EMR products

Although the behavior of one EHR vendor was wrong, more serious problems are inflicted by government-run EHR certification criteria

This week eClinicalWorks resolved a lawsuit by agreeing to pay $155 million for falsely claiming it met Meaningful Use (MU) EHR certification criteria.   Although the alleged behavior of eClinicalWorks was wrong, we have much more serious problems inflicted by the government-run EHR certification criteria.  

The business of EHR vendors is to gain clients and earn profits.  Developing innovative tools that help physicians care for patients should be the primary focus of their business.  Instead, vendors are held hostage to government-run certification criteria that are constantly changing and sometimes ambiguous.  While I do not condone the apparent behavior of eClinicalWorks, I am much more concerned about the  certification processes that led to this situation.   

The certification process evolved out of the 2009 HITECH Act that promoted the use of EHR technologies by offering incentive payments to hospitals and physicians who successfully adopted and used EHRs.   This resulted in an unprecedented rush of business for EHR vendors.  While EHR vendors began ramping up resources to meet the demands of the sales cycle and EHR implementations, they were also hit with government-imposed EHR certification criteria--criteria that are still changing frequently and sometimes are ambiguous.  This exponential increase in EHR client demands along with rapidly changing certification criteria crushed EHR vendor resource availability.  This constraint on resources forced them to focus on developing and testing EHR products to meet the specific certification criteria required by the government.  In my opinion, the unintended consequence of overwhelmed EHR vendors is that they then did not have available resources to focus more on:

  1. Improving usability
  2. Identifying and managing patient safety risks inherent to EHR use
  3. Developing innovative tools and functions that actually improve how physicians care for patients 

As a result, EHRs were developed to meet MU EHR certification criteria, but failed to improve poor usability.  EHR products could meet certification criteria, yet fail to adequately address patient safety risks associated with implementation and use.  And the constraint on EHR vendor resource availability remains an impediment to the development of innovative tools and functionalities that EHR vendors really should be focusing on today.

Physicians do benefit from EHR certification by reducing risk during the EHR selection process.  That is why the Certification Commission for Health Information Technology (CCHIT) was created in 2006 as an independent, not-for-profit group.  CCHIT certification was based on a consensus of stakeholders who determined core functionalities that a basic EHR should provide.  I participated in that effort, albeit in a brief, very small way (providing some input on pediatric core criteria).  I recall we were careful to avoid requirements that could hinder EHR product innovation.  CCHIT ceased operations in 2014 after the government created the MU EHR Certification program.  

CCHIT certification was much less prescriptive than what the government imposes today.  Less prescriptive EHR certification was, in retrospect, the right approach to take.  And we did it without government involvement.  Government works at its own hindered pace, and that pace is much slower than what an unencumbered EHR market could accomplish.  I think the government needs to get out of the EHR certification business.   But whether government remains involved or not, the EHR certification process needs to learn from CCHIT and rely more heavily on building consensus of physician stakeholders.  We will do what is best for our patients.    

So, this week one vendor was called out by the government for false claims regarding EHR certification.  But that one vendor is really not the problem.  The real problem is that the development of all EHR products has been, and still is, impeded by the government's EHR certification program.  

Matt Murray, MD

cook children's health care system


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.   

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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


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.