Leadership

Increasingly hazardous healthcare environment should urge Congress to create a National Health IT Safety Center

Discharge instructions for a child’s insulin dose were correctly entered into the electronic health record (EHR), but when the mother received the printed instructions there was a decimal point error resulting in a 10-times dosing error.  This error was fortunately noticed by the bedside nurse and corrected manually.  I reported this near-miss to the EHR vendor and they corrected the technical problem.  However, when I asked vendor representatives whether or not this problem was being corrected with other physician clients across the country, they informed  me that no other client had reported such a problem. 

This is analogous to a situation where an airbag explodes and sends shrapnel into your face.  You might ask the automaker whether this is a problem with their other vehicles.  They might tell you that they are not aware of others having the same problem.  However, in the transportation industry they are required to report safety incidents and near-misses.  These reports are collected, aggregated and analyzed by the National Transportation Safety Board (NTSB).  If NTSB notices a trend in airbag-induced shrapnel injuries, they will initiate an investigation.  When NTSB discovers a problem with a specific airbag that is used across multiple types of automobiles, not just the type you purchased in your own state, then they are authorized by Congress to make safety recommendations to help ensure the risk is appropriately managed across the industry.

This insulin dosing incident is one of many health IT-related patient safety risks I have encountered and resolved in collaboration with an EHR vendor.  When my experience is extrapolated to the experiences of all physicians and EHR vendors, the scope of health IT-related patient safety risks can be seen as immense.  But unlike the safety of interstate commerce produced by the auto industry that is overseen by the NTSB, the safety of interstate commerce produced by EHR vendors has no cohesive oversight mechanism.  

The lack of oversight for health IT-related patient safety incidents and near-misses creates a hazardous patient care environment that I believe is urgent for Congress to address. The threat is increasing because the Meaningful Use Program (MU) has led to an exponential increase in the use of EHRs and other technology.   As a result, physicians are assuming a higher level of risk and accountability for computer programs, networks and infrastructures that are increasingly used as tools to generate patient care actions and facilitate medical decisions.  Although health IT-related patient safety risks would best managed through a shared accountability between physicians and EHR vendors, the vendors are not currently held accountable for patient safety.  Furthermore, the aggressive MU timelines have required EHR vendors to make rapid changes to EHRs without sufficient time to align changes with efficient physician workflows or to improve the flow of data between systems.  As a result, EHRs are increasingly plagued by poor usability problems and  lack of interoperability between EHR systems--both of which are patient safety risks that physicians commonly encounter.

So it is time to urge Congress to create a National Health IT Safety Center that can implement an effective EHR safety program designed to reduce EHR-related patient safety risks.  Within this concept EHR vendors could be required to report patient safety incidents and near-misses to the Health IT Safety Center similar to how transportation safety incidents must be reported to the National Transportation Safety Board.   The Health IT Safety Center could collect, aggregate and analyze reported data.   It could have power to investigate incidents involving patient harm and require EHR vendors to make appropriate changes.  It could monitor near-misses to identify trends and risks.  It could coordinate with other agencies to develop and broadly disseminate educational information and tools that mitigate identified patient safety risks related to technology use.  

I also envision that this resolution would lead to an entity that has the authority and influence to drive improvements in EHR usability and

 
 

interoperability, which are the two most significant impediments to effective and meaningful use of electronic medical records.   

 .

 

  

Cultural Change at CMS is Needed to Mend Adversarial Relationship With Physicians

CMS has issued a request for information (RFI) and invited comments on the implementation of the Merit-Based Incentive Payment System (MIPS) as introduced in the MACRA legislation that repealed SGR last April.   The legislated "composite performance score" upon which "adjustments" to physician payments will be made under MIPS consists of four categories:  Quality, Resource Use, Clinical Practice Improvement Activities and Meaningful Use of CEHRT.   Comments are being sought on many topics, including certification of EHRs, technology standards, accountability for data integrity, management of "virtual groups"  and, yes, Meaningful Use (MU).

I have three overarching comments:

1.  Adversarial relationship with physicians:  Right now government programs such as MU and PQRS are generally viewed by physicians as requirements only, not as elements of best practices that lead to quality care.  I think it is vital to change this adversarial perception.  This will involve a cultural change at CMS.  Perhaps the most important tactical change to pursue is moving away from rewarding/penalizing the achievement of specific targets, and moving toward innovative programs that reward practices for making incremental improvements in quality care.

2.   Inhibition of Innovation:  Physicians support technology innovations developing in the consumer marketplace that have the potential to improve quality of care and lower healthcare costs.   While government regulations have the potential to catalyze innovations in the consumer marketplace, they also have the potential to inhibit innovation.    Regulations that strive for high-level outcomes are generally more likely to catalyze innovation, while regulations that impose specific limits or require specific actions, mechanisms and processes are more likely to inhibit inhibition.   I believe the Meaningful Use regulations have inhibited innovation--EHR vendors have been scrambling to meet specific requirements imposed by the regulations with no evidence that these requirements would result in higher quality of care or lower costs.    To change this, we need CMS to mindfully develop government regulations that maintain a high-level focus on the achievement of quality care outcomes while avoiding the development of limitations or specific requirements, methods and processes that discourage innovation. 

3.    Fair and ethical use of quality metrics for reimbursement:   The AMA has published guidelines on the Fair and Ethical Use of Quality Metrics.    The guidelines advocate for rewarding physician practices that make incremental improvements in quality care rather than rewarding/penalizing the achievement of specific levels of performance.   Although my opposition to the use of quality metrics to impose financial penalties is aligned with these guidelines, I concede that it is difficult for a value-based model of reimbursement to completely avoid penalties.    My alternative suggestion is for CMS to incorporate tiered levels of "performance achievement" instead of the "all-or-none" requirements put in place for the MU program.  Tiered levels of achievement, with lower levels of achievement designed to avoid certain penalties and higher levels designed to provide additional rewards, will help avoid the "drop-out" rate that the MU program has experienced after Stage 1 as the levels of expected performance were increased.  Many physicians just gave up.  Even though they could achieve all but one of the requirements, that one requirement eliminated the possibility of receiving any credit.  

I  would be interested in hearing your thoughts on the implementation of MIPS by CMS.


Keys to Gain Value from EHR Implementation and Use

Many physicians who use an electronic health record (EHR) are having difficulty realizing value in their investment.   A recent KLAS survey found that more than one out of every four physician practices are so dissatisfied with their EHR that they are considering replacing it.    Although many physician practices have earned a financial award by using an EHR to achieve “meaningful use”,  data is lacking on whether or not such efforts actually improve patient outcomes.  

I believe, anecdotally, that I practice higher quality medicine when using an EHR.    But I am a pediatric emergency medicine physician using a hospital EHR to document patient encounters in a children's hospital's emergency department, not a physician in private practice.  On the other hand, my past experience as a a Chief Medical Information Officer (CMIO) and Chief Information Officer (CIO) for my pediatric healthcare system provided opportunities to visit many private physician offices using a variety of ambulatory EHRs and to visit with many EHR vendors.  I met many physicians  who were happy with their EHRs and see the value.  Others I met were unhappy and see no value in their EHR.  Perhaps my most eye-opening experience came when I visited with a group of unhappy physicians who were using the same EHR as some happy physicians I had met one week earlier.   So what gives?

The answer is simple, but the explanation is complex.  

The simple answer is that the value gained from an EHR is dependent on how effectively it is implemented and used.   When well-implemented and well-used, an EHR provides clinical and financial value.   When poorly-implemented and poorly-used, EHRs detract from patient care and are a financial drain.  

The complex explanation might best be explained using examples.  So, based on my past visits with physicians who use various EHRs and on other personal research, I have created an outline of what I think are the key factors that allow physicians to gain value from their EHR.  I am in the process of writing a series of blogs with case studies to help explain each of these factors.  Stay tuned! 

Keys to Gain Value

 

cook children's

 

Dr. Matt Murray

Cook Children's


Physicians Must Level the Slippery Slope of Quality Metrics

I am concerned about the slippery slope of quality metrics that ACOs, private payors and CMS are stepping further down into.  My primary concern is that decisions being made by payors on the use of quality metrics are too often resulting in unfair or unethical use of quality metrics.   It is critical for community physicians to engage with these entities now to level the slope and establish a more optimal precedent for the future use of quality metrics.

Several years ago I participated in the Texas Medical Association's (TMA) launch of their Health Care Quality Council.  One of Council’s primary interests has been the issues inherent to pay-for-performance programs and the use of quality metrics by payors.   Some of these issues overlap onto the TMA's ad hoc Health IT Committee that I serve on as well.    Physicians in Texas have reported to these committees about unfair and unethical applications of quality metrics such as failure to consider risk adjustments for severity-of-illness or for important socioeconomic factors.   Many physicians are concerned  that they are getting overwhelmed by requests for different sets of quality metrics from different private payors as well as from CMS.   They are also frustrated by the variable, non-standardized methods by which each payor requires the physician's data to be formatted and/or submitted.

Based on my experience with these TMA committees, I have no confidence in the ability of insurance companies or ACOs to develop and use quality metrics in a fair and ethical manner without intimate involvement of working physicians from the community served by the ACOs/payors.    

There are guiding principles available regarding the fair and ethical use of quality metrics from the TMA and the AMA.     Physicians should actively engage with their ACOs and payors to ensure that these guiding principles are adhered to as quality metrics are developed.

 

 fort worthcook children's, athenahealth, meditech


Mandating Physicians to Use SNOMED codes Has Higher Potential to Improve Healthcare Than ICD-10 Mandate

I have consistently advocated for skipping ICD-10 and initiating an unprecedented effort to accelerate the development of ICD-11-CM.  Although I still believe this strategy to be the one best aligned with quality care, I fear that the sunken ICD-10 costs are now so large that skipping ICD-10 is unpalatable for most organizations, even for some physicians, and is politically perilous.  Since we must do something, I have been thinking more about the proposal to replace ICD-9 with SNOMED in physician practices.  Leveraging SNOMED to improve care, lower costs and remove physician practices from the ICD conversion melees should be a serious national conversation at this point.  
 
After several delays CMS has established October 1, 2015 as the new implementation date for the replacement of ICD-9 code sets used by medical coders and billers to report healthcare diagnoses and procedures with ICD-10 codes   But another postponement remains a possibility--especially when one considers the unclear reasons for action taken by Congress earlier this year to call off the 2014 implementation.  ICD conversion delays are costly to the healthcare industry and action should be taken to address the impediments that increase the risk of such delays.   One of the major impediments to address is the adverse impact ICD conversions have on individual physician practices.    
 
So let's jump out of the box of conventional charged impulses propagating across our cerebrums (thinking) to consider how to make ICD-10 optional for physician practices while still achieving our goal of dispensing with obsolete ICD-9 code sets.  One alternative is to mandate physicians replace ICD-9 codes sets with SNOMED code sets and require EHRs to incorporate translator technology that converts SNOMED to ICD codes in the background.  Since it would not be practicable to expect EHR vendors to incorporate the translator technology into their products by October 1, 2015, there would need to be an interim period where physician practices are exempt from the requirement to use ICD-10 codes sets until their EHR incorporates the translator technology.    This alternative mandate allows the ICD-10 conversion to proceed for the rest of the healthcare industry including any physician practices who see value in completing their conversion.  This mandate would reduce the current and future adverse impacts that ICD conversions have on physician practices, has higher potential to improve care, is more cost effective, helps EHRs be more user-friendly to physicians and mitigates the risk of further delays to ICD-10 as well as future ICD-X conversions.
 
I would anticipate a two-year transitional period where the ICD-10 conversion would be optional for physician practices based on an assumption that EHR vendors will need until 2017 to upgrade their products.  
 
Some opposition among physicians is likely to be encountered due to their lack of familiarity with SNOMED as well as questions about how this alternative strategy adds value to patient care.   I base that on the responses I heard from some respected colleagues at this weekend's Texas Medical Association meeting.  The unfamiliarity issue can be addressed by pointing out that many of us are already using SNOMED, but that we just do not know it.  CMS mandates that the problem lists in EHRs use SNOMED codes, so when one selects "Exercise-induced asthma" from a pick list of problems in their certified EHR, they are actually using SNOMED. 
 
More difficult to articulate to physicians is how this proposal to convert from using ICD-9 to SNOMED codes in our EHRs would improve healthcare, how it would improve their work flow and how this is more cost effective for physicians as compared to complying with the current mandate.  So I have developed the following bullet list to use when describing this to my colleagues:
 
  • Informatics experts are in agreement that ICD-9 is obsolete, and that although ICD-10 has potential to improve healthcare, ICD-11 and SNOMED have higher potential to improve healthcare. 
  • SNOMED, which is interwoven in ICD-11's development, is inherently compatible with ICD-11 and is already required by CMS to be incorporated into certified EHRs for Problem Lists--thus, mandating use of SNOMED is not really new to physicians and will not result in an added cost to physicians
  • EHRs can be built with technology that automatically converts SNOMED codes into ICD codes--thus, mandating use of SNOMED is agnostic to the version of ICD-X being used; the cost to physicians of using the translating technology is very small as compared to the cost of finishing the conversion to ICD-10 and then converting to ICD-11 in the next 15 years.
  • After we convert to ICD-10 in 2015, discussions about implementing ICD-11 will ensue; since ICD-10 is over 20 years old and is less sophisticated than ICD-11, it will become apparent rather quickly that we need to convert to ICD-11 as soon as possible in order to improve healthcare (i.e. today's argument about ICD-9)
  • It takes the U.S. 7-10 years to refine the international version of ICD codes into the U.S. version we use--since the ICD-11 international version is expected to be completed in 2017, the earliest conversion to ICD-11 in the U.S. would be 2024 unless an unprecedented effort to accelerate development took place
  • In any case, converting to ICD-10 in 2015 will result in two ICD conversions in physician practices over the next 15 years.  The proposed alternative strategy to convert physicians one time from ICD-9 to SNOMED results in just one conversion with all future ICD conversions occurring in the background without significant impact on physician practices--thus, mandating the use of SNOMED to replace ICD-9  would be a significant cost savings to physicians.
  • SNOMED codes have been developed for the purpose of clinical input; ICD codes are developed for important administrative and financial output purposes-- thus, use of SNOMED codes for input will improve physician work flow because SNOMED is more intuitive to use for physicians to describe clinical encounters; this also preserves the use of ICD code sets for the important administrative and financial functions that our healthcare system currently depends on.
I believe that if CMS is going to maintain their mandate to move off of ICD-9, then we should move on to an available coding system that has the most potential to improve healthcare at the lowest cost:
 
  • Informatics experts agree that ICD-11 is more sophisticated and has more potential to improve healthcare than ICD-10, but the earliest that a US version of ICD-11 could be available is 2024 unless an unprecedented effort to accelerate development occurs
  • On the other hand, SNOMED is already incorporated in EHRs and being used by physicians
Thus, I believe the mandate to convert off of ICD-9 is more likely to improve healthcare, improve physician work flow and impose the lowest costs if we make the 2015 conversion to ICD-10 optional for physician practices and mandate physicians start using SNOMED (with the translator technology incorporated in EHRs) in 2017.    There will inevitably be tactical challenges involving diverse groups of healthcare stakeholders to work on, but if we remain aligned to the goal of improving quality care, I am confident we will find mutually agreeable solutions. 
 
cook children's healthcare system

Health IT-related patient safety risks should inspire Congress to create a national patient safety board

The idea’s time has come. The U.S. healthcare system needs a national, independent entity empowered by Congress to oversee health IT patient safety. Now.

In today's world a health IT-related patient safety issue that is identified by a physician practice or hospital is investigated and managed in a nontransparent manner by the individual provider and the EHR vendor.  

Although the issue may be escalated to a local accountable care organization (ACO) or patient safety organization (PSO) that providers are increasingly becoming associated with, neither the issue nor the results of the investigation are reported to a statewide or national oversight entity. The patient safety data is therefore not collected, aggregated and analyzed at a state or national level. Without such oversight we are missing out on the opportunity to identify known avoidable health IT risks to patient safety and failing to disseminate knowledge on how to manage those risks. For example, if an issue is resolved at the physician practice between the physicians and EHR vendor but is not addressed at other practices that use the same EHR, then patients at those other practices remain at risk. 

I have observed EHR vendors tune in to patient safety issues more keenly in the past decade and sometimes make more visible efforts to ensure identified issues are addressed with all customers and not just the ones who report issues. And let's be clear that a majority of EHR-related patient safety risks are related to how an EHR product is being used or implemented by their clients and not due to inherent technical flaws with the vendor's product. Nevertheless, patient safety should be viewed as a shared responsibility between the physicians, their practices or organizations and the health IT vendors. Identifying and managing patient safety risks is done most effectively when all cooperate in a team effort.

In Texas there had been discussions within the Texas Medical Association about establishing a central, statewide EHR patient safety entity to monitor and manage health IT-related patient safety issues. The data would be rolled up from hospitals, physician practices and patient safety organizations across the state for aggregation and analysis. However, it became evident during those discussions that it would be feasible and much more beneficial to establish governance at a national level.

So why does this need to be a new, independent national agency charged by Congress to oversee health IT patient safety? 

Today there are many government agencies and private entities that I believe could and should contribute to patient safety surveillance and improvements, but none have the expertise, assets and time that are necessary to coordinate a national effort. In addition to the complexity involved with collecting and analyzing data from hundreds of institutions and PSOs, there are hundreds of unrelated EHR vendor products being used. There is not yet any available registry of health IT products, many of which are subdivided into multiple versions that sometimes vary widely in their available functionality. As a result, I strongly agree with the observations and recommendations described in an article by Singh, Classen and Sittig (J Patient Saf, Dec 2011; 7(4): 169-174) calling for a national patient safety board that is an independent government agency structured similarly to the National Transportation Safety Board. This entity would be charged by Congress to oversee HIT patient safety and coordinate with other agencies who can contribute to improvement in patient safety such as the Office of the National Coordinator, the Federal Drug Administration, the National Institute of Standards and Technology, the Agency for Healthcare Research and Quality, the Center for Medicare and Medicaid Services, the National Quality Forum, local patient safety organizations, local healthcare organizations who collect patient safety data, other local EHR patient safety reporting entities and industrial (EHR and HIT) trade associations. All of these entities need to function in a cooperative fashion in order to effectively identify and manage health IT-related patient safety risks.

The recent health IT report from the Food and Drug Administration Safety Innovation Act (FDASIA Health IT Report) proposes a framework to improve health IT-related safety risks including a proposed National Patient Safety Center. 

I am concerned, however, that the proposal does not appear to provide this entity with enough authority to get the job done effectively. A national patient safety entity must have the authority to not only monitor activity and provide learning opportunities for vendors and providers, but also to regulate activities, investigate events, ensure issue resolution and require compliance. I do not see enough "teeth" given to the entity proposed by the FDASIA report. 

The primary focus of a national Health IT Patient Safety Center should be on the dedicated surveillance of HIT-related safety risks and to promote learning from identified issues, potential adverse events (“close calls”) and adverse events. But it must also have the authority to effectively manage identified risks and ensure compliance with best practices for health IT patient safety.


It is time for the U.S. to begin implementing health IT smartly

From a national policy perspective, ICD-11 is not found anywhere on the U.S. dial.   Not even a preliminary roadmap to ICD-11 has been proposed.   I believe this to be a serious risk to our nation’s health IT planning efforts, and this risk has been inherent to U.S. health IT planning for decades.   The recent ICD-10 delay magnifies this strategic flaw.   It is time for CMS to take a deep breath, re-evaluate our national strategy, address the unmitigated strategic risks and determine whether any mid-course corrections are needed before deciding on the new ICD-10 implementation date.  It is time for the U.S. to begin implementing health IT smartly.  

What I see right now is the U.S. planning to achieve a short-term tactical goal of getting off antiquated ICD-9 while the rest of the world is focusing on the long-term strategic goal of developing and adopting the new-century ICD-11.   Unless we take action now, we are destined to be in the same predicament in the 2020s when we will be struggling to get off of last century’s ICD-10.   

But the stakes will be much higher in the 2020s.  

Most physicians and hospitals will be using EHRs, health information exchange will be flourishing, SNOMED-CT will be the common vocabulary used by clinicians and big data analysis will be... well, big.  We will be stuck, though, with an ICD-10 taxonomy that was developed before the Internet came into common use.   We will be clamoring for ICD-11 because it was developed in alignment with SNOMED and for other reasons I and others have previously described.  Delays will likely be encountered.  And we will probably be amnesic about how we got into such a predicament.  

To avoid this we need a U.S. roadmap to ICD-11 before deciding when to implement ICD-10.   We need to determine our long-term goals and then align our short-term tactical plans to those goals.   What if ICD-10 is delayed another year?   Would it then be time to leapfrog to ICD-11?    What if the delay is 2 years?   How about 3 years?   Or maybe to meet our long-term goals it is actually time to leapfrog now.   But without establishing long-term goals and developing a proposed roadmap to ICD-11,  we cannot really make an informed decision. 

Yes, we have to get off ICD-9, but not at any and all costs.   I want the U.S. to change health IT planning efforts from one that risks derailment from ostrich-style decisions to one that smartly develops long-term strategic goals and aligns them to tactical plans.  I want us to be a country that leads the world in the use of health IT to improve quality of care and one that smartly plans to optimize health IT use each decade.

.

MM


Ask Not What ICD-10 Can Do For Healthcare, Ask What Healthcare Can Do With SNOMED and ICD-11

ICD-10 is so “last century”.    The United States did not adopt ICD-10 twenty years ago when the standard was first developed.    The current version of ICD-10 that the United States is designated to adopt is based primarily on the international version of ICD-10 that the World Health Organization (WHO) published in 1990.    The international version was drafted by committees that began their work over thirty years ago in 1982 (see 2nd Edition of ICD-10 by WHO).    In other words, our version of ICD-10 is based on work done before use of the rich information space called the Internet became common and before the human genome was mapped.

ICD-11 is “this century”.    According to an article in Healthcare Financing News, Christopher Chute who is one of the leading informatics experts and a Chairman of an ICD-11 Revision Steering Group at the World Health Organization stated:

“ICD-11 will be significantly more sophisticated, both from a computer science perspective and from a medical content and description perspective…. Each rubric in ICD-11 will have a fairly rich information space and metadata around it. It will have an English language definition, it will have logical linkages with attributes to SNOMED, it will have applicable genomic information and underpinnings linked to HUGO, human genome standard representations. ICD-10, as a point of contrast, provides a title, a string, a number, inclusion terms and an index. No definitions. No linkages because it was created before the Internet, let alone the semantic web. No rich information space.”

ICD-x codes are used by non-clinicians for important administrative and financial purposes.    SNOMED-CT, on the other hand, is what physicians will actually use to communicate information about patients in their electronic health records (EHRs).    In fact, physicians must use SNOMED vocabulary in their EHRs, not ICD-x codes, for their problem lists in order to achieve Stage 2 Meaningful Use for incentive payments and to avoid Medicare penalties in the future.    Unlike ICD-10, ICD-11 is based on SNOMED.  And SNOMED includes over 311,000 concepts with unique meanings, making it more granular than ICD-10 or ICD-11.  

One way to think about the relationship is that SNOMED is the input and ICD-x is the output.  SNOMED is used by clinicians to input clinical information into the EHR at a high level of detail.  ICD-10 and ICD-11 aggregate that data into less detailed classifications that are more useful for output purposes such as quality reporting.    They really cannot replace each other.   But we could and should require EHRs to map in the background the SNOMED codes used by physicians into the ICD-x codes used by others.    No need to engage physicians in ICD-x debates or to learn new vocabularies each time WHO does their thing with the U.S. traditionally following way behind.

So what the HIT are we thinking?    Do we really believe that healthcare quality will be significantly improved based on ICD-10 that was developed out of work done over 30 years ago before the Internet was commonly used and before human genome coding was completed?    Or do we believe that we need to adopt ICD-11 for output purposes and to use SNOMED–CT in EHRs for input purposes in order to move the quality needle in the right direction?

I for one believe that we need to get to ICD-11 as soon as possible.     And I believe we should cut the umbilical cord to ICD-10 right now because:

  1. There is currently no information showing that a conversion to ICD-10 is required before ICD-11.
  2. It is intuitively obvious that the costs of going to ICD-11 directly from ICD-9 would be less than incurring the remaining costs of implementing ICD-10 in 2015 (or later) and then implementing ICD-11 sometime thereafter.    And that includes the sunken ICD-10 costs.    If you believe that this is an outrageous assumption, then prove it to be untrue.    Show the comparative costs of both pathways.    But don’t just comment or blog that it’s ridiculous without providing some kind of evidence.     Sometimes it’s wisest to go with intuition.
  3. The ICD-10 implementation has been so painful that it is unlikely the industry will have the stomach to move on to ICD-11 within a decade.    This will result in an excessively long delay to ICD-11 and an excessive period of time using a classification system from the previous century.
  4. There is consensus among leading informatics experts that ICD-11 is superior to ICD-10

 

Matt Murray, MD


EHR Interoperability is a Nervous System

For those familiar with using email applications such as Outlook, Gmail or Apple Mail, it might not seem like it should be very hard to send and receive electronic health information.   But as it turns out, maintaining privacy, security, HIPAA compliance and electronic patient consent is very complex when exchanging electronic health data over the Internet.   It is not easy even for physicians and hospitals using fully functional EHRs.

Virtual Scenario:  Imagine that your patients’ electronic medical records are packaged in individual charged impulses that can propagate along the axons of a national health IT nervous system. This neuronal circuit provides the infrastructure needed to send one of those charged impulses containing the right information on the right patient to the right receiving provider whenever and wherever needed. As physicians know, the charged impulses will propagate along the tubular-shaped axon until they reach the terminal end, which does not directly connect with another axon. Instead, there is a gap or synapse which prevents the impulses from proceeding unless an intermediary event occurs. This constraint prevents chaotic, asynchronous transmissions of impulses that would result in unwanted movements or seizures. So, trusted intermediaries (i.e. neurotransmitters, ions) are needed at the gaps or synapses to enable axons to “talk” with one another in a standard and controlled manner. This allows the charged impulses to proceed in a synchronous manner. The axons, gaps, synapses and intermediaries must work together, or be “interoperable”, so that the charged impulses travel in a secure, coordinated manner all the way to their intended destination.

In this scenario the imaginary national health IT nervous system is analogous to the real-life health IT infrastructure being developed at the national and state levels through National Health Information Network (NHIN) Direct project and the State Health Information Exchange (HIE) Cooperative Program.   The charged impulses represent each patient’s electronic health information.  The axons represent each physician’s cable to the Internet.   The gap or synapse represents the present-day constraints on our ability to send and receive electronic health information to one another.   The trusted intermediaries represent local health information exchanges (local HIEs) and health information service providers (HISPs) that allow each physician’s axon to communicate through the Internet with axons from other physicians and hospitals.  The interoperability needed among all parts of the virtual health IT nervous system is analogous to the interoperability needed among all parts of the real-life health IT infrastructure including EHRs, local HIEs and HISPs.

The Nationwide Health Information Network (NHIN), through the NHIN Direct project, defines standards, services and policies at a national level for health IT interoperability.  At the core of NHIN Direct are trusted intermediaries that physicians can connect to in order to allow electronic health information to traverse the synapses between their axons and those from other physicians and hospitals.   These trusted entities are called health information service providers (HISPs). HISPs are able to authenticate the senders and recipients of electronic health information.   This provides verification regarding who really sent information and who really received it while also maintaining privacy and security while the data passes across the axonal synapses.

The Office of National Coordinator for Health IT (ONC) is making an effort to trickle down NHIN Direct standards and protocols to each state.   Through the State HIE Cooperative Program, ONC grants funds to states who submit plans to build statewide health IT infrastructure to support interoperable health information exchange.   In order to be funded the states must adhere to NHIN Direct standards.

For example, the Texas Health Services Authority (THSA) is using the grant funds to serve as a statewide convening entity that has gained consensus from a broad base of healthcare stakeholders on a three-pronged strategic plan for HIE in Texas:

  1. Local HIE Program— Local HIEs are another type of trusted intermediaries, like HISPs, that physicians can connect to in order to allow electronic health information to pass across the synapse to the axons of other physicians, labs, radiology centers, hospitals or others with electronic health information. Twelve local HIEs were launched in 2011-2012 with partial funding through the THSA’s Local HIE Grant Program. Some are currently operational and actively providing HIE connectivity to physicians and hospitals in their area 
  2. State-level IT infrastructure and services—The goal is to develop statewide infrastructure and services that can be used by local HIEs to help them provide HIE services locally as well as to enable exchange of data from one HIE to another (statewide HIE services); also to support a transparent governance structure and develop policies and strategies that guide maturation of statewide health IT infrastructure
  3. “White Space” initiative—The goal is to make available basic health information exchange services to physicians and hospitals in regions of the state without local HIEs (the “white space”) by creating a marketplace of health information service providers (HISPs); physicians can apply for “vouchers” from THSA to offset the initial costs of connecting with the HISP they select.
Physicians should stay abreast of health IT interoperability efforts like these, especially those in their own communities like the local HIE efforts in Texas.  Physician input and involvement in these initiatives helps ensure health IT is spliced into the healthcare industry's genome in way that promotes high quality care.

Vendors Can Raise EHR Safety, Lower Business Risks Through Patient Safety Organizations

Physicians are disturbed when patient care is put at risk due to a problem caused by their use of an electronic health record (EHR).    Although they will generally tolerate the situation when their reported problem is effectively managed in a transparent manner, there are a number of situations that engender scorn for their vendor.   The most common scorn-generating situation is when they feel that the patient safety issue they reported has not received a high enough priority from their vendor.   These situations should, and often do, resolve when the doctor and vendor communicate a clear understanding of the problem and circumstances.  

But it is another situation that I think is much more frustrating.   A physician’s expectation is that EHR vendors respond to patient safety issues in the same manner physicians respond to adverse medical events.   Physicians engage in peer review activities to not only analyze and resolve a specific adverse event, but also determine a plan that reduces the risk of the adverse event happening again.  The most common peer review activities provide legal protections from discovery which promotes transparency and more effective management of the problem.  Physicians analogously expect EHR vendors to not only fix their problem, but also to transparently fix it for all other physicians using their product.   This puts EHR vendors in a quandary because the legal protections of peer review activities extended to physicians are not extended to EHR vendors.  

Resolving this problem will require assistance from the federal and state governments.    Along those lines the Office of the National Coordinator for Health Information Technology (ONC) published a Health IT Safety Plan on December 21, 2012, and is accepting public comments on it until February 4, 2013.   I believe the most important aspect of this plan is the development and use of patient safety organizations (PSOs) to identify, aggregate, and analyze health IT safety events and hazard reports.    

The aviation industry continually improves passenger safety by engaging pilots in self-reporting of errors and dangerous conditions through an offer of immunity from sanctions.   The federal Patient Safety Act of 2005 provides an analogous environment allowing physicians in the outpatient setting to voluntarily report and share quality and patient safety information to AHRQ-certified PSOs without fear of legal discovery.   Most physicians are familiar with the secure nature of communications when they are involved in hospital quality improvement activities.    The information, documents, discussions and committee reports generated under the hospital’s umbrella of quality programs are held confidential and privileged.   Privileged communications cannot be disclosed and used in medical litigation without consent.   PSOs offer an analogous umbrella of protection for physicians in the ambulatory setting.    Physicians may voluntarily report patient safety issues or quality data from their outpatient practices to a PSO on a privileged and confidential basis.    The PSO can aggregate and analyze information from multiple physicians and healthcare entities to help identify, prioritize and reduce hazards that impede quality care.

The legal protections offered to physicians through PSOs are not currently extended to EHR vendors. They should be, and I will endorse that change in my comments to ONC’s Health IT Safety Plan.   But even without this change there are ways for EHR vendors to safely engage with PSOs today.    Let’s consider one such scenario:

Fictional scenario:  Community physicians and several EHR vendors are associated with the same patient safety organization (PSO). Dr. X is one of the physician members and his EHR vendor, VendorZ, is an analytical contractor with the PSO. After entering a digoxin dose in his EHR’s Medication Reconciliation screen, Dr. X discovered that the dose displays with a misplaced decimal point on the Medication History screen. He reports this dangerous dosing error to his PSO as a patient safety issue. The PSO notifies VendorZ. VendorZ begins working with Dr. X’s office to resolve the issue. Because VendorZ is an analytical contractor with the PSO to which this patient safety issue was reported, the reported problem, analyses, results and recommendations are confidential and privileged. When a solution is identified, there is no legal threat that disincentivizes the PSO or VendorZ to withhold this known problem and solution from other physicians in the PSO who use the same EHR. The PSO notifies all of those physicians who are members of the PSO and proactive work is done to prevent this same problem from harming patients in other practices.

EHR vendors are not inclined to openly discuss EHR problems when there is the threat of litigation against them for doing so, similar to fears physicians have with discussions of their own medical errors.   But this fictional scenario exemplifies one plausible way for EHR vendors and physicians to collaborate on health IT risks today under the protective umbrella of PSOs.

As stewards of safe, quality care physicians should have a basic understanding of PSOs and carefully consider opportunities that arise to engage with a PSO on initiatives to improve outpatient care in their community.   EHR vendors should demonstrate a similar stewardship by helping educate physicians about PSOs and engaging with physicians through PSOs to improve the safety of their EHR products.