When "Human Error" Causes EHR Downtime, Who is Liable For Patient Injuries That Result?

In the Pittsburgh Post-Gazette was this story of yet another EHR "glitch":

March 9, 2013 12:17 am 

Human error the cause of UPMC electronic issue

A systemwide problem with UPMC's information systems Wednesday left electronic patient records and other data inaccessible for about three hours. A UPMC spokeswoman said the hospitals "immediately went to manual backup systems, and we quickly identified and fixed the problem." She said there was no indication that patient care was compromised by the incident, which was due to human error.

I will presume the "human error" was not a physician or nurse pressing the wrong button, but a "human error" involving the servers or IT infrastructure such as a botched system upgrade, action that caused a server room power fault, etc.

UMPC is a very large system as their webpage shows, showing approximately fifteen major facilities.

The now-expected "patient care has not been compromised" line was provided to the Gazette, a line so commonly heard after EHR outages that I  use it as a Healthcare Renewal indexing tag (see this query link).

The following questions arise:

  • What, exactly, was the "human error" and why was there no fault tolerance built into these mission-critical systems to account and compensate for it, such as via redundancy?
  • If paper is so bad as a record-keeping medium that hundreds of billions of dollars are being spent to replace it, then how can patient care not be compromised, especially when multiple hospitals unexpectedly and without warning have to return to its use? 
  • How can a very large hospital system rapidly declare that "patient care was not compromised" without a thorough and comprehensive patient review, accounting for possible delayed negative outcomes (by way of just a few simple examples, due to medication or imaging delays?)
  •  Who is liable for any adverse patient outcomes that occurred related to the sudden unavailability of past records:  the clinicians?  The "human" who committed the computer-related error?  The corporation, either for direct negligence in implementing and mandating use of a system prone to mass outage by human error, or vicariously for the negligence and/or misconduct of its information technology employees and/or agents?
  •  How many "outages" will it take before some patient is outright, no-doubt-about-it harmed or killed?  Do we want to find out, or is a priority to have redundancies so these systems don't crash?
I, for one, would not want to have a family member be "crashing" at the time of a sudden, unexpected system-wide EHR outage.

-- SS

Far more concern about Linux user experience than the EHR user experience, and your life does not depend on the former

I find this ironic and striking:

During my informatics postdoc I used a SparcStation-2 running UNIX and an old X Windows user interface.  Then a few years later, in the Windows 95 days, I installed Linux (an open-source UNIX-like operating system) on a PC and used various X Windows user interfaces on that, too.  There was a lot of debate on which features of which user interface made for the best usability, and more broadly, user experience.

This debate continues as Linux in its multiple versions continues to be extremely popular.

If the health IT sellers put as much time into considering the user experience presented by their products as does the Linux community and were as candid, as, say, the Ubuntu Linux community as here, there might not be physician rebellion groups like Twitter's #EHRbacklash springing up.

-- SS

Twitter EHR "revolt": #EHRbacklash

As noted at the new IEEE Spectrum piece "U. S. Electronic Health Record Initiative: A Backlash Growing?"  (worth reading in its entirety along with its hyperlinks), the following is noted:

There seems to be a slow but steady backlash growing among healthcare providers against the U.S. government’s $30 billion initiative to get all its citizens an electronic health record, initially set to happen by 2014 but now looking at 2020 or beyond. The backlash isn’t so much about the need for, or eventual benefits of, electronic health records but more about the perceived (and real) difficulties caused by the government's incentive program and a growing realization of the actual financial and operational costs involved in rolling out, using, and paying for EHR systems.

The first hyperlink (on the word "backlash") is to a Twitter "revolt" marked by tweets using the hash tag (index tag) "#EHRbacklash." 

I did not start the use of this tag, although have started "tweeting" using it.

The link to tweets made with the tag is:  https://twitter.com/search?q=%23EHRbacklash&src=hash

This is certainly a "first", and should be an industry and pundit wake-up call.

-- SS

Addendum:  easier to follow at this link:  http://tweetchat.com/room/EHRbacklash

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 2

Part 1 is here.

This is the second a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.

Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm.

The following quote comes from a May 2010 post "David Blumenthal on health IT safety: nothing to see here, move along":

Blumenthal, at the time Director of ONC at HHS had reportedly stated that:

http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented

... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's [rapidly and on a national scale - ed.] could impede patient safety," he said.

The "nothing" includes 44 injuries voluntarily reported to FDA and 6 reported deaths in an enviroment where few know where to report such things and where no reporting requirements exist, and a statement from the head of CDRH at FDA that due to systematic impediments to accurate knowledge the known figures likely are a small fraction ("tip if the iceberg") of the actual occurrence.

The FDA internal memo on HIT risk brought to the forefront by investigative reporter Fred Schulte and downloadable here spells out the FDA impediments in some detail.  It is not reasonable to believe the head of ONC and an entire ONC committee would have been entirely unaware of the issues.  (Later studies are even more concerning, e.g., by IOM and ECRI, as at this blog.)

Yet an ONC committee under his leadership recommended "full steam ahead" anyway.

In the corporate world that is known as gross negligence:

Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary Negligence, which is a mere failure to exercise reasonable care.

There is nothing to discuss, nothing to debate about that.


Claims about HIT beneficence this need to be taken with a big grain of this.

The ongoing "what? me worry?" attitude of the pundits needs to be counterbalanced.  This series is a small effort (the industry has a lot more control of the channel than I) to catalog the words and call out the pundits in a readily-found format.

More to come in this series.

-- SS

Deadly Over-Doses and Private Equity - the Case of Bain Capital's Methadone Clinics

Some reporting by Bloomberg provides more evidence about what happens when direct care of the most vulnerable patients is commercialized.  The vulnerable patients in this case were narcotic addicts.

By way of introduction, one method of treating narcotic addiction is the use of methadone.  Methadone is a narcotic that may block the "high" produced by other narcotics and thus may lead to the abuse of these drugs.  Because methadone is long-acting and can be given orally in liquid form, methadone clinics traditionally provided patients one dose a day which they swallowed on the spot.  The methadone would presumably block their craving for other narcotics for that day, and the method of administration would prevent diversion of the drug.  Methadone clinics became more prevalent starting in the 1960s, and like most "health care provider organizations," as we now call them, were then largely non-profit.

On a personal note, in the 1980s, I was the internal medicine physician for a non-profit hospital based methadone clinic designed for patients who had become addicted to prescription narcotics.  It was a challenging task, but the challenges seemed manageable.  That was then.

Nowadays, methadone clinics are more likely to be for-profit.  In this brave new world of for-profit "health care delivery," there may be problems unlike those seen "back in the day."   For example, Bloomberg just reported on a case with a distinctly colorful title

Dead Man Spurs Methadone Probe at Bain’s CRC Clinic in Baltimore 

Maryland state regulators are investigating an addiction-treatment clinic owned by Bain Capital Partners LLC after the methadone-related death of a Baltimore man. 

The probe is focused on the Pine Heights Treatment Center in Baltimore, one of dozens of clinics operated by Bain’s CRC Health Corp., the largest methadone-treatment provider in the U.S. It was triggered by a complaint from the public, said Dori Henry, a spokeswoman for the state Alcohol and Drug Abuse Administration. She declined to comment on the investigation’s details.

The complaint alleges that Warren Lumpkin, 34, a forklift operator, died on Jan. 4 after ingesting methadone that was given to him by a CRC patient, according to a copy obtained by Bloomberg News. An autopsy found that 'methadone intoxication' contributed to his death, records show.

Lumpkin’s ex-wife, Sabrina M. Lumpkin, who filed the complaint, said in it that he wasn’t a patient at the CRC clinic. He had a friend who was, and that friend gave half a dose of methadone from the clinic to Lumpkin, according to the complaint. 

Note that "back in the day," such an event would have been nearly impossible.  As noted above, patients were given a cup of liquid containing their daily methadone dose, and drank it under observation.   Practically, they could not "cheek" or otherwise divert the drug.  Of course, that approach required personnel to observe each patient each day.  Paying those personnel made the operation more expensive.  "Back in the day," though, non-profit hospitals and clinics were willing to provide the service in the interest of making sure the patients, and only the patients got the prescribed treatment.

Things may be different when methadone clinics are run for a profit.  A Bloomberg investigative report published in February looked into the operations of the company that owned the clinic in Maryland.  That too had a provocative title and started with a similarly disconcerting case.

Drug Users Turn Death Dealers as Methadone From Bain Hits Street 

 After Jennifer Vanlieu turned to methadone treatment to beat an addiction to heroin and pain pills, she morphed from drug user to convicted drug dealer.
 
Vanlieu said she got a carryout methadone dose at a clinic operated by CRC Health Corp. in Richmond, Indiana, in March, 2010, and then gave about 15 milligrams to her friend Carissa Plemons. Plemons died hours later, after ingesting a lethal mix of methadone and other drugs, according to police reports.

Take-home methadone -- doses patients carry out instead of taking at clinics -- enabled the abuse, said Vanlieu, 26, who was sentenced to six years in prison for dealing the drug to Plemons. While she didn’t sell it to her friend, she said in an interview that other clinic patients often resold their take- homes. CRC is owned by Boston-based Bain Capital Partners LLC and is the largest U.S. provider of methadone treatment.

'Some would sell it in the parking lot,' she said. 

As in the first case, unlike the process "back in the day," now patients, who are almost all presumably narcotic addicts, may be given multiple doses of liquid methadone to take home.  They are no longer required to take a daily dose of methadone under observation.  As the case above illustrates, it is all too easy to divert take home doses of methadone.  While methadone can be used to block the effects of other narcotics, it can also be abused.  Obviously, as in the cases above, abused methadone can cause a lethal overdose. 

Wide Use of Take-Home Methadone

The Bloomberg report found multiple instances in which CRC Health clinics handed out multiple take-home methadone doses apparently without proper consideration of the risk or supervision of the patients.

 In states where CRC has had its highest patient counts -- Indiana, West Virginia, California and Oregon -- available data and interviews show the company tries to provide take-home packages, which range from one dose to as many as 30, more often than other clinics.

In addition, 

The Richmond, Indiana, clinic gave take-home methadone to a patient who flunked a drug test, a January 2012 audit found. The company’s Williamson, West Virginia, clinic didn’t immediately revoke take-homes from a patient who had two positive drug tests in 2010, records show. In 2011, inspectors found no evidence that a physician at CRC’s clinic in Renton, Washington, used 'good clinical, judgment' in giving patients carryout doses.

A CRC center in Chattanooga, Tennessee, failed to supervise take-home doses properly in a case 'clearly indicative of drug diversion,' state authorities found in June 2011. The company’s clinics in Claymont, Delaware, and Coatesville, Pennsylvania, were faulted in May 2012 and October 2010, respectively, for giving carry-outs to patients who missed required counseling, records show.

As for the spot-checks Herschman described -- they hardly ever happened at CRC’s clinic in Goldsboro, North Carolina, said Liaudaitis, the former counselor. 
Furthermore,

In Indiana, CRC’s five clinics served 69 percent of methadone patients in 2011, while distributing 96 percent of the take-homes tracked by state records. Patients of CRC’s dozen California clinics received carryout packages of as many as 30 doses at a rate twice that of all others. In Virginia, 74 percent of patients at CRC’s three clinics got at least one take-home dose a week in August 2012, while 47 percent of patients at all other clinics did, state records show. 

The Business Model Behind Take-Home Methadone

So why would a methadone clinic hand multiple doses of an abusable narcotic to narcotic abusers?  The Bloomberg article went on to document some possible reasons which ultimately have to do with the business model of for-profit methadone clinics.

First of all, providing multiple doses of methadone requires less time from clinic personnel, which is handy when the clinics may be under-staffed by over-worked poorly paid personnel.  

'That was the culture -- keep the census up,' said Mike Liaudaitis, who worked as a counselor at CRC’s clinic in Goldsboro, North Carolina, from mid-2009 until early 2011. He recalls being swamped with a 64-person caseload that exceeded the state’s limit of 50. 

Also,

'Clearly the company is saving money if they’re distributing multiple take-home doses at one time,' said West Virginia Delegate Don Perdue, a Democrat who has pursued stricter oversight of for-profit clinics. 'They don’t have to have as many staff handing out the merchandise.'


In particular,

the Goldsboro clinic -- like others described by regulators and former CRC employees in Indiana and West Virginia -- was frequently understaffed, Liaudaitis said.

Since Jan. 1, 2009, CRC’s clinics haven’t met staffing standards more than 50 times, regulatory records from 15 states show. Clinics were cited 80 times for failing to document that they gave patients enough counseling. In response, the company agreed to hire more, recruit more aggressively and increase supervision. Competition for qualified workers is intense, CRC said in its 2011 annual report.

CRC didn’t pay well enough to attract or keep experienced counselors, said Malaysia Williams, who worked at its clinic in Huntington, West Virginia, from June 2009 through March 2010. 'Nobody stayed there,' she said. 'It paid poorly.'

Williams got $13 an hour, she said -- about the same amount other former counselors reported. That’s roughly $27,000 a year. 

There is evidence that under-staffing, under-payment of personnel, and the wide use of take-home methadone lead to big increases in short-term revenue for CRC Health, the for-profit corporation running the clinics.

 Until recently, there was little difference between the operations of for-profit and non-profit methadone clinics, said Thomas D’Aunno, a professor of health policy and management at Columbia University who has tracked the treatment centers for years. That changed in 2011 survey data, which showed 'significant differences,' he said: For-profit clinics had fewer staffers than public clinics.

As Williams struggled to catch up in Huntington, the clinic pushed its revenue up almost 8 percent to $5 million in 2010 -- while expenses increased less than 1 percent to $2.6 million, according to state regulatory documents. 
Private Equity's Take Over of Methadone Clinics

The potential for big revenues has drawn private equity into the world of methadone maintenance for the treatment of narcotic addiction.

 Nurtured by government spending, methadone clinics spread nationwide in the 1960s and ’70s until strapped state and local governments began decreasing their outlays. By 2010, for-profit providers controlled 52.8 percent of the 1,200 U.S. clinics.

Over the past seven years, private equity firms have invested more than $2.2 billion in substance-abuse treatment and behavioral health companies in 62 deals, according to PitchBook Data Inc., a Seattle-based research firm.

Addiction-treatment companies are 'some of the most sought-after -- and valuable -- acquisition candidates in health care,' partly because of profit margins that can top 20 percent, according to the Braff Group, a Pittsburgh-based mergers and acquisitions advisory firm.

 As it turns out, CRC Health was acquired by one of the more notable private equity firms.

Bain Capital, the private equity firm co-founded by former Republican presidential candidate Mitt Romney, paid $723 million for CRC in 2006, corporate filings show. Romney, who left Bain in 1999, had no input in its investments or management of companies after that, he has said.

Still, Romney reported last year that he owned more than $1 million worth of a Bain fund that holds most of CRC’s shares. He reported receiving between $100,000 and $1 million in dividends, interest and capital gains from that holding, as well as income from two other Bain funds with interests in CRC, according to the financial disclosure he filed with the U.S. Office of Government Ethics in June. Bain executives declined to comment, said Alex Stanton, a spokesman. Representatives for Romney didn’t respond to requests for comment.

 CRC has reported paying Bain about $15.4 million in management fees along with $7.2 million in fees related to the merger since 2006. The company’s revenue more than doubled to $446 million in 2011 from $209 million in 2005. Methadone clinics generated more than a quarter of the 2011 revenue, $123 million.


Note that last year, when Mr Romney was running for the US Presidency, and hence his ties to Bain Capital were particularly newsworthy, several investigative reports about care at Bain owned health care provider organizations were published.  We posted about issues at another CRC Health operation, Aspen, which operates in -patient treatment centers for psychiatric patients.  Investigative reporting about that part of CRC Health also suggested that the company was putting short-term revenue ahead of patient welfare.  We also posted about issues at HCA, a for-profit hospital chain partially owned by Bain, which again suggested revenue came before patients. 

In one sense, this should be no surprise, since the business model for private equity is all about extracting the most money in the shortest time for acquired corporations.  (Look here for more details.)

Summary

We now have more evidence that patients "cared for" directly by for-profit corporations, especially those owned by private equity firms, do not do well.  Meanwhile, the top executives of these firms do exceedingly well.

We have noted how health care organizations have increasingly been "financialized," lead by executives who put short-term revenue generation ahead of all other goals, including good patient care. Furthermore, hospitals are increasingly likely to be formally for-profit, and hence likely to be lead by such executives. Worse, hospitals are increasingly likely to be owned by private equity firms, further increasing the emphasis on short-term money making. Even worse, physicians are now more frequently employed by such organizations, which may pressure them to do what it takes to increase revenue, no matter what the effect on patients' and the public's health.

The probably effects on the quality of care, access, and costs are obvious.

In my humble opinion, before the health care bubble bursts, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. Before market fundamentalism became so prominent, many states prohibited the corporate practice of medicine, and the American Medical Association forbade the commercialization of medicine.

 It is time to heed that wisdom. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

 True health care reform will require an end to market fundamentalism in health care.

Medscape re: Class Action suit: "Doctors Who Sued EHR Company Win First Round"

Interesting article about a Class-Action lawsuit against a health IT seller, Allscripts, see Medscape link below (the story is copyrighted so I cannot repost it here).

Relevant excerpts:

On Monday, March 4, a group of doctors who are suing their electronic health record (EHR) manufacturer for selling them a "buggy" product and then discontinuing it learned that the defendant's motion to block the lawsuit and compel them to accept binding arbitration was overruled by a judge in Miami, the first step in getting a court date in what is believed to be a first-of-its-kind case.

... In December 2012, 4 physician practices -- 2 pain clinics in Florida, 1 in Missouri, and a family medicine practice in Alabama -- became plaintiffs in a class-action suit filed against Allscripts, "an action arising from an expensive, but defective electronic health records software product," according to the complaint. The bottom line: The EHR was "buggy."

Says one of the doctors plaintiffs:

Anesthesiologist Robert J. Joseph, MD, of the Pain Clinic of Northwest Florida in Panama City, a plaintiff in the suit, makes no bones about it. "Our EHR is a piece of crap," he states.

-----

Link to full article:
http://www.medscape.com/viewarticle/779721

(It seems to come up fulltext without Medscape login, but I cannot guarantee this will persist.)

-- SS

On EHR's: See No Evil, Hear No Evil, Speak No Evil: Part 1

This is the first of a series of posts I plan on the issue of "See No Evil, Hear No Evil, Speak No Evil" regarding EHR's.  Frequent reminders are needed by all stakeholders, I believe, to think critically about, and take with a big grain of salt, effusive praise by key opinion leaders, politicians, etc. about health IT, and accompanying attempts to deride those critical of the technology, to counterbalance ongoing HIT hyperenthusiasm (e.g., link).

In face of growing evidence of risk and adverse outcomes of bad health IT from multiple sources and organizations (such as this, as just one example), growing advice on risk remediation from government (such as here), and mass privacy violations (see the multiple posts under this query link), it might also be entitled a series on what health IT hyper-enthusiasts "knew, should have known, or should have made it their business to know."

Let's start out with an extract from a post I wrote on June 29, 2003 entitled "Mark Leavitt, Head of CCHIT: Behind the Times and Uninformed on Health IT Realities?". At the time Leavitt was head of CCHIT, a tester and MU compliance/safety certifier of electronic health records systems: 

... The head of CCHIT, Mark Leavitt, has penned the following at iHealthBeat: 

June 19, 2009 - Perspectives 

Health IT Under ARRA: It's Not the Money, It's the Message

by Mark Leavit  

... Before ARRA, most surveys concluded that cost was the No. 1 barrier to EHR adoption. But as soon as it appeared that the cost barrier might finally be overcome, individuals with a deeper-seated "anti-EHR" bent emerged. Their numbers are small, but their shocking claims -- that EHRs kill people, that massive privacy violations are taking place, that shady conspiracies are operating -- make stimulating copy for the media. Those experienced with EHRs might laugh these stories off, but risk-averse newcomers to health IT, both health care providers and policymakers are easily affected by fear mongering.

"Laugh these stories off?"  That was, and is, simply perverse.

Ironically, this statement was written less than a year before my own mother was seriously and fatally harmed as a result of a health IT-related error.
 

On EHR's:  See No Evil, Hear No Evil, Speak No Evil


While I don't proffer claims of "shady conspiracies" (international health IT expert Dr. Richard Cook explains that in a recent guest post "Dr. Richard Cook on the Health IT Sector's Ills"), I do proffer alternate explanations including arrogance, Radical Solutionism, and this.

More to come in this series.

There are many more statements like this one already on this blog, and elsewhere.

-- SS

Note:  Part 2 is here.