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Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments

There has recently been much debate about how to save this country from European-style financial ruin. From "GOP 2012 budget proposal cuts taxes on rich, cuts Medicare in the future", Examiner.com, April 3, 2011:

On Tuesday House Budget Committee Chairman Paul Ryan (R-WI) is expected to release the Republicans’ 2012 budget proposal. Currently Democratic and Republican leaders are trying to negotiate a compromise on the 2011 budget would make some cuts to discretionary spending. Republicans have said they would not be able to propose really significant cuts to lower the deficit until 2012. According to reports, the GOP proposal would dramatically cut taxes on corporations and the rich, while also making significant cuts to Medicare and Medicaid.

I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor,
be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed.

Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011.

At my Jan. 2011 post "US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives:

In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (link - PDF), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009":

... Spending Reduction Act of 2011

DIVISION A—APPROPRIATIONS PROVISIONS

...
TITLE XIII—HEALTH INFORMATION TECHNOLOGY

Title XIII of the ARRA along with title IV of division B is better known as
HITECH:

SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE.

(a) SHORT TITLE.—This title (and title IV of division B) may be cited as the
‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.

I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block.

Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "An Updated Reading List on Health IT" at my Drexel Univ. Healthcare IT failures site).

This recent revelation should also be considered:

The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (link) are child's play compared to the following.

The unprecedented, recent, detailed analysis of a major American electronic health record system
for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See:


If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers.

Or perhaps coffins.

I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH:

  • This country cannot afford HITECH at this time. Put simply, we are broke, and the national deficit is ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford that care.
  • HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "Draft Patient Rights Statement and Informed Consent on Use of HIT"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of poorly usable technology.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.
  • Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. In fact, the evidence might actually point in the negative direction. See my aforementioned post "An Updated Reading List on Health IT."
  • The technology is not ready. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an IT backwater). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is at this link.

To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision:

  • A similar experiment in the much smaller and strongly government-managed healthcare system of the UK didn't exactly have stellar results (link, link). We also have been warned not to make the same multi-billion dollar errors (link).
  • The cavalier attitudes by the administration-appointed ONC director Blumenthal towards evidence of health IT-caused adverse effects, including deaths, reported to him by the FDA (see this Feb. 23, 2010 Internal FDA Memorandum on Health IT Safety Issues, PDF).

Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician
and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight, that FDA's reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

These exact cavalier attitudes about "anecdotes" just failed in the Supreme Court. (See my Mar. 27, 2011 post about the Zicam decision in "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style").

More reasons for diverting HITECH funds to patient care include
government waste driven by irrational exuberance and idealism:

  • More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" in the agency's 2007 report on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view.

Finally, here's another reason to withdraw HITECH for now:

  • As I'd written in a series of essays at this blog query link, we simply don't know how to make computerized medical information reasonably private and secure. (One might wonder whether the current administration, sponsors of the out-of-the-blue HITECH act, actually wants healthcare information to be private and secure.)

I reiterate from my January 2011 post:

I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an
unrushed and careful experiment.

It would also give time to work out the significant issues causing health IT difficulty (such as raised in 2009 by our National Research Council) before we embark on national health IT diffusion.

In other words, its passing would reduce risk and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on delirium.


We would avoid the largest unconsented medical experiment in US history
, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.)

Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary."

A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed.

-- SS

The Future Pathways for e-Health in NSW

Prof. Patrick has now added a new section to his report on health IT in NSW Australia, entitled "The Future Pathways for e-Health in NSW." It is available at this link (PDF).

It inoculates against most of the 'Ten Plagues' that bedevil health IT projects (such as the IT-clinical leadership inversion, lack of transparency, suppression of defects reporting, magical thinking about the technology, and lack of accountability of the bureaucrats).

Emphases mine:

In Short Term ( 0-3 months)

1. Halt further rollouts of Firstnet or other CIS systems. The current roll-out programs use significant efforts in training staff for a system that is counterproductive to patient well being.
2. Complete a full and thorough risk assessment analysis and usability of the software. The CIS report indicates there are a number of risks in the current software that are not likely to have been assessed in the past.
3. Address the current problems before doing anything else. There are a number of problems that appear solvable in the short term that would improve the situation for current users, such as providing needed reports.
4. Create the NSW IT Improvement Panel composed of ED Directors, IT-savvy clinical and quality improvement staff responsible for advising on the preparedness and process of the rollout.
5. Create an effective error and bug reporting mechanism that is viewable by all ED directors and with the display of the priority of each entry and expected completion time.
6. Initiate a high profile campaign to encourage staff to lodge fault records on anything they discover wrong, problematic or inefficient in using the system.

In the longer term (3-12 months)

1. Review the Health Support Services and make it clinically accountable by appointing a clinical head with an IT education.
2. Create a culture change in the HSS. The current operation of the HSS seems to be devoid of influence from the clinical community.
3. All NSW CIS system procurement should be guided by an IT Advisory Board of IT experienced clinical, academic and medical software industry experts.
4. Create pathways for hospitals that wish to be early adopters and take a lead role in the development of new methods for using and deploying IT systems.
5. Support innovation within the Australian medical software communities that contribute to a culture of innovation and continuous quality improvement.
6. Adopt transparency rules in all new healthcare information acquisitions. Secrecy has bedevilled the efforts of staff and management to get improvements in the CIS systems and hold service agents accountable for their failure to comply to service level agreements. All agreements about a signed contract should be available to the ED Directors.
7. Replace the State Based Build policy with a policy of providing a technology to match the technology experience of the individual departments so that leaders are not dragged backwards with inappropriate technology installation

The de facto "National Program for IT in the HHS" here in the United States needs a similar inoculation.

I can only add that our own ONC office (Office of the National Coordinator for Health IT of the Dept. of HHS) had more granular recommendations about expertise levels required for leadership roles in such undertakings. I wrote about them at my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

--SS

Dr. Scott Monteith on "The Best Compromise" on Physicians and Use of Troublesome Health IT

I have posted two guest posts by Dr. Scott Monteith, a psychiatrist/informaticist, at the Jan. 2011 post "Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith" and the Dec. 2010 post "Meaningful Use and the Devil in the Details: A Reader's View".

Here is another, with his permission. He is responding to a talking point from a health IT commentary website that was distributed among the AMIA evaluations special interest group readership.

Dr. Monteith asks some very probing questions. He writes:

I would like to respond to what I see as being one of the most important and challenging “real-life” issues confronting clinicians, and is captured in this excerpt [below, from the multi-vendor sponsored site HISTalk - ed.]:

HisTALK: ... Somewhere between “we vendors are doing the best we can given a fiercely competitive market, economic realities, and slow and often illogical provide procurement processes that don’t reflect what those providers claim they really want” and “we armchair quarterbacks critics think vendors are evil and the answer is free, open source applications written by non-experts willing to work for free under the direct supervision of the FDA” is the best compromise.

That is, this excerpt performs the helpful task of framing “the best compromise” somewhere between two extreme viewpoints.

It would be helpful (at least for me) if this group could discuss what “the best compromise” actually ‘looks like’ in practice. How does one actually understand and live within “the best compromise”?

Let’s start with a relatively simple scenario:

What should clinicians do when they are working with EHRs that have known “problems” that are putting patients at risk, and the problems are not being immediately addressed, either directly or indirectly through, for example, an acceptable “work around,” or other adjustments to the EHR or local business processes?

Should the clinician continue to use the EHR and…

  • assume that others (e.g., vendor, IT department, administration, etc.) will fix the problem(s)?
  • report the problem(s)? Once? Twice? Three or more times? (How many?) To whom?
  • inform the patient of the known problem(s) (if the problem(s) apply to the patient)?
  • inform the patient that we do not have a good understanding of how to balance or even understand the risks posed by the EHR, given the dearth of peer-reviewed literature and algorithms? (What is “acceptable risk” for a given EHR problem? Does the EHR-related problem’s risk/benefit analysis change if the patient is in the hospital for a simple, nonlife-threatening problem vs. a complex, life-threatening problem)?
  • give the patient the option to NOT use the EHR? (Note that we almost always give patients the choice to refuse other “risky ventures” such as diagnostic procedures and treatments.)
  • inform their medical malpractice insurance company of the EHR-related problems?
  • submit the problem(s) to the organization’s ethics committee, if there is one?
  • report the problem(s) to the organization’s risk management staff?
  • report the problem(s) in writing or verbally?
  • stop using the EHR?

Etc. (including some combination of things).

Can providers (especially physicians) legitimately rationalize, given our ethical (to patients and our colleagues) and legal obligations (to patients and the state where we are licensed), the use of tools that are posing risks to patients and providers, when those risks are not spelled-out, not well understood, not peer-reviewed, etc.?

(Obviously everything we do has risks, but we are obligated to revel and discuss those risks as noted above. Further, the risks/benefits of a given diagnostic or treatment intervention are the product of peer-reviewed algorithms. Are patient’s aware of the risks associated with their doctor’s or hospital’s EHR?)

Again, the above excerpt suggests that there is a “ best compromise.” But what is/are “the best compromise(s)”?

I joke with friends that I am a “radical moderate” – that is, I usually find myself committed to the “middle ground” in most complex and thoughtful discussions. But when it comes to EHRs, I am finding it difficult to define or understand what a “moderate” or an acceptable “best compromise” looks like.

Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach really the “best compromise,” especially in light of our ethical and legal obligations?

I am anxious to hear what other people think about this matter. I am sincerely seeking help in better understanding a sensible, real-life “best compromise” for those of us in the trenches.

Note that if we cannot define “the best compromise,” then what does that say about us? How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?

My own pithy, initial responses are as follows:

Re: Given the current EHR exuberance driven by ONC’s incentive dollars and vendor profits (or hoped-for profits), we all know that the “politically correct” approach is to “go along” and be an “early adopter” (without too many protests). But is the politically correct approach [i.e, "go along to get along" - ed.] really the “best compromise,” especially in light of our ethical and legal obligations?

No, for the reasons after your comma. [i.e., in light of our ethical & legal obligation - ed.]

One should look to the past for lessons in what the "compromises" might be.

How about the Flexner Report of 1910 as a start?

The treatises on human research protections penned largely after the Tuskegee experiments and the horrors of WW2, such as these as listed on an NIH web page "Office of Human Subjects Research, Regulations and Ethical Guidelines" might also shed some light:

  • The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research

I further opine:

Re: How can we justify “getting on board” with patient care tools (e.g., EHRs, eRx’ing, etc.) that are posing risks (known and unknown), with no clear processes for informing patients, not giving patients their choice to use these e-tools, no clear evidence-based risk/benefit analyses, etc.?

Perhaps with the line that "I never make mistakes ... everything I do is an experiment."

The technology is experimental. Perhaps the best way forward is to treat it as such.

In medicine I think there's a rich history of how to conduct proper (and improper) experimental research.

Again, Dr. Monteith raises some critical questions that need to be answered.

Or, more correctly, needed to be answered a long time ago, and long before planned national rollouts of healthcare information technology.

-- SS

An Updated Reading List on Health IT

“It is only the ignorant who despise education.” - Publilius Syrus, Latin Poet, 43-85 AD

In a March 2009 post "A Primer On Why We Have Busywork Generators Masquerading as EMR's: Health IT Reality vs. the Bernard Madoff Version", I posted a "reading list" of articles about health IT that I consider essential in understanding the issues surrounding the experimental nature of this technology.

I wrote:

Anyone contemplating policy work in health IT should be intimately familiar with these works, as they illustrate the true HIT environment in 2009, not the Bernard Madoff "unlimited returns no matter what" version.

What these articles do not illustrate is the common atmosphere of irrational exuberance and complacency now prevalent about HIT, with healthcare organizations and physicians now being pushed forcefully to adopt these technologies or suffer payment penalties they can ill afford:

I've updated the list.

Updated reading list (not meant to be at all comprehensive; this is just a set I've collected over recent years writing on health IT):

[1] Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality. Max J. Romano, BA; Randall S. Stafford, MD, PhD, Arch Intern Med. Published online Jan. 24, 2011. doi:10.1001/archinternmed.2010.527

[2] Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Linder, Ma, Bates et al. Arch Intern Med. 2007;167:1400-1405

[3] The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. PLoS Medicine 8(1): e1000387 (Jan. 18, 2011). doi:10.1371/journal.pmed.1000387.

[4] Electronic Health Records’ Limited Successes Suggest More Targeted Uses. DesRoches, Jha et al., Health Affairs, April 2010 vol. 29 no. 4 639-646, doi:10.1377/hlthaff.2009.1086

[5] Health information technology: fallacies and sober realities. Karsh et al. (Oct. 2010). JAMIA 2010 17: 617-623.

[6] Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force. Goodman et al. JAMIA doi:10.1136/jamia.2010.008946. Nov. 2010.

[7] The Top Ten Health Technology Threats to Patient Safety for 2011. ECRI Institute, Plymouth Meeting, PA, Dec. 7, 2010.

[8] Current Approaches to U.S. Healthcare Information Technology are Insufficient. Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions. National Research Council of the U.S. National Academies, Jan. 2009.

[9] Evaluating the Impact of the Electronic Health Record on Patient Flow in a Pediatric Emergency Department. Mathison, Chamberlain, Children's National Medical Center – Division of Emergency Medicine, Washington, DC. Applied Clinical Informatics, Vol. 2, Issue 1, 2011, 10.4338/ACI-2010-08-RA-0046

[10] A Critical Essay on the Deployment of an ED Clinical Information System ‐ Systemic Failure or Bad Luck?, Professor Jon Patrick, Health Information Technology Research Laboratory, School of Information Technologies, University of Sydney, Australia, Jan. 2010.

[11] E-Health Hazards: Provider Liability and Electronic Health Record Systems. Sharona Hoffman and Andy Podgurski. Berkeley Technology Law Journal (2010). Followup paper on EHR medical and legal risks. This article is a first of its kind, a comprehensive analysis of the liability risks associated with use of clinical IT. The authors point out that the potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature.

[12] Meaningful Use and Certification of Health Information Technology: What About Safety? Sharona Hoffman and Andy Podgurski. Case Research Paper Series in Legal Studies Working Paper 2010-34, October 2010.

[13] Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems, Sharona Hoffman and Andy Podgurski. Harvard Journal of Law & Technology 2008 vol. 22, No. 1

[14] Emerging Trends in Electronic Health Record Liability. Chad P. Brouillard. For the Defense, July 2010 (Defense Research Institute).

[15] Electronic Health Records: Recognizing and Managing the Risks. ClaimsRx: Clinical and Risk Management Perspectives. NORCAL Mutual Insurance Company, Oct. 2009.

[16] Litigation in the Decade of Electronic Health Records. Joel B. Korin and Madelyn S. Quattrone. New Jersey Law Journal, June 11, 2007.

[17] Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

[18] Workarounds to Barcode Medication Administration Systems: Their Occurrences, Causes and Threats to Patient Safety, Koppel, Wetterneck, Telles & Karsh, JAMIA 2008;15:408-423

[19] Hiding in Plain SIght: What Koppel et al. tell us about healthcare IT. Christopher Nemeth, Richard Cook. Journal of Biomedical Informatics. 38 (4): 262-3.

[20] Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Ross Koppel and David Kreda, Journal of the American Medical Association, 2009; 301(12):1276-1278

[21] Hospital Computing and the Costs and Quality of Care: A National Study. Himmelstein. Wright, Woolhandler. The American Journal of Medicine, Volume 123, Issue 1 , Pages 40-46, January 2010.

[22] Unintended errors with EHR-based result management: a case series. Yackel and Embi; JAMIA 2010 17: 104-107; doi: 10.1197/jamia.M3294, Oct. 2009.

[23] Information Technology: Not a Cure for the High Cost of Health Care: Knowledge@Wharton, Wharton School of Business, University of Pennsylvania, June 10, 2009. (PDF version available at this link).

[24] Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties. Teaching website, Scot Silverstein, MD, Drexel University, College of Information Science and Technology, Philadelphia, PA. Site initiated in 1999.

[25] Healthcare Renewal blog. I write on healthcare IT issues at this multi-author website sponsored by the Foundation for Integrity and Responsibility in Medicine (FIRM), a 501(c)(3) advocacy group. FIRM researches problems with leadership and governance in healthcare that threaten healthcare's core values.

[26] Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop. Journal of the American Medical Informatics Association. Bonnie Kaplan and Kimberly D. Harris-Salamone.

[27] Joint Commission: Sentinel Events Alert on HIT, Dec. 2008.

[28] Internal FDA memorandum on HIT risks to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). "Not Intended for Public Use." Feb. 23, 2010. (Description/summary of memorandum is at this link).

[29] FDA's Manufacturer and User Facility Device Experience database (MAUDE) and HIT risks. Healthcare Renewal Blog, Scot M. Silverstein MD, Drexel University, Philadelphia, PA, Jan. 2011

[30] Health IT's Mission Hostile User Experience (eight-part essay), Healthcare Renewal Blog, Scot M. Silverstein MD, Drexel University, Philadelphia, PA, Feb. - Mar. 2009.

[31] The National Programme for IT in the NHS: Progress since 2006. Summary points, conclusions & recommendations. UK Parliament House of Commons, Public Accounts Committee, January 2009. (Full report at this link.)

[32] The future of the NPfIT. Program slated for major downsizing and decentralization after poor progress and expenditures exceeding £13 billion. UK Dept. of Health, Sept. 2010.

[33] "Don't Repeat the UK's Electronic Health Records Failure". Stephen B. Soumerai, Professor of Population Medicine at Harvard Medical School, Anthony Avery, Professor of Primary Care at the University of Nottingham Medical School, UK. Huffington Post, Dec. 5, 2010.

[34] Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software. UK National Health Service, DSCN18 (2009), formerly ISO/TR 29322:2008(E).

[35] Health Informatics — Application of clinical risk management to the manufacture of health software. UK National Health Service, DSCN14 (2009), formerly ISO/TS 29321:2008(E).

[36] The Impact of eHealth on the Quality & Safety of Healthcare, A Report for the NHS Connecting for Health Evaluation Programme. (Note: 7 MB in length). Car et al., Imperial College, London, March 2008.

[37] Medical Project Agency's Working Group on Medical Information Systems: Project summary. Proposal for guidelines regarding classification of software based information systems used in health care. Läkemedelsverket - Swedish Medical Products Agency (MPA), June 2009, revised Jan. 2010.

[38] Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method. Greenhalgh, Potts, Wong, Bark and Swinglehurst, University College London. Milbank Quarterly, Dec. 2009.

[39] Failure to Provide Clinicians Useful IT Systems: Opportunities to Leapfrog Current Technologies, Ball et al., Methods Inf Med 2008; 47: 4–7,

[40] IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans’ Medical Centers, JAMA Mar. 4, 2009, p. 919-920.

[41] Software hiccups cause drug, treatment errors at VA”, Associated Press, January 14, 2009

[42] Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress, Sandra Basu, U.S. Medicine - the Voice of Federal Medicine, May 2009

[43] Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, Han et al., PEDIATRICS Vol. 116 No. 6 December 2005, pp. 1506-1512 (doi:10.1542/peds.2005-1287).

[44] The Computer Will See You Now, New York Times, Armstrong-Coben, March 5, 2009.

[45] Physician testimony to HHS Standards Committee Implementation Workgroup of the ONC, Jan. 11, 2011. Reproduced with permission at Healthcare Renewal blog.

[46] Bad Health Informatics Can Kill. Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

[47] "Dutch nationwide EHR postponed: Are they in good company?", ICMCC.org, Jan. 24, 2009

[48] "The failure rates of EMR implementations are also consistently high at close to 50%", from Proceedings of the 11th International Symposium on Health Information Management Research – iSHIMR 2006

[49] Adverse Effects of Information Technology in Healthcare. This knowledge center presents a collection of information on the adverse effects of information technology in its application to healthcare. It also references sources of information on information security, and related media reports.

[50] The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records - Robert O'Harrow Jr., Washington Post, May 16, 2009

[51] American Association of Physicians and Surgeons Survey on Health IT, June 2008

[52] Pessimism, Computer Failure, and Information Systems Development in the Public Sector. Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007


I await invective that these sources are "cherry picked" and "anecdotal."

-- SS

BLOGSCAN - By Feb. all ER physicians at DePaul Health Center (MO) will be using scribes

At my Sept. 2010 post "The Ultimate Workaround To Mission Hostile Health IT: Humans (a.k.a. Scribes)" I had written that:

The EMR is a technology that was supposed to improve clinical medicine (revolutionize it, some say). It was supposed to facilitate clinical medicine. It was not supposed to slow physicians and others down to the point of impairing their ability to practice medicine. However, the rosy predictions are not proving to be the case. Instead, we have the ultimate workaround to the health IT mission hostile user experience: [the medical scribe].

On the HisTALK blog today, apparently one medical center agrees:

By February, all ER physicians at DePaul Health Center (MO) will be using scribes for electronic medical documentation. Administrators hope to improve staff productivity as well as patient satisfaction. Apparently patients were “annoyed” that doctors were sharing their attention with a computer.

In the cited article "Scribes are finding their place in emergency rooms" by Michele Munz, St. Louis Post-dispatch.com, Jan. 25, 2011:

"[With a scribe] I can just completely focus on and deal with the patient," [ED physician] Lebo said.

The emergency department at DePaul Health Center in Bridgeton, which sees about 60,000 patients a year, is the first to use scribes in the St. Louis area. By February, all the hospital's emergency physicians will have a scribe tapping away at a laptop or tablet computer while they work. Across the nation, about 200 hospital emergency departments have started using scribes, most within the last two years, according to the three major companies providing scribes.


Several points worthy of note:

  • The cost of scribes will be an issue affecting the supposed ROI of EHR's, and are necessitated by the fact that the EHR and its mission hostile nature get in the way of physicians. (See Dr. Doug Perednia's analysis at this link.)
  • You should not have to work around something that is not in the way.
  • That a technology touted as of extreme benefit now is seen to need an "isolation layer" between enduser and subject of the system's benefits is another example of how health IT remains an experiment.

-- SS

The Impact of eHealth on the Quality and Safety of Health Care: You Heard Much of This First On Healthcare Renewal ...

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research was performed; systematic review articles were collected and then reviewed systematically.

Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. (2011) The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Med 8(1): e1000387. doi:10.1371/journal.pmed.1000387.

A text version can be seen at this link and a PDF downloaded at this link.

I will reproduce only the abstract here, and then make a few comments (over and above the hundreds of posts on these issues I've authored at this blog since 2004):

The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview.

Ashly D. Black1, Josip Car1, Claudia Pagliari2, Chantelle Anandan2, Kathrin Cresswell2, Tomislav Bokun1, Brian McKinstry2, Rob Procter3, Azeem Majeed4, Aziz Sheikh2*

1 eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom, 2 eHealth Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, United Kingdom, 3 National Centre for e-Social Science, University of Manchester, Manchester, United Kingdom, 4 Department of Primary Care and Public Health, Imperial College London, London, United Kingdom

Abstract

Background

There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. [I believe it would be more accurate to write "always at considerable cost, with generous profits being made by the IT merchants, implementers and consultants"- ed.] In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.

Methods and Findings

We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.

Conclusions

There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. [You've heard that here before - ed.]

In addition, there is a lack of robust research on the risks [I believe it would be more accurate to say there's been a suppression of research and/or of publicity on the risks - ed.] of implementing these technologies and their cost-effectiveness has yet to be demonstrated [in other words, healthcare IT is an experimental technology. You've heard that here before, too - ed.], despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given.

[In other words, there's an irrational - or contrived - exuberance. You've heard that here before, too - ed.]

In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. [You've heard that here before, too - ed.]

Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption.

[You've heard that here before, too, as well as at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties", as a matter of fact previously entitled "Sociotechnologic Issues in Medical Informatics...", started in 1999 - ed.]


I can add these additional comments:


  • The findings of this study were of no surprise to me or likely to readers of this blog. I've been writing on these issues since the 1990's, and on this blog since 2004.
  • In the main article itself it is stated "... there remains a disparity between the evidence-based principles that underpin health care generally and the political, pragmatic, and commercial drivers of decision making in the commissioning of eHealth tools and services." In other words, the rigor of medical science itself is lacking in healthcare IT. I've written that repeatedly here and elsewhere. I ask again: how can IT "transform" ot "revolutionize" healthcare when the culture of IT itself is in need of reform?
  • Also stated in the article's body was this: "Risks largely went ignored apart from anecdotal evidence of time-costs associated with recording of data due to both end-user skill and the inflexibility of structured data, increased costs of EHRs, and a decrease in patient-centeredness within the consultation." See my prior post "MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?" for what I find as deeply concerning ("hair-raising") revelations regarding risk that you should think about next time you find yourself in a computerized hospital or doctor's office.
  • Also in the article body: "Our major finding from reviewing the literature is that empirical evidence for the beneficial impact of most eHealth technologies is often absent or, at best, only modest. While absence of evidence does not equate with evidence of ineffectiveness, reports of negative consequences indicate that evaluation of risks – anticipated or otherwise – is essential. Clinical informatics should be no less concerned with safety and efficacy than the pharmaceutical industry. [Having worked in both sectors, hospital and pharma , you've read that here before - ed.] Given this, there is a pressing need for further evaluations before substantial sums of money are committed [as you've read here in numerous posts, that's BEFORE, NOT DURING OR AFTER - ed.] to large-scale national deployments under the auspices of improving health care quality and/or safety." Are governments listening, I ask?
  • Study methodology and source material limitations were noted. However, also noted was this: "Our greatest cause for concern was the weakness of the evidence base itself. A strong evidence base is characterised by quantity, quality, and consistency. Unfortunately, we found that the eHealth evidence base falls short in all of these respects. In addition, relative to the number of eHealth implementations that have taken place, the number of evaluations is comparatively small." In my view, national re-engineering programs involving a large portion of the economy and a critical societal function should not be undertaken when the evidence base is weak and the number of evaluations is small. Further, national leaders should not be making statements of certainty such as made by the HHS ONC office as I wrote about at "Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records" and at "Blumenthal on health IT safety: nothing to see here, move along."
  • This article might be compared to the Dec. 2009 Milbank Quarterly article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. I wrote about that article at this link. It was also a meta-analysis; its major conclusion was that "the tensions and paradoxes revealed in this study extend and challenge previous reviews and suggest that the evidence base for some EPR programs is more limited than is often assumed."


Read the entire PLoS article at the links above.

-- SS

MAUDE and HIT Risks: What in God's Name is Going on Here?

As I wrote at my last post "Healthcare IT Delirium":

The field of health IT has become delirious.

On top of an irrational exuberance (see this blog query) largely unsupported by the literature (e.g. here), the technology is experimental, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient informed consent, nobody is in control, and nobody is taking responsibility for regulating the domain
despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.

It's worse.


Some time ago I posted on a number of cases of health IT malfunction from the FDA's MAUDE (Manufacturer and User Facility Device Experience) database of medical device risks. See posts on MAUDE
here and here.

MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.


Either I missed a Titanic boatload of cases, or MAUDE has been appended since my posts, because MAUDE links such as this , this
and this are now returning a Mother Lode of cases, at least from one vendor where these events are reported (other vendors' products suffer similar problems).

Examples just from light browsing cause the hair to stand up on my head (there are many, many more at the MAUDE links above):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195
CERNER MILLENIUM CPOE, POWER CHART
Event Type Injury Patient Outcome Life Threatening;
Event Description

The cpoe system serves and documents all transactions of communication pertaining to the patient's care. Orders are entered and delivered to an anticipated recipient and the action ordered is executed. The device-recipient interface has been unreliable with specific etiologies for failure not yet resolved or understood. Examples include orders to transfer patient from icu to a non-icu bed. Patient is moved to another bed but recipient care team does not receive communication and was not aware patient was under their charge. Patient had seizures on floor for hours throughout the night. Other patients had orders for lab tests, chemical tests on body fluids, cytological analysis of body fluids, cultures on body fluids, pathology on or specimen, and others that are not executed by the recipient, leaving the patient undiagnosed after having taken risks for a procedure. Such interface failures have been known by the vendor for years as reported by its own support team.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240
CERNER MILLENIUM CPOE, POWERCHART Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability
Event Description

The displays, formats, layouts, and interfaces of the cpoe tools at this institution contain elevated degrees of user unfriendliness. This toxic effect on the user is manifested by, to mention a few, more than 20 electronic silos in which orders are stored and extensive wordiness using descriptors that are highly irrelevant to the task of the care of pts with critical illness. This manifests itself in several ways, one of which is the ordering of duplicate medications and treatments, some of which get to the pt. These should be reported to pharmacopoeia data bases but often are not. This pt was being infused both total parenteral nutrition and a concentrated dextrose solution, the combined rate of which and cumulative dose caused pulmonary edema.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753
CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability
Event Description

Stress test orders are ambiguous. An example of the order states "stress test adenosine/dobutamine w/imaging nm -stress test adenosine nm-". Order displays on 4 lines on the screen. The type of test that the doctor intended to be performed is unclear, resulting the risk of incorrect pharmacological modalities being used. This caused life threatening acute asthma attack in patient with background asthma who incorrectly received an infusion of adenosine. All patients ordered pharmacological stress tests become subject to said risk.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421

CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening; Other
Event Description

When a pt having been in the hospital preoperatively, begins its post-operative course in the recovery room or intensive care unit, post op orders are electronically entered by deleting the unneeded orders that have been active, leaving the orders that are still needed, and adding new ones. There can be upwards of 300 lines of "active" orders on a complicated pt. Precise and safe post-operative ordering requires a time consuming line by line review of each order, counter-intuitively canceling those that are not needed. This does not always occur for any number of reasons, not the least of which is that the task is time consuming and user-unfriendly. The incidence of commingling the pre and post op orders in a hospital with cpoe instruments of care is unk, but not uncommon. At least one pt was placed at risk when the clean post operative abdomen was irrigated based on the pre-op order.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909

CERNER MILLENIUM CPOE Back to Search Results
Event Type Injury Patient Outcome Life Threatening;
Event Description

This cpoe product allows doses to be ordered that are not a multiple-s- of the pill size. A representative example is 20mg atenolol po daily. Pill size is 25mg. This feature facilitates dosing errors and enables dangerously absurd dosing without warning. When the reports such dose having been given, the clinician is left to wonder, what dose was given, actually.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802
CERNER MILLENIUM CPOE, POWER CHART Back to Search Results
Event Date 07/11/2006
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description

Hospital wide breakdown of system of electric charts and electric order gadgets resulted in confusion, neglect, failed communications and delayed treatments in the days immediately following the surgery, leaving patient with permanent musculoskeletal disability and mental anguish. Breakdowns of this magnitude endanger hundreds of patients simultaneously.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473
CERNER MILLENIUM CPOE, POWER CHART Back to Search Results
Event Date 10/09/2006
Event Type Malfunction Patient Outcome Other;
Event Description

It has been discovered that the medication review screen consisting of a list of the medications on the left most column and a grid indicating the number of doses administered in each time period. The defect manifests itself in the representation of exactly what medication was administered. For pts who are taking two or more forms of the same pharmacological agent, eg nitroglycerin in the paste form, sub lingual form, and pill form, the name of the medication is represented as "nitroglycerin" on the list. The number of times it was administered is confusingly listed as a number in parentheses without clarity on which form of the medication was administered, creating confusion in the clinician and risk to the pt.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923
CERNER MILLENIUM CPOE, POWER CHART
Event Date 04/03/2010
Event Type Injury Patient Outcome Life Threatening; Other
Event Description

The computerized physician order entry instruments were deployed. Pleural fluid specimen were obtained. Chemical and cytological analysis was ordered on the specimen using the cpoe instruments. The specimen was not analyzed as ordered. Cytology results did not become available. Similar dysfunction appeared in more than 6 patients. The hospital has resorted to paper forms to clarify the dysfunction of this cpoe instrument. The patients may have cancer causing the fluid build up. This will not be known until time passes. There may be resultant delay in diagnosis of chest organ cancer.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892
CERNER MILLENIUM CPOE
Event Date 07/08/2010
Event Type Injury Patient Outcome Life Threatening;
Event Description

The active and active prn medication list had 7 potassium doses and routes, 2 tylenol doses and routes, 3 magnesium doses, 3 narcotic medications and doses, and 6 sodium chloride and sodium phosphate orders. The defects in the device and human factors at the interface enabled duplicate, triplicate, and more medications, enabling the nurse to potentially decide the treatment for this pt. The exact incidence of medication duplication from (b)(4) systems is unk, but common.


Some examples of mere "malfunctions", again just from random browsing of the MAUDE data:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222
Model Number RELEASE 500
Event Date 10/03/2001
Event Type Malfunction Patient Outcome Other;
Event Description

Please see initial report.

Event Description

A user entered an order during the order entry process, with a frequency of every 8 hours and then used the ad hoc scheduling feature to modify the defaulted administration times for that frequency. After this was done, the user changed the frequency of the order to a 12-hour frequency without modifying the ad hoc administrations times. The software did not clear the previously entered ad hoc administration times to adjust to the default times for the new frequency. This resulted in a patient receiving a medications 3 times a day as opposed to 2 times a day. The drug was carbamazepene. This incorrect order frequency was repeated for 3 days, ultimately resulting in the patient receiving of total of 3 extra doses over a 3-day period (1 extra dose per day). On the fourth day, the nurse caring for the patient noticed the inconsistency in the order and conducted a further investigation with the pharmacist. The patient was discharged on time; no extended stay was necessary as a result of the overmedication. The patient's carbamazepene levels were checked during a follow-up visit that occurred 5 days after discharge, and were noted as normal at that time.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512
Model Number 2007.01 - 2007.17
Event Date 12/30/2008
Event Type Malfunction Patient Outcome Other;
Event Description

The issue involves cerner millennium powerchart message center inox. When the results folder is filtered by event set and the event set display and event set name are different, result filtering may not function correctly. If the result filter is in message center and is an inclusive filter, results may be filtered out incorrectly. The impact associated with this issue is that patient care may be delayed or missed as follow-up may not occur. Cerner has not received communication on any adverse patient events as a result of this issue.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673
Model Number 2007
Event Date 10/30/2008
Event Type Malfunction
Manufacturer Narrative

Cerner distributed a priority review flash notification on nov 13, 2008 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software correction is available.

Event Description

This issue involves the overview with reminder functionality on powerchart and affects sites that use cerner millennium powerchart (powerchart. Exe). If a currently open pt chart is replaced with another pt chart, and reminders are subsequently viewed in the detail pane of this visit, the incorrect patient's reminder may de displayed. Pt care could be adversely affected, as clinical decisions could be based on the wrong pt info. Cerner has not received communication of any adverse pt events as a result of this issue.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561

Model Number 2007.13
Event Date 06/30/2008
Event Type Malfunction
Event Description

The issue involves the task list functionality in carenet, and affects users that utilize the task list to view and document pt activities. When encounter security is turned on and the user documents an activity in task list, utilizing the previous or next arrows to select another pt chart, the single pt task list displays tasks for incorrect pt. Clinicians may view and document a pt's activity in another pt's record. Pt care may be affected as clinical decisions could be based on incomplete, invalid, or inappropriate info. Cerner has not received communication of an adverse pt event as a result of this issue.

Cerner has distributed a priority review flash notification july 30, 2008, to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the modification is available. Additional model #: 2007. 16.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313
Model Number 2001 THROUGH 2007
Event Date 04/23/2008
Event Type Malfunction
Manufacturer Narrative

Cerner has distributed a priority review flash notification may 23, 2008 to all potentially impacted clients sites. The notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. User documentation is being updated to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the documentation is available.

Event Description

The issue involves the order entry formats in powerorders and affects sites that use powerorders and medication profile. When creating the volume dose detail in the order entry formats (oef), the strength order formats require the volume dose to have an "=" sign as a prefix label. Failure to adhere to this build can result in an inpatient prescription order converted to produce an outpatient prescription that may be misleading. This only occurs when the inpatient order used is verified with a pharmacy product and the formulation used does not exactly match the dose. A formulation factor of more or less than one is used to achieve the volume and the order is then converted to a prescription. For example, 500 mg = 1 tab or 250 mg times 2 tabs = 500 mg. Patient care could be adversely affected, as a patient could receive either more or less of a medication therapy than intended. Cerner has received communication of order discrepancies discovered during a chart review as a result of this issue.

Again, there are many, many more examples like these in MAUDE, and I haven't even looked for data from other mfg's yet.

My relative was nearly killed last year by this technology due to issues like these, the risks of which I've been writing about for more than ten years now.


Alert to Sarah Palin:

"Death panels?" Who needs death panels
when technology like this is mediating our care and is planned for "urgent" national rollout with "meaningful use" rules and Medicare extortion - er, gentle coercion - directed towards healthcare organizations and clinicians?


I repeat, from the title of this post:

Mother Mary, What in God's Name is Going on Here?

and:


U.S. government, where the he** are you?

-- SS


Jan. 21, 2011 addendum:

One wonders if the EHRevent site I wrote about at "
EHRevent.org: Web Site to Collect EHR Safety Reports" and at "EHRevent: survey amateurism, bias, or something else?" will be as frank as MAUDE.

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