Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014". The PDF report is available at https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf.
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 (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).
From the new report:
CONCERN #1: Data integrity failures with health information technology systems
x Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended
x Providing sufficient user training and support
x Establishing a mechanism for users to report problems as they are discovered
- 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 (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).
- Regulation of E-cigarettes is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html).
- Except for children such as these, one might conclude: http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html.
|Bizarro World (http://en.wikipedia.org/wiki/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.