Sunday, April 27, 2014

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania ( has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports.

Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at

Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (

From the new report:

CONCERN #1: Data integrity failures with health information technology systems

At page 7:

With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.

For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:

Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff 
Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended
Providing sufficient user training and support
Establishing a mechanism for users to report problems as they are discovered

In the Bizarro world in which we find ourselves in 2014, however:

  • FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks ( 
(Got that?)

The E-cigarette focus is For The Children, no doubt.

Bizarro World (

Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems.

CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8):

... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.

CONCERN #3: Test Results Reporting Errors (page 10):

... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice.

As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”

I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results.

-- SS

1 comment:

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