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Guest post by Dr. Jon Patrick, U. of Sydney: On the ECRI Institute's recommendations following a "deep-dive" study of HIT-related events

At my Feb. 9, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/02/ecri-institute-pso-uncovers-health.html" target="_blank">ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis</a>", I wrote about an ECRI Institute study of well-defined client data submitted over a 9-week period (a "deep dive" study) on EHR problems.  Risk-creating events at a level that should be a significant concern to patients and clinicians fell into the following categories:  <ul><li>inadequate data transfer from one HIT system to another </li><li>data entry in the wrong patient record</li><li>incorrect data entry in the patient record</li><li>failure of the HIT system to function as intended </li><li>configuration of the system in a way that can lead to mistakes </li></ul> Dr. Jon Patrick at U. Sydney, a scientist and medical informatician who sees the issues from a number of unique perspectives (<a href="http://rp-www.cs.usyd.edu.au/~jonpat/CV/CV_brief.html" target="_blank">link to bio</a>), has offered the following critique of the key recommendations made by the ECRI Institute as a result of this study of health IT events (see aforementioned post for the text of those recommendations).  One caveat is that neither he nor I have the full report as of this writing in part due to expense: <blockquote class="tr_bq">The ECRI has produced a report on HIT errors. I was concerned about the manner in which the Key Recommendations minimised, generalised or failed to concretise important issues that I offer these comments. On ECRI Key Recommendations: 1. Enlist leaders’ commitment and support for the organization’s health IT projects. JP: This is clearly a comment from one level of  management to those levels above it. It doesn't seem to be a comment about the nature of the HIT itself but more about the internal processes to getting it established. There is really not much to say here because if upper management don't want to do anything about the introduction of HIT then engaging in the task is probably futile, hence it was difficult to understand why it was included. 2. Involve health IT users in system planning, design, and selection. JP: yes, this is crucial to successful solutions. 3. Conduct a review of workflow and processes to determine how they must be modified. JP: the missing clause at the end of this sentence is "to fit the introduced HIT system". This is putting the cart before the horse. The notion that a piece of software designed by engineers should have priority over the team of clinicians who are experts in their business is highly naive. Also this statement is in contradiction to point 2 above. The privileging of the functioning of  the IT system as the expert over that of the clinical team, AND making a recommendation in contradiction to an earlier recommendation is absurd enough by itself  to undermine the credibility of  the report. 4. Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration. JP: And after the evaluation what should be done. This is hardly an informative recommendation. It is of the form "Do Something, it doesn't matter what you do, just do something."  A more compelling statement that would have enhanced the credibility of the authors and demonstrate their knowledge of the industry would have been: " Establish unambiguously and conclusively that any health IT system under consideration has the ability to reliably exchange data with existing IT systems within the organization". Note the focus needs to be on the incoming system being the object of conformity not the incumbent systems. 5. Conduct extensive tests before full implementation to ensure that the health IT system operates as expected. JP: this is a clearly a desirable goal and applies to point 4 above as well as all other aspects of the system functions. 6. Provide user training and ongoing support; educate users about the capabilities and limitations of the system. JP: This is a motherhood statement that does nothing to contribute to the nub of training issues in the use of HIT. Training is an ongoing issue for two reasons: staff change and new staff come on to the roster and need to be trained, and, these systems are complex and expert advice and skill needs to be available to staff as an ongoing service so that work is not delayed due to confusion on how to use the IT. An alternative proposal to reduce training costs and investment would be to design the system so that it matches current best practice of the clinical team so that learning the system is minimised because it fits seamlessly into their work processes. Surely the issue of educating users about the capabilities and limitations of the system is independent of the training topic. The users will discover on their own bat the limitations of the system as they try to use it. 7. Closely monitor the system’s ease of use and promptly address problems encountered by users. JP:This is a quite inadequate description of the action that needs to be taken. The real consideration is for them to have an effective avenue for expressing the limitations in a manner that is acceptable and they are NOT chastised as malcontents [or Luddites or technophobes - ed.] AND that the unnecessary or dangerous limitations are addressed promptly. 8. Introduce alterations to a health IT system in a controlled manner. JP: It is hard to understand what is meant by this statement. Firstly I would have said "introduce alterations to the clinical processes  in a controlled manner". Secondly, alterations to the HIT system need to be done promptly  when it is defective. Once again, as in point 3 above the technology is being preferenced over the clinical processes which I argue is back-to-front. 9. Monitor the system’s effectiveness with metrics established by the organization. JP: This is definitely something that should be done but it also needs a more directed purpose. It is easy to say to assess patient safety but most systems don't readily capture relevant data or supply analytical devises to easily draw a picture of patient  safety. However there is an equally important factor in care that is often overlooked and that is staff productivity and by implication morale. There is a need to understand better ways of assessing staff productivity in positive ways and the effect a CIS has on staff morale.  Typical comments about CISs is that they cost staff  up to 20% more time to maintain the patient record. Staff wouldn't mind giving up that time if it was returned in some other form, but it isn't, so they feel the time is stolen from them or from their patients. 10. Require reporting of health IT- related events and near misses. JP: This is poorly stated and is probably meant to read "health IT - related adverse events". This is a positive recommendation but does not go far enough. A more comprehensive statement would be "Install a process and technology for reporting adverse events and establish methods for evaluating the reports and recommending changes to clinical practice, or technology functionality and implementing them. 11. Conduct thorough event analysis and investigation to identify corrective measures. JP: This  goes some way to dealing with my point in item 10 above. Its weakness is in not identifying the types of problems and taking a firm stance on completing the correct action. SOME of the Items that have been OVERLOOKED 1. The system needs to be alterable at any time by the clinical leadership so as to immediately emplace revised work practices when they are approved. 2. The system needs to have native analytics so that the clinical leadership can monitor the activities of their teams and provide evidenced based feedback to support continuous process improvement. 3. The system needs highly accurate natural language processing so that the search for required content though the clinical record can be fast, efficient and reliable. Professor Jon Patrick Chair of Language Technology School of Information Technologies Faculty of Engineering University of Sydney Health Information Technologies Research Laboratory <a href="http://www.it.usyd.edu.au/~hitru">http://www.it.usyd.edu.au/~hitru</a></blockquote> This is excellent advice coming from perhaps the only computing expert in the world who's conducted a forensic analysis of a major commercial EHR product, one intended for high-risk ED's.  His analysis of that product, intended for government-mandated rollout in public hospitals in Dr. Patrick's Australian state of New South Wales, is at this link. This work has largely been ignored by the health IT industry and the academic Medical Informatics community.  However, I can assure the industry and the academic community that the report will not be ignored by those in the legal community if (perhaps I should say when) patients are injured or killed by the system's deficiencies. -- SS

Guest post by Dr. Jon Patrick, U. of Sydney: On the ECRI Institute's recommendations following a "deep-dive" study of HIT-related events

At my Feb. 9, 2013 post " ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis ", I wrot...

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A New ECRI Institute Study On Health Information Technology-Related Events

As I wrote <a href="http://hcrenewal.blogspot.com/2012/12/pennsylvania-patient-safety-authority.html" target="_blank">here</a>, I was a reviewer of the report in the PA-based, ECRI Institute-conducted study "The Role of the Electronic Health Record in Patient Safety Events."  ECRI studied the Pennsylvania Patient Safety Reporting System database for HIT-related errors.    <blockquote class="tr_bq">The <a href="http://www.ecri.org/" target="_blank">ECRI Institute</a> is an independent organization renowned for its safety testing of medical technologies and reporting on same, and that "researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care."  I've mentioned it and its bylaws in this blog in the past as a model for independent, unbiased testing and reporting of healthcare technologies. </blockquote> The full report in PDF is <a href="http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Dec;9%284%29/documents/113.pdf" target="_blank">at this link</a>.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database (the Pennsylvania Patient Safety Reporting System or PA-PSRS, pronounced "PAY-sirs") of reported medical errors and identified several major themes. My review input led to a discrete "limitations" section.  Also, my invited July 2012 presentation to the PA Patient Safety Authority "Asking the Right Questions: Using Known HIT Safety Issues to Improve Risk Reporting and Analysis" with ECRI in attendance (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" target="_blank">link to PPT here</a>) on the danger of limited datasets due to systematic impediments to information diffusion was apparently taken seriously.  ECRI decided to do something about the knowledge gap, and they asked the right questions. They've just released this summary of a new study they conducted.  I have a few comments which follow:    <blockquote class="tr_bq"><a href="http://www.prnewswire.com/news-releases/ecri-institute-pso-uncovers-health-information-technology-related-events-in-deep-dive-analysis-190064661.html" target="_blank">ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis</a> Data transfer, data entry, system configurations, and more identified as serious problem areas   PLYMOUTH MEETING, Pa., Feb. 6, 2013 /PRNewswire-USNewswire/ -- The federal government is spending about $19 billion to encourage hospitals, physician practices, and other healthcare organizations to invest in their health information technology (HIT) infrastructure with the goal of improving patient safety and quality through the Health Information Technology for Economic and Clinical Health (HITECH) Act. Concerned about the unintended consequences of HIT and the potential for errors to cause patient harm, <a href="https://www.ecri.org/PatientSafetyOrganization/Pages/default.aspx" target="_blank">ECRI Institute Patient Safety Organization</a> (PSO) recently conducted a PSO Deep Dive™ analysis on HIT-related safety events. Their just-released 48-page report identified five potential problem areas, which can be assessed with the accompanying toolkit. The <a href="https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx" target="_blank">report and toolkit are available for purchase</a> [appx. $350 U.S. - ed.] without membership in ECRI Institute PSO. "Minimizing the unintended consequences of HIT systems and maximizing the potential of HIT to improve patient safety should be an ongoing focus of every healthcare organization," says Karen P. Zimmer , MD, MPH, FAAP, medical director, ECRI Institute PSO. Based on [voluntary - ed.] reports submitted to the PSO from participating organizations, ECRI Institute PSO experts identified the following key HIT-related problems: <ul type="disc"><li>inadequate data transfer from one HIT system to another </li><li>data entry in the wrong patient record </li><li>incorrect data entry in the patient record </li><li>failure of the HIT system to function as intended </li><li>configuration of the system in a way that can lead to mistakes </li></ul> To collect enough reports for meaningful evaluation, ECRI Institute PSO asked participating organizations to submit standardized data about HIT events during a nine-week period. This enabled ECRI Institute PSO to identify patterns and trends from the aggregated data and share the findings, as well as its recommendations. The data in the PSO Deep Dive represents only that collected using the Agency for Healthcare Research and Quality (AHRQ) HIT Common Formats.  [Not the improved formats developed by AHRQ in their <a href="http://healthit.ahrq.gov/HealthITHazardManagerFinalReport" target="_blank">IT Hazards Manager project</a>, still in development - ed.]  ECRI Institute PSO data encompasses over 800 HIT-related events. According to the report, HIT must be considered in the context of the environment in which it operates during the three phases of any HIT project: planning for new or replacement systems, system implementation, and ongoing use and evaluation of the system. "Shortsighted approaches to HIT can lead to adverse consequences," caution the authors. "Healthcare organizations should consider the findings and recommendations in the PSO Deep Dive as part of their effort to achieve those goals," adds Zimmer. The HIT PSO Deep Dive findings were published in a 48-page report and toolkit with self-assessment questionnaire and action plan form available to all ECRI Institute PSO Members and its partner PSO members. The table of contents of the report is available for <a href="https://www.ecri.org/EmailResources/PSRQ/ECRI_Institute_PSO_Deep%20Dive_HIT_TOC.pdf" target="_blank">free viewing/download</a>. Additional information will be presented in ECRI Institute PSO's Monthly Brief free e-newsletter March edition; go to <a href="https://www.ecri.org/psobrief" target="_blank">www.ecri.org/psobrief</a> to sign up. The full report and toolkit are also <a href="https://eshop.ecri.org/p-140-pso-deep-dive-health-information-technology.aspx" target="_blank">available for purchase</a>. For questions about this topic, or for information about purchasing the report, please contact ECRI Institute PSO by telephone at (610) 825-6000, ext. 5558; by e-mail at <a href="mailto:pso@ecri.org" target="_blank">pso@ecri.org</a>; by fax at <a href="tel:%28610%29%20834-1275" target="_blank" value="+16108341275">(610) 834-1275</a>, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA.</blockquote> From the free linked TOC document: Key Recommendations <ul><li>Enlist leaders’ commitment and support for the organization’s health IT projects.</li></ul><ul><li>Involve health IT users in system planning, design, and selection.</li></ul><ul><li>Conduct a review of workflow and processes to determine how they must be modified.</li></ul><ul><li>Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration.</li></ul><ul><li>Conduct extensive tests before full implementation to ensure that the health IT system operates as expected.</li></ul><ul><li>Provide user training and ongoing support; educate users about the capabilities and limitations of the system.</li></ul><ul><li>Closely monitor the system’s ease of use and promptly address problems encountered by users.</li></ul><ul><li>Introduce alterations to a health IT system in a controlled manner.</li></ul><ul><li>Monitor the system’s effectiveness with metrics established by the organization.</li></ul><ul><li>Require reporting of health IT-related events and near misses.</li></ul><ul><li>Conduct thorough event analysis and investigation to identify corrective measures.</li></ul> My comments are these: <ul><li>The ECRI study, report and recommendations are quite welcome. </li></ul><ul><li>The case reports received were apparently voluntary and probably "conservative" and understated as hospitals are not happy to release data on problems and harms that can lead to, or support, litigation.   </li></ul><ul><li>The study was just 9 weeks long, and with a limited set of healthcare organizations participating.  800 HIT-related events were identified. </li></ul><ul><li> The relevant issues discovered in the events, as summarized in the bullet points above, are capable of causing clinician distraction, incorrect decisions, "use error" (as opposed to "user error", see <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">here</a>), patient harm, and death.  (I am aware of such issues in the press including harms and deaths, as readers here have read at links such as <a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">these</a>, and others about which I am providing expert-witness consultation and cannot share.) </li></ul><ul><li>I believe ECRI has now begun to peer below the water level, through the muck of industry control of the narrative, of what FDA CDRH leader Jeffrey Shuren MD JD referred to as "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">the tip of the iceberg</a>" - i.e., the current level of knowledge of health IT difficulties, defects and harms. </li></ul><ul><li>The report is yet another red flag for a far more robust (and mandatory, in my view) post-marketing surveillance of health IT.   </li></ul><ul><li>Those who claim these findings are "anecdotes" (as <a href="http://hcrenewal.blogspot.com/2013/02/ama-news-ehr-sloppy-and-paste-and-why.html" target="_blank">here</a>) are looking increasingly foolish and cavalier. </li></ul> Finally, readers of this blog have been reading about these issues for years.  You heard it here first. -- SS

A New ECRI Institute Study On Health Information Technology-Related Events

As I wrote here , I was a reviewer of the report in the PA-based, ECRI Institute-conducted study " The Role of the Electronic Health Re...

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New York Mayor Bloomberg: Gun Control - Yes, Bad Health IT Control - No?

The Mayor of New York, Bloomberg, calls for anti-gun legislation because accidents and unexpected events such as theft or use by a child can happen, even with legally owned guns (I don't think he believes law-abiding citizens who own them for defense or for sport would break the law with them). Yet the selfsame Mayor uncritically calls for spread of another technology that in its present state is prone to accidents and unintended consequences, and unlike guns, at a level that even the Institute of Medicine has admitted in unknown due to systematic impediments to transparency (see the middle of <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">this post</a> for source). From a release at <a href="http://mikebloomberg.com/">MikeBloomberg.com</a>: <blockquote class="tr_bq"><a href="http://www.mikebloomberg.com/index.cfm?objectid=B530DDFC-C29C-7CA2-FF25BD11B52E6F7E" target="_blank">Mayor Bloomberg Announces Expansion of Electronic Health Records Result in Major Health Care Improvements</a> Feb 07, 2013 | NYC.gov Mayor Bloomberg, Deputy for Health and Human Services Linda I. Gibbs, Health Commissioner Thomas A. Farley today announced that the use of electronic health records has led to better health outcomes for tens of thousands New Yorkers in the critical areas of high blood pressure management, diabetes and tobacco control. New York City's introduction of electronic health records, which has become a national model, was a result of the Primary Care Information Project, a program that began in 2005 to help medical providers, particularly those with underserved patients, use technology to improve the quality and efficiency of health care. The prompts that electronic health records give doctors, such as signaling a daily dose of aspirin to prevent heart disease or follow up questions for someone who smokes, make a dramatic difference in how aggressively they treat the chronic health conditions of their patients. Through 3,200 primary care providers serving more than three million New Yorkers with electronic health records, over 96,000 additional patients reduced their high blood pressure, 81,000 patients improved their diabetes management and an additional 58,000 smokers were given assistance and successfully quit. The Mayor made the announcement at the “NYC Celebrates Improved Health Through Technology” event at the New York Institute of Technology where he was joined by Centers for Disease Control and Prevention Director Dr. Thomas Frieden, National Coordinator for Health Information Technology Dr. Farzad Mostashari and Director of Health Services Andrea Cohen.</blockquote> There is no doubt the technology can accomplish such goals.  The IT I authored or spearheaded at major hospitals improved quality of care in areas such as diabetes and asthma care, invasive cardiology, and others. The release, however, is missing the most important points. The issue is not whether benefits can accrue from health IT. The issues are ... at what level of harms in its present state, since the technology is unregulated and unvetted for potential risks, and also - are there simpler and cheaper ways to accomplish these ends, e.g., so that the underserved can get more access to care. There is no mention of unintended harms, or even concern about harms, in the release - the very same harms mentioned by Joint Commission, FDA, Institute of Medicine (for example see <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">JC</a>, <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">FDA</a>, <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM</a>) and many others. That qualifies the press release as propaganda.  It is not balanced, almost like an ad for, say, VIOXX. Apparently, for the Mayor it's OK to have increased risk and innocent victims due to bad health IT (like <a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">these</a> and <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html" target="_blank">these</a>, and others I cannot talk about due to case settlements), but not innocent victims of legally owned but stolen guns. Medicine's tradition for centuries has been "first, do no harm", not "when you have benefits to the many, it's OK to overlook the risks and the roadkill." We don't tolerate that any more from the likes of Merck, Pfizer, or Medtronic (to name a few examples). Why does health IT always get special accommodation, as I have frequently asked? <blockquote class="tr_bq">With new federal funding for 2013, NYC REACH is now working to help behavioral health professionals and specialists with high numbers of Medicaid patients adopt and implement electronic health records to continue to improve care across the City. </blockquote> Let's hope they don't have an Avatar rerun (<a href="http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html" target="_blank">link</a>) or Contra Costa meltdown (<a href="http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html" target="_blank">link</a>, <a href="http://hcrenewal.blogspot.com/2012/09/in-addition-to-nurses-doctors-now-air.html" target="_blank">link</a>). Note: this post is not about gun control, a complex issue unto itself, but about medical ethics and hypocrisy.  -- SS Feb. 8, 2013 Addendum:  Prof. Jon Patrick of U. Sydney opines: I can only say the story is a well crated ANECDOTE. The pertinent text is this: <blockquote class="tr_bq">Between 2008 and 2011, the number of preventive care services participating doctors provided grew, on average, by about 290%, from 39 services per 100 patients to 113 services per 100 patients – nearly a threefold increase.</blockquote> Which tells us the only tangible piece of information in that services are increased - where are the figures from the EDs or hospital intakes that show the number of visits for these diseases have gone down? The other interesting point is the valid claim of better analytics - but they don't say how they were used, if at all: <blockquote class="tr_bq">"Patients served by doctors participating in the program were, for example, reminded to take daily aspirin doses to prevent heart disease or counseled to quit smoking. Electronic Health Records also permit doctors to view data on their entire population of patients, which helps them modify their routine office practices to help all of their patients and then evaluate how well those changes work."</blockquote> -- SS

New York Mayor Bloomberg: Gun Control - Yes, Bad Health IT Control - No?

The Mayor of New York, Bloomberg, calls for anti-gun legislation because accidents and unexpected events such as theft or use by a child can...

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From Parallel Universes? Dueling Accounts of VA/DoD EHR Integration

At a March 2010 post "<a href="http://hcrenewal.blogspot.com/2010/03/will-it-take-luminosity-of-dozen.html" target="_blank">VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?</a>" I wrote about problems with ongoing efforts to integrate the Veteran Administration's EHR and the Dept. of Defense (active military) EHR. Now there appears to be two dueling accounts of the task's progress: Account One: <blockquote class="tr_bq"> <a href="http://www.defense.gov/news/newsarticle.aspx?id=119206" target="_blank">DOD, VA to Speed Integration of Health Records</a> By Jim Garamone American Forces Press Service WASHINGTON, Feb. 5, 2013 – The secretaries of Defense and Veterans Affairs announced their departments will speed implementation of the Integrated Electronic Health Record program, allowing service members and veterans better access and more importantly, better medical care. This approach is affordable, achievable, and if we refocus our efforts we believe we can achieve the key goal of a seamless system for health records between VA and DOD on a greatly accelerated schedule,” said Defense Secretary Leon E. Panetta following a meeting with Secretary of Veterans Affairs Eric Shinseki at VA headquarters here. The departments are able to step up the records program because of advances in information technology while working with existing platforms. The original goal was to have the system deployed by 2018. Now the expectation is by the end of next year. The goal is to provide one set of electronic records from entry into the military through veteran status. The program is designed to allow service members or veterans to download information and present it to doctors or other health care providers without delays. Previously, service members had to hand carry paper files from DOD facilities to Veterans Affairs. Once complete, the record program will provide DOD and VA clinicians with the complete medical records of more than 18 million service members, veterans and their beneficiaries. “We’ve agreed to improve interoperability before the end of this year by standardizing health care data,” Shinseki said. The two departments will also accelerate the exchange of real-time data by September. The departments are upgrading the graphical user interface to display the new standardized VA and DOD healthcare data by the end of this year, Shinseki said. ... “By this summer, DOD and VA will field and begin conducting a pilot program on the common interface for doctors at seven joint rehab centers across the country and we’ll also expand its use at two other sites,” Panetta said. “All of these facilities will be interoperable by the end of July 2013, so fast time track, but we think we can get it done.”</blockquote><blockquote>“Rather than building a single, integrated system from scratch, we will focus our immediate efforts on integrating VA and DOD health data as quickly as possible by upgrading our existing systems,” Panetta said.</blockquote>  Account Two: <blockquote class="tr_bq">IMMEDIATE RELEASE: February 6, 2013 CONTACT: Curt Cashour (202) 225-3527 <a href="http://www.sanders.senate.gov/newsroom/news/?id=39d4cb1d-1653-4c0e-9ce5-8e389dbe1e64" target="_blank">Senate and House Veterans’ Committee Leaders Fault VA and DoD on Integrated Health Record System</a> WASHINGTON, D.C. – The chairmen and ranking members of the Senate and House Committees on Veterans’ Affairs today faulted the Pentagon and Department of Veterans Affairs for backing off plans to create a single computer system to integrate electronic medical records for troops and veterans. Senate Committee on Veterans’ Affairs Chairman Bernie Sanders (I-Vt.) said: “I am deeply disappointed by the VA and Defense Department decision to back away from a commitment to develop and implement a truly integrated, single, electronic health record. President Obama charged the departments with creating a seamless system of integration so that service members transitioning from active duty to civilian life don’t have to worry about whether their health records will be lost or their claims delayed. An integrated record would allow for a streamlined and timely claims process, faster decisions on benefits, less duplication in medical testing and more efficient, cost-effective treatment for both physical and mental health needs. Now more than ever we need greater cooperation between the departments to solve the serious challenges that continue to confront our service members and veterans. I will continue to work to achieve better coordination by the departments and to ensure that the needs of veterans are met.” House Committee on Veterans’ Affairs Chairman Jeff Miller (R-Fla.) said: “The decision by DOD and VA to turn their backs on a truly integrated electronic health record system is deeply troubling. The need for a record system integrated across all DOD and VA components has been universally accepted for years, and until yesterday, both agencies have given us nothing but assurances they were working toward that goal. Previous attempts by DOD and VA to use disparate computer systems to produce universal electronic health records have failed, and unfortunately it appears they are repeating past mistakes.  [This seems the "focal point" of the apparent discrepancy, one system vs. two that are interfaced - ed.]  When DOD and VA take shortcuts, the veterans and service members under their care will be shortchanged.” Sen. Richard Burr (R-N.C), the ranking member of the Senate committee, said: “The fact that VA and DoD would reverse course on a plan they have been working towards for years that would create a coordinated electronic health record system between the two agencies is concerning and disappointing. I am concerned about what this means for our nation’s service members and veterans, particularly those who will be transitioning from active duty service to civilian life in the near future. We owe it to our nation’s defenders to do all we can to care for them and provide the most effective, efficient service we can, and coordination and communication between these two agencies is absolutely vital.” Rep. Mike Michaud (D-Maine), ranking member of the House committee, said: “This is a huge setback and completely unacceptable. For years we have been told by both agencies that progress was made and that things were on track. I’m disappointed that our nation’s two largest government agencies – one of which is the world’s foremost developer of high-tech machines and cyber-systems – could not come together on something that would have been so beneficial to those that served. We have just witnessed hundreds of millions of dollars go down the drain.” Additional Contacts: Michael Briggs (Sanders) 202 224-5141 David Ward (Burr) 202 228-2971 Ed Gilman (Michaud) 202 225-6306 </blockquote> So, some are touting a marvelous effort ready for prime time in 2014, and others are speaking of hundreds of millions of dollars down the drain with nothing to show for it. As Captain Kirk said to Mr. Spock in the award-winning Star Trek episode "<a href="http://en.wikipedia.org/wiki/The_City_on_the_Edge_of_Forever" target="_blank">The City on the Edge of Forever</a>" about conflicting accounts of the early 1930's death of <a href="http://penciledin.com/wp/wp-content/uploads/2006/12/edith_keeler_and_jim_kirk.jpg" target="_blank">Edith Keeler</a>, played by a pre-Dynasty Joan Collins, vs. Keeler's mid-to-late-1930's rise to national fame and her becoming the cause of World War Two being lost ... "They both can't be true."  <blockquote class="tr_bq">(Using the clock-mender's tools, Spock gets an image on his tricorder screen of a newspaper report. Edith Keeler, social worker from 21st Street Mission was killed today, it says. Kirk enters.) KIRK: How are the stone knives and bearskins? SPOCK: I may have found our focal point in time. KIRK: You may also find you have a connection burning someplace. SPOCK: Yes. I'm overloading those lines. I believe we'll have our answer on this screen. KIRK: Good. SPOCK: And, Captain, you may find this a bit distressing. KIRK: Let's see what you have. SPOCK: I've slowed down the recording we made from the time vortex. KIRK: February 23rd, 1936. Six years from now. (reading below the headline FDR confers with slum area 'angel') The President and Edith Keeler conferred for some time today (Then the whole thing goes up in flames.) KIRK: How bad? SPOCK: Bad enough. KIRK: The President and Edith Keeler. SPOCK: It would seem unlikely, Jim. A few moments ago, I read a 1930 newspaper article. KIRK: We know her future. Within six years from now, she'll become very important. Nationally famous. SPOCK: Or Captain, Edith Keeler will die - this year. I saw her obituary. Some sort of traffic accident. KIRK: You must be mistaken. They both can't be true.  </blockquote> Based on the points I raised in the aforementioned March 2010 post about current IT leadership and organizational structures (not to mention <a href="http://en.wikipedia.org/wiki/Beltway_bandits" target="_blank">Beltway Bandit</a> IT consultants), I am skeptical that either plan - monolithic vs. interfaced - has a snowball's chance of success. Edith Keeler dies in either scenario.  Let's just hope a war is not lost because of this cybernetic "how to do health IT poorly" feud. -- SS Feb. 7, 2013  Addendum: I've received a comment that this post is a bit "geeky" but droll. My response is a word often used by another highly popular SF character:  <a href="http://www.youtube.com/watch?v=xYnzZ2rczSo" target="_blank">Indeed</a>. -- SS

From Parallel Universes? Dueling Accounts of VA/DoD EHR Integration

At a March 2010 post " VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious ...

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More on the lengths a hospital will go through to protect their EHR from discovery

At "<a href="http://hcrenewal.blogspot.com/2013/02/the-lengths-hospital-will-go-to-in.html" target="_blank">The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Objections</a>" I wrote about obstruction of litigation by the defense regarding a case where an EHR contributed to patient injury and death.  The major basis for the new "Motion for Reconsideration" (a request for the court to reconsider its prior denial of an earlier Motion for Reconsideration of an initial court decision to dismiss defense objections to the Complaint) is this.  From the actual filing (emphases mine): <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhnpG-m0KgmFf1SDTC66r0r7UnCNShPd4C2wjS-vC4ICCVN-LvfjydhYYnVLTyVgnjCIliJ3x7QJQDN-YEAN55-zXD6kow4DToFtvO1M26f8UzqGBMrjZgP9OVmiji0pjqswEMereUeo-rC/s1600/request.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhnpG-m0KgmFf1SDTC66r0r7UnCNShPd4C2wjS-vC4ICCVN-LvfjydhYYnVLTyVgnjCIliJ3x7QJQDN-YEAN55-zXD6kow4DToFtvO1M26f8UzqGBMrjZgP9OVmiji0pjqswEMereUeo-rC/s400/request.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">(click to enlarge)</td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"></div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhS22oiR8aMkHGUg3PGnMd1dp12SNGeDrYDdZky60rEmnbLepkXDK7JsneauL06oBAf0qNt8XyluCWNhwCRqahW3xVIadJiDvXv265Rg6JzZ90rb3H3nIFiXmUC2G7UvCQbe3okTtQlAOpS/s1600/request.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"></a> Here is likely why the court "never addressed the issue":  they don't have time to address frivolous claims.  Neither does the Superior court that also declined to hear this argument.  (It's actually the defense who never addressed the following in all their filings): From the official publication of the Civil Procedure Rules Committee in the state, effective a decade ago: <div class="MsoNormal"> </div> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg0U6lMWpjedAb5GxPK8VKdmEN5cCoppS1TRPf228O7KvGm60pqw9uTO7kDyM7PFH3T-3hntaHlXp4PBRHB2SVcrtj3I_KWJNd1pnWyqorZ1PymkMNcwjVXxCy3bofu1Gstkqu0aPlRju5H/s1600/COM_rule.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="310" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg0U6lMWpjedAb5GxPK8VKdmEN5cCoppS1TRPf228O7KvGm60pqw9uTO7kDyM7PFH3T-3hntaHlXp4PBRHB2SVcrtj3I_KWJNd1pnWyqorZ1PymkMNcwjVXxCy3bofu1Gstkqu0aPlRju5H/s1600/COM_rule.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">That's pretty clear.  One certificate for non-defendants for whom the defendant is vicariously liable.  Further, a decade ago recommendation 200 also was approved and added to the note; the medical professional providing the justifying statement doesn't even need to name the 'other professionals who deviated.'</td></tr></tbody></table><div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg22mcCEeRXP6J0T8uCwMR_WMYh_KlE4b53G1RbYOYlD415zo2hEdXBlSmsJps5YPBTZ9OgZ8gCvTFht0DJgzk6S6BQumdLpe52okhBxBfjHAURrHMqILHQLpKBw9GjfCLDlSO59dsFgIUB/s1600/COM_rule.jpg" style="margin-left: 1em; margin-right: 1em;"> </a></div> <div class="MsoNormal">The mandated Certificate was timely filed, as was a separate Certificate of Merit for direct corporate liability in the malpractice suit. Further -  from the actual mandated Certificate of Merit document, direct from the State code:</div><div class="MsoNormal"> </div><div class="MsoNormal"> </div><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEixAa3B99m6MO7XethT5ZgWA_TAhXznYeumzRo3sLnqZYl6P989MybhhtxMvtT3ts-7x_SuobMm20p2LRwuNhxOUC5-yrsc86xUxBa-ESfvJL1laqlM65z8ZmzSyJf5caaYUaY7bHN95sDw/s1600/COM.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEixAa3B99m6MO7XethT5ZgWA_TAhXznYeumzRo3sLnqZYl6P989MybhhtxMvtT3ts-7x_SuobMm20p2LRwuNhxOUC5-yrsc86xUxBa-ESfvJL1laqlM65z8ZmzSyJf5caaYUaY7bHN95sDw/s1600/COM.jpg" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">I don't think the Courts expect parties to edit their documents to accommodate their own whims.</td></tr></tbody></table><div class="separator" style="clear: both; text-align: center;"></div><div class="MsoNormal"></div><div class="MsoNormal"> </div><div class="MsoNormal"> The only option for identifying those sued is “Name of Defendant.”  No fields are present specifying “Name(s) of Defendant’s agent, employee (etc.) for whom Defendant is being held vicariously liable”, or similar, nor is some other multi-labeled Certificate of Merit for such purposes in existence.</div><div class="MsoNormal"> </div><div class="MsoNormal">This is some rather inventive lawyering and misuse of court process, either to needlessly prolong the case, or to harass the plaintiff.  The judges will likely not be amused. On the other hand, the delays have allowed me to be able to see and review metadata (e.g., audit trails and other "data about data") produced from the very same EHR system that was in use at this hospital, via my legal support work in another case in the state.  It took time for that production to occur.  This will make it much harder for the hospital to pull the wool over my eyes regarding metadata discovery. That's one reason why I'd been patient with all this. My patience is now long expired. My mother, the original plaintiff, is unavailable for comment.</div><div class="MsoNormal"> </div><div class="MsoNormal">-- SS</div>

More on the lengths a hospital will go through to protect their EHR from discovery

At " The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsiderati...

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CPRIT, Part 7 (Conclusion): Reflections

The story of CPRIT is not over. Revelations and reactions come out almost daily as the power struggles continue. It is ultimately in the legislature's hands what will occur. But the situation is not encouraging. There is no reason to believe that there is a way to put Humpty Dumpty back together again after this fiasco. Nothing I've seen looks at all hopeful about change even though the new CPRIT officials are making compliant noises. The vigorous pro-rapid-commercialization defenses being made are not reassuring. Those who promote a "business" or "engineering" approach to cancer drugs while disdaining scientific evaluation are misguided, but they with probably some sincerity think they are marvelous people who plan to combine "doing good" with "doing well." After all, if Governor Perry had my opinion of the dangers of unproven therapies, he would never have permitted his surgeon to inject him with multiplied stem cells. And, these people are extremely tenacious. The focus seems to be on saying there will be "better management procedures" henceforward and I don't have confidence that will address the impetus to eschew scientific evaluation. There is some hope that some of the earlier monies spent by CPRIT may prove worthwhile, and there is some satisfaction that such a large group of people stood up for the principle that scientific review MUST be a part of deciding what is commercialized. In her resignation letter, Monica Bertagnolli of Harvard Medical School said it best: <blockquote class="tr_bq">In awarding funding, I believe that it is critically important for commercialization potential to be secondary at all times to scientific quality. Many projects that have significant commercialization potential in the short term also lack scientific validity.</blockquote> I would like to shout her last sentence out from the rooftops, or put it on a sign:  Many projects that have significant commercialization potential in the short term also lack scientific validity. When evidence is ignored or suppressed while "products" are put on the market, people are bilked, money is wasted, and very often people are physically harmed as well (cf. Ben Goldacre's sensible reflections on <a href="http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html" target="_blank">Health Care's Trick Coin</a>). The more commercialization without evidence becomes the norm, the more people are injured by bad medicine. Of course, there is another way to look at this. Money out of one person's pocket is indeed money into another person's, and, as Governor Perry astutely observes, this makes for a lot of "wealth creation." (And as he also astutely observes, basic research doesn't always do that.) If we want to make some people very wealthy and our medical system even more ahead of the rest of the world in being most costly -- hey, way to go! If we want to turn a supposed cancer research endeavor into yet another of the Governor's taxpayer-funded slush funds for campaign contributors -- great work!

CPRIT, Part 7 (Conclusion): Reflections

The story of CPRIT is not over. Revelations and reactions come out almost daily as the power struggles continue. It is ultimately in the leg...

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The Story of CPRIT, Part 6: Reactions

There has been a lot of dismay in Texas as all this has become public (with the word "cronyism" being mentioned very frequently). As the Houston Chronicle asked in May: <blockquote class="tr_bq">Why is CPRIT even funding commercial enterprises? Didn't voters expect the bond money to support research?</blockquote>[Answer: Voters did, and there was no mention of commercialization in the ballot measure. Legislators did get language about commercialization into the enabling legislation, however.] Newspapers and bloggers have not been happy with what is going on. Nor have some former supporters. Cathy Bonner, a cancer survivor and activist who had worked hard to get the agency established, said succinctly:  <blockquote class="tr_bq">The vision was to make Texas the center for curing cancer. It wasn't to make Texas the center for capitalizing on cancer.</blockquote> But those in power show few signs of giving ground. After the resignations in October, a joint letter from the governor, lieutenant governor and speaker of the House urged more commercialization: <blockquote class="tr_bq">It is now time for CPRIT to take further steps to fulfill its statutory mission and expedite innovation that will deliver new cancer treatments to patients within three to five years.</blockquote> In an October appearance at CPRIT, Perry stated: <blockquote class="tr_bq">Since CPRIT's creation, you all have helped lay a sound foundation to establish one of the greatest cancer-fighting tools in human history. The challenge that remains before us is to build on that foundation and finally begin curing cancer once and for all. </blockquote>As The Cancer Letter <a href="http://www.cancerletter.com/articles/20121026_1" target="_blank">tartly observed</a> : <blockquote class="tr_bq">This statement could mean either that (a) Perry doesn’t realize that his claim that Texas has done all the basic science required to proceed to cranking out cancer cures would not gain wide traction among scientists and clinicians, or (b) CPRIT has become precisely what the governor and others in Texas politics want it to be: a pot of public money that can be dispensed for commercial or political purposes. <div></div></blockquote><div>Interviewed by the Houston Chronicle in January, Perry <a href="http://eyeonwilliamson.org/?p=12092" target="_blank">continued in the same vein</a>: </div><blockquote class="tr_bq"><div>The way that the Legislature intended it was to get cures into the public's area as soon as possible and at the same time create economic avenues (from) which wealth can be created. Basic research takes a long time and may or may not ever create wealth.</div></blockquote>Matt Winkler, a member of CPRIT's Scientific and Prevention Advisory Council, last week <a href="http://www.statesman.com/news/business/winkler-commercialization-is-the-key-to-new-cancer/nT5GT/" target="_blank">expressed his opinion to the Austin Statesman</a> that the criticism of commercialization -- Winkler prefers the term "product development" -- was totally on the wrong track. "Continuing to short-change commercialization, Winkler said, comes at the expense of patients because money for basic research is unlikely to benefit patients during the 10-year lifetime of CPRIT. Winkler says lawmakers should insist on more investment in commercialization companies, not less." According to Winkler: <blockquote class="tr_bq">Much of the essential basic research that has given us our fundamental understanding of cancer has been done. The challenge now is to fill in the details and to move this knowledge into the clinic.</blockquote> Disagreeing strongly with these ways of thinking,Walt Goodpastor, who lost a son to cancer, <a href="http://www.chron.com/opinion/outlook/article/CPRIT-belongs-to-the-people-of-Texas-4211814.php" target="_blank">angrily wrote</a>:  <blockquote class="tr_bq">I don't know where Perry studied economics. But CPRIT's wealth has already been created. It was created by the productive citizens of Texas. What Perry wants to do is transfer that wealth into the pockets of private corporations.</blockquote><blockquote class="tr_bq">I do not believe the industry is particularly interested in finding true cures. Its business model is based on treating cancer. As in prevention, there is little profit to be made in a cure. Treating cancer provides an ongoing stream of revenue. Curing or preventing cancer would end that revenue stream. </blockquote><blockquote class="tr_bq">I believe that the most bang for our buck would come from awarding grants to independent individual scientists who are working on promising leads.</blockquote> And the Houston Chronicle <a href="http://www.chron.com/opinion/editorials/article/Mission-creep-4196805.php" target="_blank">edito</a><a href="http://www.chron.com/opinion/editorials/article/Mission-creep-4196805.php" target="_blank">rialized on January 15</a>: <blockquote class="tr_bq">To get the most cancer-fighting bang for its bucks, CPRIT ought to focus on important research that private companies won't do: the slow, might-not-pay-off basic research that sometimes yields enormous breakthroughs; and research on cheap therapies and prevention measures - stuff that, even if it works beautifully against cancer, won't yield a patentable, profitable drug.</blockquote><blockquote class="tr_bq">     If there's a high probability that a given line of research will create wealth in a short amount of time, you can bet that a pharmaceutical company will bankroll that project on its own - no government help needed.</blockquote> Nobel laureates Gilman and Sharp, who had led the walkout, wrote <a href="http://www.cancerletter.com/articles/20121019_1" target="_blank">their own editorial</a>, which says in part:  <blockquote class="tr_bq">Texans deserve to hear the truth about cancer. They must understand that miracles will not happen in a short time. Progress will not be made by those who simply proclaim without explanation that they can do better than hundreds of skillfully staffed and well-financed pharmaceutical and biotechnology companies. . .</blockquote><div></div><blockquote class="tr_bq"><div>Reliance on peer review to identify the best science must continue to guide CPRIT in the future. Of course, there are other ways to distribute public funds, but they are worse.  </div></blockquote>

The Story of CPRIT, Part 6: Reactions

There has been a lot of dismay in Texas as all this has become public (with the word "cronyism" being mentioned very frequently). ...

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