HIPAA Omnibus Rule had a few surprises

I am sitting in a webinar regarding the federal Omnibus Final Rule which was published January 25, 2013 (compliance date is September 23, 2013).  This rule made modifications to several other federal rules such as HIPAA, HITECH and GINA (Genetic Information Non-discrimination Act).  

There were two small bombs that were dropped of which, I admit, I was previously unaware:

1. The omnibus final rule now has officially and expressly stated that genetic information is protected health information.  
2. The omnibus final rule specified that genetic information could not be used for underwriting purposes.  Specifically:
   • The Rule prohibits the use or disclosure of genetic information for underwriting purposes by all health plans, except long-term care plans.  
   • Terms and definitions in the Rule track regulations prohibiting discrimination in health coverage based on genetic information.

(see press release at http://www.hhs.gov/news/press/2013pres/01/20130117b.html and the final rule at http://www.gpo.gov/fdsys/pkg/FR-2013-01-25/pdf/2013-01073.pdf)

Supreme Court rules that native DNA is NOT patentable!

See full decision here.  This is a great day for genomic medicine.  No more requirement to send your specimen to a black box to get tested.

Hot off the presses - ASCP and API Forge Alliance

From Liron Pantanowitz, MD (Current president of the Association of Pathology Informatics):

ASCP and the Association for Pathology Informatics Forge Alliance for Mutual Benefits

ASCP and API signed a Memorandum of Understanding (MOU) effective March 7 to collaborate on education, advocacy, and membership strategies to the mutual benefit of members from both organizations. Informatics has become an increasingly relevant component for the future of pathology and laboratory medicine. This strategic alliance enables each society to gain from each other’s areas of expertise.

“The future of diagnostics is the future of informatics,” says John Tomaszewski, MD, FASCP, a former ASCP President and a member of API since the 1990s. “API is the dominant and growing society for informatics. ASCP’s focus on precision diagnostics can be best accomplished in partnership with API. This is a great alliance for both organizations, especially for education.

“The faculty of ASCP and API overlap significantly. ASCP delivers great depth into its educational sessions, which is a plus for API members. API will bring ASCP members more knowledge in informatics. The Association embeds the informatics tools into the challenges of the broader laboratory in a very dynamic way.”

Education is at the forefront of this alliance. API will hold its fall Annual Meeting in conjunction with the 2013 ASCP Annual Meeting, Sept. 18–21, in Chicago. Participants from both organizations can select 19 hours of education in informatics delivered by API faculty experts. In addition, API will continue to hold its regular “Pathology Informatics” conference May 13–16 in Pittsburgh. API has moved this conference to the spring from the fall to accommodate and avoid conflicts with the ASCP Annual Meeting.

“API is at a crossroads in its infrastructure,” says Liron Pantanowitz, MD, FASCP, API President and a member of ASCP. “That requires us to change how we do things. The alliance with ASCP comes at the right time for us and brings us different expertise and additional resources that will help us reach the next level.”

For all API members, ASCP is extending a complimentary membership effective from May 1 to Dec. 31, 2013. Through the new ASCP Institute of Science, Technology, and Policy, API members will have a stronger voice in Washington, D.C., and can play an integral role in advancing the ASCP Institute’s Health Services Center.

Through free ASCP membership effective from May 1 to Dec. 31, 2013, API members can take first-rate online courses at no charge to earn up to seven continuing medical education credits; gain online access to the prestigious ASCP journals, the American Journal of Clinical Pathology, Lab Medicine, and Critical Values, as well as online publications such as Daily Diagnosis, eNews Briefs, and ePolicy News; and be eligible for member discounts for the 2013 ASCP Annual Meeting, Sept. 18–21, in Chicago and books, as well as educational products and services.

“Pathology informatics shows us how to practice pathology in the modern age,” says Dr. E. Blair Holladay, ASCP Executive Vice President. “One major role of informatics in diagnoses and analytics will be to accelerate fused diagnostic signatures from many types of big data streams as an aid to patients in their choosing of their best therapy. Our members have told us that they want to learn more about informatics and how to apply it in their pathology practices. This is where the profession is headed.”

ASCP pathology residents will have access to API members who attend and teach at the ASCP Annual Meetings and can learn firsthand about how informatics will affect their futures and the future of the profession. Membership in API is free for residents. Residents interested in informatics research who lack opportunities at their own institution can now take advantage of the API’s Research Matching Program, which pairs interested residents with mentors, with research conducted remotely.

Liron Pantanowitz MD

API President

Email: pantanowitzl@upmc.edu

A tribute to Jeffrey A. Kant, MD, PhD

Jeffrey A. Kant, MD, PhD, my former fellowship director, passed away this morning.  Jeff was truly a pioneer and a giant in the field of molecular pathology.  While training with him, Jeff recognized and encouraged my interest in pathology informatics.  Not only did he realize the importance of informatics to molecular pathology, he just believed in my abilities, just as he believed in the abilities all his fellows and trainees. 

Jeff was genuine and impolitic.  He had the uncanny ability to make me and others who trained with him feel smart and made them want to work harder at the same time.  I saw him on a regular basis at professional meetings and any time we happened to be passing through each other's towns.  I am so very, very grateful for the time I had with him, and words will never be able to express how much he meant to me or how sad I am now that he is gone.  It has become clear over the last week that Jeff touched many lives besides my own, and my heart goes out to his family and all who had contact with him. 

The Need for the API Strategic Summit - Part 2 of 2

For part two of this blog, I have incorporated data from the API Strategic Summit committee, chaired by J. Mark Tuthill, MD.

Right now, for reasons both understandable and not, the federal government has been focusing on meaningful use and certification of Electronic Health Records (EHRs).  It would seem that laboratory information systems (LISs) have largely been left out of this equation, seemingly relegated to merely a data feeder to the EHR.  Under current regulations, the only way to "certify" an LIS is when it is a module within an EHR.  Regardless of where a LIS sits (either as an EHR module or a independent system), the importance of high quality and highly-specialized laboratory systems cannot be over-emphasized.  

The API Strategic Summit will take place June 7-8, 2012, in Pittsburgh, PA.  It is entitled "The Future of the LIS and Pathology Informatics in the Era of the EMR".  During the summit, we will address the following questions:

• What is the value of the LIS to pathology departments and how is it documented and demonstrated? How to improve the inadequate understanding on the part of hospital CMIOs and CIOs of clinical labs operations and functionality requirements of the LIS?
• How can Departments of Pathology work together on information standards (and mandates) that affect Pathology?

We have commitments from major LIS corporations to attend this meeting.  This is an unparalleled opportunity to strategize with multiple vendors at the table on how we can ensure our collective ability to provide patients and providers with the most up-to-date, accurate, rapid and safe laboratory testing through our LISs.  

Interested parties should contact Nova Smith with the Association of Pathology Informatics for information on how you can attend the summit.  I hope to see you there.

The Need for the API Strategic Summit - Part 1 of 2

Laboratory Information Systems are at a cross-roads.  With the passed and impending legislation surrounding health information technology, the primary focus has been on Electronic Health Records (EHRs).  Laboratories generate vast amounts of data.  The reason why we generate vast amounts of data is because providers order laboratory tests on patients at almost every encounter.


If laboratories don't have high quality and highly specialized systems to support the work that they do, providers will find it very difficult to take care of of patients.  Here's why:

• Laboratories generate a huge amount of data, and much of that data, while not seen by providers, is critical to store, manage and review as part of our quality and compliance processes.  These are data generated by intermediate steps during the testing process.  These data are often more important than the final result when trying to troubleshoot a problem that occurs at the time of testing or at a later date.  I estimate that the final result (the piece that providers see) comprises only about 20% of the actual data that is produced and stored by the laboratory during the performance of a simple test.  For highly complex tests, this estimate goes down to 5% or less.  Laboratories that cannot utilize their information system to store critical pieces of testing data such as this must resort to paper worksheets which are subject to retrieval and permanent loss.  Use of paper worksheets can facilitate:
• Manual data entry errors
• Delays in turnaround times (when compared to automatic batch run generation in an appropriately configured information system)
• Errors in manual calculations
• The workflow within an individual laboratory is largely managed by the routing of the specimen in the information system.  When the workflow in the laboratory does not match that of the information system, the results typically cause confusion, delays in turnaround time, and rarely patient-to-specimen mismatches.
• Just as patients do not always present with the typical by-the-book signs and symptoms of a particular disease, neither do their laboratory results.  Laboratories need systems that can flex to the strange and unexpected, and those systems should be able to communicate those results to EHRs in clear and unambiguous ways. 
• Providers make a LOT of decisions based on the data that laboratories provide them.  If we can't provide the right test and right result at the right time, then patients suffer.  Laboratories are full of smart people who want to help others.  Imagine what it is like to try and do that when the computer is fighting you at certain steps in the process.

The Association for Pathology Informatics (API) is working to help laboratories get the very best information systems for their laboratories.  Over and over again, we hear stories of laboratories being "burned" by unanticipated problems in functionality, resulting and mis-interpretation of those results by a provider due to poor display of those results in the EHR.  These are all being compounded by new technologies that providers need and want for their patients that current information systems are struggling to house.  Standard molecular tests, next generation sequencing, whole slide imaging, proteomics, and high-throughput image analysis with the future promise of combined imaging/molecular analyses are either currently in use in some laboratories or will be in the next five years...and laboratories currently using those modalities are having to work-around the deficiencies in their information systems to bring this needed technology to patients.  See my next blog entry for more on some of the exciting activities that API is working on to help laboratories work with vendors to bring in the next generation of systems.

So What is Pathology Informatics?

Imagine my chagrin when, after my last post, my father informs me that he found my blog.

Oops.

It is a good thing that my dad has a sense of humor. He then took the opportunity to inform me that after whining poetical about how no one understands what I do for a living, I still managed not to explain what I do for a living.

Touché.

So, dad, this beer, I mean blog, is for you.

Let's start with informatics. The American Medical Informatics Association (AMIA) defines informatics as “A general term used to refer to biomedical informatics and its many areas of application and practice (e.g., bioinformatics, clinical informatics, public health informatics).” They subsequently go on to define biomedical informatics as “the interdisciplinary, scientific field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving and decision making, motivated by efforts to improve human health.” Additional definitions can be found on AMIA’s glossary page.

Pathology Informatics is essentially biomedical informatics practiced by pathologists within the scope of pathology practice.  Unknown to many in the non-medical profession, the scope of pathology practice is huge. Surgical pathology, cytopathology, chemistry, transfusion, microbiology, hematology, molecular diagnostics, immunology, transplant immunology and autopsy medicine all fall within our purview.

Laboratories generate enormous amounts of discrete data on patients every hour of every day. Providing faculty oversight for the acquisition, management, storage and retrieval of this data in our laboratories is my job. In order to get an idea of the weight of the responsibility that I feel, let’s review how much data we are talking about…

If you work in a hospital, think about the numbers of lab results that you use to manage your patients on an hourly basis. Now multiply that across all patients in all of our facilities 24 hours a day, 7 days a week. Now, just to make it more fun and to complicate matters, let’s tweak, change out or add new computer systems (a.k.a. information systems) here and there constantly to improve the care we deliver to patients. Existing care cannot stop during these changes, and our patients’ data have to be delivered on the right patient at the right time to the right provider. We have hundreds of systems running at my multi-facility institution, and most of them are tied to one another via interfaces. Information is flowing at super-speeds between these systems. The laboratory alone has numerous systems humming with data being brought in, updated, and sent back out to the tune of billions of data elements each year. Ensuring that a patient’s data is transferred accurately and quickly from one system to another is a very complex task in this environment, especially when some but not all of the systems may be undergoing changes which could affect the transfer of the data. Checking and rechecking systems before changes are released into production can be very tedious and requires immaculate attention to detail. Fortunately for me, I work with a group of laboratory information system support personnel who are very good at doing this.

So, if I have personnel to do the checking, what is my role? As a physician who specializes in pathology and a techno-nerd with knowledge of healthcare computing, I review the design and implementation of new and updated systems using my hybrid experiences in pathology and information technology in these and other areas:

• Hardware infrastructure
• Data models
• Network design and security
• Software design, display and security
• Result reporting
• Interfaces
• Barcoding
• Digital imaging and image analysis

It also includes other not-so-fun but necessary things such as:

• Reviewing information technology contracts
• Trying to explain to various individuals that yes, we really do have to comply with local, state and federal laws such as HIPAA, HITECH, CLIA and others and what that means for application X that they want to install
• Ensuring that our laboratory information practices meet or exceed the standards put forth by the aforesaid regulations as well as by the College of American Pathologists Laboratory Accreditation Program, the Joint Commission and other programs.
• Preventing medical errors due to poor data management or design before they happen.

However, there are a lot of truly fun things that I get to do:

1. Improve patient care and prevent errors that can hurt people
2. Help develop new tools to improve data retrieval and management so that our work is safer and easier
3. Teach residents and fellows
4. Give talks at meetings about my activities with #1 and #2
5. Collaborate with my pathology informatics colleagues
6. Travel lots of places to see and learn new things

At some point, when Emory finishes overhauling massive laboratory information systems, I hope to inspire a new generation of pathology informaticists/informaticians, some of whom I hope will share my admittedly wacky sense of humor.