ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis

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 Record in Patient Safety Events."  ECRI studied the Pennsylvania Patient Safety Reporting System database for HIT-related errors.   

The ECRI Institute 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.

The full report in PDF is at this link.  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 (link to PPT here) 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:
  

ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis

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, ECRI Institute Patient Safety Organization (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 report and toolkit are available for purchase [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:

• inadequate data transfer from one HIT system to another
• data entry in the wrong patient record
• incorrect data entry in the patient record
• failure of the HIT system to function as intended
• configuration of the system in a way that can lead to mistakes

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 IT Hazards Manager project, 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 free viewing/download. Additional information will be presented in ECRI Institute PSO's Monthly Brief free e-newsletter March edition; go to www.ecri.org/psobrief to sign up. The full report and toolkit are also available for purchase.

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 pso@ecri.org; by fax at (610) 834-1275, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA.

From the free linked TOC document:

Key Recommendations

• Enlist leaders’ commitment and support for the organization’s health IT projects.

• Involve health IT users in system planning, design, and selection.

• Conduct a review of workflow and processes to determine how they must be modified.

• Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration.

• Conduct extensive tests before full implementation to ensure that the health IT system operates as expected.

• Provide user training and ongoing support; educate users about the capabilities and limitations of the system.

• Closely monitor the system’s ease of use and promptly address problems encountered by users.

• Introduce alterations to a health IT system in a controlled manner.

• Monitor the system’s effectiveness with metrics established by the organization.

• Require reporting of health IT-related events and near misses.

• Conduct thorough event analysis and investigation to identify corrective measures.

My comments are these:

• The ECRI study, report and recommendations are quite welcome.

• 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.  

• The study was just 9 weeks long, and with a limited set of healthcare organizations participating.  800 HIT-related events were identified. 

•  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 here), 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 these and these and these and these, and others about which I am providing expert-witness consultation and cannot share.)
  

• 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 "the tip of the iceberg" - i.e., the current level of knowledge of health IT difficulties, defects and harms. 

• The report is yet another red flag for a far more robust (and mandatory, in my view) post-marketing surveillance of health IT.  

• Those who claim these findings are "anecdotes" (as here) are looking increasingly foolish and cavalier.

Finally, readers of this blog have been reading about these issues for years.  You heard it here first.

-- 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 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 this post for source).

From a release at MikeBloomberg.com:

Mayor Bloomberg Announces Expansion of Electronic Health Records Result in Major Health Care Improvements
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.

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 JC, FDA, IOM) 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 these and these and these and these, 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?

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.

Let's hope they don't have an Avatar rerun (link) or Contra Costa meltdown (link, link).

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:

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.

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:

"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."

-- SS

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 Reconsideration of Denial of Objections" 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):

(click to enlarge)

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:

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.'

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:

I don't think the Courts expect parties to edit their documents to accommodate their own whims.

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.

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.

-- SS

AMA News: Dangers of "EHR Sloppy and Paste" - And Why Was An Informatics Expert Apparently For "Anecdotes" Before He Was Against Them?

In the AMA News an article by Kevin O'Reilly appeared entitled "EHRs: “Sloppy and paste” endures despite patient safety risk."

It addresses the dangers of a common feature of EHR's used recklessly:  copy-and-paste.

EHRs: “Sloppy and paste” endures despite patient safety risk

Copying and pasting information is common within EHRs, but the practice sometimes can lead to confusion and endanger patient care.

By Kevin B. O'Reilly, amednews staff. Posted Feb. 4, 2013.

During the winter holidays, a patient at Yale-New Haven Hospital in Connecticut had a large pressure ulcer with an abscess. A surgical intern made a note in the patient’s electronic health record that said, “Patient needs drainage, may need OR.”

The problem? The same note appeared for several consecutive days, even after a surgical team successfully drained the abscess. The intern had copied and pasted the previous day’s note, but failed to appropriately update it to reflect the fact that the drainage was done. The note confused the consulting infectious disease team and nearly led to an unneeded change in the patient’s antibiotic regimen.

That's somewhat ironic.  I performed my postdoc at Yale Center for Medical Informatics where we discussed.among other issues, potential drawbacks of badly-designed or implemented EHRs.   Unfortunately, I hear from people who've left that the Center is relatively marginalized these days with respect to influence.  (Actually, the marginalization goes way back; if they'd listened to us in the mid 1990's they might have avoided this multimillion-dollar federal lawsuit for billing fraud.)

Mr. O'Reilly continues:

The practice of carelessly copying and pasting previous information, often dubbed “sloppy and paste,” is on the decline at Yale-New Haven Hospital but is widespread across medicine and can lead to mix-ups that sometimes harm patients, research shows.

“It’s especially problematic when you have multiple teams taking care of the patient and we’re communicating through the chart, which happens very often nowadays because physicians don’t see each other as often as we used to,” said Dr. Horwitz [General internist Leora Horwitz, MD], assistant professor of medicine at Yale University School of Medicine. “We do rely on the chart in many cases, and it can lead to genuine confusion.”

When you rely on an information system and the information system contains incorrect information (for whatever reason), patients are put at risk.  That the systems are implemented without simple controls on copy-and-paste (such as permanently embedding substantive metadata in the output) is a significant flaw.

From Sec. II of Aguilar v. Immigration and Customs Enforcement Div. of U.S. Dept. of Homeland Sec. 2008 WL 5062700 (S.D.N.Y. Nov. 21, 2008), available at this link:

... Substantive metadata, also known as application metadata, is “created as a function of the application software used to create the document or file” and reflects substantive changes made by the user. Sedona Principles 2d Cmt. 12a; Md. Protocol 26. This category of metadata reflects modifications to a document, such as prior edits or editorial comments, and includes data that instructs the computer how to display the fonts and spacing in a document. Sedona Principles 2d Cmt. 12a. Substantive metadata is embedded in the document it describes and remains with the document when it is moved or copied. Id

Microsoft Word's "Track Changes" feature is an example of substantive metadata being displayed.

The available stats on the phenomenon are of great concern:

... A study in February’s Critical Care Medicine found that copying and pasting is the rule in EHRs rather than the exception.

Using a software program that can detect identical matching word sequences, researchers examined the assessment-and-plan portions of more than 2,000 progress notes for 135 patients created by 62 residents and 11 attending physicians working in a Cleveland medical intensive care unit. For the residents, 82% of the notes contained 20% or more copied text, while 74% of attending doctors’ notes also exceeded that rate of copying and pasting.

A similar study in the January-February 2010 issue of Journal of the American Medical Informatics Assn. found a copy-and-paste rate of 78% in sign-out notes generated by internal medicine residents. The rate of copied text in progress notes was 54%, the study said.

An example of physician embarrassment at relaying quite outdated information to a patient's family due to repeated note-copying was cited, and then a case of actual harm:

... Other times, patients are harmed. In a July/August 2007 case study in AHRQ WebM&M, an online patient safety journal, William Hersh, MD, described the case of a 77-year-old woman hospitalized for diarrhea and dehydration after chemotherapy.

An intern noted that the patient would receive heparin to prevent venous thromboembolism. The note was copied and pasted for four days in a row and signed by a resident and an attending physician, who appeared to believe the heparin had been ordered and administered. Ultimately, the patient was discharged without ever receiving the preventive medicine and two days later was rehospitalized and diagnosed with a pulmonary embolism. Only then did physicians realize the patient never got the correct prophylaxis.

“The problem is getting worse now with the rise of EHRs,” said Dr. Hersh, professor and chair of the Dept. of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland.

That caught my eye.

This is the same Dr. Hersh who in Sept. 2010 in an American Medical Informatics Association mailing list, regarding the issue of risk and "anecdotes", accused me of not knowing my field, as I documented at this link:

... At "Health IT: On Anecdotalism and Totalitarianism" I posted these thoughts:

At the article Blumenthal on EMRs: Debate "raging" over competition vs. standards, ONC czar David Blumenthal is cited as saying several interesting things:

... EMRs make him a better physician, he said, recounting personal anecdotes of discovering patients' allergies through automated EMR alerts and using stored image date to more quickly get a diagnosis for a patient without subjecting them to more radiation and toxic radiation agents ...

It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").

Yet anecdotal reports of EMR "saves" are used by a czar to justify tens of billions of dollars of expenditures?

To the anecdotalists, I say: you can't have it both ways.

I also posted nearly the same complete Healthcare Renewal post to several mailing lists of the American Medical Informatics Association including the Clinical Information Systems working group (CIS-WG). CIS-WG is a mailing list read by something over 1000 healthcare informatics professionals at last time I had access to the statistics a few years ago.

I received some supportive replies from colleagues, including collaborators on the AHIMA (not AMIA) book we co-authored in 2009 entitled "H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations" - itself not exactly a popular exercise among the strictly positivist informatics leadership class.

Now, I thought my posting on the double standard regarding "anecdotes" highly straightforward. From a high ranking academic leader of a major national informatics program, Bill Hersh at OHSU, however, the following reply was posted:

Scot,

For someone who is a faculty in informatics, I am surprised at how unfamiliar you are with the literature. There is solid evidence, much more than anecdotes, on the efficacy of health IT. Even Dr. Blumenthal himself has posted on that. (I think you are taking this quote out of context.

I am then served a platter of literature I must be "unfamiliar with" such as:

Goldzweig, C., Towfigh, A., et al. (2009). Costs and benefits of health information technology: new trends from the literature. Health Affairs, 28: w282-w293.

[Note - I had commented on and linked to this very article at this Aug. 29, 2010 post - ed.]

Garg, A., Adhikari, N., et al. (2005). Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. Journal of the American Medical Association, 293: 1223-1238.

Amarasingham, R., Plantinga, L., et al. (2009). Clinical information technologies and inpatient outcomes: a multiple hospital study. Archives of Internal Medicine, 169: 108-114.

Longhurst, C., Parast, L., et al. (2010). Decrease in hospital-wide mortality rate after implementation of a commercially sold computerized physician order entry system. Pediatrics, 126: 14-21.

Now, aside from the serious breach of academic etiquette of attacking the competence of your colleagues in a public forum, I seem to be hearing that it's OK to purvey positive anecdotes about health IT (usually based on weak retrospective observational studies alone, not randomized clinical trials), but not anecdotes of HIT malfunctions or of HIT-related adverse outcomes, since there's 'solid evidence' of the efficacy of health IT.

In plain English, an ad hominem fallacy is followed by an appeal to authority of sorts ("the literature") to justify public Pollyanna attitudes towards HIT by high ranking officials. And since the literature is so glowing, negative anecdotes must be of low worth.

I never received an apology for this.  Apparently Dr. Hersh was for "anecdotes" before he was against them.

I've had an email exchange with him just a little while ago on this, and his expressed point of view is that:

"After all these years, you still do not understand what I am saying. Kinda sad, actually.  Anyways, there is a role in medical science for anecdotes, sometimes called case reports. [Conflation of science and risk management is quite apparent here; see Australian essay linked below - ed.]  They are, however, the least strong type of evidence. We make inferences and broad pronouncements about them at our own peril, though you seem to do this years after your one anecdote [my mother's death from a 2010 accident - ed.], which I have always acknowledged was personal and devastating to you."

Readers of this blog will probably be puzzled at the implication that my "one anecdote" is all that I am 'making inferences' about.  (Actually, I am making recommendations about caution traditional in medicine.)  I leave it to readers to decide as to why an informatics program director and AMIA leader would make such a statement.

My reply was polite, reminding Dr. Hersh that my writings on HIT problems began in 1998, not 2010, and were largely ignored by the informatics and HIT community (other than "iconoclasts").  I included the recent Modern Healthcare article "HIT Iconoclasts" and a link to the post about anecdote vs. science at "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" here.

That is all I can and will do.

That said, I find the statement "We make inferences and broad pronouncements about [anecdotes, sometimes called case reports] at our own peril" rather remarkable on its face.

The reverse actually applies in my opinion.  In medicine, with its ethical considerations and obligations, and especially in the domain of EHR's with its known, reported, systematic impediments to adverse information diffusion per JC, FDA, IOM and others, the following is true:

"We" (well, not I) actually fail to make repeated anecdotes (like these and these and these and these, and others I cannot talk about due to case settlements) a top priority as a red flag for systemic, rigorous investigation, e.g., formal, transparent HIT premarketing evaluation and postmarket surveillance and a regulatory infrastructure, at patients' peril.

And, in case anyone was wondering, it's not exactly endearing to refer to the death of someone's mother as an "anecdote" or even a "case report", but I digress.

The AMA News article continues:

HHS OIG (Office of the Inspector General) announced that it plans to review multiple EHR notes for the same patient by the same physician to see whether doctors are copying and pasting the identical note from visit to visit. The practice is sometimes called cloning and could be implicated in fraudulent coding and billing practices.

That might serve to partially stem the process, but the HHS OIG's resources are not infinite.

The article concludes:

John Halamka, MD, calls for a more radical fix.

“The way we document in medicine has grown up over decades for medical reasons, for billing, for medical-legal justification,” said Dr. Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston. “You wind up with 17 pages of replicated and duplicated and challenging-to-read documentation. I propose we blow up the way we do documentation altogether and replace it with a Wikipedia-like structure.”

Such an approach would allow physicians to edit the progress note collaboratively, just as the popular open-source encyclopedia is updated. Dr. Halamka hopes to pilot-test the idea within the next year. “With that concept, you wouldn’t ever really need to copy and paste,” he said.

An interesting concept and experiment.  My questions:

• Do we first rigorously investigate and understand the causes of the copying, i.e., cryptic and difficult-to-use data entry methods that significantly slow clinicians down?  

• Do we get informed consent from patients for the experiment?

• If so, what do we tell them?  We are conducting an experiment in charting, risk unknown, to solve cheating and risks due to poorly-designed EMRs?

• Would not simpler solutions (such as the embedded-metadata identifiers indicating text has been copied as I described above)  be important to implement first, before experimenting with medical documentation?

That said, I believe the practice - an unintended and potentially adverse side effect of a new information technology, HIT - must stop.  I think Mr. O'Reilly makes that point clear.  Read his article at the link above.

-- SS

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

My mother was injured and then died as a result of an EHR foul-up.  She sued the hospital where the mid-2010 accident occurred while she was still lucid, and I am now substitute plaintiff.  Yet the case has been held up through the defense (mis)using court process to stall.

It seems the lengths a hospital will go to in order to protect their EHRs (i.e., from Discovery by an expert such as myself, which could show many problems) are amazing.

To wit, their latest filing, in an attempt to throw a monkey wrench into the gears of the legal discovery process:

2/1/2013

Motion

BY [redacted] HOSPITAL MOTION FOR RECONSIDERATION OF JANUARY 17, 2013 ORDER DENYING MOTION FOR RECONSIDERATION OF COURT ORDER DATED JUNE 22, 2012 WITH MEMORANDUM OF LAW WITH SERVICE ON 02/01/2012

They've filed a motion asking the Court to reconsider its decision that denied their mid-2012 motion asking the Court to reconsider its denial of their objections to the legal paperwork.

Yes, that probably needs to be read several times in order to be understood; I cannot simplify it any further ...

The new motion is a mere 521 pages in length (the original Motion for Reconsideration was a slim 485; of course they charge the hospital by the hour for document preparation and electronic filing with the Court).

The major objection about the paperwork is, in essence, that a "Certificate of Merit" (a certification of case merit by a qualified medical professional) needed to be filed not just for Defendant (the hospital) but for each and every employee/agent for whom the Defendant is vicariously liable under the doctrine of Respondeat Superior:

Respondeat superior (Latin: "let the master answer"; plural: respondeant superiores) is a legal doctrine which states that, in many circumstances, an employer is responsible for the actions of employees performed within the course of their employment. This rule is also called the "Master-Servant Rule", recognized in both common law and civil law jurisdictions.

A major problem with this claim is that the law simply says otherwise.  Also, Certificates of Merit have, under the identification field where the sued party's name is penned in, the label "defendant" ... not "defendant, employees, agents, their uncles and aunts, and their little dogs too for whom defendant is vicariously liable."  Not to mention, among other issues, that such misconceptions are specifically put to rest by the actual Civil Procedural Rules Committee rules as published by the state's court administrative body:

"The [certificate of merit] rule requires the filing of only a single certificate of merit as to a claim against a defendant that is based on the activities of licensed professionals who are not named in the action."

Such a certificate was timely filed.  In fact, one Certificate was timely filed against the defendant hospital for corporate negligence, and another timely Certificate was filed for defendant's vicarious liability.

That's why the court threw out the objections, and the Motion for Reconsideration of its denial of the objections..

In defense of their position that Certificates for each person for whom the defendant is vicariously liable should have been filed (which is an especially frivolous argument since there is a statement in the law that they do not need to be named), the hospital defense ignored all plaintiff's arguments regarding the filing of the Certificates of Merit such as above.  It then cites two cases where the Certificates of Merit were filed over a year late (there is a 60 day limit) or not filed at all.  

But they didn't stop there.  The defendants also wanted the (local) court to 'certify' (give permission for) them to appeal the denial of their objections to Superior Court (the certification may be done if the issues at law are felt possibly controversial).  The local court threw that request out, too.

The defense appealed to Superior Court anyway, apparently claiming manifest injustice was done by the local court.  Several hundred more pages, more fees.  The Superior Court dismissed the appeal - or, perhaps stated more accurately, refused to even consider it.

All this eats up time.

Now, I'm not an attorney, nor do I have access to the major legal databases.  However, Google is getting to be very good at pulling up legal cases due to its indexing of many other resources, such as legal books and publications and public case docket repositories.

When I Google "Motion for Reconsideration of Denial of Motion for Reconsideration" or "Motion for Reconsideration of Motion for Reconsideration", very little comes up.  One case is from the early 1990's in the High Court of American Samoa. (If you know where that is without looking it up, you're more geographically literate than I.)

When all else fails ... throw a monkeywrench into the Wheels of Justice  ... and be paid handsomely for it!

The Defense stalling maneuvers have served to help me advise other Plaintiff's attorneys in EHR-related medical malpractice and evidence spoliation matters (the motion above will be presented at my upcoming talk at the American Association for Justice Winter Conference in Florida as an example of how far a hospital will go to protect their EHR).  

The stalling has also been serving as a useful learning experience for me regarding the working of the Court system, enhancing my abilities to assist the Plaintiff's side.  Perhaps I should be paying tuition to the Defense in my mother's case ...

(The Plaintiff's Bar - and injured patients - need help.  I have, for instance, learned in sworn testimony of hospital IT experts that some major commercial EHR's permit a clinician to alter their notes prior to their final "signoff" and resultant "record lock" -- which can be days later -- without leaving an electronic trail or any evidence whatsoever of the changes.  I have learned that some EHR's permit late-entered notes to appear in apparent chronological sequence in an EHR printout with whatever apparent time is desired.  I have learned that the audit trails and other metadata themselves of major commercial EHRs can be altered by someone with sufficient database privileges with no trace, save for perhaps database engine transaction logs on backup tapes, highly difficult to retrieve.)

In effect, one motive for hospitals to acquire EHR's might be the EHR's abilities to facilitate "retroactive risk management" through, in essence, alteration of history.

Finally, I hope I won't have to see a "Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of objections to the paperwork."

-- SS

How the HIT zealots and profiteers have harmed physicians and nurses, not to mention patients, taxpayers, and the government

Any new technology introduced into a complex system, especially when introduced recklessly, has the potential to produce unexpected consequences, and the problems introduced can be worse than the problems the technology was attempting to solve.  This is a fundamental precept and empirical observation in the field of social informatics, a domain that studies information and communication tools in their cultural or institutional contexts.

Idealism combined with zealotry (excess of zeal; fanatical devotion) and/or hyper-enthusiasm that ignores the downsides of an intervention, and silences credible critique,  has also proven to be a dangerous combination.

Characteristic of the health IT hyper-enthusiasts been zealotry, silencing of credible critics, and spreading of illusory memes and technologies not yet fit for purpose; the characteristics of HIT profiteers is similar but for a different motive.  The end result in either case is harm to the interests and well-being of patients, physicians and nurses and other clinicians, taxpayers, and the government.

(Doctors and nurses ... after reading the findings below, be prepared to countersue the health system officers who mandated your use of EHR's for breach of fiduciary responsibilities, including due diligence, if you are sued for EHR-caused medical malpractice.)

---

Medscape 
Business of Medicine
Malpractice 'Discovery' Dangers in Your EHR
Leslie Kane, MA
Jul 16, 2012

Introduction

Picture this: You've been sued, and now the plaintiff attorney has the right to send in an expert to sit at your computer and examine information in your electronic health record (EHR). Besides any mistakes you might have made, system-wide bugs or design flaws that lead to data inconsistencies could be found and held against you in the discovery phase of a malpractice lawsuit.

Doctors are becoming increasingly aware that EHRs can create certain malpractice risks. However, an expert in EHR and liability says there is a new category of malpractice risks in EHRs that most doctors have never considered. These include EHR system issues that you were never aware of and didn't cause.

You may have been coerced into using the EHR system via threat of Medicare cuts -- embedded without a public comment period in the HITECH section of ARRA thanks to the zealots and profiteers -- or via draconian hospital policies set by senior executives that threaten adverse personnel actions or other retaliation for those who refuse to use or are unable to learn to "effectively" use the corporate-chosen EHR (I have seen such policies in print).

These executives have simply taken the word of the sellers that the technologies are harmless, and have likely negligently signed hold-harmless agreements with the sellers as a symbol of their confidence in the assessment.

"Every aspect of EHR selection, implementation, and use may be examined in the course of medical malpractice discovery to uncover the source of the incident, or undermine the records that are being presented in defense of the malpractice claim," says Ronald B. Sterling, CPA, MBA, national EHR expert, Silver Spring, Maryland, and author of Keys to EMR Success (Greenbranch Publishing; Phoenix, Maryland; second edition, 2010). "Anything could be a malpractice issue, from the product itself, the way it was set up, or how you've been using it."

The same applies, I add, to any technology a clinician or healthcare facility might introduce into practice.

For example, authorized software upgrades can unknowingly cause liability problems. Upgrades to the software can change the historical data presentation you've already worked with. "An EHR upgrade can go back and affect data being stored for a patient," says Sterling. "The upgrade can affect the presentation and the reporting and usage of that information. I'm aware of upgrades in which a large amount of data was lost."

I'm aware of numerous "upgrades" that nearly caused catastrophes - in fact they may have caused catastrophes that were not publicized- such as here.

"Even if the practice does everything perfectly, there could be design flaws in the electronic health record or the way the practices uses it or sets it up. This gets exposed in the light of discovery during a malpractice suit. If the plaintiff attorney spots errors in the record -- even if the system, not the physician, creates them -- it calls into question every record you produce and every statement you make."

Considering the evidence spoliation that can and does occur thanks to electronic systems, of which I am becoming aware of an increasing number of incidents, discrepancies ("errors" in the record) should arouse suspicions.   Those "hold harmless" agreements should look less and less appealing....

... "There are all kinds of issues I can now delve into, more than I'd find in the paper world. In the paper world, there is not a lot of supporting information," he says. "However, with an EHR, you can see what time each event or note happened, whether it was before or after another event. These could become critical points in a trial."

Thank the zealots for this, docs.

Sterling described several types of problems that could create difficulties for a doctor in a malpractice liability case.

... System or product bugs (defects). One doctor was using an EHR that had inherent errors in it. It wasn't documenting information correctly. The information being entered was not being stored in the right location, and the patient's medical note was ultimately incorrect. "This now calls into question anything in the note, even if you did the right thing," says Sterling.

Caveat emptor.

Transferring paper records to EHR. What happens to the patient's history that was stored in the paper medical chart? The new EHR form may not specifically account for or match up with every notation you have in the old medical chart. If some information doesn't get transferred in, the plaintiff attorney may ask, "Did the doctor have the full picture of the patient's condition?" The discovery process may include comparing the patient's old paper record (if you still have it) with the history now in the EHR.

Signing notes. Some doctors don't sign their notes. This creates a problem with billing, but it also could prompt the question of whether the doctor actually provided those services to the patient.

The zealots never considered these issues, or didn't care.   "You're going to use EHR's whether you like it or not, because they WILL transform medicine.  So say we all."

... One physician was inadvertently distributing clinical notes that included inappropriate findings (such as results of tests that would not have been given to that patient). When the note was challenged during a malpractice trial, it called the patient's entire record into question.

"Unfortunately, the physician had been using software that contained the test setups from the vendor," explained Sterling. "He was recording information on the screen and printing it, and the printed copy was appropriate when he gave it to the patient, but the electronic record contained inappropriate findings and events. Because the doctor was using the forms that contained the original test data (even though the data were not quite visible), the EHR incorporated these old findings."

Just a "glitch", of course.  

One template affects other screens. When you use templates and you're charting by exception, you're viewing 1 screen. But when you check off items in the box, it sends those data to 5 or 6 other screens, and you may not be aware that the information is now contained on those screens. A doctor may decide to remove the information on 1 screen, but that deleted information has already populated 6 other areas and is still in the patient's medical record.

Why would one expect that using tools of grossly inappropriate provenance would not create problems?

Usage issues. The vendor stored it one way, but the doctor stored information another way, which changed the location in which information was stored. The historical record actually changed.

"What happened when the doctor could not produce the record he gave to the patient because it no longer existed?" asked Sterling. "The attorney would look at it and say, 'This is not the piece of paper you provided.' "Any of these could be the killer issue that ends your chance of successfully defending yourself in a malpractice trial," he says.

Sure, EHRs will 'revolutionize' medicine, once the EHRs actually don't introduce booby-traps to the practice of medicine exposing clinicians to the revolutionary guillotine.

Vendor Says, "Not My Fault!"

One might think that a product defect or design flaw should be the responsibility of the vendor, and the doctor should be held harmless for those types of errors. But it doesn't work that way.

"The doctor can be held liable because most vendors' contracts (signed by the physician) essentially say, 'We do not practice medicine; it is up to the physician to make sure this EHR is being used correctly.' The practices have to understand what they're using and verify that the system is appropriately set up to document the care they provide."

I note that doctors forced to use hospital EHR's never see nor sign those contracts.

In a trial, the doctor would be held responsible for product problems.

But just as scary, doctors could be held responsible for following vendor instructions. "I've seen situations in which the vendor tells doctors to do something, and doctors are relying on vendor and not doing their own proper analysis and design of the EHR that's tailored for their own practice," says Sterling. "The vendor is not the one responsible for maintaining the patient's medical record."

More than $20 billion of taxpayer "incentive" money has already gone to the accountability-free sellers of this technology, I might add. 

Bad News: You Need to Delve Into Technicalities

Most doctors are unprepared to explore the technical elements of working with an EHR. "Doctors have to understand what happens when you push the buttons," says Sterling. That means they have to take the time to work with the EHR and explore various screens and scenarios before they ever use it with a patient.

It would help to have people who actually know what they're doing around, a lesson hospitals have not yet fully learned when they depend on grossly inappropriate personnel of a business-computing background to lead HIT projects and make critical decisions on vendor contracts.

In summary, the HIT hyper-enthusiasts and profiteers have successfully conned the government and healthcare sector into using, or coercing clinicians to use, technologies unproven to provide the fantastical levels of clinical and financial benefit claimed (as in many other posts), that introduce booby-traps to users' legal safety, that can be injurious to patient safety, and that suck money from healthcare that could be better used in, say, care of the underserved.

What an enviable arrangement for the enthusiasts.

-- SS

New York Times: "In Second Look, Few Savings From Digital Health Records", and AMA Med News on EHR Harms

This post should perhaps be entitled "I told you so."

A letter I wrote in response to the Wall Street Journal's "A Health-Tech Monopoly", Feb. 11, 2009 was published Feb. 18, 2009 under the header Digitizing Medical Records May Help, but It's Complex.

I wrote:

Dear Wall Street Journal,

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

I also had penned essays on the need for a moratorium on HITECH (Nov. 2008, "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and Jan. 2009, "I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?").  My theme was that the issues with implementation of good health IT and elimination of bad health IT, and the issue of how to implement most efficiently, needed to be better understood before a national rollout.  Hold off multi-billion dollar national initiatives "until we know how to get HIT right", I wrote.

Now the New York Times has this, citing a new RAND paper:

In Second Look, Few Savings From Digital Health Records
By REED ABELSON and JULIE CRESWELL

January 10, 2013

The conversion to electronic health records has failed so far to produce the hoped-for savings in health care costs and has had mixed results, at best, in improving efficiency and patient care, according to a new analysis by the influential RAND Corporation.

Optimistic predictions by RAND in 2005 helped drive explosive growth in the electronic records industry and encouraged the federal government to give billions of dollars in financial incentives to hospitals and doctors that put the systems in place.

“We’ve not achieved the productivity and quality benefits that are unquestionably ["unquestionably?" why?- ed.]  there for the taking,” said Dr. Arthur L. Kellermann, one of the authors of a reassessment by RAND that was published in this month’s edition of Health Affairs, an academic journal.

Noted is the provenance of the 2005 report that created the windfall for the electronic records industry:

RAND’s 2005 report was paid for by a group of companies, including General Electric and Cerner Corporation, that have profited by developing and selling electronic records systems to hospitals and physician practices. Cerner’s revenue has nearly tripled since the report was released, to a projected $3 billion in 2013, from $1 billion in 2005.

A retraction:

The report predicted that widespread use of electronic records could save the United States health care system at least $81 billion a year, a figure RAND now says was overstated. The study was widely praised within the technology industry and helped persuade Congress and the Obama administration to authorize billions of dollars in federal stimulus money in 2009 to help hospitals and doctors pay for the installation of electronic records systems ... But evidence of significant savings is scant, and there is increasing concern that electronic records have actually added to costs by making it easier to bill more for some services.

In my Feb. 2009 WSJ letter, I'd written that "it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants."  It appears I was correct.

Officials at RAND said their new analysis did not try to put a dollar figure on how much electronic record-keeping had helped or hurt efforts to reduce costs. But the firm’s acknowledgment that its earlier analysis was overly optimistic adds to a chorus of concern about the cost of the new systems and the haste with which they have been adopted.

Not mentioned are harms that bad health IT is creating.

The recent analysis was sharply critical of the commercial systems now in place, many of which are hard to use and do not allow doctors and patients to share medical information across systems. “We could be getting much more if we could take the time to do a little more planning and to set more standards,” said Marc Probst, chief information officer for Intermountain Healthcare, a large health system in Salt Lake City that developed its own electronic records system

A "little more" planning?  How about several years' worth, to ensure the technologies are safe, effective and properly vetted, along with a system for post-market surveillance as exists in other healthcare sectors?

Technology “is only a tool,” said Dr. David Blumenthal, who helped oversee the federal push for the adoption of electronic records under President Obama and is now president of the Commonwealth Fund, a nonprofit health group. “Like any tool, it can be used well or poorly.” While there is strong evidence that electronic records can contribute to better care and more efficiency, Dr. Blumenthal said, the systems in place do not always work in ways that help achieve those benefits.

Dr. Blumenthal seems to be triangulating from his earlier 2010 NEJM statement that:

... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

Meantime, in the real world signs of my expressed concerns about a quagmire are appearing:

... Late last year, a physician practice in Panama City, Fla., filed a lawsuit against the health care technology firm Allscripts after the company stopped supporting an electronic records system called MyWay that it had sold to 5,000 small-group physicians at a cost of $40,000 per physician. The lawsuit said that the system had problems and that the physician group was unable to meet the criteria for federal incentive money. A spokeswoman for Allscripts said it would defend itself vigorously.

A clue as to the candidness of the new report:

... The new analysis was not sponsored by any corporations, said Dr. Kellermann, who added that some members of RAND’s health advisory board wanted to revisit the earlier analysis.

Finally, this from the horse's mouth:

Dr. David J. Brailer, who was the nation’s first health information czar under President George W. Bush, said he still believed tens of billions of dollars could eventually be squeezed out of the health care system through the use of electronic records. In his view, the “colossal strategic error” that occurred was a result of the Obama administration’s incentive program.

I repeat my admonition from 2009 that I can only hope patients get something worthwhile for the $20 billion, which by now is probably many times that amount.

Finally, I note the American Medical News cites me in a Jan. 14, 2013 article as follows:

... Other experts on health IT said the Pennsylvania [PA Patient Safety Authority] study probably underestimates the extent of health IT safety problems. They say that is because the research is based on voluntary reports and that health professionals are unaware that a patient safety incident was caused by an EHR failure.

“These systems are incredibly complex,” said Scot M. Silverstein, MD, a consultant in medical informatics at Drexel University in Philadelphia. “They’re not just huge filing cabinets, they are enterprise resource management systems. There are many ways that things can go wrong that may not be seen as the computer having caused the mess-up in the first place.”

For example, he said, it would be difficult for a practicing physician to detect when data are missing from a record or that an alert failed to pop up.

Yet the title of the article is "EHR-related errors soar, but few harm patients" with a table at the bottom labeled "How rarely EHR problems harm patients." More evidence that EHRs always receive special accommodation. 

I was an invited reviewer of the PA Patient Safety Authority report, and wrote about the major deficiencies of its dataset at my posts Dec. 13, 2012 post "Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events" and a follow-up Dec. 19 post "A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk."

My major point was that one simply cannot know what one cannot know, when using a very incomplete dataset gathered in a setting of systematic impediments to accuracy and completeness.  For instance, as I wrote in those earlier posts, through my work I personally know of cases of harms up to and including death that should have been in the PA database, but apparently are not - and I'm just one person.

We simply don't know in 2013 how many EHR errors harm patients, and the effects of increasing adoption by organizations and physicians less technology-able than current adopters.  I hope the magnitude of harms is truly small, but hope is not enough; this study and report was just a 'dipping of the toes into the water' towards understanding the realities.

Incidentally, we also don't know how severely the known toxic effects of bad health IT might affect care in times of duress, e.g., an epidemic.  However, I am certainly not sanguine about EHRs in their present state as robustly facilitating national emergency preparedness.

My dreaded prediction for the future?  A 2016 AMA News story entitled "Known EHR-related harms soar."

-- SS

A Significant Additional Observation on the PA Patient Safety Authority Report "The Role of the Electronic Health Record in Patient Safety Events" -- Risk

At a Dec. 13, 2012 post "Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events" I alluded to risk in a comment in red italics:

... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) [a risk best avoided to start with, because luck runs out eventually - ed.], and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event. 

The focus of the report is on how the "events" did not cause harm.  Thus the relatively mild caveat:

"Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure."

It occurs that if the title of the paper had been "The Role of the Electronic Health Record in Patient Safety Risk", the results might have been interpreted far differently:

In essence, from from June 2, 2004, through May 18, 2012 (the timeframe of the Pennsylvania Patient Safety Reporting System or PA-PSRS database), from a dataset highly limited in its comprehensiveness as written in the earlier post, there were approximately 3,000 "events" where an error did occur that potentially put patients at risk.

That view - risk - was not the focus of the study.  Should it have been?

These "events" really should be called "risk events."

It is likely the tally of risk events, if the database were more comprehensive (due to better recognition of HIT-related problems, better reporting, etc.) would be much higher.  So would the reports of "harm and death" events as well.

That patient harm did not occur from the majority of "risk events" was through human intervention, which is to say, luck, in large part

Luck runs out, eventually.

I have personally saved a relative several times from computer-related "risk events" that could have caused harm if I were not there personally, and with my own medical knowledge, to have intervened.  My presence was happenstance in several instances; in fact a traffic jam or phone call could have caused me to have not been present.

What's worse, the report notes:

Analysts noted that EHR-related reports are increasing over time, which was to be expected as adoption of EHRs is growing in the United States overall.

In other words, with the current national frenzy to implement healthcare information technology, these "risk events" - and "harm and death events" - counts will increase.  My concern is that they will increase significantly.

I note that health IT is likely the only mission-critical technology that receives special accommodation regarding risk events.  "If the events didn't cause harm, then they're not that important an issue" seems to be the national attitude overall.

Imagine aircraft whose avionics and controls periodically malfunction, freeze, provide wrong results, etc., but most are caught by hyper-vigilant pilots so planes don't go careening out of control and crash.  Imagine nuclear plants where the same occurs, but due to hypervigilance the operators prevent a nuclear meltdown.

Then, imagine reports of these "risk events" - based on fragmentary reporting of pilots and nuclear plant operators reluctant to do so for fear of job retaliation - where the fact of their occurrence takes a back seat to the issue that the planes did not crash, or Three Mile Island or Chernobyl did not reoccur.

That, in fact, seems to be the culture of health IT.

I submit that the major focus that needs addressing in health IT is risk - not just confirmed body counts.

-- SS

Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events

The Pennsylvania Patient Safety Authority has released a report "The Role of the Electronic Health Record in Patient Safety Events."  A press release is at this link, and the full report in PDF is at this link.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database of reported medical errors and identified several major themes.

The report was prepared with the assistance of Erin Sparnon, Senior Patient Safety Analyst the ECRI Institute near Philadelphia.  The ECRI Institute 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 techonlogies.

Regarding the Patient Safety Authority:

The Pennsylvania Patient Safety Authority was established under Act 13 of 2002, the Medical Care Availability and Reduction of Error ("Mcare") Act, as an independent state agency. It operates under an 11-member Board of Directors, six appointed by the Governor and four appointed by the Senate and House leadership. The eleventh member is a physician appointed by the Governor as Board Chair.  Current membership includes three physicians, three attorneys, three nurses, a pharmacist and a non-healthcare worker.

The Authority is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and certain abortion facilities. Under Act 13 of 2002, these facilities  must report what the Act defines as "Serious Events" and "Incidents" to the Authority.

The Authority maintains a database of serious events and incidents:

Consistent with Act 13 of 2002, the Authority developed the Pennsylvania Patient Safety Reporting System (PA-PSRS, pronounced "PAY-sirs"), a confidential web-based system that both receives and analyzes reports of what the Act calls Serious Events (actual occurrences) and Incidents (so-called "near-misses").

Cutting right to the chase, the paper's summary:

As adoption of health information technology solutions like electronic health records (EHRs) has increased across the United States, increasing attention is being paid to the safety and risk profile of these technologies. However, several groups have called out a lack of available safety data as a major challenge to assessing EHR safety, and this study was performed to inform the field about the types of EHR-related errors and problems reported to the Pennsylvania Patient Safety Authority and to serve as a basis for further study. Authority analysts queried the Pennsylvania Patient Safety Reporting System for reports related to EHR technologies and performed an exploratory analysis of 3,099 reports using a previously published classification structure specific to health information technology. The majority of EHR-related reports involved errors in human data entry, such as entry of “wrong” data or the failure to enter data, and a few reports indicated technical failures on the part of the EHR system. This may reflect the clinical mindset of frontline caregivers who report events to the Authority.

Results:

... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) [a risk best avoided to start with, because luck runs out eventually - ed.], and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event. Fifteen reports involved temporary harm to the patient due to the following: entering wrong medication data (n = 6), administering the wrong medication (n = 3), ignoring a documented allergy (n = 2), failure to enter lab tests (n = 2), and failure to document (n = 2). Only one event report, related to a failure to properly document an allergy, involved significant harm.

A significant "study limitations" section was included that addressed: 

• Issues regarding reporting statutes of the PA-PSRS errors database; 

• lack of awareness of EHRs as a potential contributing factor to an error;

• limitations of narrative reporting affecting both the types of reports queried and the tags applied (the study used textual data mining methodolgies);

• query design of the study; and

• the need for further refinement of the machine learning tool used in creating the working dataset, which may have missed relevant cases.

Some of these impediments to knowing the magnitude of extant HIT issues are also present in the 2008 Joint Commission Sentinel Events Alert on HIT, the 2010 FDA internal memorandum on HIT Safety, and the 2011 IOM report on the same topic.

(The IOM report specifically observed that the "barriers to generating evidence pose unacceptable risks to safety.") 

The major obstacle to this study in my view, though, was the nature of the dataset.  The database is for general reporting of medical errors, and it contains no specific fields or reminders about EHRs or the known ways in which they can contribute to, or cause, medical mistakes.  

The attempt was made, as acknowledged in the study, to glean information about EHR-related events from, in large part, textual analysis of narrative in the hopes that the reporter recognized the role of IT, and reported it using terms that could be detected by the search algorithms.  In other words, the data was not "purposed" for this type of study.  

It is axiomatic that one cannot find data that is simply not present, no matter how fancy the search algorithm.  Further, passive analysis of clinical IT risk/harms data in an industry where lack of knowledge of causation and misconceptions abound will produce only partial results that suggest further study is needed, and not give an indicator of just how incomplete the results are.

Thus, this cautionary statement was made in the new PA Patient Safety Authority report:

"Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure." 

My comments:

The report is welcome.

The most important part of the paper, I point out, is the “Limitations” section. FDA, IOM and others have made similar observations – we don’t know the true magnitude of the problem due to systematic limitations of the available data. 

Therefore, at best what is available must be deemed as risk management-relevant case reports, a “red flag” that could represent (using the words of FDA CDRH director Jeffrey Shuren regarding HIT safety), the tip of the iceberg.

It is imperative far more work be done in post-market surveillance as this technology is deployed nationally and internationally.  This is to ensure that good health IT (GHIT) prevails and bad health IT (BHIT) is either remediated or removed from the marketplace.  I had defined those in other writings as follows:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

An additional major factor that also contributes to lack of knowledge of EHR-related adverse events is hospital reporting non-compliance. For instance, I know of cases from my own legal consulting work and personal experience that I would have expected to appear in the database, but apparently do not.

But don’t take it from me alone. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on this.

From “Hospitals Are Not Reporting Errors as Required by Law, Phila. Inquirer”, pg. 4,http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:
  

... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board.

He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.]

Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years.

Fixing this “is not a priority,” he added.

This coincides with my own personal experience precisely.  In a case where my relative was permanently injured as a result of EHR-related medication error, and then died of the injuries, I never received the required report in writing from the hospital.  I also do not believe the case was reported to the Safety Authority, at least not as IT-related.

I suspect the true rates of EHR-related close calls, reversible injuries, permanent injuries and deaths is significantly higher than the limited data available suggests. That data is merely a red flag that much more education, stringent reporting requirements,  templates of known causes of error, and enforcement are needed.  (An April 2010  "thought experiment" on this issue I wrote about at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" certainly suggested as much.)

Slides where I made those types of recommendations to the Patient Safety Authority, at a presentation I gave in July 2012 at their invitation, are at http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt

A major concern I have is that the HIT industry will use this new report in a manner that ignores its limitations.

(Disclosure: I was an invited reviewer of this new PPSA report.)

-- SS 

Addendum Dec. 13:   

Also worth review is "Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration", Magrabi, Ong, Runciman, and Coiera, AMIA Annu Symp Proc. 2011.  

Data here came from FDA's voluntary (i.e., also tip of the iceberg) Manufacturer and User Facility Device Experience (MAUDE) database.  Ironically, the study was done in Australia using Australian grant funds.

-- SS