More Perspectives Appear On Health IT Safety. I Don’t Think NEHTA is Paying Attention. They Should Be!

Some interesting articles appeared on Health IT safety around the time I published a link to an article in the Australian.

That Australian article is linked from here:

http://www.aushealthit.blogspot.com.au/2011/12/this-really-is-article-that-is-too.html

In chronological order we have:

New Institute of Medicine Report on Health IT and Patient Safety

POSTED BY: Robert Charette  /  Mon, November 14, 2011

Last week, the Committee on Patient Safety and Health Information Technology at the Institute of Medicine released a very interesting report concerning its investigation into health IT and improving patient safety. The title of the 197-page study, appropriately called "Health IT and Patient Safety: Building Safer Systems for Better Care," is focused on assessing "... some of the important issues surrounding health IT and its introduction and to indicate the activities most likely to bring the potential value of health IT to the U.S. health care system."

The IOM study was necessarily narrow in scope, and therefore the Committee did not look at issues such as "... whether health IT should be implemented, access to health IT products, medical liability, privacy, security, and standards." The Committee recognizes these critical issues need to be addressed, but its mission was to examine "..the aspects of health IT directly pertaining to safety."

A great deal more here:

http://spectrum.ieee.org/riskfactor/computing/it/new-institute-of-medicine-report-on-health-it-and-patient-safety

I referred to this article in my Senate Enquiry Submission here:

http://aushealthit.blogspot.com.au/2011/12/near-final-draft-of-submission-to.html

Then we have a much later and very comprehensive effort from iHealthBeat.

Wednesday, December 21, 2011

Gov't Seeks To Ensure Patient Safety While Promoting Health IT

by Helen R. Pfister and Susan R. Ingargiola, Manatt Health Solutions

One of the most sacred maxims in health care is "first, do no harm." Following this principle, the federal government has taken a number of steps to balance patient safety with its promotion of widespread adoption of health IT to improve care.

As part of this effort, the Office of the National Coordinator for Health IT asked the Institute of Medicine to explore the effect of health IT on patient safety and to define the roles of the public and private sectors in ensuring safe and effective health IT use. On Nov. 8, IOM released its recommendations in a report titled, "Health IT and Patient Safety: Building Safer Systems for Better Care." 

Background

How best to protect patients from health IT-related harm is an important policy issue that has been the subject of considerable debate. Unlike pharmaceuticals and medical devices, health IT tools are not currently subject to comprehensive safety review.

Some have suggested that ONC -- which is responsible for coordinating the development of a national health IT infrastructure and promoting use of health IT -- should oversee health IT safety. Others have suggested that FDA is best suited to ensure health IT safety.

As the IOM report acknowledged, the level of safety risk associated with health IT tools is unclear, although case reports suggest that poorly designed health IT tools can create new hazards in the delivery of care, such as the loss or corruption of vital patient data.

However, there is industry concern that FDA regulation could slow health IT innovation. The IOM report noted that the "current FDA framework is oriented toward conventional, out-of-the-box, turnkey devices. However, health IT has multiple different characteristics, suggesting that a more flexible regulatory framework will be needed in this area to achieve the goals of product quality and safety without unduly constraining market innovation." 

IOM did not take a definitive position on the question of whether health IT tools should be subject to comprehensive, FDA-type regulation. Instead, IOM recommended that Congress create an independent federal entity to investigate patient safety deaths, serious injuries or potentially unsafe conditions associated with health IT and that FDA exert its regulatory authority only if HHS determines that progress toward safety and reliability is insufficient.

Major Themes From IOM Recommendations

ONC asked IOM to examine a variety of patient safety topics, including how to reduce health IT-related safety concerns, as well as the role of private-sector groups (e.g., accreditation bodies and professional societies) and federal government agencies in ensuring health IT safety. IOM's recommendations apply to electronic health records, patient engagement tools, such as personal health records and patient portals, and health information exchanges.

In general, IOM noted that because health IT is not used in isolation and instead is part of a larger "sociotechnical" system that also includes people, organizations and processes, safety emerges from the interactions of these factors. Thus, safety analyses should not look for a single "root cause" of problems but should consider the system as a whole; health IT vendors, users, government and the private sector all have roles to play.

While IOM made 10 recommendations, four main themes emerge. First, fostering a system-based approach is key. According to IOM, creating safer systems begins with user-centered design principles and includes adequate testing and quality assurance conducted in real or simulated clinical environments. Designers and users of health IT should work together to develop, implement, optimize and maintain health IT tools.

Second, health IT vendors and users must be able to freely share safety information. The ability to generate, develop and share details of safety risks is essential for health care providers to choose health IT tools that best suit their needs. Non-disclosure clauses in health IT vendor contracts can discourage users from sharing information and should be limited. Comparative user experiences with health IT should be publicly available.

Third, standards, measures and criteria for safe use of health IT are necessary. Without them, it is difficult to reliably assess the current state of health IT safety and to monitor improvements.

Finally, transparency and accountability can help turn errors into lessons learned. There should be a government-run mechanism for reporting health IT-related deaths, serious injuries or unsafe conditions. This will help quantify patient safety risk and enable vendors and users to act on the information.

.....

MORE ON THE WEB

• IOM report on health IT and patient safety
• "Improving Patient Safety Through Health IT" (Mostashari, Health IT Buzz blog, 11/8).
• "IOM Calls for Creation of New Agency To Investigate Health IT" (iHealthBeat, 11/8).

The full article is here:

http://www.ihealthbeat.org/features/2011/govt-seeks-to-ensure-patient-safety-while-promoting-health-it.aspx

The latest - after Christmas is here:

Unintended - but Predicted - Consequences of Electronic Health Record Usage Grows

POSTED BY: Robert Charette  /  Tue, December 27, 2011

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) announced that nearly $2 billion has been paid out in electronic health record (EHR) adoption incentives as of the end of November. In 2009, the US government, as part of the American Recovery and Reinvestment Act of 2009, set aside nearly $30 billion to support EHR adoption in the US. Eligible Medicaid professionals can get up to $63,750 over six years (eligible Medicare professionals up to $44,000 over five years) in incentive payments if they can meet certain technological certification as well as healthcare practice criteria called "meaningful use."

According to a story in Government Health IT, so far the CMS has made EHR incentive payments to 12,070 Medicaid providers (amounting to $916.3 million) and 10,556 Medicare providers (amounting to $920.3 million). Government Health IT also reports that:

"... 115,093 physicians and hospitals are [currently registered] in the Medicare incentive program; 39,503 physicians and hospitals are in the Medicaid program; and 2,634 hospitals are registered for both the Medicare and Medicaid programs."

As more physicians and hospitals adopt EHRs, the more operational risk issues surface. In mid-December, the RAND Corporation in cooperation with the University of Pennsylvania School of Medicine, Kaiser Permanente-Colorado and the American Health Information Management Association Foundation released an EHR "Unintended Consequences Guide" which is available from the US Agency for Healthcare Research and Quality web site.

The guide, says RAND, is aimed at helping "... hospitals and other health care organizations anticipate, avoid and address problems that can occur when adopting and using electronic health records." Some common unintended consequences the guide addresses are:

• More work for clinicians
• Unfavorable workflow changes
• Never-ending demands for system changes
• Conflicts between electronic and paper-based systems
• Unfavorable changes in communication patterns and practices
• Negative user emotions
• Generation of new kinds of errors
• Unexpected and unintended changes in institutional power structure
• Over-dependence on technology

I must admit that I am a bit mystified by what qualifies to be an "unintended consequence" of EHRs since all of the above issues have been discussed for years in the medical as well as computer literature, including by myself here in IEEE Spectrum as a direct consequence of EHR implementation and use. What is interesting is that other issues, e.g., like protecting the security/privacy of electronic health records, do not seem to be mentioned in the guide at all. I'll return to this subject in a few moments.

Another so-called "unintended consequence" missing from the list is "doctoring while distracted," i.e., doctors and other healthcare professionals paying too much attention to their EHR system or other digital devices and not enough to their patients. Sometimes it has to do with doctors having to futz with inputting information into the EHR system, and losing eye contact with their patients (PDF).

Other times, it's being tempted to just forget the patient is there are all. There was an article in the New York Times just two weeks ago about distracted doctors and other health care workers that contained some troubling examples. For instance:

"A peer-reviewed survey of 439 medical technicians published this year in Perfusion, a journal about cardio-pulmonary bypass surgery, found that 55 percent of technicians who monitor bypass machines acknowledged to researchers that they had talked on cell phones during heart surgery. Half said they had texted while in surgery."

Lots more here:

http://spectrum.ieee.org/riskfactor/computing/it/unintended-but-predicted-consequences-of-electronic-health-record-usage-grows

The bottom line in all this is that we have to have a structured, co-ordinated and learning approach to the development, implementation and post implementation of health systems to ensure that we are obeying the first rule of medicine - “First, do no harm”.

I look forward to being told that NEHTA is changing their ways - and until then I will keep banging on about the issue!

David.