred during the study. Press release: Sernova Announces Positive Results of its Proprietary Cell Pouch System(tm) in Preclinical Diabetes Model ... Sernova's technology page...... Michael
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EHR Vendor Gets Lab Results Help

Physician software vendor Medrium Inc. will use the laboratory results distribution technology of McKesson Corp.'s Relay Health division.

Draper Working on Inner Ear Drug Delivery Device

Draper Laboratory from Cambridge, MA, is developing a new implantable device that can deliver drugs right to the inner ear. The programmable wearable microfluidic drug delivery system consists of a housing with control electronics, battery and pump, and connecting tubing. The pump is implanted in the temporal bone, with the tube leading onto the cochlea, injecting drugs from the tip. Drug dosing can be precisely timed. The device can be used for local delivery of drugs that might promote regeneration of inner ear hair cells. Tests so far have been conducted only in guinea pigs, but the researchers are working on making a smaller human-implantable version and aim to have it ready for clinical trials within five years. News story: Technology Review: Drug Device for Hearing Loss... Project website: Draper Laboratory: Intracochlear Drug Delivery...... Wouter Stomp
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The Challenge of Creating a True Longitudinal Health Record

iTriage is an app that runs on the iPhone and provides some of the following functionalities (see: Physicians Using an iPhone Application to Triage Their Patients):

• Information on thousands of symptoms, diseases and medical procedures
• A nationwide directory of hospitals, urgent care, retail clinics, pharmacies and physicians
• Help negotiating medical bills through an iTriage partnership with ...claims adjudication organizations
• Emergency Room wait times for hospitals in select parts of the country

Apparently one of the founders of the company is now moving in the direction of of integration and support by the device for Google Health, a PHR, according to John Moore who blogs over at Chilmark Research (see: Consumer Challenge: Creating a Longitudinal Record). Below is an excerpt from the note:

John highlights in the note a critical aspect of EMRs that is often neglected -- the difficult pursuit of the longitudinal record. Simply put, the longitudinal record consists of the aggregated medical records of an individual across time or, put another way, a life-long record of a patient's care. Up to this point, most EMRs lump the records for a single episode of care such as an inpatient stay. If a patient has multiple inpatient episodes within a single health system, that institution's EMR can usually aggregate records across them.

The challenge is that we Americans tend to frequently move to different cities and receive care from a broad set of healthcare providers and systems. Each of them probably uses a different brand of EMR. As John points out above, most of our hospital information systems are designed to move data "point-to-point" and we lack a central clearing house for healthcare data across multiple providers. The HIE may serve this purpose in the future.

I made reference to the idea of a "an electronic clearinghouse" for clinical data on a much smaller scale in a previous note about comparative effectiveness research (CER) (see: The Inclusion of Molecular Diagnostic Testing in Comparative Effectiveness Studies). The key points are listed below.

For the sake of efficiency, let me distill from this article the key recommendations made by AMP [Association for Molecular Pathology] retarding all comparative effectiveness research (CER) going forward:

• Development of a model process for CER regarding clinical laboratory tests
• Creation of an electronic clearinghouse for information on CER projects 
• Development and adoption of standards for the collection and storage of data from genetic testing laboratories

Putting Some Numbers to Digital Pathology Adoption Trends by Pathologists

I recently posted two guest blog notes by Steve Potts, Ph.D., focusing on the more rapid adoption of digital pathology by veterinary pathologists than MD pathologists (see: Veterinary Pathologists Adopting Digital Pathology Faster than MDs; Reasons Why DVM Pathologists Are Adopting Digital Pathology Faster Than MD Pathologists). Coincidentally, an article has just been published in Laboratory Economics entitled Adoption Trends in Digital Pathology (Volume 5, No. 6, June 2010) that provides survey data on this topic. I copy it in its entirety below.

Today, education and training is the most common use for labs using digital pathology. The biggest barrier to more clinical use is the cost of scanning digital slides, which don’t eliminate the need to first prepare glass slides. Among surveyed labs using digital pathology, 72% are using it for education and/or training, according to LE’s Digital Pathology Trends Survey. Sixty-three percent use it for second opinions and/or consultations, and 62% for quantitative immunohistochemistry for HER2 scoring. In terms of market share, 44% of digital pathology users have an Aperio system; BioImagene has a 16% share; Ventana, 9%; and Olympus, 8%. Other vendors have a combined 23% share, including Nikon, Leica Microsystems and Dmetrix.

More than half of surveyed labs without digital pathology cited “too expensive” as a barrier to adoption. Another 36% said traditional pathology/microscope works fine and 23% had LIS integration concerns. Only 15% said digital pathology systems were too slow and only 3% had concerns about image resolution. Meanwhile, Amanda Lowe, principal of Digital Pathology Consultants...believes the limited menu of FDA-cleared tests is a bigger issue than our survey suggests. “There’s no doubt that if the FDA would ‘gold stamp’ digital pathology on the clinical diagnostic end, it would help significantly,” she says.

In an email to me, Jondavid Klipp, the founder and editor of Laboratory Economics provides additional information about this trend: Roughly 500 commercial labs, pathology groups and academic medical centers have a digital pathology system/scanner in place. Digital pathology utilization for clinical diagnostics in United States is extremely limited, currently less than 1% of all slides.

One of the drivers for adoption of digital pathology by veterinary pathologists, emphasized by Steve Potts in his guest blogs, was that many of them work for pharmaceutical companies. They are thus heavily involved in drug toxicology studies as part of basic research studies and clinical trials. In such settings, global image networks have been established by these companies for sharing and storing animal and human whole slide tissue images. It is thus readily apparent that a far more convincing business case can be made for the deployment of digital pathology systems in Big Pharma than can be made for a pathology group working in, say, a mid-size community hospital. Note the barriers to adoption cited by the pathologists above. Here's a quote from Steve's first note:

Nearly all of the top 15 pharmaceutical companies have completed multisite-integration with digital pathology. The result of such conversions is that a pathologist working in one location can access slides at any other one or participate in an informal peer review or pathology working group.

Fuzzy Logic Used to Predict Cell Aging

Researchers from Drexel University and Children's Hospital Boston are using "fuzzy logic" algorithms to better understand the complex mechanisms involved in cell aging. Fuzzy logic refers to algorithms that can handle imprecise input unlike the typical 0 or 1 digital nature of precise algorithms. The study, which appears in the June issue of PLOS Computational Biology, relates progressive damage and dysfunction in aging, dubbed a vicious cycle, to inflammatory and metabolic stress response pathways. Interestingly, the activation of these pathways remodels the inner functioning of the cell in a protective and adaptive manner and thus extends lifespan. This is the first time that scientists have applied fuzzy logic modeling to the field of aging. "Since cellular biodynamics in aging may be considered a complex control system, a fuzzy logic approach seems to be particularly suitable," said Dr. William Bosl, co-author of this study. Dr. Bosl, a staff scientist in the Informatics Program at Children's Hospital Boston, developed a fuzzy logic modeling platform called Bionet together with a cell biologist, Dr. Rong Li of the Stowers Institute for Medical Research in Kansas City, to study the complex interactions that occur in a cell's machinery using the kind of qualitative information gained from laboratory experiments. Image: Several key processes related to biological aging can be described by positive feedback-loop motifs, as shown by this “vicious cycle” model. Metabolic fluxes (marked by blue lines) are initially in homeostasis. Reactive oxygen species (ROS) damage intracellular proteins including mitochondrial structures (red lines). This leads to impairment of ATP generation and biosynthesis, further increasing ROS levels. A portion of oxidized proteins is removed by autophagy, which constitutes a sink in this model. Press release: Fuzzy Logic Predicts Cell Aging... Abstract in PLoS Computational Biology: Rule-Based Cell Systems Model of Aging using Feedback Loop Motifs Mediated by Stress Responses... Michael
Read more [Medgadget]

FDA Shelves IVDMIA Regulatory Initiative; Will Focus on Laboratory Developed Tests

I have posted a number of notes about IVDMIAs (in-vitro diagnostic multivariate index assays), a term that was coined by the FDA to refer to panels of biomarkers plus a computer algorithm that is used to analyze the set of test results. The agency is now dropping the idea of issuing a final guidance on IVDMIAs and focusing more broadly on the agency's role in ensuring the safety and efficacy of all laboratory-developed tests (LDTs) (see: FDA Shelves IVDMIA Final Guidelines in Order to Focus on Overall LDT Regulation). Below is an excerpt from this article:

The FDA said in a Federal Register notice...that due to "public health concerns, … it is time to reconsider its policy of enforcement discretion over LDTs."....In a meeting scheduled for July 19-20 in Washington, DC, the agency will invite stakeholder input on its regulation of LDTs. After the July meeting and a subsequent comment period ending Aug. 15, the agency is planning to develop guidelines for public comment and "phase in" the regulatory framework outlined in the guidance over time. FDA's move to regulate all LDTs in a risk-based manner comes after industry stakeholders and advisory groups argued that the agency's selective regulatory approach to regulate only a subset of high-risk LDTs — IVDMIAs — led only to more confusion and created an uneven playing field. In December 2008, Genentech petitioned the FDA to take make its in vitro diagnostics regulations more consistent by extending its oversight over LDTs in a risk-based manner. The HHS Secretary's Advisory Committee on Genetics, Health, and Society issued a report in 2008, recommending much the same. The agency's public meeting on LDTs comes three years after the agency convened stakeholders to discuss its regulatory approach for IVDMIAs, lab-developed multiplex tests that employ mathematical algorithms to interpret a person's molecular-based risk for disease or likelihood of response to a drug.

That highly contentious meeting led to a second draft guidance on the topic that satisfied few players in industry. Along the way, FDA never finalized its IVDMIA guidance, but as the industry eagerly awaited more clarity on the topic from FDA, agency officials have issued conflicting timelines for when a final guidance may come out. Now, in light of the regulatory uproar surrounding the direct-to-consumer marketing of genetic tests [see: FDA Cracks Down on Consumer-Oriented Genetic Testing Web Sites], it seems FDA is dropping its work on an final IVDMIA guidance in order to clarify its broader regulatory authority over all LDTs, an authority the agency says it has, but hasn't exercised since the implementation of the Medical Device Amendments of 1976. The FDA has practiced enforcement discretion over the majority of LDTs, which are assays developed and analyzed at laboratories that have been accredited under...Clinical Laboratory Improvement Amendment [CLIA]. Although laboratories are certified to develop and analyze these tests, the assays themselves do not hold 510(k) clearance or a premarket approval from the FDA.

I don't have much to add to this -- the article is largely self-explanatory. In summary, after working on its IVDMIA policy for some three years, the FDA is integrating this discussion into the large issue of LDTs. You may better recognize by the slang term of home-brew tests. This controversy has simmered for years. I discovered an article on the web from 1992 on this same topic (see: Threat to 'home brew' products angers labs - Food and Drug Administration draft policy guide). This expanded discussion by the FDA will, no doubt, also encompass genomic/genetic testing. As noted above, all of this brouhaha boils down to the following question: what regulatory authority does the FDA hold over all LDTs.

Reasons Why DVM Pathologists Are Adopting Digital Pathology Faster Than MD Pathologists

This is the second portion of guest blog note written by Steve Potts, PhD. The first was posted yesterday (see: Veterinary Pathologists Adopting Digital Pathology Faster than MDs). Steve is the CEO of Flagship Biosciences, a pathologist-owned CRO and provider of digital pathology services in the pharmaceutical and medical device industries.

I would propose the following reasons why the adoption of digital pathology among DVM pathologists is faster than among their MD counterparts:

• Veterinary pathologists have benefited from the development of a strategic, forward-looking vision by pathologists working in executive management at the various pharmaceutical companies. These individuals are required to manage studies generating hundreds, if not thousands, of slides each and requiring review by pathologists within groups and across groups. Many of the multi-site implementations of digital pathology have been driven by top-down decision-making on the basis of careful planning and ROI calculations by these executives. In short, the decisions to adopt digital pathology have not been made casually or informally.
• Quantitative data has always been a powerful driver in pharmaceutical research. Because the cost to bring a drug compound to market is measured in hundreds of millions of dollars, strategic go/no-go decisions are generally based on such quantitative data (e.g. real numbers on beta cell mass changes for a proposed diabetes compound or objective vascular changes for an anti-angiogenic compound). Digital pathology delivers the requisite quantitative information for the industry.
• Numerous pathologist-led committees have developed standards for imaging in the veterinary pathology societies, including ACVP, and STP, and PhRMA. This leadership in standards has provided strong incentives for the rank-and-file DVM pathologists to adopt the technology.
• A small core group of veterinary pathologists have provided leadership in identifying new applications for digital technology and subsequently demonstrated them to their peers in conference settings. Some examples include Bob Dunstan from Biogen Idec, Frank Voelker with preclinical image analysis from Novartis and Flagship Biosciences, David Young with companion diagnostics at OSI Pharmaceuticals, Sam Machotka from Merck with preclinical workflow requirements, and Gary Knutsen of Systems Pathology with automated toxicity screening.
• Veterinary pathologists, particularly at pharma companies, have benefited from some talented informatics leaders within their companies who have planned and delivered successful global deployments of digital pathology systems. Even, or maybe especially, in companies ranging up to 100,000 employees, a single person leading these efforts has made the difference. Examples of such leaders and presentations include Jim Deeds from Novartis, Xiaoyou Ying from Sanofi-Aventis, and Beverly Maleeff from GSK.
• Broad conversion to the technology will require a substantial time commitment and most MD pathologists are already challenged by their current daily work commitments. What is required now is a broad swath of MD pathologists coming on-line and demonstrating that digital pathology is an important technical component for the practice of the field. When this tipping point occurs, many more of them will be able to replicate the earlier digital footsteps of their veterinary pathologist colleagues