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Thursday, September 05, 2013

Study Explains Errors Caused by EHR Default Values - With Only Four Reports of "Temporary" (By the Grace of God) Patient Harm

From Health Data Management and the Pennsylvania Patient Safety Authority:

Study Explains Errors Caused by EHR Default Value
Sept. 5, 2013

A new study analyzes errors related to “default values” which are standardized medication order sets in electronic health records and computerized physician order entry systems.

The Pennsylvania Patient Safety Authority, an independent state agency, conducted the study. “Default values are often used to add standardization and efficiency to hospital information systems,” says Erin Sparnon, an analyst with the authority and study author. “For example, a healthy patient using a pain medication after surgery would receive a certain medication, dose and delivery of the medication already preset by the health care facility within the EHR system for that type of surgery.”

These presets are the default value, but safety issues can arise if the defaults are not appropriately used. Sparnon studied 324 verified safety reports, noting that 314, or 97 percent, resulted in no harm. Six others were reported as unsafe conditions that caused no harm and four reports caused temporary harm involving some level of intervention.

One might ask:  how many unreported or yet-to-be-reported EHR/CPOE cases involved, or will involve, permanent harm?

Sept. 9, 2012 Addendum:  We learn this from Healthcare IT News (http://www.healthcareitnews.com/news/ehr-adverse-events-data-cause-alarm):  "Sparnon said two of the reports involved temporary harm that required initial or prolonged hospitalization."  I note that hospitalization, especially prolonged hospitalization, exposes the patient to still more risk.

Regarding the "temporary harms", one which includes "default times" as opposed to doses:

The four cases requiring intervention involved accepting a default dose of a muscle relaxant that was higher than the intended dose, giving an extra dose of morphine [keep playing with 'extra doses' of drugs like morphine enough, and you're going to kill someone  - ed.] because of an accepted default administration time that was too soon after the last dose, having a patient’s temperature spike after a default stop time automatically cancelled an antibiotic [do this enough, and you're going to get sepsis and septic shock to deal with - ed.] and rising sodium levels in a patient because confused wording made nurses believe that respiratory therapy was administering an ordered antidiuretic. [Apparently the 'default'- ed.]

More on the errors:

The most common types of errors in the study were wrong time (200), wrong dose (71) and inappropriate use of an automated stopping function (28). 

Any of these, especially the latter two, could have caused harm depending on degree...and to those Risk Management majors out there, eventually will.

 “Many of these reports also showed a source of erroneous data and the three most commonly reported sources were failure to change a default value, user-entered values being overwritten by the system and failure to completely enter information which caused the system to insert information into blank parameters,” Sparnon says. 

Hence my claim that the term "EHR" is anachronistic, and that these systems now are really cybernetic command-and-control mediators and regulators of care (via cybernetic proxy).

“There were also nine reports that showed a default needed to be updated to match current clinical practice.”

The need for a constant, rigorous updating process (which will in the real world likely always be 'behind'), among many others, is a factor that makes the idealistic belief/promise that "health IT will save money and increase safety" (let alone "revolutionize" medicine) unpersuasive.

I note that the "default values" risk is only one of many, many "features" of EHRs and other clinical IT that cause risk and error.  This issue is but one layer of a very, very large and multi-layered onion (cf. AHRQ Health IT Hazards Manager, http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf, for example).

And this, at the same time that the The HIT Policy Committee, a body of industry stakeholders who advise federal officials, on Sept. 4 adopted final recommendations on health IT risk consistent with an attitude of health IT exceptionalism that included:

"HIT should not be subject to FDA [or any - ed.] premarket requirements" and "Vendors should be required to list products which are considered to represent at least some risk if a non-burdensome approach can be identified."  

If not, no list? ... And what, exactly, is a "non-burdensome" approach, one might ask? 

(See www.healthdatamanagement.com/news/health-information-technology-regulation-fda-onc-fcc-46557-1.html)

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Perhaps the penalty for health IT hyperenthusiasts**, short of the Biblical penalty of one of their loved ones suffering the fate of a guinea pig in a medical experiment, should be to be compelled to fly some third rate air carrier with a safety record of "we only had a few near-crashes last month."

-- SS

** [See definition of health IT hyperenthusiast at Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality' at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html]
 

2 comments:

  1. The comment period for the FDASIA recommendations just ended on August 31, 2013. Either there were very few comments or the ONCHIT Policy Committee ignored ALL of them.

    The default drug doses are put in there to give the illusion to the users, who would otherwise raise hell about the waste of time caused by these devcies, that these devices are efficient.

    It is tedious to overide the fixed regimen specified by those who program the device but do not take care of the patient.

    That gets me to, how is it that those who do not take care of the patient wield such control over what can be ordered?

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  2. What is a burden for the vendors, exactly?

    It is a burden for the physician and the patient's survivors when a death occurs because of a flawed and defective EHR device, indeed.

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