InformaticsMD in Podcast by Neil Versel

Neil Versel is a journalist specializing in health IT, mobile health, patient safety, quality of care and the business of healthcare.  He is a prolific writer of the web site Meaningful HIT News and others (http://www.informationweek.com/author-bio.asp?author_id=690).

He interviewed me recently for a podcast on health IT safety.

The podcast can be accessed here:  http://www.meaningfulhitnews.com/2014/10/20/podcast-scot-silverstein-talks-health-it-safety-risks/

Readers of this blog will recognize many familiar themes.

1:10 How this interest came about
3:05 His blogging
3:45 His 11 points demonstrating why he believes the FDA should be concerned about health IT risks
5:00 IOM, FDA and ECRI Institute statements on health IT safety
5:50 Comparing EHRs to medical devices and pharmaceuticals
8:35 Lack of safety testing in health IT
9:25 Issues with EHR certification
10:00 Safety validation of software
10:35 EHR’s role in Texas Health Presbyterian Hospital’s initial discharge of Ebola patient
11:50 EHR failure causing medical harm to a close relative
13:10 Poor design vs. poor implementation
14:35 Who should regulate?
15:55 Billions already spent on EHRs
16:45 Threat of litigation
17:40 “Postmarket surveillance” of “medical meta-devices”
18:50 EHRs now more like “command and control” systems
19:30 Movement to slow down Meaningful Use
20:17 Safety issues with interoperability
21:40 Importance of usability
22:30 His role at Drexel
24:18 “Critical thinking always, or your patient’s dead”
25:05 Lack of health/medical experience among “disruptors”
29:30 Training informatics professionals and leaders
31:15 Concept vs. reality of “experimental” technology
32:50 Advice for evaluating health IT
33:55 Guardians of the status quo
35:10 Health IT “bubble”
36:10 Good health IT vs. bad health IT

-- SS

EHR safety, a false sense of security, and epistemological problems in the Medical Informatics community

Neil Versel is an author of many articles about healthcare information technology.  He recently published "Patient safety in the balance: Questions mount about EHRs and a wide range of patient safety concerns" (http://www.healthcareitnews.com/news/patient-safety-balance) in Healthcare IT News, August 27, 2014, also appearing in the Sept. 2014 print edition.

His article contained a sidebar on my views "A 'false sense of security'" (http://www.healthcareitnews.com/news/false-sense-security).

I thought my feedback back to him would be of interest, centering on a published comment of the typical hyper-enthusiast variety made by a prominent member of my Medical Informatics professional community.  The view exemplifies a widely-held but erroneous (and decidedly non-scientific) viewpoint in my professional community - and many others, including government -  regarding drawing conclusions in the face of significant evidentiary gaps and impediments regarding harms.

Here are my emails to Mr. Versel.  They speak for themselves, especially the short second supplementary email seen at the bottom of this blog post

-- SS

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

---

EMAIL #1:

From: Silverstein,Scot
Sent: Friday, September 05, 2014 10:05 AM
To: Neil Versel
Subject: Re:" A 'false sense of security'"

Neil,

Thanks for citing me in your article at http://www.healthcareitnews.com/news/patient-safety-balance, http://www.healthcareitnews.com/news/false-sense-security etc.

Want to call your attention to one of my largest disappointments and frustrations in health IT that evolved over the past decade or two, namely, cheerleading for the technology in the face of commonly understood Western science and epistemology ("the theory of knowledge, especially with regard to its methods, validity, and scope. Epistemology is the investigation of what distinguishes justified belief from opinion").

My concerns are best exemplified by the comment posted at the article site by a prominent member of my Medical Informatics professional community:

"The question is not whether EHRs are safe or not; sometimes they are, and sometimes they are not. The real question is whether they are safer than paper records, and the weight of scientific evidence is that they are."

The actual truth, considering the explicit statements with explicit reasons given by IOM, FDA, ECRI, and others as to why what we know about electronic harms is incomplete ("tip of the iceberg", see below), is that "while the potential for electronic systems to be safer than paper exists, the scientific evidence is inadequate to make any statement about comparative safety on the ground."

The data inadequacy is made far worse by the known and stated systematic impediments to discovery and diffusion of the harms, and a lack of robust studies on ACTUAL harms due to paper-based record keeping, especially and critically regarding optimal and well-staffed paper systems.  (Try a Medline search on that topic!)

The hyper-enthusiasts who favor the theoretical over reality on the ground and who push for speedy national rollout without proper safeguards, surveillance and regulation, are, in fact, killing people. [I.e, whose injuries and deaths at the hands of bad health IT were otherwise preventable had appropriate industry safeguards been in place - ed.]

There is actually nothing to argue, nothing to debate on this issue.

Some material backing up these assertions is below, mostly already covered in my blog-based 11 points.  [As at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html - ed.]

Cheers,

Scot

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

Examples: 

1)  IOM report on HIT safety, 2012 (as I report at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html , midway down):

.. While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, little published evidence could be found quantifying the magnitude of the risk.
Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.[IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press, pg. S-2.]

Also in the IOM report:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.
More worrisome, some case reports suggest that poorly designed health IT can create new hazards in the already complex delivery of care. Although the magnitude of the risk associated with health IT is not known, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”

2)  FDA Internal memo on HIT risk, 2010 (as i report at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html):

... In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

 This is especially true considering the FDA's own noted limitations of their information sources:

Limitations of the MAUDE search and final subset of MDRs include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
Memo: H-IT Safety Issues
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

3)  Jeff Shuren MD JD, head of FDA CDRH (as I report at http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html):

The Office of the National Coordinator for Health IT held a meeting of the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010. The topic was "HIT safety." The agenda, presenters and presentations are available at this link.

At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking:

He wrote:

... In the past two years, we 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.

Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.

4)  ECRI Institute Deep Dive study of health IT safety (as I report at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html):

Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals

(There were 8 injuries and 3 possible deaths associated with these 171 IT-related events over just 9 weeks, suggesting a damn serious problem way ahead of paper errors.)

5)  Statement by Medical Director of ECRI, same link as above:

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."

6)  ECRI's continuing concerns based on continuous data submitted by their PSO member hospitals that health IT systems are "one of the top ten (and in fact in 2014, risk #1) technology risks in healthcare" (as I report at http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html)

This is a short list, but you get the idea about making any statements about comparative risks of paper v. electronic.

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

---

EMAIL #2: 

 From: Silverstein,Scot 
Sent: Friday, September 05, 2014 10:08 AM
To: Neil Versel
Subject: RE: Re:" A 'false sense of security'"

Not to mention that the "real" question isNOT "whether they [electronic systems] are safer than paper records."

The real question is:  is it ethical, based on the current clinical reality and incomplete state of knowledge, to push this technology on patients?

I also could add to that question:  "...especially without informed consent?"

Scot

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

-- SS  

Athens Regional Medical Center: Hospital management is "addressing computer problems" AFTER patients are put at bodily risk, not before, only in response to irate clinicians; then claiming everything will be fixed soon while doctors resign.

(Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html)

Maybe hospital management gurus could address these computer problems BEFORE turning them loose on patients?

Physicians in Georgia seem to have more guts than their colleagues elsewhere.  Rather than letting patients be guinea pigs for the naive fantasies of hospital executives about health IT, these physicians said "get these [expletive] computer systems out of our hospital"...

Then they started resigning their appointments:

Athens Regional addressing new computer system problems encountered by doctors

By Donnie Z. Fetter
Friday, May 23, 2014

http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors

Doctors affiliated with Athens Regional Medical Center (http://www.athenshealth.org/) have expressed concerns that a computer system installed this month at the hospital endangers patients.

Not "may endanger patients."  "Endangers patients."  That's quite direct.

However, the hospital's chief executive said Athens Regional is taking "swift action" to address those concerns.

I'm not impressed.  The executives should perhaps have done due diligence and taken action BEFORE this bad health IT was set loose on live, unsuspecting patients.

It's not as if the issues are unknown (as Google or anyone who actually knows what they're doing regarding health IT will easily demonstrate).  Further, those executives have the legal obligation to maintain a safe healthcare environment.

In a letter dated May 15 and provided to the Athens Banner-Herald this week, multiple doctors noted such concerns as “medication errors ... orders being lost or overlooked ... (emergency department) patients leaving after long waits; and of an inpatient who wasn’t seen by a physician for (five) days.”

Any of these issues and the multitude more I can predict exist can lead to severe injury or death, especially in fragile patients and the elderly.  Trust me, I know both professionally and personally...
 

The letter was addressed to ARMC President and CEO James G. Thaw and Senior Vice President and CIO Gretchen Tegethoff. It was signed by more than a dozen physicians, including Carolann Eisenhart, president of the medical staff; Joseph T. Johnson, vice president of the medical staff; David M. Sailers, surgery department chair; and, Robert D. Sinyard, medicine department chair.

The doctor who provided the letter to the Banner-Herald refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues.

Refused a request to openly discuss the issues with the computer system and asked to remain anonymous at the urging of his colleagues ... due to fear the executives would then return the doctor's concerns with genuine love and appreciation, and give him or her a generous promotion and pat on the back, no doubt.  (Actually, quite likely was a fear of retaliation, e.g. sham peer review as at http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians.)

Note the educational background of CIO Gretchen Tegerhoff, the executive with fiduciary obligations to implement health IT of the highest quality and to have robustly researched all of the issues involved (and whom the Board should have thoroughly vetted as to required background for health IT leadership):

University of Georgia
Terry College of Business, Executive Program, Finance
2014 – 2014 (expected)

The George Washington University - School of Business
Master of Science, Information Systems Technology
2001 – 2003

West Virginia University
BS, Medical Technology
1993 – 1997

Note the career progression that is the envy of, say, someone who's completed the rigors of medical training (premed, medical school, internship/residency, clinical postdocs) and beyond that, completed an additional PhD, MS or post-doctoral fellowship in Medical Informatics at unknown universities such as Harvard, Yale, Stanford, Johns Hopkins, Columbia, etc. (reverse chrono):

Technical Analyst
STG (9 months)
[Provided U.S. Department of State with systems support and application maintenance.]

Clinical Systems Analyst
George Washington University Hospital (3 years 8 months)

Technical Support Specialist/Installer
Intellidata, Inc. (9 months)

Clinical Research Associate
QUINTILES, INC. (9 months)

Information Specialist
THE EMMES CORPORATION (1 year 8 months)

Writer/Editor
ASPEN SYSTEMS CORPORATION (7 months)

Medical Technologist
PROVIDENCE LABORATORY ASSOCIATES (8 months)

This background led directly to:

Chief Information Officer
George Washington University Hospital (6 years 8 months)

and then the current role:

Athens Regional Health System
Vice President and Chief Information Officer
Athens Regional Health System

If you believed that the qualifications required for medical practice - let alone medical leadership roles - is at least an order of magnitude more robust, you'd not be mistaken.

Perhaps even worse, business-IT amateur meddlers in clinical affairs sell the "best practices" that lead to debacles like this, and perhaps to IT-related patient injury and death, via their alphabet-soup "leadership" organizations.  This CIO also holds this credential:

Faculty

CHIME Healthcare CIO Boot Camp (8 months)

It should be noted, and scandalously so considering the negligence that leads to patient endangerment and this kind of physician revolt from the outset, that IT-related patient harms are not uncommon.  For example, per the Harvard community's med mal insurer CRICO, see "Malpractice Claims Analysis Confirms Risks in EHRs" at
http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html, the ECRI Institute, see "ECRI Deep Dive Study of Health IT harms" at
http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html as well as "ECRI Institute's 2014 Top 10 Patient Safety Concerns for Healthcare Organizations" at
http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html, "FDA Internal Memo on H-IT risks - for internal use only" (uncovered by investigative reporter Fred Schulte) at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html, and others as posted at this blog.

“From the moment our physician leadership expressed concern about the Cerner I.T. conversion process on May 15, we took swift action and significant progress has been made toward resolving the issues raised,” Thaw wrote Thursday in an email. “Providing outstanding patient care is first and foremost in our minds at Athens Regional, and we have dedicated staff throughout the hospital to make sure the system is functioning as smoothly as possible through this transition."

This raises several questions:

• How about the moments from the time of decision to acquire the technology?  What safety consideration were in effect during that time? 

• What if the "significant progress" is insufficient to prevent a patient from being maimed or killed due to toxic effects of bad health IT?  Who's responsible? 

• Perhaps most importantly from the human rights perspective - are patients being provided informed consent about these "issues raised" and are they afforded the opportunity to seek care elsewhere until the "swift progress" is completed?  

One wonders if the executives were aware of analytic work on Cerner ED systems such as performed by U. Sydney professor Jon Patrick at "A study of an Enterprise Health information System",  http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146; or this site on health IT difficulties:  http://cci.drexel.edu/faculty/ssilverstein/cases/, or this blog and others.

It's not as if a simple Google search won't find them, such as https://www.google.com/search?q=healthcare+IT+failure.  Perhaps they need to read more...or hire experts BEFORE go-live.

Back to the article:

The intended goal of the system designed by health care information technology company Cerner is to improve efficiency and connectivity by providing doctors, nurses and other medical professionals with a shared data set and to eventually allow patients online access to their medical records, Athens Regional executives previously said.

Good intentions or not, badly designed and/or implemented technology harms or kills, and those harmed, or the dead, really don't care what the system is 'intended to do.'  Patients are not guinea pigs towards an IT company's or hospital's experiments with computers - regarding which the executives are usually in to at a level way over their collective heads.

But doctors noted the new system often proved too cumbersome to be effective at the time the letter was written.

“The Cerner implementation has driven some physicians to drop their active staff privileges at ARMC,” noted the letter. “This has placed an additional burden on the hospitalists, who are already overwhelmed.

That's just horrendous for safety.

Joint Commission, where are you?
 

Other physicians are directing their patients to St. Mary’s (hospital) for outpatient studies, (emergency room) care, admissions and surgical procedures. ... Efforts to rebuild the relationships with patients and physicians (needs) to begin immediately.”

Doctors voted with their feet.  Bravo.

I suggest they consider the following remedies as well if appropriate, from my post at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html:

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

• Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).

• Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

• Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.

• Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.

• Inform the State Medical Society and local Medical Society of your locale.

• Inform the appropriate Board of Health for your locale.

• If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."

• Inform a personal attorney.

• Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.

• As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:

"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."

• If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.

• As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These measures can help "light a fire" under the decision makers, and "get the lead out" of efforts to improve this technology to the point where it is usable, efficacious and safe.

More from the article:

Doctors called the time line to install the EHR system too “aggressive” and said there was a “lack of readiness” among the intended users.

For financial incentive reasons in part, I'm sure.  Computers, after all, seem to have more rights than patients...or than physicians and nurses.

Since receiving the letter, Thaw said Athens Regional has added "specialized staff" to meet daily with physicians to discuss computer system and safety issues.

Again, the key word is "AFTER."   A good move, considering the hospital will be up to its head in defections, accreditation inspections and hearings, and possible medical malpractice and corporate liability lawsuits otherwise.

"Regardless of what system we are using, our focus on patient safety is unwavering, and we will never put a system ahead of doing what is right for our patients," Thaw said. "Our team is working around the clock to resolve any remaining issues, and we remain dedicated to delivering outstanding patient care every step of the way."

Feel-good executive boilerplate and an outright lie on its face.  If the focus on safety was unwavering, this problems would not now need emergency remediation.  As I had written many years ago here: http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story, this type of shallow executive puffery and rhetoric only makes clinicians angrier.

And while events like this go on, the industry pundits suggest all that's needed is a Health IT 'Safety Center' instead of regulation like the rest of the healthcare industry ("Feds Call For Health IT Safety Center", May 20, 2014, http://www.govhealthit.com/news/feds-call-hit-safety-center?topic=,26#.U4FVDnYsC).  This is sort of like putting the safety of our country's hospitals in the hands of Consumer Reports.

That's not exactly the ticket to a rapid cure to these problems, which are more common than most physicians have the bravery (or career options in the face of retaliation) to admit.

At least nurses' unions are taking action, as at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and http://hcrenewal.blogspot.com/2014/05/a-nurses-union-national-nurses-united.html.

Additional thought:  at least the writer of the article did not use the customary euphemism for problems with patient-endangering bad health IT, specifically: "glitches" (http://hcrenewal.blogspot.com/search/label/glitch).

-- SS

May 27, 2014 Addendum:

The CEO has apparently resigned, see http://onlineathens.com/local-news/2014-05-23/thaw-resigns-athens-regional-ceo. 

I also solicit physicians from the area of this hospital to contact me regarding any patient harms that did occur as a result of this debacle, via my email address located here: https://www.blogger.com/profile/03994321680366572701.  I will forward any reports through appropriate legal channels to attorneys who can take action, which in 2014 is probably the only language this industry will actually listen to.

-- SS

May 27, 2014 Addendum 2:

The reader comments at http://onlineathens.com/health/2014-05-22/athens-regional-addressing-new-computer-system-problems-encountered-doctors are interesting, and distressing.

-- SS

May 29, 2014 Addendum:

More here:  http://flagpole.com/news/in-the-loop/james-thaw-out-as-armc-ceo

If I were that's hospital's new leadership, I'd immediately go back to whatever system (whether paper or not) was in place before this implementation, and take the time to implement new health IT properly, safely and carefully.

For at this point, if patient injury or death occurs as a result of a system flaw (whether in design or implementation), I believe charges of criminal negligence against the organization and its leaders would be justified.

The following is an example of one state's statute defining criminal negligence:

''A person acts with 'criminal negligence' with respect to a result or to a circumstance described by a statute defining an offense when he fails to perceive a substantial and unjustifiable risk that such result will occur or that such circumstance exists. The risk must be of such nature and degree that the failure to perceive it constitutes a gross deviation from the standard of care that a reasonable person would observe in the situation.''

I believe other states' statutes are similar.

-- SS

June 13, 2013 Addendum:

My post on Athens Regional Medical Center's physician revolt was accessed today by someone at Cerner; note the referring link:  http://cerner.vertabase.com/project/document/index.cfm?&0.12455576848

Vertabase (http://www.vertabase.com/) makes project management software.

Cerner.vertabase.com/project/document is some sort of password-protected document resource.

I find that interesting - perhaps it's for internal communications and they are learning something from me.

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IP Address		159.140.254.# (Cerner Corporation)
ISP		Cerner Corporation
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 -- SS

Note: also see my June 16, 2014 followup post at http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html

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

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following:

Dear Dr. Silverstein,

As you write, there is not a transaction of medical care that does not go through EHR systems.

However, these poorly usable EHR systems stifle creative and artistic thought required to link risk, benefit, and probability of diagnosis with risks and benefits of testing and therapeutics.

Assuring safety and efficacy with pre- and  aftermarket surveillance will maximize the possibility of achieving the potential of the technologies.

Additionally, when I use these electronic ordering systems and  libraries of medical information, they fail to keep up with the agility and nimbleness of my mind as I seek 'random access' to pieces of data to formulate and synthesize diagnoses and therapeutic strategies.

The EHRs are too slow, do not have a robust (if any) search function, randomly and whimsically store key information with ever changing formats, and generally obfuscate what should be simple. They are cumbersome and disable the ability to simultaneously and contemporaneously compare myriad data points.

They get an "F" as enablers of complex diagnostics.

Paper, since it can be organized as needed and set out on a desk to be seen and compared as quickly as the eye registers the data, gets an "A".

The EHRs  are impediments and disrupters of communication.

Example: Just today, I was witness to the fact that a stat EKG was ordered by CPOE  on a heart patient yesterday at or shortly after 4:30 pm. The intended recipient of the order (heart station) never got it because they close near 4:30 pm and there was no warning to the ordering health professional that was so.

Thus, the EKG was never done, and this morning, when the requisition was seen, no one did it because it was ordered stat "yesterday", and the techs asked themselves "what good would it do for a 'stat' to be done now, a day late?"

I do not know what happened to the patient.  I have many other examples of such delays facilitated by the CPOE and EHR systems that I am required to use at numerous facilities.

They facilitate 'stealth' alterations in care.  Also just today, a disease-critical test ordered 3 days ago was not done because it was cancelled in 'stealth' (automatically "expired") without warning to me by the lab responsible for doing it.

There is the "silent silo" syndrome as you've called it.  Also just today, a disease critical test ordered 5 days ago came back with results, but the results were posted in the information 'silo' of 5 days ago. The lab screen default on the EHR only goes back 4 days (so unless I knew to look for it, it would not be seen or acted on), further obfuscating data and delaying treatment.

The EHRs lose data and orders.  Also just today, I found that blood coagulation monitoring tests that were ordered to be done with kidney dialysis (3 days per week) on a patient somehow got "lost" and were not being done for 5 days, putting my patient at risk of bleeds - or stroke if the blood was not 'thin' enough.

I just walked in to examine a hospitalized patient with multi-organ failure and diabetes, on multiple meds including insulin, and recovering from respiratory failure.

The nurse anxiously informed me that the blood sugar was dangerously low. I ordered treatment stat.

I see patients in the morning before labs come back, and depend on nurses to review labs and notify me.

Turns out that the patient was hypoglycemic on yesterday morning labs that arrived in the EHR 'silo' after I left the hospital; and was also low in potassium, but the tests just laid there comfortable in their silos; and were not communicated to anyone like in the old days when a human ward clerk or other undistracted human received them and disseminated them to the appropriate professionals.

Thus, instead of getting less insulin, the patient got the usual dose with near catastrophic adversity.

Misidentifications are facilitated by EHRs.  I  noticed that on several critical clinically significant changes that arose on my patient that were entered as such in an EHR silo by the RN, it was stated that they called attending physician 'Dr X', which was not me...obviously a case of EHR-facilitated misidentification.

Here is a misidentification variant:  yesterday, someone (non doctor but not clear who) ordered a specialist consultation on one of my patients under my name. I did not order it nor was it needed, yet it showed up as an order for me to sign.

Like you, I agree this is representative of a toxic impact of these systems on medical care and I feel like the care environment is foul, like a cesspool, compared to what has been replaced.

These systems of medical devices cannot be trusted in the care of sick patients. Perhaps, they are OK for managing hang nails.

I offer no additional comments other then if I am sick, I do not want my care interfered with in this manner by IT.

Rest assured, though - there are IT hyper-enthusiasts out there (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html) who would see little problem with this, as any accidents that occur are "anecdotes", "learning experiences" or "bumps in the road."

That's if they don't simply blame the user.

-- SS

Quality and Safety Implications of Emergency Department Information Systems: ED EHR Systems Pose Serious Concerns, Report Says

A report "Quality and Safety Implications of Emergency Department Information Systems"
appeared in the Oct. 2013 issue of "Annals of Emergency Medicine."  It is available fulltext at http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext, or in PDF via the tab, free as of this writing.

First, a preamble:  I once tried to alert a hospital where I'd trained decades before, Abington Memorial Hospital (http://www.amh.org/), of impediments to safe care I'd noted in their EHR's, predominantly their ED EHR.  They did not listen.  In fact, their response to my concerns was characterized by an apparent incompetence regarding conduct of safety investigations.  For instance, to my written concern in an April 2010 letter to the CEO and CMO about the ED EHR that:

... I've also had to stop administration [to my mother] of an antibiotic (Levaquin) in the recent past in the ED that she has had an adverse reaction to (torn rotator cuff), despite my having told ED intake she was allergic to it. She relates that administration of Levaquin was then almost repeated on the floor until she herself refused it during that past admission.

This was the sworn testimony in May 2013 about the "investigation" that resulted, from the hospital's VP of Risk Management, Regina Sturgis:

A:      Deborah [hospital General Counsel] asked me to investigate the Levaquin issue which I did.
Q:      Did you do that on your own or did you delegate some of the --
A:      No.  I did it on my own.
Q:      Do you know whether any of the IT folks were ever brought in to look at the -- the EMR issues referenced in this letter?
A:     No, I do not.  I know that I was asked to look at the Levaquin because of my clinical background.
Q:      Okay.  Did you come up with any conclusions?
A:      Yes.
Q:      What was your conclusion?
A:      That she had been ordered Levaquin in the ETC [Emergency Trauma Center a.k.a. ED], that it had been discontinued about a very short period of time later, under a half an hour, and that she never received it.

So, the investigation of a complaint that family and then the patient themselves had to stop the administration of a drug whose staff and EHR had been informed of an allergy consisted of confirming that the medication was never given.  No problem, the ED EHR is safe.

(I am not joking; that is the testimony given.  Imagine such an investigation and conclusion about, say, reported aircraft flaws, or, in the industry in which I was once a safety officer, public transit vehicle defects and dangers.)

However, when competent people investigate similar issues, the findings are concerning.  From Modern Healthcare (http://www.modernhealthcare.com/), a publication for healthcare executives, on the new Annals of Emergency Medicine article:

ED EHR systems pose serious concerns, report says

By Joseph Conn
Modern Healthcare

June 24, 2013

Electronic health-record systems used in emergency departments are beset with poor data displays, loaded with so many alerts warning of potential patient-safety issues that they can lead to user alert fatigue, and may be generating incorrect physician orders, according to a report by two emergency physicians' study groups.

Meanwhile, providers wanting to address these EHR issues are hampered by a lack of research and solid evidence of the extent of the problem with these systems, and by contract provisions with EHR vendors that stymie the free flow of information about system-linked safety concerns, the report authors say.

So, ED's across the country are rolling out technology, often taking advantage of ARRA's HITECH incentives ... but there is a lack of research and solid evidence into the risks.  Allow me to opine - that's simply crazy.

The groups found that “poor data display is a serious problem with many of today's EDISs,” while “the sheer volume” of alerts that range from the “completely irrelevant to life threatening” [or lack of appropriate alerts to relevant, simple issues such as data input errors - ed.] can “dull the senses, leading to a failure to react to a truly important warning.” They also found that “an alarming number of clinicians are anecdotally reporting a substantial increase in the incidence of wrong order/wrong patient errors while using the computerized physician order entry component of information systems.”

The word "anecdote", as I have written, is being misused.  The reports are not "anecdotes."  They are risk management-relevant incident reports.  (See "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" at http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html.)

Two study groups from the American College of Emergency Physicians have recommended a program of systemic vigilance over electronic health-record systems used in emergency departments to improve patient safety and enhance quality of care.

ACEP workgroups on informatics and on quality improvement and patient safety published their findings in an article, “Quality and Safety Implications of Emergency Department Information Systems,” in the current issue of the Annals of Emergency Medicine.

Post marketing surveillance, a standard for decades in other healthcare sectors, has been absent from health IT due to a long-obsolete special regulatory accommodation afforded that industry.  This accommodation was initiated when systems were simple and merely advisory - not the comprehensive enterprise clinical resource and clinician command-and-control systems they are today.  Now, clinician investigators of the technology such as the authors of this study are realizing that continuing this accommodation is a mistake.

It follows in the wake of, and references, an Institute of Medicine report from 2011, “Health IT and Patient Safety: Building Safer Systems for Better Care.” That report concluded that “current market forces are not adequately addressing the potential risks associated with the use of health IT.” It also comes eight months after the New England Journal of Medicine published “Electronic Health Records and National Patient-Safety Goals,” which warned that recent evidence “has highlighted substantial and often unexpected risks resulting from the use of EHRs and other forms of health information technology.”

I note that if you frequent this blog, you likely read material similar to the bolded red statements above here first, as authored by me, dating to the founding of this blog in 2004.

... “The rush to capitalize on the huge federal investment of $30 billion for the adoption of electronic medical records led to some unfortunate and unintended consequences, particularly in the unique emergency department environment,” said Dr. Heather L. Farley, the lead author of the report, in a news release. “The irreversible drive toward EDIS implementation should be accompanied by a constant focus on improvement and hazard prevention." Farley is assistant chairwoman of the Department of Emergency Medicine at Christiana Care Health System in Newark, Del.

Ironically, I note in Dr. Farley's statement some of my own advice, given to ED staff when I was Chief Medical Informatics Officer at Christiana Care 1996-8.   I had in that time period advised Charles Reese IV, MD, Chair of Emergency Medicine, to not implement EHRs or, at best, implement document imaging systems (since ED charts are not that long or complex), not full field-based EHRs, due to the "unfortunate and unintended consequences" of bad health IT in such an environment I recognized even then.  It was only a few years ago that my advice was finally overturned.

The authors also report “(t)here are few consistent data on how commonly these errors occur, and few studies are actually focused on collecting evidence of these errors.” Meanwhile, “there is currently no mechanism in place to systematically allow, let alone encourage, users to provide feedback about ongoing safety issues or concerns” with EHRs in general, and EDISs specifically.

On its face, that is not a safety-conscious environment and the rollout and use of such systems seems a fundamental violation of patient's rights, made worse by the fact that there is no informed consent process whatsoever to ED EHR use.

The workgroups came up with seven recommendations: appointing an emergency department “clinician champion,” creating within healthcare delivery organizations an EDIS performance improvement group and an ongoing review process, paying timely attention to EDIS-related patient-safety issues raised by the review process, disseminating to the public lessons learned from performance improvement efforts, distributing vendors' product updates in a timely manner to all EDIS users and removing the “hold harmless” and “learned intermediary clauses” from vendor contracts.

Many of these issues have been discussed on this blog.

“The learned intermediary doctrine implies that the end users (clinicians) are the medical experts and should be able to detect and overcome any fallibility or contributing factor of the product,” the authors said.

I have also pointed out the absurdity of such a "doctors are clairvoyant" attitude, e.g., at my 2011 post on basic common sense on IT adverse consequences at http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html.

They conclude that the “lack of accountability for vendors through hold harmless clauses and the shifting of liability to the clinicians through the learned intermediary doctrine are significant and additional impairments to safety improvement. Electronic health records and EDISs are sufficiently complex that the physician and other users cannot be expected to anticipate unpredictable errors.”

That aligns with the work of Dr. Jon Patrick in Sydney, whose treatise "A study of an Enterprise Health information System" on the Cerner FirstNet ED EHR is available here: http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

Earlier this month, the Electronic Health Record Association, an EHR developers trade group affiliated with the Chicago-based Healthcare Information and Management Systems Society, announced the launch of a voluntary “code of conduct” in which adherents would agree to drop “gag clauses” in the contracts with their provider customers.

Great.  Per the wonderful 2007 article "The Denialists' Deck of Cards: An Illustrated Taxonomy of Rhetoric Used to Frustrate Consumer Protection Efforts" by Chris Jay Hoofnagle, available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462, as of this writing free:

... At this point [of losing the argument], the denialist must propose "self regulation" to deal with the problem that doesn't exist. The cool thing about self regulation is that it cannot be enforced, and once the non-existent problem blows over, the denialist can simply scrap it! [20]

[20] In the runup to passage of bank privacy legislation, data brokers created a group called the "Individual Reference Services Group" that promptly disappeared after the legislation passed.

("Denialism" is the use of rhetorical techniques and predictable tactics to erect barriers to debate and consideration of any type of reform, regardless of the facts.)

IMO 'self regulation' of healthcare is, on its face, a deception.  There are simply too many conflicts of interest.

On use of "integrated" big systems:

“These systems do have glitches [indeed - see http://hcrenewal.blogspot.com/search/label/glitch - ed], but it can be plain and simple bad design that can lead to clinical errors,” Cozzens said.  But ED physicians, he said, are “having the enterprise systems forced upon them. To think you can take one system and adapt it to those different environments is totally wrong. That's why you see low physician satisfaction and the productivity is going down, all for the sacrifice of having an integrated system.”

In fact, so-called "best of breed" systems can be bad health IT as well.  See the aforementioned evaluation by Dr. Patrick in Australia.

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, hard to customize, 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. 

Through my own work, I've seen bad health IT result in patient harm and death.  It's just unfortunate that I got started in this line of work by being, in effect, shot out of a cannon.  That is, my own mother was a victim.

-- SS

Addendum 10/8/13:

From the article:

End-User Recommendation 4: EDIS-related patient safety concerns identified by the review process should be addressed in a timely manner by ED providers, the EDIS vendors, and hospital administration. Each of these processes should be performed in full transparency, specifically with openness, communication, and accountability. 

I'm not sure the aforementioned levaquin near-accident "investigation" meets these standards.

-- SS

American Medical Association finally on board with EHR views expressed on this blog since 2004

- Posted on the Healthcare Renewal Blog May 17, 2013 -

It seems to have taken awhile, but organized medicine seems to finally be recognizing that today's commercial health IT is not quite the revolutionizing, transformative, plug-and-play panacea to healthcare's ills it is often touted as:

AMA Wire
May 15, 2013
AMA board chair: HHS should address EHR usability issues immediately

The government needs to act quickly to remedy the impaired usability of electronic health records (EHR) if the technology's touted benefits are to be realized, AMA Board of Trustees Chair Steven J. Stack, MD (left), told officials during a federal hearing last week.

"The AMA and most physicians believe that, done well, EHRs have the potential to improve patient care," Dr. Stack, an emergency physician in Lexington, Ky., said during his 30-minute testimony. "At present, however, these EHRs present substantial challenges to the physicians and other clinicians now required to use them."

He emphasized that many of today's EHR systems require significant changes before they can deliver the promised outcomes. Referring to Medicare's meaningful use program, he pointed to undesired consequences of pushing EHR systems on physicians before the technology was completely ready for prime time.

"Immediately" is strong language.

I note that the phrase "health IT done well" is a term I've been using since 1998 at my now-Drexel-based health IT teaching website at http://www.ischool.drexel.edu/faculty/ssilverstein/cases, as well as at this blog.

Penned by me at my aforementioned Drexel graduate teaching site, originally housed on AOL, in 1998 and still appearing in its main essay:

... While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition:  the benefits will be realized only if clinical IT is done well.  For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources. 

Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity.  This website is about the meaning of "done well" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.

(I have more recently switched to the easier-to-parse terminology of "good health IT" vs. "bad health IT" after discussions with Dr Jon Patrick at U. Sydney during my visit Down Under last summer, http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html.)

I've also heard "not ready for prime time" before.  It is a phrase I used in speaking with a New York Times reporter that then appeared in the Oct. 8, 2012 NYT article "The Ups and Downs of Electronic Medical Records" (http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2) by Milt Freudenheim, October 8, 2012, where I am quoted and this blog cited:

... Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.”

The AMA Board chair went on to opine:

"Attempting to transform the entire health system in such a rapid and proscriptive manner has compelled providers to purchase tools not yet optimized to the end-user's needs and that often impeded, rather than enable, efficient clinical care," he said.

He noted that physicians are "prolific technology adopters" but that adoption of EHR systems has required federal incentives because the technology still is "at an immature stage of development."

My near-exact terminology has been that the technology is still experimental.

"EHRs have been and largely remain clunky, confusing and complex," he said.

Perhaps he read my ten-part series on the health IT mission hostile user experience at this blog, at http://www.tinyurl.com/hostileuserexper.

According to a recent survey by AmericanEHR Partners, physician dissatisfaction with EHR systems has increased. Nearly one-third of those surveyed in 2012 said they were "very dissatisfied" with their system, and 39 percent said they would not recommend their EHR system to a colleague—up from 24 percent in 2010.

A survey I posted about in Jan. 2010 is here:  "An Honest Physician Survey on EHR's", http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html

Dr. Stack spoke at a "listening session" hosted by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), a division of the U.S. Department of Health and Human Services (HHS). The agencies coordinated the session to examine how a marked increase in code levels billed for some Medicare services might be tied to the increased use of EHRs.

Dr. Stack noted that some Medicare carriers have begun denying payment for charts that are too similar to other records.

"In this instance, even when clinicians are appropriately using the EHR, a tool with which they are frustrated and the use of which the federal government has mandated under threat of financial penalty, they are now being accused of inappropriate behavior, being economically penalized, and being instructed ‘de facto' to re‐engineer non‐value‐added variation into their clinical notes," he said. "This is an appalling Catch‐22 for physicians."

"Mandated under threat of financial penalty" has been one of my stated "cart before the horse" issues with HITECH (e.g., http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html).

Dr. Stack advised officials that three key actions are necessary to rectify these issues with EHR systems:

• The ONC promptly should address EHR usability concerns raised by physicians and add usability criteria to the EHR certification process.
• CMS should provide clear and direct guidance to physicians concerning use of EHRs for documentation, coding and billing.
• Stage 2 of the meaningful use program should allow more flexibility for physicians to meet requirements as EHR systems are improved.

The AMA will continue to work with federal agencies to improve EHR systems and the Medicare meaningful use program.

I've been calling for usability evaluation to be added to the certification process, including in comments during public comment periods to HHS, for some time.

What the AMA Board Chair is apparently missing, though, is health IT safety.  They should perhaps read my post on the recent ECRI Institute Deep Dive Study on health IT risk - itself based on a report in their own AMNews (amednews.com) publication ("Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events", http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

I don't think any prudent person would consider a 9-week study of 36 hospitals with volunteered reports of 171 health information technology-related problems, where eight of the incidents reported involved patient harm and three may have contributed to patient deaths, information to ignore.

-- 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