Yet another observation that known health IT-caused injuries and deaths are "the tip of the iceberg"

I've noted a new observation of the limited data available on health IT harms being the (quote) "tip of the iceberg."

This statement appears in "Electronic Health Record–Related Events in Medical Malpractice Claims", Gruber et al., J. Patient Saf 2015, http://journals.lww.com/journalpatientsafety/Abstract/publishahead/Electronic_Health_Record_Related_Events_in_Medical.99624.aspx (PDF available free from link on right side of page.)

From the abstract:

Background: There is widespread agreement that the full potential of health information technology (health IT) has not yet been realized and of particular concern are the examples of unintended consequences of health IT that detract from the safety of health care or from the use of health IT itself. The goal of this project was to obtain additional information on these health IT-related problems, using a mixed methods (qualitative and quantitative) analysis of electronic health record-related harm in cases submitted to a large database of malpractice suits and claims.

Methods: Cases submitted to the CRICO claims database and coded during 2012 and 2013 were analyzed. A total of 248 cases (less than 1%) involving health IT were identified and coded using a proprietary taxonomy that identifies user- and system-related sociotechnical factors. Ambulatory care accounted for most of the cases (146 cases). Cases were most typically filed as a result of an error involving medications (31%), diagnosis (28%), or a complication of treatment (31%). More than 80% of cases involved moderate or severe harm, although lethal cases were less likely in cases from ambulatory settings. Etiologic factors spanned all of the sociotechnical dimensions, and many recurring patterns of error were identified.

Conclusions: Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future.

Note the statement at pg. 5:

... The actual incidence of harm cannot be reliably estimated from this data; nonetheless, it is generally agreed that safety events represented in malpractice claims are the ‘tip of the iceberg', insofar as the vast majority of cases, even cases that involve harm, do not result in suits.

I've heard claims that up to 95% of potential meritorious medical malpractice suits never make it to the lawsuit stage due to difficulties in, and costs of, prosecution.  Anecdotally, the latter observation corresponds to my own family's experience; several attorneys would not take my mother's EHR-related medical malpractice case initially, due to her age and concerns about expenses.

I note at my post today "Repeated crushing by alligators and crocodiles: ICD-10 has you covered. Harmed by bad health IT? No codes for that" at http://hcrenewal.blogspot.com/2016/01/repeated-crushing-by-alligators-and.html that repeated attacks and crushings by creatures of Order Crocodilia are well-covered by ICD-10, but health IT harms do not appear to be covered by the same mandatory coding system.  My view is that this is likely by design, not due to lack of knowledge of these events by ICD-10 experts involved in creating this coding system.

Below is a checklist of such failure modes causing patient harms from the May 2012 AHRQ Health IT Hazard Manager Report (http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf).  These should be represented in ICD-10 so that the issues can be further known and studied:

 

AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT (click to enlarge)

Other taxonomies exist, such as in the 2010 FDA Internal Memo on Health IT harms, "not intended for public use" and unearthed by investigative reporter Fred Schulte.  See my post at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html and the memo itself at the link below.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking here.

--------------------------------------------------------------------- 

• Other use of that same "tip of the iceberg" phrase of which I have written:

FDA CDRH Director Jeff Shuren MD, JD's statement that the known risks are "the tip of an iceberg" was made at the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010, where the topic was "HIT safety" (The text is available at http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf):

... In the past two years, we [FDA] have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

For more on these issues, see my April 9, 2014 essay "FDA on health IT risk: "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.

--------------------------------------------------------------------- 

ECRI Institute:  http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI:

HIT Errors 'Tip of the Iceberg,' Says ECRI
Cheryl Clark, for HealthLeaders Media , April 5, 2013

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.

... Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

On the ECRI Deep Dive study of health IT risk, see my Feb. 28, 2013 essay "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

Tip of the iceberg:  ignore it at your peril

 -- SS

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.

Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR-related harms and lack of informed consent processes regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights.

This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others.

Forbes contributor Nicole Fisher (http://www.forbes.com/sites/nicolefisher/) published an article in Forbes dated 3/18/2014 and entitled "Electronic Health Records - Expensive, Disruptive And Here To Stay" (http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/).

You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently.

Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source:

Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs"
hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html

Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events"
http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html

Internal FDA memorandum on HIT risks
http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html

IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care"
http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html

EHRs and Deadly glitches
http://hcrenewal.blogspot.com/search/label/glitch (multiple posts)

Not to forget issues of breach of privacy: 
http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy (multiple posts)

Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care.

The only mention of "unintended consequences" links to "Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles."

This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine):

http://www.forbes.com/sites/nicolefisher/

Nicole Fisher is the Founder and Principal at HHR Strategies, a health care and human rights focused advising firm. Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, specifically as they impact women and children. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions had an emphasis on underserved populations, women's and children’s issues. She presides on several Boards for domestic and international health organizations and frequently speaks on health reform and human rights.

One might conclude the computer has more rights than the patient and the clinician via this Forbes piece.

Finally, although I am a domain specialist (http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way. 

The title of the Forbes piece should have been "Electronic Health Records - Expensive, Disruptive, Deadly."

To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.   http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html

A few babies too:  http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html

A family man:  http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html

I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person.

If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention?

-- SS

** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at "EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?" at http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html.

Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "Malpractice Claims Analysis Confirms Risks in EHRs" (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html) I pointed out that the annual medical malpractice claims related to health IT received by the insurer for the Harvard medical community, one of the world's best users of health IT, might represent a significant percentage of the annual med mal claims in the state of Massachusetts.  Many involved serious injury.

I also pointed out that the claims themselves represent only a small fraction of total incidents of med mal-related harms (including due to IT), due to the economic realities of med malpractice litigation.

In the press release reproduced below, CRICO writes of poor integration and "design deficiencies" - bad health IT - and that "there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind", and that they hear "significant frustration from physicians related to their experience with EMRs." 

However, CRICO does not write of the reasons why these issues are as prevalent as they are.

Their claim appears to be, in essence, that these problems will be solved through dialog and "conversation" - in other words, appeals to corporate altruism.

Why this industry receives special accommodation even from those who have to pay for their mistakes is beyond me:

CRICO Challenges EMR Complacency 
http://www.rmf.harvard.edu/EMR 
February 6, 2013

In a recently released video, CRICO offers a vision of how EMRs of the future might improve health care safety for both patient and physician. 

Press Release:  Cambridge, MA — CRICO, the patient safety and medical professional liability company serving the Harvard medical community, has produced a video that puts forth a future vision of how Electronic Medical Records (EMRs) might be embedded into the physician workflow in a manner that would improve health care delivery. CRICO has based the dramatization on real malpractice cases. Through combined analysis of how harm can come to patients from flawed encounters with providers, and conversations with medical and technological visionaries across the country, the video integrates various scenarios into an idealized patient/physician encounter. 

Hearing significant frustration from physicians related to their experience with EMRs, CRICO was inspired to envision a way in which they might be better integrated into  the clinical workflow. This would allow the EMR to offer some relief to physicians and nurses who face seemingly insurmountable challenges of time and data management.

Luke Sato, MD, chief medical officer and senior vice president for CRICO said, “The impetus behind this video was to facilitate a dialogue among health care professionals—physicians, IT, hospital administrators—about why we aren’t making better progress in the development of EMRs.  Through analysis of medical malpractice claims, we have line of sight to design deficiencies in the EMR that contribute to claims. The best technological design is one that is integrated seamlessly into one’s workflow. The current EMR is passive—the physician has to actively look for data instead of the technology anticipating what the physician needs to act on.”

Opinions within the health care industry are diverse about EMRs but there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind. In addition to a need for standards across systems, the manual data entry of today’s EMRs adds to the burden of already time-pressed physicians.

The film was created as a collaborative effort between CRICO’s Luke Sato, MD and David Ting, MD, associate medical director for information systems at Massachusetts General Physicians Organization, who acted as an expert resource for script development and video production. Ting said, “The actual purpose of the video is to ask whether we might intelligently prioritize today’s choices to move our institutions toward improved patient care and improve provider and practice work-life experience.”

While most of the technology that is used in this dramatization is available today, other elements are further out. CRICO’s future vision, as depicted in the video, is meant as a launching pad to begin the conversation about how new technologies can provide a way to enable EMRs to enhance, streamline, and make safer the patient-physician encounter.

Dr. Ting has encouraged his colleagues at MGH to view the video and share their feedback. The physician reaction has elicited a variety of reactions and diverse feedback ranging from “cool, efficient, saves time, and improves outcomes” to “I don’t want voices interfering with my patient interactions.”  The video is available for viewing on the CRICO website, www.rmf.harvard.edu/EMR. 

ABOUT CRICO

For more than 30 years, CRICO has been the patient safety and medical professional liability company owned by and serving the Harvard medical community.

CRICO is an internationally renowned leader in evidence-based risk management, proudly serving more than 12,000 physicians (including residents and fellows), 22 hospitals, and nearly 209 other health care organizations.

They see the problems but do not engage the human reasons for the problems, including generic leadership, conflicts of interest, incompetence, territoriality, profit motive, and the other ills that we write of till our faces turn blue at Healthcare Renewal.

In other words, their "challenge to EHR complacency" is about as powerful as our challenges have been to Vladimir Putin regarding Crimea and Ukraine.

Perhaps when the payouts become even more severe, insurers will think it a good idea to stop 'making nice' with an intrusive and unregulated industry that has invaded clinical affairs like a bull in a china shop.

Can we please, pretty please dialog for a bit about your breaking the dishes?

-- SS

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"

Two "EHR beneficence is not exactly as advertised" stories in one day.  It's hard to keep up:

After my earlier post today "EHRs: The Real Story" - Sobering assessment from Medical Economics, now there's this.

From the journal "Patient Safety & Quality Healthcare" (PSQH):

Malpractice Claims Analysis Confirms Risks in EHRs
Jan/Feb 2014

Article available at this link.

[Short header on several EHR-related care foul ups]

... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Although these systems promise to reduce costs and improve quality and safety, they’ve also ushered in unintended consequences as a result of human error, design flaws, and technology glitches.

Recognizing these emerging risks, CRICO—the patient safety and medical malpractice insurer for the Harvard medical community— is taking action. The Massachusetts-based company has expanded its proprietary coding system to capture EHR-related problems that have contributed to patient harm, and to guide the hospitals, physicians, and other providers it serves toward addressing vulnerabilities in their systems.

I had previously written about another Med Mal insurer who had noted these problems at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal.

... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.

The article notes this:

... Half of the 147 cases resulted in severe injury.

Patient deaths were a likely result, too, I note.

Note that this is just one insurer's data and assuming a good number of them were local to Massachusetts, could represent a significant percentage of the annual medical malpractice lawsuits in the state (Pennsylvania, a much larger state, has about 1500 med mal lawsuits filed annually). 

Note also that most cases of harm never make it to litigation due to the harsh economics of medical malpractice.

Numbers such as this will be going up as implementation, driven by HITECH incentives and penalties, accelerates in coming years.  This is especially true as medical centers and physician practices with far less clinical IT expertise and savvy than Harvard's become HIT users, and as the ability to capture such events increases.

The ECRI Institute "Deep Dive" study of health IT risk also speaks to a rise in numbers, with its finding of 171 health IT "events" in just 36 hospitals over 9 weeks voluntarily reported (i.e., just a fraction of the total), with 8 injuries and 3 possible deaths as a result (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

... The team asked its CRICO and Strategies members, “What vulnerabilities are you seeing? What are your risk managers worried about? What are your doctors complaining about?”

It used that feedback to draft a set of EHR-specific codes and then tested them in three datasets: CRICO (Harvard users) and two of Strategies’ larger clients, !e Doctors Company and Princeton Insurance. Based on those results, CRICO revised and approved 15 new EHR codes that went “live” in January 2013.

That means CRICO’s cadre of nurse coders can now identify EHR as a contributing factor to a malpractice claim, instead of using one of the less specific factors available in the past. [It's about time for a dose of transparency in the health IT sector - ed.]  And they can flag whether the problem involved user issues, system/technology issues, or both. “In some cases,” Sato points out, “the system design sets up humans to make errors.”

This should all be no surprise to any reader of this blog.  Read the whole article.

A more comprehensive list of "EHR harm modes" are at my posts "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide" (http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html) and "Cart Before the Horse, Part 3: AHRQ's Health IT Hazard Manager" (http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html).

The actual Hazards Manager report is at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf. It contains this summary of known hazards:

AHRQ's taxonomy of health IT hazards.  Click to enlarge.

-------------------

Having written on these issues since 1998 as a "health IT iconoclast" (http://rtg.cis.upenn.edu/MDCPS/Posters/IT%20Iconoclasts.pdf) and having been largely ignored by the cognoscenti, can I now say "I told you so?"

-- SS