FDA Considers Regulating Safety of Electronic Health Systems - Now that would shake up the industry!

WOW - now this is a true news alert to think about!
FDA Considers Regulating Safety of Electronic Health Systems

Here are some quotes from this article - with my thoughts in parentheses:

But digital medical systems are not risk-free. Over the past two years, the FDA's voluntary notification system logged a total of 260 reports of "malfunctions with the potential for patient harm," including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person's file and lost vital medical information.
(Hmmmm... let me add some more: how about crashes, slowness, broken decision support tools, awkward workflows that result in both errors of omission and commission.)

The FDA official outlined three possible approaches for tighter scrutiny. The agency could require makers of the devices to register them with the government and to submit reports on safety issues and correct problems that surface. The FDA could track this information "to help improve the design of future products."
(I wonder if the government would have any better luck than the rest of us in asking our vendors to fix technical and design problems that cause safety issues!)

In a second scenario, the agency could require manufacturers to report safety concerns and set minimum guidelines to assure the quality of products on the market. In a third approach, the systems could be subject to the broader regulatory actions that new medical products must face before they ever reach the market.
(I have a feeling the government has no idea how poorly designed most EMRs are... they would never allow clunky, erratic software to be put into pacemakers, IV pumps, etc...I also wonder if they truly understand the difference between inpatient and outpatient systems.)

The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government's campaign to spur widespread adoption of the technology.
(Sure- let's put cars on the road that have hard-to-turn steering wheels, and which only go 10 mph - because we need to stimulate buying of cars!)

Regulation will not necessarily create a "safer" electronic medical record "and might actually limit innovation and responsiveness when it is needed most," Carl Dvorak, executive vice president of Epic Systems Corporation....
(Well, that is true - but I'm still waiting for any significant innovation and responsiveness from the EMR vendors... the systems we use today are honestly just slight variations of the same paper-paradigm based EMR systems originally developed in the 19060's - except those were actually more consistent and reliable to use.)

Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the "right thing to do," a company official said.
(Really, that's great- I've got to find out from Cerner who is collecting those incidents... I wonder if they fully understand the volume they might face if they really wanted to hear it all. Did my sarcasm come through? I can't believe any EMR vendor wants to REALLY hear how screwy their systems can act in ALL its different forms and types of implementations.)

The federal government's Office of the National Coordinator for health information technology also has recognized the need for better surveillance. In January, the office issued a contract to address "undesirable and potentially harmful unintended consequences" of the systems.
(Tricky part here is clarifying the difference between an error, a safety issue, and unintended consequence. There is some overlap but also some parts that are clearly separate issues.)

Though officials in some other countries have tightened oversight of the systems, U.S. manufacturers have managed to stave off formal regulation, telling the FDA in May 2008 that their products should be excluded from review partly as a means to speed up their adoption.

But critics argue that tighter scrutiny is needed to protect the public. "Oversight and quality control may slow things down, but it's absolutely critical," said Hoffman, the law professor. "Patients' lives are at stake."

In all honesty, it's a tough call - one on hand it seems insane that these important systems have no regulation as to how crappy they might be - they directly impact care! On the other hand, over-regulation may increase costs, stifle innovation and create new problems we can't fully predict...and finally, who is the final decision maker on what is truly a safety issue vs. just an unintended consequence?

Addendum (3/13/10)...things could start getting more interesting...
FDA Asks Hospitals to Report Safety Glitches in Digital Health Systems

And another perfect Dilbert reflects the confusion in understanding the difference between a true error and a poorly designed system...

Checklists: Moving from Procedures to Clinical Care Workflow

I am a big fan of the Checklist philosophy (see past post reviewing this), as espoused by docs like Atul Gawande and Peter Provonost. And I like to combine that with the writings of Dr. Richard Bohmer (Designing Care) who talks about "Islands of Standardization" that stand out in a sea of unstructured medical thinking (those areas where docs need to take in a lot of info and make a decision). In other words, we should use checklists for those areas of clinical care that should be standardized... and be careful not to overuse them in places where the care cannot be as structured.

For example, as part of the Szollosi Healthcare Innovation Program , we have studied some "inflection points" in healthcare (i.e. A new and important finding that can have a large impact). Whereas traditional checklists focus on procedures, we have started adopting the concept to parts of the clinical care process. To help understand this, it's important to understand that the clinical care process has three basic phases:

1. The Initial Diagnosis Phase: : An "unstructured" time where the doctor takes in all history, physical exam, and test elements and decides on a "final diagnosis". To date, we have explored (in order of increasing complexity): Hematuria, Atrial fibrillation, and Cancer.

2. The "Workup" Phase: Once one of these "Diagnoses" has been decided by the physician, there is usually an "island of standardization" that often involves further testing and a consult to a specialist. For Atrial fibrillation, it involves getting a stress ECHO and a Holter monitor, and then seeing a Cardiologist after those tests are completed. We therefore created a "Checklist" within an EMR message that allows the doctor to send a note to our Care Coordination team. The doctor needs to choose the message type (called "PATHWAY - Atrial Fibrillation"), answer one question within the message (which helps decide how acute the problem is), and then send it to a coordinator who follows the directions of the message (e.g. set up the tests, and then the consult).

3. The Management Plan Phase: This is another unstructured time where the PCP or specialist reviews all the information and decides on the treatment plan. But note, depending on certain issues, it is possible to make this part somewhat standardized as well.

4. The Stable Follow-Up Phase: This is a very structured time where the patient is stable on their treatment plan and just needs routine follow-up care, such as checking some blood tests and vital signs every 6 months. This can often be done by an NP or even an RN, and the doctor is only notified if a patient's findings veer off course. This area is particularly ripe for Checklists.

In other words, we do not want to try and create checklists for the unstructured thinking part of the physician's job- that part is critical and is very hard to replicate or standardize- but the time it takes is relatively small. Unfortunately, physicians instead waste their valuable time on trying to remember the exact protocol for the workup phase, and helping their patients complete them as quickly as possible and make sure they do so in the right order. THAT is where a checklist helps, and even better if we can hand it off to a "lower level" person on our team! As the saying goes, make sure each team member is working to the top of their ability and licensure!

__________
Since we are on the topic of using Checklists appropriately... you should read this new article from HealthLeaders magazine: "Use Medical Checklists as Tools, Not Cure-Alls, for Patient Safety Problems". Three great quotes from this article point to how we need to be careful in further understanding how to be successful with Checklists:

However, in reality, these checklists need to be accompanied by a "change in the culture"—where nurses, for instance, are empowered to question doctors who don't follow the steps properly or where members of a healthcare team toss out long held beliefs that infections are an inevitable cost of being in the hospital. "Just having a checklist on a piece of paper isn't going to be enough," Pronovost said in a statement.

"Everyone wants to do a checklist. The message becomes that . . . checklists are the simple solution for solving an adaptive problem with a technical solution," he says. "It needs to be embedded in a broader effort to evaluate and address local context. It needs to add value. If providers don't believe in the value of the checklist, they'll just check a box." (Sean Berenholtz, MD, an associate professor with the departments of anesthesiology, critical care medicine, and health policy and management at Hopkins)

The eventual goal, the researchers wrote, is that checklists should be created that are "succinct, unambiguous, focused, and ultimately effective, and efficient." And, when ultimately faced with a crisis, "we can react quickly and decisively, knowing that the items we act out from the checklist are well thought out, tested, and will provide us with the results we want."


UPDATES
Medical Personnel Taking a Page Out of the Pilot Handbook
Dec, 2009: Medical personnel who used procedural checklists modeled after preflight checklists used by pilots were more likely to report safety-related incidents and feel empowered to address safety issues, according to an online report in the December 21, 2009 Archives of Surgery (PDF).  After preoperative checklists were introduced to certain medical teams, their use rose from 75 percent in 2003 to 100 percent in 2007, the study found.  The introduction of checklist-based programs, known in the aviation industry as "crew resource management programs," or CRMs, was accompanied by an increase in self-initiated reports of safety breaches among medical staff, from 709 per quarter in 2002 to 1,481 per quarter in 2008 among teams using the checklists.

HITECH Showers...really, how come we aren't just focusing on Paying for Value?

I am involved with the Association of Medical Directors of Information Systems (AMDIS), and our list-serv often brings up good topics. I'll often post my thoughts, with my bias of being a very pragmatic, in-the-trenches primary care physician. I've incorporated some of those thoughts into past posts, but will also occasionally blog the (almost) verbatim posts I've made.

Here is a recent one I wrote, in response to discussions about whether the government is doing the right thing by using the HITECH funds ($39 billion) as "EMR Stimulus money" vs. thinking about restructuring how we pay for care so that EMRs will actually make business sense for physicians:


Yep- we've said it all before, the government (and other payors) need to pay for value, not volume. Align the healthcare system wisely, and there is no need for "stimulus dollars" to push for something which does not make business sense in today's environment. Make it valuable for us to practice high quality medicine - and that will happen… and in fact, the level of innovation in making that happen will be much greater than by trying to force untested EMRs onto everyone… it will mean more teamwork, more clinical standards of care, more checklists, more follow up, more competition…

What I don't get is that almost EVERYONE in healthcare policy knows this to be the case - and yet neither the HITECH bill nor the current healthcare legislation really touches on this.

Yes, there is some money for "experiments" - but we need payment reform as one of the foundations for care improvement. Can you imagine how much better the EMRs and other IT applications would be if they were being created in a world where payment didn't:
1. Rely on massive documentation of visits for any payment - and forced doctors to be the one to do this documentation themselves
2. Insist only doctors to be the ones to deliver care
3. Encourage volume over value

Take away those three restraints and replace with these two tenets… and just imagine what would happen:
1. Allow doctors to be part of a team that took care of patients as a whole - the right type of provider can do the right type of care and document in the way that makes the most sense for care
2. Encourages value over volume - so you can take care of many more people, but actually see less people

Sorry… dreaming again…

So what will happen in the meantime? Smart EMR companies will hopefully start making products that at least allow for better efficiency…It's hard to believe how poorly they have done in this arena to date… mainly all they have done is make it easier to document for higher level visits.

But in this real world, I do give HITECH some credit - MU is painful to look at right now, but at least it is making EMR vendors think more about how their systems can deliver quality. And while the overall reimbursement system has not yet caught up, it is fulfilling its promise of being a "stimulus".

The question will be whether this will be more like the April showers bringing May flowers… or a hailstorm that f's up your car.

Replicating High-Quality Medical Care Organizations

Just as I posted my blog about this topic of understanding and replicating "the best places"... I read another article discussing it: "Replicating High-Quality Medical Care Organizations" by David Mechanic, PhD in the Feb 10th issue of JAMA.

Dr. Mechanic starts by proposing that there is strong interest in developing accountable care organizations (ACOs) that have the capacity to:
1. Monitor meaningfully patient needs and outcomes
2. Use performance indicators for assessment of physicians and other professionals
3. Implement new forms of reimbursement that result in improved quality while constraining increases in cost.

He notes the typical examples (Mayo, Kaiser, Cleveland Clinic, Geisinger) don't match well with the typical medical organization and thus pushes us to think about how other organizations can replicate the giants.

He proposes that even if reimbursement systems improve, there is still a need for a strong collaborative organizational culture which has 4 key elements:
1. Strong focus on mission
2. Strong Leadership
3. Good measures and feedback of results including clinical quality indicators
4. Tools for care coordination, operational system support, and an outstanding clinical information system.
More info on these key elements can be found in a 2008 Kaiser report entitled "Keys to Stronger Hospital/Physician Relationships: Culture and Incentives".

Then, Dr. Mechanic wisely points out that "Few organizations use pure payments types without modifications and additional incentives to encourage initiative, productivity, performance quality and loyalty to the organization. The distinction between how these organizations are reimbursed and how they pay their professionals is important".

He points out that "there is considerable agreement about essential tools, including development of information technology, electronic medical records, and system connectivity; better dissemination and use of evidence for making decisions; and improved clinical measures with continuing feedback to clinicians. Better organized teamwork, coordination and collaboration are also needed". Be he then adds that "Although financial and organizational coordination are important, the ultimate test is success in clinical integration, which is the most challenging of the changes needed".

He ends with the thought that "Innovative approaches to primary care are needed along with new ideas for how physicians and other primary care clinicians can be educated to work together effectively and to fill their roles in thoughtful and more satisfying ways". Amen to that.

Mayo - The Mirage of the Mirage

I have always been intrigued with how the Mayo Clinic (and Cleveland Clinic) succeeds in the same vein as organizations like Kaiser and Group Health. They all are regarded as "the best" - those healthcare organizations which provide high quality care at a lower price and with high patient satisfaction - but Mayo and Cleveland Clinic have to do it in a predominantly FFS (fee for service) environment which rewards Volume over Value, in contrast to the capitated environment of a Kaiser or Group Health.

Sort of like the old joke about Ginger Rogers - she had to do everything Fred Astaire did, but she had to do it backwards and in heels. I blogged on this issue a bit back in September, 2009 when I described futurist's Joe Flower's discussions of "How to Mayo Up".


I recently stumbled upon a Washington Post article from September, 2009 entitled "Is the Mayo Clinic a Model Or a Mirage? Jury Is Still Out". It suggests their success is due to the fact that "their patients are wealthier, healthier and less racially diverse than those elsewhere in the country" - and thus they can make more money and have better outcomes. Therefore, their model of care cannot be easily replicated (unless you have the same type of wealthy, healthy patients I assume). Hmmmm... I could see why one might say that on a superficial level, but it really disrespects what they have done at that Clinic over a hundred-year plus odyssey. And yes, that success has brought in some money - but their core ideals are the same as they ever were.

I thought a follow-up opinion piece called "Mayo Clinic's Model" summarized Mayo's success factors very well. It was written by Dr. Henry Weil (assistant dean for education at the College of Physicians and Surgeons of Columbia University) and Stuart Guterman (assistant vice president of the Commonwealth Fund for the program on payment system reform). Here are some of the salient parts:

"Mayo's performance is no mirage. In fact, there are multiple examples of health systems -- the president and other policy makers also have cited Geisinger, Cleveland Clinic, Bassett, Kaiser Permanente and others as models for health-care reform -- that consistently and reliably achieve similar results: providing good care at low cost, with high patient satisfaction."

"What these systems have in common is that they are integrated systems that employ their physicians, emphasizing patient-centered care, better outcomes, and prudent stewardship of health-care resources, with accountability for results. A group of these systems met in Washington earlier this month to discuss how the elements of their success could be adopted more broadly in the context of health-care reform. They concluded that comprehensive care, collaboration, integration, and measurement and accountability, as well as strong corporate leadership, were key to their success and could provide an example for other systems."

So would this be easy to replicate in any environment (rich or poor)? No way. But is it something for all of us to strive for? Absolutely!

Scribes may be the answer to EMR adoption

One of my favorite HIT writers, Joe Conn, just published a two part article in Modern Healthcare about the use of scribes by physicians using EMRs - part 1 and part 2. He pointed out the increasing use of scribes in ER departments, as well as some early projects in primary care offices.

Here are some of the key quotes from this article:
Today, however, organizations seeking to implement the latest wrinkle in medical record-keeping, electronic health-record systems, are looking to new generations of scribes—to increase physician productivity and to overcome the pitfalls of the still typically clunky physician/EHR interface, and to ease the strain of EHR implementations and replacements...scribes do more than transcriptionists by assisting physicians in fully documenting a patient encounter, most recently, entering encounter data in an EHR.

Randall Oates is a family physician who founded an EHR-system development company, Soapware, Fayetteville, Ark., with software products designed for office-based physicians. Oates said the combination of scribes, EHRs and practice redesign, could provide the saving grace for economically threatened primary-care physicians.
The current approach to EHR implementation, in which the physician is supposed to document the encounter on a computer, is, Oates said, “complete insanity, turning doctors into data-entry clerks. We're going to look back on these days the way we look back on bloodletting with leeches."

Physicians using the system have one computer in the exam room with the patient and another computer in a room set aside for the scribe, who listens in via a microphone in the exam room and documents the encounter. “Both the scribe and the physician have to be able to control the desktop,” Oates said. “The scribe is creating the documentation, but most of the documentation is already collected before the doctor ever gets in the exam room. If the patient is in for hypertension, the scribe will know to automatically pull up the vital signs in a view. The doctor should not have to do that navigation. The doctor should be able to be empowered to do the high-touch patient care."

The system radically accelerates patient throughput, according to Oates. “They're scheduling eight an hour with very high patient satisfaction, structured data entry and the note is completed at the end of the encounter,” Oates said. “The bottom line, and I'll make it real simple, the family practitioner only has to see one extra patient every three hours to cover the cost of the remote scribe and the technology.”

And then my part at the end:
Lyle Berkowitz is a physician informaticist who has written extensively on the need for an improved interface between computers and physicians. He uses an EHR in his outpatient internal medicine practice in Chicago. Berkowitz said he has never used a scribe, but in doing personal research on high-performance “superpractices,” he has run across several examples of physicians who do.

Berkowitz said he doesn't view scribes as an interim measure, but “as part of the evolution to get to the better solution.”

“A scribe is the ultimate of artificial intelligence,” he said.

Well, I know what I meant, but I think it makes sense to explain further. I think the ultimate holy grail is when the physician can walk into a room and the EMR can be the perfect assistant - gathering history from the patient ahead of time, displaying exactly what is needed to help the physician make a decision, listening to the physician and documenting the visit as well as creating orders, making pertinent suggestions at the right time…

But while that level of EMR artificial intelligence is not yet available, a scribe can fulfill many of those same functions. The result is that the physician can concentrate their time on the patient and not on the computer.

In other words, we have to decide "what is the doctor's job". Is it to take care of patients, or document that they took care of a patient? I think we will all agree that it is the former, and so we have to start rethinking the current paradigm where doctors are using EMRs more like data clerks than healers. This will likely be a combination of (1) making documentation a BYPRODUCT of care, and (2) Figuring out other ways to get our care documented in the system easily - whether that be from scribes or voice recognition combined with artificial intelligence that supports both care and documentation.

Well... at least until the computers overtake everything we can do and tell us to go retire!

UPDATES
* Electronic medical records systems create need for scribes to input data (April, 2011)