2011, Meaningful Use Stage I, Year I Showtime. Opportunities and Issues

I hope and trust everyone had a happy and safe New Year celebration.

Game on, really now. January 3rd, 2011, the day providers can begin registering their forthcoming eligibility for the Meaningful Use reimbursement money (via a new portal within the CMS PECOS system). I say "forthcoming" because everyone** will still have to traverse an initial continuous 90-day Meaningful Use compliance attestation period prior to filing for the year-one incentive money.

[** On the Medicare eligibility side, that is. Providers participating under Medicaid need only attest to having "Adopted, Implemented, or Upgraded" to an ONC Certified EHR during year one. In fact, the first checks have already been issued for Medicaid providers under that provision, in Kentucky and Oklahoma. Reimbursement timelines under Medicaid will vary by state. Nevada, for example, will reportedly not be ready to accept attestions and issue payments until late Q3 2011. We had been quietly worried here that Nevada, owing to its huge state budget deficit, might choose to opt out entirely (state participation is 'voluntary'), so this news was at least a bit welcome, notwithstanding the delay.]

As usual, I have much to ponder and discuss. e.g.,

• The December 2010 PCAST Report on HIT (PDF)
• The December 23rd CMS Data Systems Modernization report (PDF)
  

From the Better-Late-Than-Never Departments:

• The November 2010 NIST EHR Usability report (PDF), and its antecedent
• AHRQ May 2010 Electronic Health Record Usability report (PDF), and its antecedent
• HIMSS 2009 EMR Usability Report (PDF)

HIT "Usability" suddenly being again all the federal rage.


Also, "HIE" (Health Information Exchange). I got to write the Executive Summary proffer for our Nevada proposal, which has been accepted by an initial core group of convening entities, with my company designated to be the stakeholder-inclusive not-for-profit administrator. As I concluded,

RETURN ON INVESTMENT CONSIDERATIONS

Health care is fundamentally an information science, and, more importantly, the clinical information at its core is information about science – the science of treatment, healing, and wellness. Consequently, it is expensive to accurately acquire (given the considerable breadth of data to be usefully captured) and expensive to effectively interpret and act upon – in light of the extensive expertise required for quality health care. The labor time of everyone involved in the delivery of care is an invaluable resource, a precious, finite resource whose effectiveness can only be enhanced by improving the way we deliver its information lifeblood to the point of care.

More broadly, while the apparent nominal HIE capital and early operational outlays might seem to pose daunting barriers, such must be viewed in the context of the underappreciated but very real (and largely unimprovable) costs of the status quo. All of the health care stakeholders in Nevada stand to materially benefit from the adroit deployment of HIE, and, while any speculative ROI “hard dollar benefits” calculation is beyond the scope of this executive summary, suffice it to say that that the convening stakeholder parties will bring both the acumen and the goodwill necessary to make a Nevada HIE both an exemplar financial success and a significant contributor to quality health care.

HIE activity has ramped up to a fever pitch across the nation, given that it is central to the visions laid out in PCAST (itself inclusive of the outer stage HHS/ONC/CMS goals of HITECH in general).

Stay tuned, lots to discuss...

JAN 6th UPDATE

From the National Quality Forum, two more (PDF) documents to ponder concerning HIT "usability"

• Driving Quality—A Health IT Assessment Framework for Measurement;
• Driving Quality and Performance Measurement—A Foundation for Clinical Decision Support;

A total of about 132 pages of eminently-proffered reading. While it's a lot of fine material, I was a bit disappointed to find only a couple of overt references to HIT "usability," e.g.,

“Currently, standards exist only for EHR certification, not for assessing effective health IT use. The meaningful use EHR incentive program and certification requirements for interoperability (sending information from one system to another) provide the incentive, but a standard mechanism to determine appropriate utilization of EHRs does not yet exist. Standards are needed to assess EHR use; without them consistency and comparability are not guaran­teed. The framework described in this report will significantly inform standardization efforts with respect to structural components of EHRs and other clinical information systems. Such standardization will allow for clearly defined measures with reliable, consistent, and achiev­able results while reducing the effort required to assess clinical system effectiveness by system vendors, implementers, or users of such systems. Performance measures of health IT systems using these standard user interactions and transactions will enable clinical effectiveness research, help determine unintended consequences of health IT, and evaluate the real-world usability of products and applications.”

"Usability" is generally summarized conceptually with three overlapping, outcome-reinforcing characterizations:

• Efficiency;
• Effectiveness, and;
• User experience

In other words, task(s) time(s) to completion, error rates, comprehensiveness of necessary data captured and reportable, and user satisfaction across the breadth of functions (front/back office, MAs, nurses, mids, providers, OMs, IT support/admin staff, etc). The ONC-ATCB Meaningful Use certification addresses none of these issues beyond the NIST-tested capability of an EHR (or module) to be able to minimally capture and record the Meaningful Use data. Whether doing so requires two clicks or twenty, takes a user six seconds or sixty, and/or results in "x" number of entry errors along the way, are not considerations.

I would love to see a comparative certified EHR assessment matrix comprised of elements such as workflow navigation clicks, task time-to-completion, error rates, user experience ratings, etc, for each MU criterion (inclusive of those that are essentially "once-only," e.g., "turn on your Meds-Meds, Meds-Allergies Alerts functionality and thereafter leave it alone," or "conduct one test of HIE").

On the subject of HIT usability, I have struck up an interesting internet conversation with Dr. Scot Silverstein of Drexel University.

A focused, erudite, credible critic of the persistent shortcomings of HIT.

Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs. As we enter the second decade of the 21st century, however, this potential has been largely unrealized. Significant factors impeding HIT achievement have been false assumptions concerning the challenges presented by this still-experimental technology, and underestimations of the expertise essential to achieve the potential benefits of HIT. This often results in clinician-unfriendly HIT design, and HIT leaders and stakeholders operating outside (often far outside) the boundaries of their professional competencies. Until these issues are acknowledged and corrected, HIT efforts will unnecessarily over-utilize precious healthcare resources, will be unlikely to achieve claimed benefits for many years to come, and may actually cause harm...

Interesting to me is Scot's opening sentence: "Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs."

Precisely the essence of the opening riff of the first of the the above-cited NQF reports: "HEALTH INFORMATION TECHNOLOGY (HEALTH IT) offers great promise to improve healthcare quality, safety, and affordability, and the health of the population."

Much to ponder.
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NEWS ERRATA:
The upcoming HIT Pro Exam (click either image below for link)

That'll be interesting. HHS competition (however limited) for those expensive proprietary professional organization cert exams. They had better do a good job with this from a BOK sampling perspective. Back during DOQ-IT, we all had to take a CMS online "DOQ-IT Certification Exam." It did not go well. There were numerous QIO people with substantive cred such as years of HIT experience and advanced degrees in clinical informatics who "failed" it during the first rollout. The ensuing firestorm was something to behold. And, a complete waste of time and tax dollars.
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UPDATE: A NAYSAYER

So as far as I see it, meaningful use is a brakeless train heading for a solid mountain. Some, to be sure, will jump before impact, abandoning the program rather than continuing to throw good money after that spent on a project which will not qualify for reimbursement. Far worse, others will continue to shovel coal into the rickety engine of their organization, pushing the train beyond capacity and hurting patients in an attempt to qualify for monies, ironically, set aside to help them. Any which way you slice it, this is ugly and going to get uglier.

- Anthony Guerra, InformationWeek, January 19, 2011

He's not the only one, by any means. Sometimes I tire of all the contention, so much of it of the "perfectionism fallacy" flavor. Not that I am an unreflective, uncritical cheerleader for this effort, by any means, as anyone taking the time to read my posts carefully and fairly should surely concede.
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INTERESTING:
CAPITALIZING ON THE REC "BRAND"?

"...For almost two years now HITECH Answers has been an independent source for educating eligible professionals on details of the HITECH Act. In that time, we’ve amassed a fairly significant library of pre-recorded webinars for viewing, along with a body of exclusive white papers and research. The time for analyzing the HITECH Act has ended. Our next logical step is to expand our resources to help shepherd EHR adoption and implementations. So we asked ourselves this question – how can we best utilize both our existing knowledge base and that of the independent experts who so graciously contribute their time and effort to HITECH Answers?
..
We concluded the answer to that question to a great extent is very similar to the purpose served by the 62 Regional Extension Centers – support as much as we can the process of adoption of a certified EHR system that meets meaningful use criteria..."

This is obviously a for-profit initiative via which to sell Meaningful Use related stuff to providers. Leveraging the public, non-copyrightable Regional Extension Centers "brand." Not that I have any problem with HITECH Answers -- I've long had them in my right hand side "Links of Interest" column.
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TANGENTIAL ERRATA:
A PRETTY COOL DATA VISUALIZATION WEBSITE

Click the image to enlarge.

This comes from the very interesting "informationisbeautiful.net" website. I came across it during my daily surfing over to the "Science-Based Medicine" blog, one of my favs. They didn't cut him any slack, either, nothwithstanding the stellar interactive presentation:

As a pharmacist, I constantly need to contextualize data directly for patients, translating trial results into more understandable figures like numbers needed to treat and numbers needed to harm. I’m always searching for better ways of communicating the understanding of risks and benefit. Information is Beautiful is one of my favourite blogs, as the authors highlight innovative and effective ways of graphically presenting data. So I was initially excited about their attempt to summarize the data for supplements...

Clicking each bubble will link you to the supporting clinical data. But there’s a crucial element missing in their presentation: harms. You cannot evaluate the value of a treatment based on efficacy alone. For example, selenium is ranked very highly for colorectal cancer prevention based on this study. Not only is there evidence to the contrary, selenium consumption is associated with a significant increase in the risk of type 2 diabetes. The risks actually seem more compelling and relevant than the potential benefits. Or look at red yeast rice, another supplement rated highly. While RYR does seem effective, is less effective and more dangerous than drugs derived from it. I like the IiB visual approach, but it fails in communicating meaningful data on risk and benefit, both of which are essential for decision-making.

Much to consider, as always.
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MU "RECORD PATIENT DEMOGRAPHICS"

I recently did gap analysis visits with a SOAPware client and an Alteer client. As we discussed the Meaningful Use compliance requirements for "record patient demographics" (§170.304(c) "Enable a user to electronically record, modify, and retrieve patient demographic data including preferred language, insurance type, gender, race, ethnicity, and date of birth"), it became clear that confusion continues as to "race" and "ethnicity." The SOAPware install in particular had drop-down response options that numbered in the dozens to hundreds (mostly with respect to "ethnicity" -- seemingly everything this side of the fork in the family tree). I'm sure some database programmer was thoroughly thrilled at the swell inclusion of this granular "functionality."

I dropped the requisite MU options into an Excel sheet pick list to illustrate. It's pretty simple.


These (or their radio button/check box equivalents) are all you want to see for MU compliance. Nothing more. Not that you can't collect every additional bit of fine-grained (and non-reimbursable) data you wish. Note below: the same thing applies to §170.302(g) "Smoking status."

Some EHRs enable you to capture more specific data such as "how many packs per day?", "for how long?", "other tobacco products?" (e.g., cigars, pipes, oral), but the above are what are specifically required for MU.

UPDATE

Saw a webinar demo today of a certified EHR product known as DigiDMS. Below, I did a screen capture of their Smoking Status template. There you go.


LATE JANUARY NEWS

As reported in Government Health IT, RECs get a bit of "breathing room." Sort of...

The Office of the National Coordinator for Health IT will expand the time period, from two to four years, in which it will foot most of the costs for the regional extension centers to boost the chances of their success in the difficult economic environment...

...Under the original four-year grants, the extension centers would be responsible for only 10 percent of costs during the first two years and ONC would pay 90 percent. In the final two years, that ratio would switch...

...However, the Health & Human Services Department found that the cost sharing as originally laid out would be “detrimental to the program” because of the tight economic conditions, according to an announcement in the Jan. 25 Federal Register. Instead, ONC will pay for 90 percent of the costs for the four years of the extension center grants...

A bit of ONC angst regarding potential REC staff CV updating / "brain drain" impetus owing to "sustainability" concerns, perhaps?

Left unreported, though, is that, while they are "doubling" the 90/10 subsidy period (contingently so), they are not doubling the funding. The REC funding remains, for now, as initially allocated. Moreover, I don't know about all of the other RECs, but our SLA (provider contract for Meaningful Use assistance) obligates us only through Stage 1, Year 1 attestation. Stages 2 and 3 criteria are already in tentative draft and slated to be issued in a new IFR later this year. What will providers be expecting of us? Should we hit anywhere close to our recruitment targets, RECs are likely to be buried just trying to successfully assist their client providers with reaching Stage 1 compliance and reimbursement.

Then what?
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ACRONYMANIA:
HIT ALPHABET SOUP


In the Year of Our Lord 1 A.P. ("after paper"), verily, it came to pass that there emerged the earliest MS-DOS based PMS (Practice Management Systems) with their monochrome character-based screens (followed soon by up to 16 bit neat-o color, replete with the arduously coded extended ASCII character set single and double rectangular boxes, borders, and miscellaneous symbols).

[The IBM-AT PC data input screen from one of my late 80's radiation lab QC apps]

First generation clinical PM database apps more or less tolerably handling patient demographics, scheduling, and billing, and programmers soon busily begat the rudimentary "mid-office apps," the "EMRs" (Electronic Medical Record) via which to capture clinical encounter data, apps which were also necessarily subjected to arduous "interface" coding to marry up to the front and back office PM functions, in order to avoid redundant data entry tasks and provide more seamless encounter management.

While a good bit of interface programming still carries on (particularly in complex inpatient settings wherein multiple non-interoperable, department-specific IT platforms reside), today's mainstream outpatient "EHR" (Electronic Health Record) is typically a fully integrated GUI application capable of capturing and reporting back out the gamut of data comprising the interactions of patients, clinical support staffs, providers, and payors. Most broadly construed, "EHR" is often intended to include the "PHR" (Personal Health Record), comprised of either a login-secured online "patient portal" attached to a provider's system, or free-standing commercial online sites where patients may choose to independently repose their medical/health information.

What to do with all of these (now-digital) data "silos"?

Well, HIE, of course. We'll use the HL7-driven CDA to generate CCRs and CCDs (XML documents, to add yet another acronym), all to be pushed out through HIEs (eventually ubiquitously interconnected via the NHIN), all in support of [1] authorized (HIPAA-secured, we are soothingly assured) "anytime / anywhere point-of-care" access to patient health information (including within and across the nascent PCMHs and ACOs), and [2] data mining via which to conduct CER to advance the causes of EBM (and SBM?). Maybe we'll eventually be able to leverage in the results of HIA (not to mention epigenetics research) to complete the picture of improving health care (from the clinical perspective anyway -- which, we are exhorted, will inexorably "bend the cost curve" down from its current economically eviscerating FFS-driven trajectory to a long-overdue P4P paradigm).

All with the indispensable technical assistance of the RECs, IIRC, LOL...
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PCAST on CER

[Click the title graphic above for the full PDF report]

From Chapter VII. "Health Data and the Research Opportunity"

Today, most information about the effectiveness of therapies such as drugs derives from small­scale observations of a handful of patients (often a few hundred, sometimes fewer) in clinical studies. The most convincing clinical studies incorporate design elements, such as randomization of subjects to alternative treatments, to reduce the impact of unmeasured confounders on the treatment effect. These studies are appropriately considered to produce the highest quality evidence regarding a particular agent’s efficacy, but they also suffer from well­recognized problems.

Efficacy, not effectiveness: Clinical research studies usually focus on highly selected and often non­ representative patients. They are designed to detect differences in the main outcome of interest, which means they are often too small to pick up less common but potentially important outcomes (such as serious adverse events) and are too brief to capture fully the long­term consequences of different treatment strategies.

For efficiency’s sake, the studies often exclude patients with complex medical histories or many illnesses. This is problematic in that the treatments are needed by patients with complex illnesses where multiple different conditions make the range of choices greater than the usually simple comparison of a single trial.

Out of date before they are even finished: Today’s clinical research studies are not carried out in real time. Instead, they take years to design, fund, launch, and complete. Sometimes, by the time they are completed the question under investigation is obsolete. For instance, it is quite common for multiple clinical trials in cancer to be occurring simultaneously. New drugs can then be approved that have never been compared with each other, so the physician and patient do not have any way of knowing which is best. They only know that each is better than some other drug that is no longer used.

Burdensome and costly: Today’s clinical research enterprise is, at best, a sidecar loosely tethered to the clinical care enterprise. What is done in clinical research has its own expense structure and funding stream. The oversight of research is separate and apart from the oversight for clinical care. Its partici­ pants—both patients and investigators—are involved in sometimes redundant or repetitive activities. For instance, data often are collected twice for patients in clinical research studies: once for the patient’s chart, and again for the research database.

Narrow focus: Most research focuses on a narrow set of questions regarding therapeutic choices. Yet many important questions in healthcare stretch far beyond the choice between drug A or drug B. For example, healthcare research needs to evaluate operational aspects of the delivery system and evaluate arrays of therapeutic choices side by side. Ideas for new directions for research can and should come from observations about health trends independent of specific hypotheses. [pg 63]

Under "The Potential for Real-Time, Real-World, and Comprehensive Data," the report continues: "Numerous questions that clinical research is poor at addressing today could be answered using large datasets gathered through ongoing medical care, particularly if the data were available in near real time..."

• Syndromic surveillance and public health monitoring
• Adverse event monitoring
• Assessments of dissemination and utilization

and, finally, the Money quote:

Comparative effectiveness research: Perhaps the greatest potential of the data that can be captured using health IT lies in the potential to fuel comparative studies of diagnostic and therapeutic approaches. Comparing treatment and management approaches in a way that can easily be accessed by both physicians and patients could improve patient outcomes and reduce healthcare spending. Funding for comparative effectiveness research is already growing. Electronic health information, in the eas­ ily accessible form enabled by metadata­ tagged data element collection, aggregation, and security standards, would enable this kind of research to advance much more rapidly than with the traditional, institutional EHR model...

...Methodological issues will need to be considered as data from EHRs become available for research studies of increasing sophistication. Practicing physicians are busy, not necessarily trained in research, and not always ideal collectors of patient data for research. Patients, exercising their right to opt in or out of studies, will cause data to be collected from incomplete, or incompletely defined, populations. Effects like these complicate the design and validation of research results. But the availability of data in quantities orders of magnitude larger than today will allow subtle and sophisticated experimental designs, more than compensating, we think, for the data’s complexities... [pp 65-66]

Yes. But I would add that among the methodological issues to be taken into account by the data miners is that of the potential problem of "the large 'N'." Given a large enough sample (or simply "hitting against the universe," as my Starbucks corporate analyst pal Joey puts it), it can be quite easy to demonstrate findings indicating textbook "statistical significance" yet lacking any any substantive (clinically actionable) practical significance. Statisticians equivalently note this as the potential "Standard Error of the Mean Problem." Related to this might also be naivete with respect to the difference between "relative" and "absolute" differential findings.

Another caveat goes to "multicollinearity" among essentially redundant predictor variables in a model, which can spuriously inflate correlation/regression statistics (a result of "overfitting"), particularly given a large sample (or data "universe").

Still, huge near-real time streams of clinical data -- properly vetted and analyzed -- cannot but yield important findings for improvements in care. I'm with the PCAST authors on this point. Our "On The Mend" authors Toussaint and Gerard would surely concur:

Data drives the scientist
Deep within every doctor, a scientist lurks. Trained in data collection and usage, taught to rely on the scientific method, doctors are most comfortable with arguments that include numbers. Unfortunately, the fear of malpractice and damaged reputations has made medical professionals profoundly reluctant to publicly release scores on critical quality markers. That fear must be conquered...

A Lean health care initiative always begins with data collection and dissemination. What date is [sic] collected, and how it is presented, will change over time as an organization's needs and focus changes, but getting and broadcasting the facts is always necessary because data can cause people to change behavior. Doctors are competitive by nature. It is a necessary attribute to getting through medical school and then earning desirable residencies and fellowships. Making data public-–if the date is [sic] honest and relevant-–taps into every doctor's competitive nature. [pp. 105-106]

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GAWANDE STRIKES AGAIN

I could not recommend this article more highly. Wow. Talk about adroitly using data (and advocating persuasively from the bleakest of the trenches -- Camden, NJ -- for the PCMH/ACO concept)!

...[Dr. Jeffrey Brenner] persuaded Camden’s three main hospitals to let him have access to their medical billing records. He transferred the reams of data files onto a desktop computer, spent weeks figuring out how to pull the chaos of information into a searchable database, and then started tabulating the emergency-room visits of victims of serious assault. He created maps showing where the crime victims lived...

...Besides looking at assault patterns, he began studying patterns in the way patients flowed into and out of Camden’s hospitals. “I’d just sit there and play with the data for hours,” he says, and the more he played the more he found. For instance, he ran the data on the locations where ambulances picked up patients with fall injuries, and discovered that a single building in central Camden sent more people to the hospital with serious falls—fifty-seven elderly in two years—than any other in the city, resulting in almost three million dollars in health-care bills. “It was just this amazing window into the health-care delivery system,” he says...

...Brenner wasn’t all that interested in costs; he was more interested in helping people who received bad health care. But in his experience the people with the highest medical costs—the people cycling in and out of the hospital—were usually the people receiving the worst care. “Emergency-room visits and hospital admissions should be considered failures of the health-care system until proven otherwise,” he told me—failures of prevention and of timely, effective care.

If he could find the people whose use of medical care was highest, he figured, he could do something to help them. If he helped them, he would also be lowering their health-care costs. And, if the stats approach to crime was right, targeting those with the highest health-care costs would help lower the entire city’s health-care costs. His calculations revealed that just one per cent of the hundred thousand people who made use of Camden’s medical facilities accounted for thirty per cent of its costs. That’s only a thousand people—about half the size of a typical family physician’s panel of patients...

Cutting to the chase (it's a lengthy piece; read all of it):

...Every country in the world is battling the rising cost of health care. No community anywhere has demonstrably lowered its health-care costs (not just slowed their rate of increase) by improving medical services. They’ve lowered costs only by cutting or rationing them. To many people, the problem of health-care costs is best encapsulated in a basic third-grade lesson: you can’t have it all. You want higher wages, lower taxes, less debt? Then cut health-care services.

People like Jeff Brenner are saying that we can have it all—teachers and health care. To be sure, uncertainties remain. Their small, localized successes have not yet been replicated in large populations. Up to a fourth of their patients face problems of a kind they have avoided tackling so far: catastrophic conditions. These are the patients who are in the top one per cent of costs because they were in a car crash that resulted in a hundred thousand dollars in surgery and intensive-care expenses, or had a cancer requiring seven thousand dollars a week for chemo and radiation. There’s nothing much to be done for those patients, you’d think. Yet they are also victims of poor and disjointed service. Improving the value of the services—rewarding better results per dollar spent—could lead to dramatic innovations in catastrophic care, too.

The new health-reform law—Obamacare—is betting big on the Brenners of the world. It says that we can afford to subsidize insurance for millions, remove the ability of private and public insurers to cut high-cost patients from their rolls, and improve the quality of care. The law authorizes new forms of Medicare and Medicaid payment to encourage the development of “medical homes” and “accountable care organizations”—doctors’ offices and medical systems that get financial benefits for being more accessible to patients, better organized, and accountable for reducing the over-all costs of care. Backers believe that, given this support, innovators like Brenner will transform health care everywhere.

Critics say that it’s a pipe dream—more money down the health-care sinkhole. They could turn out to be right, Brenner told me; a well-organized opposition could scuttle efforts like his. “In the next few years, we’re going to have absolutely irrefutable evidence that there are ways to reduce health-care costs, and they are ‘high touch’ and they are at the level of care,” he said. “We are going to know that, hands down, this is possible.” From that point onward, he said, “it’s a political problem.” The struggle will be to survive the obstruction of lobbies, and the partisan tendency to view success as victory for the other side...

PCMHs, ACOs. Data-driven, "high touch," intensive preventive care (in particular directed at the higher-risk yet chronically underserved strata). Seems like we need not await the expansive empirical deliverance envisioned by the PCAST report. We can in fact act now.

But, formidable countervailing forces continue to campaign against the implementation of reform:

Friday, January 28, 2011
GOP Bill Could Rescind Funding Under Meaningful Use Program

A bill (HR 408) recently introduced in the House could have implications for the meaningful use incentive program and other provisions authorized under the HITECH Act, Health Data Management reports...

...Section 301 of the bill could affect other programs under the HITECH Act, which includes the authorization of:

• Expanding HIPAA transaction sets;
• Health IT programs at colleges and universities;
• Regional extension centers; and
• Strengthened privacy and security rules.

This section states that any unused funds from the act's $2 billion in discretionary spending allocated to the Office of the National Coordinator for Health IT would be rescinded if the funds are considered "un-obligated balances."

The bill also would prohibit appropriating funds to implement any programs under the federal health care reform law...

While this House measure will never prevail in the Senate -- passage by the House notwithstanding (and would certainly be vetoed by the President were it to reach his desk), Senate "poison pill" amendments tied to otherwise "must-pass" appropriations legislation might well effectively achieve the same anti-reform goals. Certainly bears watching.

Moreover, the ACO and PCMH concepts viewed as crucial to sustainably improved care, even should they not be rendered stillborn, will still need to surmount and resolve some core policy questions. As reported in the New England Journal of Medicine recently:

Physicians versus Hospitals as Leaders of Accountable Care Organizations
NEJM | November 10, 2010 | Topics: Accountable Care Organizations, Reform Implementation
Robert Kocher, M.D., and Nikhil R. Sahni, B.S.

Enactment of the Affordable Care Act (ACA) was a historic event. Along with the Recovery Act, the ACA will usher in the most extensive changes in the U.S. health care system since the creation of Medicare and Medicaid. Under this law, the next few years will be a period of what economists call “creative destruction”: our fragmented, fee-for-service health care delivery system will be transformed into a higher-quality, higher-productivity system with strong incentives for efficient, coordinated care.1 Consequently, the actions of physicians and hospitals during this period will determine the structure of the delivery system for many years. The implications will be profound for hospitals’ dominant role in the health care system and for physicians’ income, autonomy, and work environments.

The ACA aims to simultaneously improve the quality of care and reduce costs. Doing so will require focused efforts to improve care for the 10% of patients who account for 64% of all U.S. health care costs.2 Much of this cost derives from high rates of unnecessary hospitalizations and potentially avoidable complications,3 and these, in turn, are partially driven by fee-for-service incentives that fail to adequately reward coordinated care that effectively prevents illness. The ACA includes numerous provisions designed to catalyze transformation of the delivery system, moving it away from fee for service and toward coordinated care...

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YET ANOTHER BRILLIANT CONTRIBUTOR TO THE DIALOGUE


I implore everyone to read his fine "Frameworks for the Future" papers (PDFs). They're free. You just have to register a name and email address to get the download links.

If we don’t pull a rabbit out of a hat real soon now, we’re in serious trouble.

The good news? There is a hat, and it has a rabbit in it. Lots of rabbits.

In my constant survey of the healthcare scene I am seeing a change, a new pattern that grows increasingly solid with passing months. It’s a pattern in which innovative organizations, systems, and physicians, are creating new business models and processes that are already providing better, faster, and cheaper healthcare. They are not just lowering healthcare inflation, a “bending of the cost curve,” but are causing a substantial drop in the cost of healthcare for themselves and the consumer, while increasing their margins.

These innovators, probably your competition, are not waiting. Their momentum is growing. Most important, you can make similar choices where you are...

The first four Frameworks for the Future are available now:

1. Frameworks: A Strategic Survival Kit for Hospitals and Health Systems
2. An Opportunity and Survival Kit for Physicians and Medical Groups
3. A Strategic Healthcare Survival Kit for Employers
4. A Strategic Survival Kit for Health Plans
   
   

Click his logo graphic or title link above. I read my first one today. Came away more inspired than I have been in quite some time. Joe is all over it.

I am optimistic. In almost every healthcare gathering I am the most optimistic person in the room. I am an optimist because I can see a path out of the wilderness in which we are wandering. It is emerging from experiments and pilots all across healthcare. Each of the pieces is tested and has been shown to work. None of it requires any kind of rationing, and little of it requires political action. It is all possible within the system we have.

Great stuff. You owe it to yourselves to check it out in detail. I love this kind of boldness:

Waste
A good rule of thumb in systems thinking says that the solutions inevitably lie in the problems themselves. In the face of all this extraordinary chaos and uncertainty, one factor shows special promise. It is a problem so large that its solution could solve all other problems. That is the problem of waste. Healthcare in the United States is done with such astonishing inefficiency, maldistribution, and waste that it turns out to be an extremely useful question to ask whether we could actually do it better, for everyone, for less money than we now spend— and to ask whether any mechanisms exist (or could be imagined) that would get us there.

We could, in fact, do healthcare for less. How much less? Ten percent less? Twenty percent? Thirty percent? How about 50 percent?

We could do healthcare for half of what it costs today.
We could do healthcare, at markedly higher quality, for everyone in this country, without rationing or denying anybody the care that they need, without having the government dictate how doctors practice or whether hospitals could expand, at half the cost we do it now...

...The remarkable thing about this assertion is that most of the economists, statisticians, and policy experts who most deeply study healthcare in the United States would not find it remarkable at all. They would argue how we got here and how we could get out of it, but the idea that theoretically we could do healthcare for half as much would not be that controversial.

Why would I make such an assertion? Where is the evidence to back it up?

The most obvious evidence is the experience of other countries: All other advanced economies render healthcare to all their citizens for half (at most two thirds) of what we do, whether measured per capita or as a percentage of the national output, and they have better health outcomes. In other words, they get more for less than we do.

In the public conversation, on talk shows and at parties and in online forums, people immediately ask the obvious question: “What are we spending so much more on?” They all have their favorite answers: Malpractice, the profits and overhead of insurance companies and drug companies, greedy doctors, wasteful government bureaucrats, lazy and unhealthy patients, answers that spring from their particular political worldview or their experience. It’s like a Rorschach inkblot test.

But there is a real answer to the question, “What are we spending so much more on?” The real answer is: Everything. A number of careful, thoughtful analyses that compare U.S. healthcare spending to that of other wealthy countries come to the same conclusion: We pay more across the board. We pay more for each drug—and we buy more expensive kinds of drugs, and more of them. We pay our doctors and nurses more, and each of us on average uses them more. We also use our clinicians far less efficiently, with many doctors spending inordinate amount of time on non-productive tasks such as arguing with insurance companies and filling out forms to comply with HIPAA and other measurement regimes. We pay more for inpatient care, and for outpatient care. Administrative expenses for insurance are higher than other countries with private insurance because of our highly fractured system, but even our public program expenses are higher than theirs. We spend far more on public health and prevention (public health departments, community health centers, the FDA and the CDC), research, and medical facilities. Compared to the size of our economy, we spend substantially more on every category of healthcare except long-term care, home care, and durable medical equipment than every other OECD country...

Mr. Flower is also keenly attuned to our exigent and looming circumstances:

Aging patients, aging workforce, rising chronic disease, steeply rising cost: All of these point to a vast and increasing need for some kind of new efficiency and effectiveness in the way we provide healthcare. And that crying need is sharpened by the increasing awareness that we could do healthcare for less—much less...

Such thoughts invariably again drive me back to things like the patient-centered "Lean Model" of care delivery processes such as those proffered by people like Toussaint and Gerard in their fine book 'On The Mend," which I've reviewed in a earlier post. Couple a full-court press focused on driving out care delivery waste with the ever-more-refined knowledge accruing from HIE-enabled comparative effectiveness research, along with a rational restructuring of our current maddening payment perplex (admittedly the most difficult part), well, perhaps there is indeed a case for optimism.

Read all of Joe's stuff to see what you think.
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My Excellent Adventure into the Mecca of Quality

American Society for Quality (ASQ) Healthcare Division Chairman Dr. Joe Fortuna (an enthusiastic REC supporter, it should be noted) invited me (no, emphatically, repeatedly implored me) to come and participate in the 2010 December weekend Strategic Planning Retreat of ASQ's Healthcare Division (HCD) Leadership.

You just can't say "no" to that (I was honored and flattered). So, above, here I am on final approach over Lake Michigan into snow-covered MKE. Below, downtown Milwaukee, the ASQ headquarters building.

Above, "River Walk," right outside HQ and the adjacent hotel. Yeah, it was cold. And got progressively colder across the weekend. By the time I flew out last night, the wind chill was 5 degrees F, with 40+ MPH wind gusts. My plane fishtailed down the runway and then seemed to just jump right up off the ground after only several hundred yards.

"...uh, yes, thanks, I would like a drink. What Scotch do you have? Dewars? That'll be fine. Rocks. Make it a double..."
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Below, a wall of ASQ history.

Above, in the foyer just outside the main conference room, a Deming Red Bead display.

Mecca for us QC/QA/QI types. I, in particular, am hardcore Deming. In addition to internalizing his acclaimed work "Out of the Crisis," I even own and have read "Some Theory of Sampling" (not that I fully grasp all of it).

My wife and I have been loyal ASQ members for more than two decades. We live and breathe this stuff.(BTW, you can click on any of the photos to see the original size shot).

We worked hard the whole time. A packed agenda (all focused on how the ASQ HCD can add tangible value and consequently grow the membership for the Division and ASQ more broadly). On Saturday we went straight through from 8 a.m. to 6 p.m., with a "working lunch" amid the proceedings. Dr. Joe was an active and forceful (and genial) taskmaster.

Everyone I met was utterly impressive, too. Lots of talent in that assemblage. Pretty cool weekend for this lowly REC grunt.
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ASQ REBRANDING INITIATIVE

We had a presentation regarding ASQ's strategic plan, part of which involves the organization's "re-branding" effort. We are to henceforth regard ourselves as "ASQ: The Global Voice of Quality." No more reference to the "American Society for Quality" long the descriptive phrase allusive of the ASQ acronym. It's now an explicity international effort.

ASQ CEO Paul Borawski, who presented to us on the current and upcoming ASQ strategic direction, blogs about ASQ's new path on his "View from the Q" blog.

Here's Paul speaking to the future of "quality" in 2009:

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We also had a nice presentation on the "Socially Responsible Organization" of which ASQ is an integral part.

"The SRO* is a new international movement to share insights and expertise on, and examples of, the evolving area of social responsibility, and to help define what it means to be a socially responsible organization.

"The SRO* aims to explain the business case for social responsibility and the role of quality to achieve results..."

"...ASQ was awarded the administration of the U.S. Technical Advisory Group (TAG) on Social Responsibility by the American National Standards Institute. The U.S. TAG is the U.S. member of an international working group chartered with developing an international standard on social responsibility. ASQ’s involvement is a direct extension of its existing leadership role in standards development."

"The social responsibility guidelines will be released in mid- to late 2010 as ISO 26000. The ISO 26000 guidelines will cover seven core areas:

• organizational governance
• human rights
• labor practices
• fair operating practices
• environment
• consumer issues
• contribution to the community and society..."

I signed up to participate. We'll see what ensues.
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THE ASQ MEANINGFUL USE / BALDRIGE
SELF-ASSESSMENT CROSSWALK APP

This was a very interesting demo presentation of a web app built by ASQ wherein clinical providers can sign up, enter data, and receive continually updating dashboard status feedback regarding their readiness for both ARRA / HITECH Meaningful Use and Baldrige criteria. This was to have been presented to ONC brass in DC the week following our conference, and, as soon as I learn of the upshot, I will report on it.
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First, Do No "Hold Harmless"

I read a very interesting post the other day, "The Fine Print," written by one of my favorite heath care blogging colleagues, Margalit Gur-Arie, regarding the

"alleged contracting practices of EHR vendors and their notorious “hold harmless” clauses, which indemnify the EHR vendor from all liability due to software defects, including liability for personal injury and death of patients. What this means in plain English is that if a software “bug” or incompetency caused an adverse event, and if you (or your hospital) are faced with a malpractice suit, the EHR vendor cannot be named a co-defendant in that suit and you cannot turn around and bring suit against the vendor for failure to deliver a properly functioning product."

"The AMIA paper also asserts the existence of contractual terms preventing users and purchasers from publicly reporting, or even mentioning, software defects, including ones that may endanger patient safety..."

Wow. Assertions of blanket indemnity, coupled with a "gag order"? Is this something regarding which our REC provider clients be made aware during EHR vendor selection and contract negotiation? (Beyond things such as practice "data ownership" and -- relatedly -- EHR "source code escrow"?) How substantive is the liability concern?

The grist for this post was the recent publication of an American Medical Informatics Association (AMIA) Board Position Paper entitled "Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force." (PDF)

"...Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards..."

One commenter made this observation on Margalit's post:

"I'm still waiting to see an installation of any EMR be fully tested by either the vendor or the organization who purchased it."

Indeed.

All of which set me to reflecting on my first professional technical paper, written in 1988 during my tenure as an environmental radiation lab programmer and quality control analyst.

While those days were a time prior to indoor plumbing in IT terms, some of the points still resonate. As I began the paper:

"... [vendor] makes no representations or warranties with respect to the content hereof, and specifically disclaims any implied warranties or merchantability or fitness for any particular purpose for both this manual and the product it describes. Furthermore, [vendor] reserves the right to revise this publication and make changes in the content hereof without obligation to notify any person of any such revision or changes..."

"In less than a decade, microcomputers and software applications have become ubiquitous, indispensable tools in business, industry, and the sciences. The end-user faces a bewildering array of options with respect to makes, models, peripherals, and software compilers, libraries, firmware, and applications packages. since the foregoing disclaimer may be found in the product documentation of virtually every commercial microcomputer hardware and software vendor, the end-user must blend the array of options, possible algorithmic deficiences, and system incompatibilities into a comprehensive product. The user assumes -- usually unwittingly -- the cumulative responsibility for assuring a quality output..."

Twenty three years later, the core liability concerns remain. And, still, the "user assumes -- usually unwittingly -- the cumulative responsibility for assuring a quality output."

The lab wherein I worked did a signification volume of "forensic-level" analysis, i.e., much of our output was destined for use as evidence in radiation contamination and dose-exposure liability litigation. Consequently, we turned over every rock, pebble, and grain of sand in search of conditions inimical to legally-defensible data "quality." Our Technical Director in particular, Dr. James Dillard (my mentor on this and other projects), had amonished us to never take computer-generated results at face value. He was fond of saying "you get what you INspect, not what you EXpect." As I note on my website preface citing and linking my paper:

You enter some numerical data into a computer and get some results back out. Do you simply assume they are "accurate" and report them to the client? Not in our lab. For example, even assuming your data and formula/function entries into a spreadsheet are correct, does it thereby necessarily invariably follow that the calculated results will be so?

And so it came to be express policy (reflected in our "IT/ORL Software Quality Assurance SOP" I had a hand in writing) that we thoroughly test every software application -- in-house developed and commercial (off-the-shelf and 3rd-party custom-developed alike) -- and every computer wherein they would be installed for use in generating client-reportable results.

Complex as all of that was, those were the bucolic ancien days of relative computing simplicity. Today's hyper-connected, mobile world of 24/7 exponentially increasing digital apps and platforms -- from the client-server to the "Cloud" -- presents a potential host of new challenges.

Given the considerable complexities comprising Health Information Technology (very little of which go to actual mathematical computing, it should be noted), these challenges are already within the crosshairs of the Medical Liability people. Recall, again, my prior citation of the Brouillard article.


Brouillard concludes:

"Although EHRs have now achieved mainstream, clinical adoption, EHR-related liability trends have not developed fully. At this early point, we can discern some potential liability areas. In an early EHR implementation stage, source of truth issues and expansion of liability issues may arise. In using EHR systems, the evolving standards of care for clinical documentation and work-arounds pose risks. Security as mandated by data breach laws or retention and storage issues involving e-discovery liability and data integrity have also emerged as important areas."

Consequently, it is rather unsurprising that Counsel for EHR vendors would insist on boilerplate blanket "Hold Harmless" beg-offs. I rather doubt such stipulations would survive the first serious court test, given a case (assuming a jury trial) wherein a patient was harmed as a result of a documentable software flaw that prevented a provider from being made aware of an exigent patient circumstance (or induced a provider to take injurious action she would otherwise have not absent the software flaw). Moreover, I am with AMIA on this point:

"f. “Hold harmless” clauses in contracts between Electronic Health Application vendors and purchasers or clinical users, if and when they absolve the vendors of responsibility for errors or defects in their software, are unethical." [pg 3]

Indeed.

To be fair, one principal reason for attempts at fine print "hold harmless" inoculation goes to the civil litigation reality of "Joint and Several Liability" -

Joint and several liability is a form of liability that is used in civil cases where two or more people are found liable for damages. The winning plaintiff in such a case may collect the entire judgment from any one of the parties, or from any and all of the parties in various amounts until the judgment is paid in full. In other words, if any of the defendants do not have enough money or assets to pay an equal share of the award, the other defendants must make up the difference.

e.g., if you are found to be perhaps only, say, one percent "liable" (exacerbated by the fact that civil liability is determined by subjective "more-likely-than-not" "preponderance" criteria), but your relatively deep pockets finds you with 100% of the attachable assets via which to satisfy a judgment, well...

So, what're really perhaps at play here are the relative deep pockets of EHR vendors vis a vis the materially shallower ones of individual potential defendant physicians.

UPDATE:
TIMELY TOPICAL NOTES FROM THE NEW ENGLAND JOURNAL

"Medical errors and adverse events may result from individual mistakes in using EHRs (e.g., incorrectly entering information into the electronic record) or system-wide EHR failures or “bugs” that create problems in care processes (e.g., “crashes” that prevent access to crucial information)." [pg 2061]

'...as the use of EHRs grows, failure to adopt an EHR system may constitute a deviation from the standard of care. The standard of care is usually defined by reference to what is customary among physicians in the same specialty in similar settings. Once a critical mass of providers adopts EHRs, others may need to follow..." [pg 2065]
Medical Malpractice Liability in the Age of Electronic Health Records Sandeep S. Mangalmurti, M.D., J.D., Lindsey Murtagh, J.D., M.P.H., and Michelle M. Mello, J.D., Ph.D. n engl j med 363;21 nejm.org November 18, 2010

So, given that the ever-wider-spread deployment of HIT is seemingly inevitable (and, a prospect which I obviously support), what are the some of the truly salient liability risk concerns?

• EHR "Usability" issues (PDF) that might contribute to inadequately "idiot-trapped" data input errors (including mistakes and omissions);
• Code logic flaws that could lead to exigent "alerts" missed (or, conversely, irritating recurrent "false positive" alerts that precipitate user cynicism and apathy);
• Relatedly, "clinical decision support" logic flaws (or simple inadequacies);
• More general code flaws resulting in "crash" prone systems, leaving clinicians potentially in the lurch during time-sensitive points of care;
• OS and other incompatibilities (including adverse interactions with other resident apps);
  
• Math errors.

As I've previously noted, EHRs typically do very little outright math of any appreciable sophistication, so I put that last on the list (though that may indeed a bit change over time -- apps going beyond, e.g., simply doing BMI arithmetic, lab value averages, and growth chart plotting, etc). The typical EHR (at least of the ambulatory variety) is really just usually a Java or C++ (or otherwise ".net") coded GUI front end app sitting atop and hooking into a relatively complex RDBMS (typically a multi-table SQL relational database these days), one whose principal purpose is to record and then re-display (either onscreen or in print) the myriad requisite subsets of administrative and clinical data as efficiently as possible (ideally).

Nonetheless, the systems are indeed extremely transactionally complex, and, absent thorough and consistent QA (including industry consensus stds? FDA oversight?), they could be vulnerable to a host of "gremlins," the upshot of which could range from the merely exasperating-to-the-workflow to the punitive "joint-and-several liability" class-action judgment in the wake of patient harms.

I have to note yet again that ONC-ATCB EHR "certification" for Meaningful Use has to do exclusively with an application's ability to reliably record and regurgitate the MU measures, in a HIPAA-compliant manner. Nothing more. Nothing pertaining to application "quality" more broadly (and in the more truly "meaningful" sense of efficient, "usable" functionality).

I will be watching the developing law here with interest. I would also exhort all vendors and users alike to think long and hard proactively about the considerable breadth of EHR "software quality" issues.

FYI:
A NEW ANTI "HOLD HARMLESS" WEBSITE

"Physicians and other healthcare providers are increasingly relying on EHR systems for the practice of medicine. As the number of EHR system providers increases and as these systems integrate with other systems to import and exchange data, it is important to track and understand issues of concern as they develop. This will, in-turn, allow for improvement in EHRs, in patient safety, and may result in liability reduction..."

Interesting: www.ehrevent.org
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DEC 7th UPDATE

I was sifting through papers in my office today, and ran back across this law journal article I'd read a while back (PDF) and had given the thorough yellow highlighter treatment.

I should have cited this by now. Just slipped my attention. It antedates both the Brouillard and NEJM pieces. It's the first place wherein I ran across a call for FDA (or some federal entity) regulation of EHRs.

...the novel and significant risks generated by EHR systems cannot be ignored. Products with poor information display and navigation can impede rather than facilitate providers’ work. The growing capabilities of EHR systems require increasingly complex software, which heightens the danger of software failures that may harm patients...

...Thus far, the legal literature has not assessed the need for careful regulatory oversight of EHR systems akin to that required, in principle, by the Food and Drug Administration (“FDA”) for life-critical medical devices. This Article begins to fill that gap. It analyzes EHR systems from both legal and technical perspectives and examines how law can serve as a tool to promote HIT. Extensive regulations already exist to govern the privacy and security of electronic health information. Privacy and security, however, are only two of the concerns that merit regulatory attention. Perhaps even more important are the safety and efficacy of these life-critical systems. [pp. 106-107]

A good read. And, in light of the more recent news of EHR vendor "Hold Harmless" attempts, this observation near the end of the monograph is interesting:

...the threat of product liability or medical malpractice litigation could deter misconduct by both EHR system vendors and health care providers. Plaintiffs may sue providers if they suspect that they suffered poor outcomes because providers failed to implement or properly use EHR systems, for example, by neglecting to utilize decision-support features that may have averted a medical mistake. Likewise, plaintiffs might name EHR system vendors as defendants if they believe the harm is rooted at least partly in a design flaw, and health care providers might bring in vendors as third party defendants if they believe the vendors to be partially at fault. Audit logs and capture/replay would be helpful to all parties in investigating and proving their claims concerning system failures and provider negligence or lack thereof. [pg 161]

Do no "Hold Harmless."
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November 2010 updates

FIRST, A SERENDIPITOUS PRODUCT DURABILITY REPORT

The Ingenix 2 gig USB flash drive is apparently machine-washable. Tumble dry, medium heat. LOL. I can't believe I did that. Found it in my cargo jeans pocket after the dryer stopped. Didn't lose a single file. Wow. (It was a freebie I got a while back at some HIT marketing event; has an Ingenix "CareTracker" demo on it. This is not to compromise my REC "vendor neutrality," BTW.)
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REC "PPCP" RECRUITING TO DATE

No one at ONC really wants to talk about it for the public record these days (nor even much privately). One number that wafted my way recently was ~17,000 sign-ups nationally to date. "PPCP" means "Priority Primary Care Providers," who can get federally subsidized REC soup-to-nuts consulting/facilitation services during the first two years of the HITECH program. Eight months in, then, this means that REC "enrollment" (which is optional, recall) is running only about 50% of target-to-date in the aggregate, in light of the national goal to bring 100,000 primary care providers "meaningfully" on board within two years.

REC provider recruitment barriers persist, obviously - to wit,

• EHR cost and concomitant ROI dubiety (given productivity loss and "everyone-benefits-except-me" concerns);
• Skepticism that the Meaningful Use reimbursement money will actually be forthcoming (particularly in the wake of the 2010 mid-term election outcomes -- with Republicans now loudly vowing to de-fund everything associated with "ObamaCare");
• Specific physician anxiety and anger regarding the yet-again pending draconian Medicare reimbursement cuts;

For example: "Unless Congress acts, physicians are just weeks away from taking a 23% cut in Medicare reimbursements mandated by the sustainable growth rate (SGR) formula. The cut is scheduled to go into effect on Dec. 1 and will be followed on Jan. 1 with an additional cut, bringing the total to 25%."

• Medicaid provider participation remains an acute concern. Some states (including my own) are considering dropping out of the Medicaid program, in light of rapidly increasing patient enrollment (owing to our record high and seemingly intractable unemployment rate) concomitant with reductions in provider reimbursements during a difficult time of state budget deficits. Even should this not happen, their participation in the HITECH Meaningful Use program is voluntary, and not fully federally funded (states have to submit a "plan" to the feds, and come up with an unfunded 10% of "reasonable administrative expenses");
• More broadly, antipathy toward anything related to the motives of "the government," one being the allegation that this is all about the feds wanting to be able to easily gather all of our medical information in order to dictate [1] what treatments we can obtain (and how doctors must perform them) and [2] what we can eat (Michelle Obama's menacing BMI Violator Celery Stick Police);
• Vendor, VAR, and commercial consultant assertions that "you don't need REC help, we'll get you to MU" (owing to that many of us have to charge subscription, hourly, or back-end fees, given that the HITECH subsidy is not 100% and is incrementally "milestone" based);
• General resistance-to-change inertia. As my mentor Dr. Brent James was fond of saying, "the only person who enjoys change is a baby with a wet diaper."

etc. It's all getting a lot of news coverage these days, pro and con.

"...Noting that the private sector has not been able to develop and adopt methods for significantly improving health outcomes in the U.S., [Paul Tang, MD] called recent federal legislation "transformative" by providing the goals, timetables, and financial incentives necessary to achieve desired change. "All the necessary forces are aligned," he said.


The Affordable Care Act (ACA), and the American Recovery and Reinvestment Act (ARRA) of 2009 share many of the same requirements for achieving and documenting cost and quality of care criteria, said Tang, and both will depend on the "meaningful use" of certified EHRs targeted by ARRA for widespread use by 2014. Meaningful use requirements address key health goals, including improved quality, safety and efficiency; engaging patients and their families; improving care coordination; improving population and public health; and ensuring privacy and security protections.


Tang was a keynote speaker at the MedeAnalytics Clinical Leadership Summit held Nov. 11-12 at the Fairmont Hotel in San Francisco."

Notwithstanding the truth of the foregoing assertions, I detect increasing wafts of circle-the-wagons angst, given that The Tea Party Cometh soon to the halls of Congress. While some feel that HITECH and the RECs will be safe from the 2011 legislative truncheon, I am not so sure.

HIT (and REC assistance) continues to be a tough sell, at least from my perspective in Nevada (but, in fairness, my state is the fiscal basket case of the nation; highest unemployment rate, highest mortgage foreclosure rate; 80% of non-foreclosed residential mortgages "under water," largest state budget deficit in the nation, proportionally, etc. A swell place to live these days).

I had a bit of irascible Photoshop commentary fun with this entire "recruitment" notion early on.

Whatever. They ostensibly re-hired me for the Meaningful Use Adoption Support "technical assistance"/QI effort, upon which I really want to focus my energy in lieu of all this "sales rep" stuff.
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OUR CORE ADOPTION SUPPORT M.O.


The minimal essence I fought hard internally to establish. It was not universally loved within my REC team, having been deemed in some incumbent quarters too "old school / industrial." Right. Click the image to enlarge.

Rather simple, conceptually (props to my QA Guru wife for giving me her SOP template to use). My argument (which prevailed in the end) was that, should we manage nothing else beyond getting our client providers to Stage One Meaningful Use compliance, we would have met both our ONC and client-contractual obligations. Simply a matter of exigent priority, i.e.,

1. Document and visualize the workflow components for each Meaningful Use criterion, as dictated by each EHR platform;
2. Write it all up in a "Standard Operating Procedure" (SOP*) for client distribution;
3. Include in the SOPs the sets of "screen shots" (where relevant) that can navigate any authorized users to the target MU "money fields" (where the data have to be consistently recorded).

[* We tend to soft-pedal to a degree the "SOP" thing, using the "softer" phrase "Standard Work" that is part of the "Lean Methodology" lexicon. "SOPs" conjure up MEGO inducing images of dull ring binder "Policies and Procedures Manuals" that typically sit on shelves unopened once written.]
As I have stated before, I would favor laying this sort of thing off on the EHR vendors (given that they know their products -- specifically the MU documentation navigation paths within their respective systems, and that such are -- implicitly, anyway -- part of ONC Certification), leaving RECs the time to concentrate on actual "process improvement" via which to make the entire effort a bottom line winner for the providers.

In fact, were I setting ONC EHR Cert policy, I would have made such explicit instructions part of certification requirements. Perhaps once "permanent certification Registrar" requirements are set forth, such will be the case. I will certainly lobby for it. But, I won't be holding my breath.

EHR WORKFLOW,
TASK TIME-TO-COMPLETION CONCERNS

You might recall my earlier blog post reflections regarding how Meaningful Use compliance could easily consume so much additional FTE labor cost as to negate the incentive reimbursements. "Use" case in point, from a study I found posted on our HITRC (again, click the image to enlarge).


I'm just too sorry: THIRTY FIVE seconds to document a CPOE lab order (in the VistA EHR)? OK, annualize that, extrapolating from a couple of dozen patients per day. It's not viable. As I've pointed out elsewhere on this blog, just adding an aggregate additional couple of minutes labor per chart documenting all the Meaningful Use criteria will serve to nullify the reimbursement payments. Hence my personal imperative of trying to inculcate "Lean" principles within my client clinics as I work with them in order to find ways to decrement the workflow FTE burden overall in support of effective HIT adoption.
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RE: "LEAN HEALTH CARE" AN UNSOLICITED SHOUT-OUT

Nice resource. Click the image to visit their site.

MY ONE-PAGE SUMMARY TAKE ON "WORKFLOW"

Click the image to enlarge.

SOME THOUGHTS ON "LEAN TRANSFORMATION"

Returning for a moment to the excellent book "On The Mend."

"Lean transformation is all about Dr. Deming’s Plan Do Study Act (PDSA), otherwise known as the scientific method. There is no simple formula to copy and no quick path to success. Instead you must perform your own experiments— tailored to the mission and circumstances of your organization. And then you must honestly study the results and act on your findings, including sharing them with the healthcare community.

Yeah, "PDSA." All the rage in progressive process QI circles for quite some time now (and, color me a believer, as I stated early on).



I would revise to acronym, however, to "SPDSA," i.e., "STUDY, Plan-Do-Study-Act." At the risk of belaboring a point that may be implicit in the minds of most people involved in this work (i.e, that initial quantitative baseline assessment "study" is reflexively included in the "Plan" phase if it's truly "scientific"), I never lose sight of the source, the late Dr. Deming himself:

"Statistical control. A stable process, one with no indication of a special cause of variation, is said to be, following Shewhart, in statistical control, or stable. It is a random process. Its behavior in the near future is predictable. Of course, some unforeseen jolt may come along and knock the process out of statistical control. A system that is in statistical control has a definable identity and a definable capability (see the section "Capability of the process," infra).


In the state of statistical control, all special causes so far detected have been removed. The remaining variation must be left to chance -- that is, to common causes -- unless a new special cause turns up and is removed. This does not mean do nothing in the state of statistical control; it means do not take action on the remaining ups and downs, as to do so would create additional variation and more trouble (see the section on overadjustment, below). The next step is to improve the process, with never-ending effort (Point 5 of the 14 points). Improvement of the process can be pushed effectively, once statistical is achieved and maintained (so stated by Joseph M. Juran many years ago)."

["Out of the Crisis," Ch 11, page 321]

In Deming's view, attempting to "improve" processes that are empirically unstable constitutes what he called "tampering," interventions that typically only serve to make matters worse.

A quick example from my own environmental lab "SPC" experience more than 20 years ago (before indoor plumbing, in IT terms). One of my projects (PDF) involved the development of a computerized system via which to track the accuracy, precision, and stability of the lab's numerous multi-channel radiation detector instruments.



QC personnel ran and recorded daily "sealed source" and "background" checks for every detector, along with QC specimens known as "matrix spikes," "D.I. water spikes," "matrix blanks," "matrix dupes," etc (we were also subject to "blind" QC samples submitted by clients and regulators, posing as production samples). My software calculated the requisite statistics every day (e.g., mean response, std deviation/"coefficient of variation," upper and lower "warning" and "control limits," and linear regression trend slope), updating them with each new data point (through the first 20 entries, that is). Statistical "outliers" would then be readily apparent, and any out-of-calibration "drift" would become apparent via the fitted "slope." In the foregoing example, the detector looks to be "stable," evincing a random daily variablity of about 1% of the average.

Below, same chart, annotated to call attention to a couple of early potential "mini-trends." Across the initial 20 or data entries, it appeared that the detector might be trending sharply down, and, shortly thereafter, after the "dive" had abated, there was a downward "run" of six consecutive entries (the red oval).



Given that our lab hewed to "forensic standards," owing to the fact that much of our work was destined for use as evidence in contamination/dose exposure litigation, we tended to be hyper-vigilant when it came to QC. Nonetheless, textbook "applied process control statistics" can't do your thinking for you. Should detector LB5100/TA/002 have been taken offline for intervention after the first 20 accrued data points? Or, in the wake of a subsequent negative "run" of six daily results? Obviously, our lab's Technical Director didn't think so, and the overall plot tended to back his sanguinity.** No SPC "outliers" and about a 1% or less daily average variation across nearly three months; what's not to love? (LOL, such was not always the case.)

** In this case, you bring to bear contextual expert judgment. Like an aircraft pilot cross-referencing her instrument panel under IFR conditions for accurate and safe flight absent the ability to see outside the cockpit, our lab manager would take into account not only the daily sealed-source detector disintegration "counts," but also the correlative results of routine bench-chem derived lab QC samples (the breadth of spikes and dupes inserted into the production stream). Morever, expert judgment also informs that, given the stochastic nature of radionuclide decay eminations (all of them half-life "decay-corrected" in our system btw), were you to re-run sealed sources multiple times per day (not practical), you would still see random intra-day variation.

Statistical estimates are tools. They don't properly replace domain knowledge and experience. (Moreover, just because Excel now enables you to effortlessly fit an "nth-degree" polynomial to a scatter of a handful of data points -- replete with a nicely displayed equation and impressive R-Squared stat -- doesn't mean you should.)

Those were fun times. And, I have tried to internalize all of the "lessons learned," foremost among them that, should you fail to discover (or you otherwise ignore) knowable "special causes" impacting a process and rectify them, your efforts at "improvement" way well be counterproductive.

But, as I now begin to actually work with my small outpatient primary care clinics doing "workflow analysis and re-design," though, I know I'm not even going to get close to such a level of rigorous statistical process analysis. Most of our workflow assessments are necessarily bound to be mostly "qualitative" (and MU compliance driven, at least across the Stage One period).

I guess we'll just take our "wins" where we can get them. Still, I remain drawn to true PDSA "lean" process improvement principles and procedures, e.g., as set forth by leading organizations such as the Thedacare Center for Healthcare Value:

"The A3 method assures that the PDSA cycle is followed and the changes are monitored. The process steps can be documented in a variety of formats, but it typically includes the following elements, on a single piece of paper. A3 refers to the standardized paper size of 11” x 17”.

1. Title – Names the problem, issue, or topic
2. Owner/Date – Identifies who owns the problem or issue and the date of the latest revision
3. Background – Why is this important? What background information is important? What have we seen in gemba?
4. Current Conditions – Show the current state using pictures, graphs, data, etc. What is the problem?
5. Goals/Targets – What results do you expect? What are the key measures? (quality, cost, morale, delivery, access, etc.)
6. Analysis – What is the root cause(s) of the problem? If you work to eliminate this root cause, will you make progress toward solving the problem?
7. Countermeasures – What proposed actions do you intend to take to reach the target condition? How will you show how your countermeasure will address the root causes of the problem? What is the new standard process?
8. Implementation – What needs to be done? Who will do it? By when? What are the performance indicators to show progress? How will people be trained in the new process?
9. Follow Up – What issues can be anticipated? How will you capture and share learning? How will you continuously improve or begin the cycle again (PDSA)?"

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MORE ON CLINICAL "SCIENCE"

One place I wherein routinely hang out.


These people are hardcore. (I have to admit to some episodic "scientism" wariness when reading some of their content). Among other topics, there's an ongoing debate at SBM regarding the epistemological and utilitarian differences (if any) between "EBM" (Evidence-Based Medicine) and "SBM" (Science-Based Medicine). As we ponder expanded "CER" (Comparative Effectiveness Research) as envisioned to be facilitated by ever more widespread HIT adoption, I would expect to see some heated debate at SBM on the subject (CER is already much unloved in other curmudgeonly clinical circles).
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BTW: ONC now has a blog.


Worth visiting and perusing.

QUICK UPDATE:
ANOTHER NICE RESOURCE I JUST FOUND AND JOINED

www.ReachMD.com

Very nice topical podcasts. Two thumbs up.
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