Today's Bad Health IT Systems: More Dangerous Than Paper?

I believe in 2013 that they are.

(Definition of bad health IT is here:  http://www.ischool.drexel.edu/faculty/ssilverstein/cases/)

I recently posted about two "glitches" in a major EHR seller's clinical systems, Siemens Healthcare, affecting safety-critical functions of medication reconciliation and medication ordering.

• Another Health IT "Glitch" - Can Digital Disappearing Ink Kill Patients?

• Can Digital Disappearing Ink (An EHR "Glitch") Kill Patients? Part 2

Considering these, plus the many "glitches" reported by the only EHR seller who does so via FDA's MAUDE database (see here: http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and the others posted at this blog at query link: http://hcrenewal.blogspot.com/search/label/glitch, the following issue needs serious consideration by policymakers.

Namely, the issue that enterprise electronic medical command-and-control systems, which today's "EHRs" in reality are, are on their face more risk-prone than the paper systems they are replacing.

The "glitches" reported above are clearly the tip of the iceberg due to industry norms of secrecy, the absence of most of the industry in reporting to FDA MAUDE or anywhere, and my limited sources of information.  It is likely the true level of "glitches" in live EHR/clinical IT installations is far, far higher  - conservatively, I believe, at least two orders of magnitude.

Workarounds to IT "glitches" such as recommended in the Siemens bulletins at the aforementioned posts cause hospital officials to have to  reliably get the notices to all users of the systems, including medical students, nurses, physicians and allied health professionals.

The workarounds also cause users to:

1)  have to deviate from habits of use acquired in training and active use of the systems in question;
2) remember, without fail, to deviate from habits of use acquired in training and active use of the systems in question, in effect giving them the responsibility of caring for sick patients and for "sick" information technology;
3) keep in mind any other extant workarounds that exist waiting for "fixes"; and
4) be constantly on guard for information storage failures.

In fact, the recent Siemens "glitches" and workarounds represent a clear danger to patient safety.  If these were more conventional medical devices, they'd be recalled.

See my Dec. 14, 2011 post "FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death" (http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html) and July 23, 2012 post "Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems"(http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html) for examples where health IT defects similar to the Siemens issues were, in fact, recalled.

Further, with paper records or tangible images, a page or image can be lost, or it can be illegible.  In the case of lost, in any quality paper record keeping system the information stewards or others using the paper (e.g., office staff or ward clerks) will generally note the absence and act accordingly.  Further, illegible notes or orders will most often be recognized as illegible and result in attempted clarification or other corrective actions.

On the other hand, when electronic systems:

1)  lose modified information en masse as in the Siemens examples but keep the old, or
2)  when outright errors such as en masse truncation occur (as in the thousands of prescriptions whose long-acting suffixes were cut off at Lifespan in Rhode Island, see "Yet another health IT "glitch" affecting thousands" here: http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html), or
3)  images are lost (see "Potential Image Loss in GE Centricity PACS" here:  http://hcrenewal.blogspot.com/2012/11/potential-image-loss-in-ge-centricity.html) without warning-

- There are no "flags" that the obsolete, truncated or missing information is erroneous.

What remains is perfectly legible, perfectly convincing and perfectly deceiving.

Electronic healthcare information systems on their face create more risk than paper record systems.  Further, the problem with "bugs" and "glitches" will not go away with today's industry models of "hiring down" and lack of regulation.  Every new upgrade or patch is suspect for introducing new bugs.

Paper does not suffer these issues, unless disappearing ink is used to cross out the old and add new information ...

Not that I am advocating for a return to 100% paper, but certain critical functions probably are best left to paper.  Further, hundreds of billions of dollars can certainly buy:

1)  a lot of Health Information Management professionals to perform continuous QA of paper,
2)  a lot of document imaging systems to make the paper records available anywhere, anytime they are needed, and
3)  a lot of data entry personnel to relieve clinicians of clerical burdens so they may use their valuable experience more productively, as guest poster Howard Brody points out at http://hcrenewal.blogspot.com/2013/07/guest-post-incompetent-management.html.
4)  a lot of sensible regulation of this industry's product quality.

-- SS

Bad Health IT -Yet Another Health IT 'Glitch' - Potential Image Loss in GE Centricity PACS; ECRI Again Reports Health IT a Top Ten Hospital Risk

From my definition of bad health IT (BHIT) at this link:

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

Considering the problem of lost data (lost x-rays) that affects not one, but two versions ("versions 3.x and 4.x and higher") of a common GE PACS (radiology image management) system, as in the attached memo to hospital radiology and IT executives, one might ask:

• How long has this been going on before this 'glitch' was discovered? 

• What validation and safety testing does GE use before releasing its health IT to production? 

• Why was it discovered in several successive versions of PACS systems being used on live patients, instead of in laboratory testing?

• How many delayed diagnoses, injuries and/or deaths might have occurred as a result of this "disappearing image" bug?

• What is the likelihood this "workaround" will be uniformly adopted in short order?  

• What levels of hypervigilance, stress and increased likelihood of error will this temporary "workaround" engender?

• When will it be fixed in all implementations worldwide?

 Beware disappearing x-rays.  Make sure every system user performs this workaround, too (click to enlarge).

Page 2 (click to enlarge)

It's not as if missing x-rays are a trivial matter.  One routine x-ray lost to followup resulted in the needless and rather horrible death of an infant, and a $1.5 million settlement, as at the June 2011 link "Babies' deaths spotlight safety risks linked to computerized systems" (case #2).

Patient safety is being compromised.

Lack of regulation of health IT, and lack of reporting and accountability, needless to say, are major contributors to the prevalence of BHIT.

I also note for several years running, including in the latest report of 2013, the ECRI Institute (an independent tester of healthcare technology) reports health IT-related problems as among the top ten technology problems in hospitals (link to report):

...Five of the top 10 hazards explained in ECRI Institute’s [2013] report are:

    1.  Alarm hazards
    2.  Medication administration errors using infusion pumps
    3.  Unnecessary radiation exposures and radiation burns during diagnostic radiology
         procedures
    4.  Patient/data mismatches in EHRs and other health IT (HIT) systems
    5.  Interoperability failures with medical devices and health IT systems

Three of the ten topics on the 2013 list are directly associated with the still-maturing [i.e., experimental - ed.] health IT field where the interplay between complexity and effectiveness and potential harm is most evident; several of the other topics are peripherally related to HIT issues.

“The inherent complexity of HIT-related medical technologies, their potential to introduce new failure modes, and the possibility that such failures will affect many patients before being noticed—combined with federal incentives to meet Meaningful Use requirements—leads us to encourage healthcare facilities to pay particular attention to health IT when prioritizing their safety initiatives for 2013,” says James P. Keller, Jr., vice president, health technology evaluation and safety, ECRI Institute.

The hazards included in the 2013 list, published in the November 2012 issue of ECRI Institute’s Health Devices journal, met one or all of the following criteria: it has resulted in injury or death; it has occurred frequently; it can affect a large number of individuals; it is difficult to recognize; it’s had high-profile, widespread news coverage.

-- SS