Wednesday, August 04, 2010

Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight

The Huffington Post Investigative Fund has published a remarkable expose of health IT difficulties and the Big Politics that surround them regarding safety and efficacy:

FDA, Obama Digital Medical Records Team at Odds over Safety Oversight
Aug. 3, 2010
By Fred Schulte and Emma Schwartz

Computers at a major Midwest hospital chain went awry on June 29 [after an 'upgrade' - ed.], posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

[In other words, data entered by clinicians was going into the wrong charts. How many charts were involved? Does the hospital system even know, I wonder? - ed.]

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

... Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.

Yet despite the high [actually, potentially catastrophic - ed.] political and financial [and clinical -ed.] stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.

I began to document some of the problems and the resistance of what Washington Post reporter Robert O'Harrow Jr. in May 2009 called the "Healthcare IT lobby" a decade ago in a website. That website, now hosted at Drexel University, is entitled "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties."

Few in government and industry were apparently listening, despite ongoing worldwide interest in the topic (PPT).

Read the Huffington Post report in its entirety. It includes a slide-show timeline of the health IT industry's sidestepping of government oversight and safety concerns.

As I am currently busy helping out my ill mother, I will offer more commentary later.

However, one quote really stuck out. Is the Chairman of the Office of the National Coordinator for Health IT (ONC) Dr. David Blumenthal lying, or simply misinformed?

Judging by the quality of academic discourse these days, I'd hope the latter (an alarming situation in and of itself), but the former is also possible.

He is quoted as stating:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

As at my July 14, 2010 post Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records" , however, I pointed out some examples that contradict this meme.

This list is just for starters:

(Hyperlinks to these and others can be found at my Medical Informatics teaching site here and here:)

1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA.

2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks

3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.”

5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand)

Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient."

8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program.

9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act).

10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I wrote here, is slated for abandonment. I cannot imagine it was greatly improving outcomes).

11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care.

12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London.

14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al.

15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF here)

My healthcare informatics graduate students are well aware of studies such as these.

[Feb. 2011 addendum: see a much longer list at this link - An Updated Reading List on Health IT - ed.]

Why isn't ONC Chairman Dr. Blumenthal?

Perhaps equally as remarkable is this from Trinity Health, the healthcare system whose health IT crashed:

We are not aware of any patient safety or quality of care issues caused by this event,” he said.

Many of the "safety and quality" issues due to erroneous data in charts can come out weeks, months or even years later. The issue that the health IT cheerleaders seem to ignore is risk.

Has the erroneous data been identified and corrected, I wonder?

Probably not. According to the Huffington Post Investigative Fund article, they don't even know what caused the problem:

... While doctors were concerned about the problems, ...

[well, yes, I'd be quite frightened myself, especially considering who
holds the liabilities for health IT defects - ed.]

... Shivinsky said that most are happy with the system and would “never go back to paper.”

[That sounds very nice. Is it true? - ed.]

Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.

Eventually, I would hope, since the kludged "correction" I heard about is that clinicians can now only open one electronic patient chart at a time, potentially slowing and impairing their work.

I've emailed Mr. Shrivinsky asking if they'd truly identified and remediated the problem yet.

-- SS

1 comment:

Anonymous said...

Trinity is not the only hospital or hospital system in which the medical records of thousands of acutely sick patients vanish, leaving no trace of what has happened and what care needs to be given.

This is in the category of criminal negligence.

This has happened repeatedly and the events are covered up.

Blumenthal knows or should have made it his business to know. Amazing that he is telling the FDA what it can or can not regulate for safety.

Imagine that...a family doctor giving the directives to the FDA...or is it Sebelius, a lawyer, telling the FDA how to do its job?