Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1], and due to vague or incomplete seller language that could be misinterpreted by buyers (perhaps by design), I recently asked several ONC-ATCBs (HHS's Office of the National Coordinator for Health IT-Authorized Testing and Certification Bodies) the following.

I sent this question via email to their "questions" email addresses:

"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"

One ONC-ATCB provided the following in response to my request for information.

From: Trivedi, Amit V (ICSA Labs)
Sent: Thursday, February 16, 2012 11:22 AM
To: Scot Silverstein
Subject: RE: Form submission from: Contact Us

Hello Scot,

Thanks for your email. Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system.

Here is a list of the specific criteria involved in our testing:
http://healthcare.nist.gov/use_testing/effective_requirements.html

In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.).

What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question.

Thanks,

Amit

Amit Trivedi
Program Manager - Healthcare
ICSA Labs, an Independent Division of Verizon Business

Mar. 5, 2012 Addendum:  I also received a response from another ONC-ATCB, the Drummond Group:

From: Joani Hughes (Drummond Group)
Sent: Monday, March 05, 2012 1:06 PM
To: Scot Silverstein
Subject: RE: EHR certification question

Per our testing team:

It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology.

Please let me know if you have any questions.

Thank you,
Joani.

Joani Hughes
Client Services Coordinator
Drummond Group Inc.

These are direct and clear statements.

My question was certainly answered. ONC cerification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "Certification Processes for Safety-Critical and Mission-Critical Aerospace Software" (PDF) which specifies at pg. 6-7:

In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following:

• Description of the system/software
• Evidence of competence of personnel involved in development of safety-critical software and any
safety activity
• Specification of safety requirements
• Results of hazard and risk analysis
• Details of risk reduction techniques employed
• Results of design analysis showing that the system design meets all required safety targets
• Verification and validation strategy
• Results of all verification and validation activities
• Records of safety reviews
• Records of any incidents which occur throughout the life of the system
• Records of all changes to the system and justification of its continued safety

Health IT testing conspicuously lacks attention to most of the aerospace software safety points above. I note that there appears to be no reasonable excuse for such omissions.

IOM has recently studied the issue of HIT safety. IOM states in a Nov. 2011 report that HIT safety and safety testing is unsatisfactory, and has recommended HHS study it as well. IOM recommends HHS annually re-evaluate whether regulation is needed to improve safety, although IOM favors industry self-policing [2].

Thus, buyers and users of even "ONC certified" health IT are not indemnified from liability due to medical errors or problems caused by the health IT.

Sellers who exaggerate the value of certification or imply its meaning is akin to FDA device approval, likewise, could be faulted for making false representations about their products.

It would appear the sellers could potentially be sued for doing so by purchasers/users who themselves get into legal hot water due to EHR defects or other problems.

-- SS

Note:

[1] I believe confusion about EHR "certification" is in part due to the term itself. I raised objections to this term when it was first proposed based on my experience in pharma, suggesting what I felt was the more accurate expression "features qualification" instead.

[2] "Health IT and Patient Safety: Building Safer Systems for Better Care", Institute of Medicine of the National Academies, Nov. 2011, http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx

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Former US Secretary of Health and Human Services Saunters Through Revolving Door, Ends Up as Director of Medtronic

There they go again.  Another US government health care leader, this time the top health care leader at the end of the previous George W Bush administration, has wound up in a leadership position in a big, for-profit health care corporation.  As per the press release published in the Minneapolis-St Paul Business journal,

Mike Leavitt, the former Governor of Utah who also oversaw the Food and Drug Administration for four years, has been elected to the board of Medtronic Inc.

Leavitt is the founder and chairman of Leavitt Partners, which advices clients in the healthcare and food safety sectors, according to a news release from Fridley-based Medtronic (NYSE: MDT).

He served as governor of Utah from 1993 through 2003. Former President George W. Bush appointed Leavitt administrator of the Environmental Protection Agency in late 2003 and secretary of Health and Human Services in January 2005. Leavitt served in that position into January 2009.

At Health and Human Services, he oversaw the FDA and the Center for Medicare and Medicaid Services — two agencies that are important to Medtronic, which makes medical devices.

Mr Leavitt's full-time job is to chair Leavitt Partners, which advertises that it "advises clients that invest in health care and food safety." It does not publicize its client list, but that list apparently includes Alliance Health Networks, whose press release noted that Leavitt Partners "will help it expand its presence in the US health industry and beyond "(look here); and Connextions, Inc, whose press release noted that it would work with Leavitt Partners to " refine existing health insurance exchange models for federal and state governments, as well as private sector organizations that are navigating health care reform law," (look here.)

Note that Mr Leavitt's official Department of Health and Human Services biography listed no training or experience in direct health care (or in biomedical sciences or the engineering of health care devices, for that matter.) Before he was Secretary of HHS, he was Governor of Utah, and before then, he was the CEO of an insurance company.  Since I very much doubt Mr Leavitt is a large Medtronic shareholder, it would appear that the rationale for his position on its board is his conectedness with other powerful health care insiders.

Summary: the Revolving Door

Mr Leavitt did not transit the revolving door as quickly as did other health care leaders from that administration.  We noted in 2010 that the leaders of the US Food and Drug Administration (FDA), US National Institute of Health (NIH), and US Centers for Disease Control (CDC) at the end of the Bush administration had already gotten powerful positions in the health care corporate world.  Mr Leavitt is not the first recent former Secretary of HHS to become the director of a big health care corporation whose fortunes may be affected by what HHS does.  We noted in 2011 how rapidly the Secretary of HHS at the end of the William Clinton administration, Donna Shalala, signed up as a director for UnitedHealth.  We have also noted a variety of other examples of the revolving door phenomenon.

These examples suggest how the leaders of government health care agencies and health care corporations are becoming interchangeable, forming a giant embedded network of influence.  Furthermore, they suggest how top government health care leaders can now expect a cushy corporate position to open up as soon as they can legally accept it.  Whether government leaders who expect such future job opportunities will avoid offending possible corporate employers while in office, even if giving such offense would be good for patients' or the public's health, is an open question.  The answer, I fear, may be obvious.   

These examples suggest that the US is becoming increasingly corporatist, a country dominated by an unholy alliance between top leaders of government and of large corporations, who are becoming increasingly interchangeable.  Another way of putting it is the country is increasingly dominated by an insider elite that manipulates the system for its own benefit. 

A recent article in the Atlantic juxtaposed two cases, one that of a CEO given a golden retirement package after presiding over the decline of his media company, and two union lobbyists who gamed the system to get outsized pensions.  While the first example would commonly draw condemnation from the left wing, and the second from the right, they are similar, and similar to those of  revolving doors we have discussed.   Author Conor Friedersdorf summarized the cases thus

neither the CEO nor the lobbyists were paid what they earned, nor were they compensated in a way that made the relevant stakeholders better off. Instead they were taken care of in a way that reflected their elite insider status and their ability to take advantage of wrinkles in the system while breaking no laws. In both cases, less politically connected people -- other Gannett employees, Gannett shareholders, readers of Gannett newspapers, Illinois school teachers, and Illinois taxpayers -- were unjustly made worse off by what transpired. And isn't the overlapping ethic that guided the behavior of these people a big part of what's wrong with America?

Behavior like theirs is one reason Americans on the right and left have recently taken to the streets. Ours is a society that has always tolerated inequality of wealth; and so long as some imperfect degree of fairness is maintained in the getting of material goods, the system functions smoothly. But if people feel that wealth they struggled to earn is being taken from them to pad the nest eggs of dishonorable union lobbyists; or that they're at risk of being fired from their $14 an hour job if they're ten minutes late, whereas their ultimate boss retires with an eight-figure package after presiding over plummeting stock prices and massive layoffs; people put in situations like that eventually revolt, if they've concluded that injustice is the norm rather than an aberration.

I would propose that the fundamental injustice of having an insider elite run health care so as to put their self-interest first is the basis of what has gone wrong with health care (and the rest of the country, and maybe the world.) If we do not have the courage to first say this out loud, and then restore some rationality and justice to the structure and leadership of health care, the spiral will continue downward.

Additional Thought

I expect if any of the insider elite's defenders bother to read this, one argument they might propose is it was always thus.  How can one expect people who work as government leaders for a short time not to take advantage of the best possible job offers when they leave?  My answer is that an admittedly cursory look at history suggests it has not always been thus.  Using Wikipedia as an imperfect but quick source, I found that Joseph A Califano Jr, the last Secretary of Health, Education and Welfare under President Carter worked at a law firm, founded the National Center for Addiction and Substance Abuse, and wrote books after he left office.  He did serve on a corporate board (CBS), but not for a health care corporation.  Patricia Roberts Harris, the first Secretary of HHS under President Carter, became a law professor.  Dr Otis R Bowen, the last Secretary of HHS under President Reagan, retired after that, but served on some non-profit boards and government committees.

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Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman Renee Ellmers, (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Business, Subcommittee on Healthcare and Technology was just sent to Secretary of the Dept. of Health and Human Services Kathleen Sebelius.

The themes in the letter will be familiar to readers of Healthcare Renewal.

A PDF copy of the letter can be downloaded by clicking below, and the text follows.

(click here to download PDF)

Here is the text, along with several comments:

August 11, 2011

The Honorable Kathleen Sebelius
Secretary
U.S. Department of Health and Human Services
200 lndependence Avenue, S.W.
Washington, DC 20201
Via Facsimile: 202. 690.7380

Dear Secretary Sebelius:

The House Small Business Committee, on which I serve, is required by the Rules of the House to study and investigate the problems of all types of small businesses. This jurisdiction extends to matters concerning small businesses and health care. I chair the Committee’s Subcommittee on Healthcare and Technology.

On June 2, 2011, the Subcommittee held a hearing on the barriers to health information technology that are encountered by physicians and other providers in small practices. At the hearing, physicians testified that the cost to purchase and maintain a health IT system, is addition to staff training and downtime during the transition to health IT, are significant burdens for small practices. These barriers mere mentioned even by physicians who believe health IT would ultimately benefit their practices. Providers at the hearing also stated their concern about the Medicare reimbursement penalties that will be assessed against providers who do not demonstrate “meaningful use” of health IT by 2015.

One of the frequently mentioned benefits of health IT has been a reduction in medical errors. However, recent news reports have noted incidents of health IT errors. An article in Sunday’s Pittsburgh Post-Gazette [a series, actually, here and here- ed.] cited a baby who was killed while computerized IV equipment prepared a lethal dose of an intravenous sodium chloride solution. The machine did not catch the pharmacy technician’s error. The article also noted that when a hepatitis C-positive kidney was accidentally transplanted from a live donor into a recipient, the physician team missed the electronic records alert, and the physicians complained that their electronic records system is cumbersome and difficult to adjust to any one physician’s needs.

[You can be sure that my writings on health IT mission hostility, poor quality, lack of regulation, etc. as well as the cases of health IT-related injury and death I know of, including that of my own relative, will find their way to Rep. Ellmer's office - ed.]

The Journal of the American Medical Association recently published a study of almost 4,000 computer-generated prescriptions that were received by a pharmacy chain. The report found that 12 percent of the prescriptions contained errors, which, the report said, is consistent with error rates with handwritten prescriptions. [I wrote about that here - ed.]

A modern, well-equipped office is critical to the practice of medicine, and health IT offers promise to all medical professionals. [But only when done well - and there is massive complexity behind those simple two words "done well" that is poorly recognized and/or ignored - ed.] Health IT has the potential to improve health care delivery, decrease medical errors, increase clinical and administration efficiency, and reduce paperwork.

We most do all we can to ensure a commitment to our health care system and patient care. As technology rapidly evolves, I ask that you consider a study of health IT’s adoption, benefits and cost effectiveness.

[Cart before the horse when being done AFTER a national multi-billion dollar rollout is put into law, as I wrote here, but better late than never - ed.]

As part of the study, I hope you will also consider medical error rates — both human and technological --so that all errors can he better assessed and prevented.

[I have been calling for this for years now - ed.]

Sincerely,
Renee Ellmers

Chairwoman
Subcommittee on Healthcare and Technology
House Committee on Small Business

I find this letter from a leading member of the House of Representatives remarkable. Importantly, Chairwoman Ellmers has a medical background (HHS Secretary Sebelius, to my knowledge, does not). Here is part of Chairwoman Ellmer's background from Wikipedia:

In 1990, she graduated with a Bachelor of Science degree in Nursing. Ellmers worked as a nurse in Beaumont Hospital's surgical intensive care unit. In North Carolina, she was clinical director of the Trinity Wound Care Center in Dunn.

The only other letters like it asking questions like this that I know of came from a Republican Senator to the HIT vendors, Sen. Grassley of Iowa (see here and here). Sen. Grassley also wrote directly on HIT problems to HHS Secretry Sebelius on Feb. 24, 2010; see the letter here.

-- SS

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ONC Workgroup Document Misindentification - Just the Type of Computer "Glitch" That Can Kill People

A provocative title indeed.

The Office of the National Coordinator's Health IT Standards Committee Implementation Workgroup recently had a meeting, Jan. 10-11, 2010.

They've posted the testimony and supporting documents here: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1482&&PageID=17128&mode=2 .

I've copied & pasted these document links directly from the site, at 12:45 PM EST 1/14/2011:

• Instructions and Questions for Panelists [PDF - 381 KB]
• Presenter Bio Sketch [PDF - 549 KB]
• Paul Kleeberg, MD [PDF - 443 KB]
• Dan Nelson -Testimony [PDF - 330 KB]
• Lisa Levine [PDF - 125 KB]
  
• CCHIT -Testimony [PDF - 95 KB]
• Alisa Ray -Testimony [PDF - 219 KB]
• Patricia Daiker - Bio [PDF - 75 KB]
• Medhost [PDF - 100 KB]
• Cerner - Testimony [PDF - 716 KB]
  
• John Travis [PPT - 486 KB]
• Brad Melis [PDF - 100 KB]
• Hammer -Testimony [PDF - 214 KB]
• Linda Reed - Testimony [PDF - 320 KB]
• James Fuzy [PDF - 146 KB]
• Reid W. Coleman [PDF - 164KB]
• Careen Whitley -Testimony [PDF - 238 KB]
• Lyle Berkowitz Presentation [PPT - 325 KB]
• Lyle Berkowitz -Testimony [PDF - 289 KB]
• Robert Murray -Testimony [PDF - 135 KB]
• Willa Drummond [PDF - 135 KB]
• Willa Drummond - Vital Sync System Test Bed [PDF - 128 KB]
• Willa Drummond - Collection of Problem Scenarios from Professional List Serve [PDF - 255 KB]
• Willa Drummond - Timeline [PDF - 413 KB] *
• Willa Drummond - Ten Commandments for Computerized Healthcare Information Systems [PDF - 431 KB]
• Richard Sadja -Testimony [PDF - 291 KB]
• Harm Scherpbier [PDF - 24 KB]
• Sunquist -Testimony [PDF - 542 KB]
• Nanvy Vogt -Testimony [PDF - 44 KB]
• Chuck Christian [PDF - 95 KB]
• Denni McColm -Bio [PDF - 78 KB]
• Denni McColm -Testimony [PDF - 449 KB]
• Russ Branzell [PDF - 13 KB]
• Len Bowes [PDF - 301 KB] *
• Gillette Congressional Tesimony [PDF - 163 KB]
  

The problem is, some of the URL's are simply wrong, including several of the ones I've bolded.

For instance, I tried to download Dr. Willa Drummond's documents:

• Willa Drummond [PDF - 135 KB]
• Willa Drummond - Vital Sync System Test Bed [PDF - 128 KB]
• Willa Drummond - Collection of Problem Scenarios from Professional List Serve [PDF - 255 KB]
• Willa Drummond - Timeline [PDF - 413 KB] *
• Willa Drummond - Ten Commandments for Computerized Healthcare Information Systems [PDF - 431 KB]

The links for "Collection of Problem Scenarios from Professional List Serve" and "Ten Commandments for Computerized Healthcare Information Systems" are simply wrong.

They lead to the incorrect documents as of this writing.

By experimentation (borne of experience!), I found I could locate the correct documents by manually altering a number in the URL.

For example, to locate the "Problem Scenarios" document whose URL is linked as:

http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf

I had to alter the number 949972 to 949973, like this:

http://healthit.hhs.gov/portal/server.pt/document/949973/drumexsum-imwg-11011_pdf

I further had to experiment to find the "Ten Commandments" document, also erroneously listed as at this URL ...

http://healthit.hhs.gov/portal/server.pt/document/949972/drumexsum-imwg-11011_pdf

... but actually here at 949971:

http://healthit.hhs.gov/portal/server.pt/document/949971/drumexsum-imwg-11011_pdf

Presumably these erroneous indices will be fixed at some point. Are they due to computer and/or software error, or human error -- as in medicine, due to busy schedules, cognitive overload from a suboptimal IT user experience, and other factors?

I do not consider these errors "minor" or at all humorous. Leadership by example - through fine attention to detail - in a supposed "HITECH" paperless-medicine promoting government organization - is what I expect.

Similar "misidentification" errors in EHR systems can and do cause medications to be missed or given to the wrong patient - such as in the example at the Trinity Healthcare System as mentioned in my post "Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight" where an EHR "upgrade" caused considerable risk:

... Computers at a major Midwest hospital chain went awry on June 29, 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.

See the many questions I raised about this episode at the followup post "More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight." (I understand that the initial "fix" to the problem of "orders going to the wrong chart" was to prevent clinicians from opening more than one chart at a time, thus further interfering with clinicians' work.)

"Glitches" cause sometimes crucial data to be lost, and even patients to be harmed or killed (e.g., see the gray banner at top of my site on HIT failure, and my recent post "EHR Problems? No, They're Merely Anecodotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits" on this blog).

Ironically, the First Commandment in the mislinked Ten Commandments document above is:

"The Computer shall find and collate all data generated by other computers."

Perhaps it should read:

"The Computer shall find and correctly collate all data generated by other computers."

-- SS

1/14 addendum:

I looked specifically for those documents as my first retrievals on the HHS site due to past correspondence with Dr. Drummond. The pinball machine then tilted.

Perhaps it is simply those bad electrons and stale bits that follow me around once more.

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