Wednesday, November 09, 2011

The Issue Of The Safety of Deployment and Use Health IT Is Becoming Hotter. We Need To Pay More Attention!

The following appeared a few days ago.
Tuesday, November 01, 2011

Health IT: A Boon or Bane for Patient Safety?

WASHINGTON -- Last week, health care experts warned that although health IT adoption holds much promise, there is a risk for unintended patient safety consequences.  
The experts were part of a panel discussion, titled "International Perspectives on Patient Safety and Health Information Technology," at the American Medical Informatics Association's 35th Annual Symposium on Biomedical and Health Informatics.
Rainu Kaushal -- director of the Center for Healthcare Informatics and Policy at Weill Cornell Medical College, and director of pediatric quality and safety at the Komansky Center for Children's Health at New York Presbyterian Hospital -- said there are documented patient safety benefits for certain technologies in certain settings.
For example, one study found a 20% decrease in inpatient mortality after the implementation of a computerized provider order entry system, while another study found that a stand-alone electronic prescribing system led to an 85% decrease in medication errors, Kaushal noted.
However, Kaushal said that there has been limited research on the unintended risks of health IT use and how those risks can be addressed.
Dean Sittig -- a professor of biomedical informatics at the University of Texas Health Science Center at Houston -- said he believes health IT can improve patient safety, but "we're not doing it optimally."
Sittig said that EHR-related errors can occur when:
  • EHR systems are unavailable because of a power outage or other incident;
  • An EHR malfunctions;
  • An individual incorrectly uses an EHR system; or
  • An EHR system interacts with another health IT system component incorrectly.
He said he is "a little worried" that the meaningful use incentive program could complicate patient safety issues as the country experiences rapid advances in EHR development, implementation and regulation.
Former National Coordinator for Health IT David Blumenthal said, "Safety is absolutely important," but he noted that safety is always a concern whenever a new technology or new drug is introduced.
Blumenthal, a Samuel O. Thier professor of medicine at Harvard Medical School, noted that improving patient safety and care quality is one of the five main goals of the meaningful use incentive program.
Blumenthal said, "There has been and there will continue to be controversy" over whether the meaningful use program "was the right solution." However, he said it is "way, way too soon to reach judgment" and it will "be years before we'll know with clarity if it was successful."
How To Bolster Safety of Health IT Systems
Sittig said improvements are needed in EHR design, development, implementation and evaluation, including oversight.
He compared the strategy of improving the safety of health IT systems to previous efforts by the National Transportation Safety Board to boost the safety of cars through policies related to speed limits, seat belts, airbags and anti-lock brakes.
Sittig said that new safety features and practices likely will place an additional burden on clinical users and vendors, just as putting on a seat belt takes a few extra seconds for passengers in a car. However, Sittig said he is confident that such safety practices will be well worth it in the long run.
Sittig offered three recommendations for limiting EHR-related errors that could jeopardize patient safety:
  • Identification of best practices for design and development of EHR systems;
  • Better monitoring and analysis of problems from the field; and
  • Development of a culture of high reliability.


Lots more here:
This issue was emphasised by this announcement a day or so ago.

IOM to release new report on health IT and patient safety

November 04, 2011 | Bernie Monegain, Editor
WASHINGTON – Citing concerns raised over the potential harm that could stem from a digital healthcare system, the Institute of Medicine, best known for its 1999 report on medical errors “To Err is Human,” is poised to release another report – this time on the risks associated with electronic health records.
IOM will make its report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” public on Nov. 10 at a briefing in the nation’s capital.
The federal government is investing billions of dollars to encourage hospitals and healthcare providers to adopt health information technology so that all Americans can benefit from the use of electronic health records by 2014,” said IOM officials in a statement. “However, concerns about potential harm are emerging as providers increasingly rely on electronic medical records, secure patient portals and other information technologies to deliver care.”
“Health IT and Patient Safety: Building Safer Systems for Better Care” examines a broad range of health information technologies and recommends actions the government, healthcare providers and technology vendors should take to improve patient safety.
More here:
A quick search on the web does not show a great deal:
I did however come across this press release:

Clinical Safety Assessment Program (CSAP) developed for NEHTA

The Clinical Safety Assessment Program (CSAP) is an initiative of the National E-Health Transition Authority (NEHTA) to help ensure the discovery and effective control of safety related risks, hazards and issues surrounding the creation and use of clinical terminologies.  Initially CSAP is to be applied to those clinical terminologies and related software created by NEHTA itself.
The CSAP developed by Software Improvements, supported by Hyder Consulting, essentially comprises two key, generic processes drawn from standards used in the safety critical systems industry and standard practices employed as part of the independent verification and validation of safety critical software/systems.
Overall, the CSAP aligns with two newly released (draft) health informatics standards – ISO/TS 29321 and ISO/TR 29322, which are largely based on the key safety critical systems standard (AS/ISO/IEC 61508) and to a lesser extent DEFSTAN 0056.
The generic CSAP processes are configurable for enabling the assessment of differing clinical system products or practices according to ascertained safety levels.   The configured processes consist of a set of steps to assess whether a clinical terminology product and/or the associated processes used to construct the product are appropriate for the ascertained safety level.  That is, to determine whether a product possesses the requisite quality and behaviour deemed necessary to consider it safe, and whether management and implementation processes support practices that help ensure delivery of a safe product.
The two key CSAP processes are based on: a), a hazard identification and analysis technique referred to as Hazard and Operations Studies (HAZOPS), and b), independent verification and validation processes.  Other essential CSAP processes include assessment planning and management, estimation, recommendations and reporting.
Software Improvements has extensive experience in the application of, and training in, these processes and standards.
The release is here:
It also seems there is a Clinical Safety Unit within NEHTA. Here is a link to a conference where this unit was discussed in late 2011.
What there is not - as usual - is any documentation on just what is being done, and how it is being done in the public domain.
It can hardly be that NEHTA clinical safety processes are a State Secret. Really all this lack of openness just goes way to far!
It will be interesting to see what the Institute of Medicine has to say!
Note: After I had finished this blog - this appeared this morning. The issue is real and not properly addressed in what NEHTA is doing!

e-Health authority defends work record

THE National e-Health Transition Authority insists that after two years in operation, the work of its clinical safety unit is "fully embedded" into all areas of software product development, despite not having produced any formal reports on IT systems and patient safety.
Patient safety is emerging as a key risk as the adoption of clinical information systems accelerates.
While technology is generally seen as the best way to reduce adverse outcomes, it is increasingly clear that IT also introduces new risks.
NSW Health is currently reviewing the use of Cerner’s FirstNet software in hospital emergency departments after concerns were escalated by Sydney University e-health expert Jon Patrick this year.
Professor Patrick found the software “increased risks to patient safety” due to data being lost during transfers between administration and clinical systems, “antiquated” messaging standards that did not alert users to non-received mail and a "practically unusable" electronic discharge system.
Other problems involved mislabelling of patient samples on the pathology orders system, and the deletion of forward orders for services like x-rays after three weeks when appointments were booked up to three months in advance.
Clinical safety work is intended to identify and mitigate situations that put patients at risk of e-health harm, and is generally conducted in parallel with the technical design and testing of new systems.
Key concerns also include the risk of patient misidentification, incorrect medical records or clinical reference data, and unavailability of health IT services.
Sources in the health systems development community say they have been seeking information on the CSU's work for over a year, but have been unsuccessful so far.
In particular, they want access to a patient safety risk assessment apparently conducted by Nehta a year ago, as well as other findings and recommendations that may involve remediation by software vendors as they prepare to support the $500 million national personally controlled e-health record system.
A Nehta spokesman said its clinical safety unit (CSU) has undertaken work as part of the organisation’s overarching responsibility for the nation’s e-health rollout.
"It is a legitimate expectation of software vendors that products developed by Nehta are safe and have clinical utility," he told The Australian.
Vastly more here:
In extremely late breaking news. The IOM Report mentioned above is now online here:
and the MSIA has just released a white paper expressing a range of concerns with the safety of the Health Identifier Service. It is all happening!

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