Should "Diagnosing While Texting" Be Illegal?

I saw an interesting comment at Medscape in the comment thread of the article "Do Your EHR Manners Turn Patients Off?" (MedScape subscription required).

Dr. [redacted] | Neurology

I live in a town that has passed legislation criminalizing texting and driving. A driver is more impaired and distracted when texting than when intoxicated.  EHR's and the practice of medicine should be no different. Do you really believe that your physician is actually concentrating on the patient in front of them while their attention is primarily focused on entering data on a computer? The reality is that EHR's true value is data collection for statistical analysis by our government and there is an obvious deficiency for enhancing the physician-patient collaborative experience.

Medicine, like driving, is a very cognition, thinking and concentration-intense activity.   Failures lead to injury and death (although not quite as dramatically in the former compared to the latter).

I think the point about distraction the commenter makes is valid, or at least worthy of healthy consideration.

Unless you're a health IT hyperenthusiast, that is (see http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html).

-- SS

UnitedHealth's Latest Blunders Include Lax Fraud Detection, Recalled EHRs - So Why is its CEO Worth $13.9 Million, or is it $34.7 Million?

We managed to go four months since our last post about UnitedHealth, but sure enough, the company that keeps on giving... examples of poor management to contrast with ridiculous management pay... has done so again.

There were two obvious examples of poor management that recently appeared in the media.

Lax Fraud Dection

The background, as noted in a Kaiser Health News article published in September, is that it is now fashionable for American states to outsource some or most of their Medicaid health insurance programs to managed care organizations, often for-profit, as is UnitedHealth.  These programs are meant to provide insurance to the poor and disabled.  Yet once they have outsourced Medicaid, the states may be reluctant to cancel contracts, even if the outsourcing is not working:

 In Florida, a national managed care company’s former top executives were convicted in a scheme to rip off Medicaid. In Illinois, a state official concluded two Medicaid plans were providing 'abysmal' care. In Ohio, a nonprofit paid millions to settle civil fraud allegations that it failed to screen special needs children and faked data.

Despite these problems, state health agencies in these - and other states - continued to contract with the plans to provide services to patients on Medicaid, the federal-state program for the poor and disabled.

Health care experts say that’s because states are reluctant to drop Medicaid plans out of fear of leaving patients in a bind.

'You probably won’t find many examples of states flat out pulling the plug. That’s sort of the nuclear option,' said James Verdier, a senior fellow at Mathematica Policy Research, a nonpartisan think tank. 

Never mind that leaving such programs as is means taking money meant to finance care for the poor and using it to finance fraud, and reward managed care organizations for failing to find fraud.

One of the examples, but not a new one, used in the Kaiser Health News article, involved UnitedHealth:

Linda Edwards Gockel, spokeswoman for the Texas Health and Human Services Commission, said that in 2009, officials were concerned about a pilot program in the Dallas-Fort Worth area run by Evercare, a subsidiary of UnitedHealth Group. The program, which coordinated care and long-term services for elderly and disabled people, had been fined more than $600,000 for not providing proper access to care and failing to coordinate services.

Gockel said Texas decided to cancel the contract 15 months early, but continued to do business with Evercare because the problems in Dallas-Fort Worth weren’t affecting services it was providing elsewhere.

Then in July, NJ.com reported an investigation by the state of New Jersey into UnitedHealth's ability, or lack thereof, to detect fraud in the Medicaid managed care program it runs for the state.

 An HMO that earned $1.7 billion from 2009 to 2010 by providing Medicaid coverage to 350,000 low-income and disabled New Jerseyans didn't try very hard to detect fraudulent billing — identifying only $1.6 million, or one-tenth of one percent in improper payouts, according to a report the Office of the State Comptroller released today.

UnitedHealth did not even come close to fulfilling its obligations to provide sufficient resources to fight fraud:

The HMOs in the Medicaid program are required to dedicate one investigator for every 60,000 Medicaid clients. At that ratio, United's special investigations unit should have been comprised of about six employees whose sole focus is to detect fraud and abuse by medical providers and patients.

Instead, United reported it had dedicated the equivalent of two investigators during the two-year study period based on the amount of hours devoted to the unit. Upon scrutiny, the comptroller found United 'overstated' its staffing levels; the unit had one investigator, the report said. 

Note that this abject failure appeared to violate the contract UnitedHealth had with the state,

UnitedHealthcare Community Plan of New Jersey failed to hire enough investigators and train them properly, in violation of the managed care company's contract with the state, according to the report. 

Presumably, if fraud led to excess program expenses, it would be New Jersey, not UnitedHealth who ultimately had to pay them.  Again, it appears that money meant of pay for health care for the poor and disabled was diverted to fraudsters, and to revenue for UnitedHealth (partly because the latter did not see fit to spend enough money up front to detect the fraud.)  Of course, such management by UnitedHealth helped to increase its already fat revenue stream.

Faulty Electronic Health Records

In September, Bloomberg reported that UnitedHealth had to recall electronic health record software because of faults that likely increased the risk of bad patient outcomes,

UnitedHealth Group Inc has recalled software used in hospital emergency departments in more than 20 states because of an error that caused doctor’s notes about patient prescriptions to drop out of their files.

Certain versions of the software made by the largest U.S. health insurer had a bug that didn’t print information related to the medication and failed to add data to patients’ charts,according to a document filed with the U.S.Food and Drug Administration and posted July 29.

The technology is used in 35 facilities in states including California, New Jersey, and Florida, the document shows. The recall began June 21. There were no reports of patient harm and each facility was notified and received a digital fix, said Kyle Christensen, a spokesman for the UnitedHealth division that makes the Picis ED PulseCheck software that was recalled.

The incident shows how software errors can create dangers for patients at a time when digital health records are being implemented as a cornerstone of President  Barack Obams's modernization of the nation’s health-care system.

The "bug" could potentially harm patients,

 Doctor’s notes are critical for some medications, as they contain directions about diet and use. Failure to include the instructions could lead to serious injury or death, [University of Pennsylvania adjunct professor of sociology and medicine Ross] Koppel said.

It turns out that the Picis software has had other problems that could have increased the risk of harm to patients,

An online database maintained by the FDA shows that Picis Inc., a Wakefield, Massachusetts-based company that UnitedHealth acquired in 2010 for an undisclosed price, has reported six recalls involving electronic health record software since 2009.

One incident in 2011 involved anesthesia-management software sold nationwide that in one instance displayed a patient’s medical information in another patient’s file. Anotherinvolved software sold worldwide where on an unspecified number of occasions, the program failed to display the discontinued status on medication orders. Others included glitches that caused a failure to display appropriate allergy interaction warnings, the freezing of administrative controls, and other issues.

Note that it is the same Picis software that our blogger, InformaticsMD, has alleged lead to the death of his mother,

Alleged flaws in electronic health records have led to lawsuits. Scot Silverstein, a doctor and health-care informatics professor at  Drexel University, sued Abington Memorial Hospital in Pennsylvania in 2011 over the death that year of his 84-year-old mother. He blamed her death on a flaw in her electronic health record that he claims caused a critical heart medication to vanish from her file. One of the systems involved was made by Picis, according to his lawsuit. Picis is not being sued.

Linda Millevoi, a spokeswoman for Abington Memorial, declined to comment.

The latest InformaticsMD posts on this case are here and here.

Summary

These cases are just the latest in a long list of blunders and ethical missteps made by UnitedHealth and its top management.  The most significant examples of the latter about which we have posted appear in the appendix at the end.  The latest examples likely diverted money that should have supported health care for the poor, and and may have put patients' health and lives at risk.

Yet UnitedHealth is now the largest US health insurance company, and it has succeeded in making its current and former CEO fabulously wealthy.  According to filings with the US Security and Exchange Commission (SEC), its current CEO, Stephen J Hemsley, got $13.9 million in 2012, up from $13.4 million in 2011, as we posted here.  However, an analysis by the Minneapolis Star-Tribune that took into account stock gains and shares vesting suggested he got $34,721,122 in 2012, admittedly down from a breathtaking $48,075,614 in 2011. 

The previous UnitedHealth once was worth over a billion dollars due to back dated stock options, some of which he had to give back, but despite all the resulting legal actions, was still the ninth best paid CEO in the US for the first decade of the 21st century (look here).

So UnitedHealth continues to provide us with examples of how top leaders of health care organizations can become tremendously rich, despite, or perhaps because of repeated mismanagement and apparently unethical management on their watches.  Only when we make health care leaders truly accountable for their organizations, and especially for their organizations' ethics and effects on patients' and the public's health will be begin to challenge health care dysfunction.

(Note to readers recently joining us from countries other than the US - UnitedHealth is a multi-national that claims to operate in 33 countries (look here).  For example, its UK web-site is here.  So beware the export of bad management for enhanced prices.) 

 
Appendix - UnitedHealth's Ethical Lapses

 - as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
- UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
- UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
- UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
- UnitedHealth frequently violated Nebraska insurance laws (see post here);
- UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).
- UnitedHealth was accused of hiding the fact that the physicians it is now employing through its Optum subsidiary in fact work for a for-profit company, not directly for their patients (see post here).

A New And Quite Perverse Hospital Ploy to Defend Medical Malpractice - Blame the Dead Patient? Two Examples

I did not think hospitals would ever get to the level of perversity, in defense of EHRs and EHR-related malpractice, seen herein.

Just a few days ago I came across the following article on a web search.

It is an astonishing story of a 49 year old man who died in part because an ED physician in a Suffern, NY hospital did not know how to use the EHR that had life saving diagnostic information within, and the hospital attempted to BLAME THE PATIENT for not "explaining his medical history thoroughly enough" to the ED doctor.

You read that correctly.

Ironically and sickeningly, yesterday my dead mother and I just had something similar done to us by a suburban Philadelphia hospital, Abington Memorial, as below:

Family Awarded $3.4 Million After ER Misses Aneurysm

http://blogs.lawyers.com/2012/02/family-awarded-3-4-million-after-er-misses-aneurysm/
Posted February 17, 2012 in Medical Malpractice by writer Aaron Kase

It’s gospel in health care– if you have chest pains, get to the emergency room, especially if you have a history of heart problems. But an inexperienced ER doctor in New York thought his patient’s complaints weren’t serious, and sent him home with muscle relaxers. The result was deadly.

A Rockland County jury Wednesday awarded $3.4 million to the family of Michael McKenzie, who was discharged from the Good Samaritan Hospital in Suffern in 2007 after complaining of chest pains and other symptoms consistent with a serious heart problem. The hospital determined that McKenzie, 49, was not having a heart attack, then ER doctor Michael Kane diagnosed him with a muscle strain and sent him home with muscle relaxers.

Two days later, McKenzie was found dead in his house by his 10-year-old son, killed by an aortic aneurysm.

The hospital should have found the aneurysm, argued Anthony DiPietro, the attorney for McKenzie’s family.”They just blew it,” says DiPietro, who headquarters his practice in New York City. “He had textbook signs of an aortic dissection [bleeding into the wall of the main artery that carries blood from the heart]: Chest pain, back pain, shortness of breath, sudden onset, woke him up from sleep, and he wasn’t doing any activities when it happened.”

Compounding the hospital’s error, McKenzie had a history of heart problems that should have pointed them toward the correct diagnosis. In 2003, he had been diagnosed with a dilated aortic root, or enlarged artery, with is a huge red flag for a future rupture. Good Samaritan knew about the dilated root because they had noted it in his chart during a heart procedure McKenzie had undergone the year before his death.

But the doctor, who had been at the hospital less than a month and was working unsupervised, never knew about McKenzie’s history. Why not? Because he didn’t know how to use the hospital’s electronic medical records system.

That's beyond pathetic, but it gets worse.  Far worse:

“He admitted it as part of his deposition,” DiPietro says. “They equivocated. First they said the system wasn’t working [an apparent attempted mistruth - ed.], but then he said he really didn’t know how to use it yet.” According to a local news report, the doctor was certified in obstetrics and gynecology at the time, and didn’t receive his certificate in emergency medicine until the following year.

The hospital argued that the aneurysm wasn’t present when McKenzie visited their ER–despite the fact that his certificate of death stated it had been present for days. The hospital also claimed that McKenzie was responsible for his own death because he didn’t explain his medical history thoroughly enough– the same history that was documented in the hospital’s own records. 

Let me repeat that for emphasis:

The - hospital - also - claimed - that - McKenzie - was - responsible - for - his - own - death - because - he - didn’t - explain - his - medical - history - thoroughly  - enough– the - same - history - that - was-  documented - in - the - hospital’s - own - records.

A hospital dares blame a likely frightened-out-of-his-wits patient presenting to their ED with chest pain, back pain, shortness of breath, of sudden onset that woke him up from sleep, for his own death?   

That, readers, is the most perverse hospital behavior I have ever encountered since entering medicine in 1977 (actually 1972-3 in summer NSF programs at Hahnemann Hospital in Philadelphia).

Not to mention, of course, that said patient cannot defend himself, because he's dead and buried...

In fact, in a highly unusual move, the judge in the case allowed doctors to recount conversations they had with McKenzie to the jury, statements usually prohibited under New York’s “Dead Man’s Statute” designed to keep hearsay out of the courtroom. 

It's a very special hearsay indeed when the hear-sayers know the patient is in his grave and cannot respond.

The tilted playing field notwithstanding, the jury nevertheless found the hospital negligent and awarded $3.4 million to McKenzie’s widow, two adult daughters and now 14-year-old son. The money couldn’t come soon enough– the widow, now sole provider for her son, recently lost her job and their home went into foreclosure. “Hopefully this will allow them to keep the house,” DiPietro says.

The ironically-named hospital planned an appeal:

A Good Samaritan spokesperson said the hospital plans to appeal.

I will attempt to find if the dockets are publicly accessible.

So, to recap, an ED doc didn't know how to use an EHR that contained lifesaving diagnostic information misses an aneurysm, the patient dies, and the defense attempts to blame the patient for his own death for (allegedly) not telling the doctor thoroughly enough about his own medical condition, i.e., the frightened, in-severe-pain patient didn't know medicine but should have - doesn't everyone?

-------------------

I could almost not believe this story, thinking maybe it was exaggerated - until just a few days later I EXPERIENCED THE SAME ISSUE MYSELF, PERSONALLY.

As substitute plaintiff in the death of my mother in 2011 due to a 2010 medication reconciliation failure at Abington Memorial Hospital, as mentioned on this blog and in the press (e.g., Bloomberg News, http://www.bloomberg.com/news/2013-06-25/digital-health-records-risks-emerge-as-deaths-blamed-on-systems.html and Kaiser Health News, http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx), the hospital responded (finally) to the points raised in the Complaint filed in October 2011, after exhausting many procedural delay tactics.

The are attempting to blame my mother, who I took to the ED while she was in process of nearly having a stroke, and me as well for her injuries.

From their Sept. 9, 2013 filing:

... 41. The injuries allegedly sustained by [substitute] Plaintiffs decedent [my dead mother - ed.] were caused in whole or in part or the same may have been contributed to by the actions of the Plaintiffs decedent [my dead mother - ed.], and accordingly, any claim for damages is barred or the damages recoverable herein must be reduced in accordance with the provisions of the Pennsylvania Comparative Negligence Act, as may be applied to facts disclosed in discovery.

They're apparently claiming (quite falsely, as I was there) that my mother, brought to the ED by me with a headache and suffering cerebral ischemia, never advised the doctors and nurses about her heart medication Sotalol (which was in their ED and floor EHR's from prior visits - just as in the aneurysm case above) that they summarily terminated, leading to disaster, so that her injuries and death are her own fault. 

Of course, my mother is dead, so only I can speak for her.

My mother would personally respond to Abington Memorial Hospital's charges blaming her for her injuries under their care and subsequent death, but she is not available to do so, at least in this world.  Rest in Peace, Mom, I have your six.

They also attempt to blame me for my mother's harm and death, a layperson (I have not practiced medicine in over 21 years):

54. Upon information and belief, Scot Silverstein’s actions and/or omissions may have been the cause or one of the causes of the harm suffered by the Decedent and/or her Estate.

55. Upon information and belief Scot Silverstein may be contributorily or comparatively negligent for any harm to the decedent and/or her Estate.

They also falsely claim I never informed medical staff about my mother's heart medication, nothwithstanding their own medication reconciliation (verification) policy calls for a best-effort complete re-verification of medications from all available sources at every transition of care, such as when she went from ED to ICU, and then ICU to floor, when I was not present.  Such resources would include, among others:  1) me, via telephone (not used);  2) the patient (apparently this resource was not used); 3) past EHR visit med lists showing the heart medication (also, apparently not used). 

As the Abington Hospital filing was signed and verified by their VP "Patient Advocate" / Director of Risk Management Regina Sturgis, considering these cases, I must ask the question if the practice of "blaming the harmed or dead patient" for their harm is a risk management strategy taught in the seminars these folks attend.

Blaming dead patients or their families for harm from medical misadventures is absolutely horrifying.  It shows disrespect for the dead and is depraved, especially coming from a hospital, I think any prospective patient would agree.

-- SS

Setback for Sutter after $1B EHR crashes (in followup to post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals")

At my July 12, 2013 post "RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" (http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html) I reproduced a California Nurses Association warning about rollout of an EHR at Sutter:

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today.

Problems with technology are not unique to health care ...  [What is unique to healthcare IT is the complete lack of regulation - ed.]

In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe.

Patient care concerns included computerized delays in timely administration of medications and contact with physicians, ability to properly monitor patients, and other delays in treatment.  Many noted that the excessive amount of time required to interact with the computer system, inputting and accessing data, sharply cuts down on time they can spend with patients with frequent complaints from patients about not seeing their RN.  [Note: patients are not given the opportunity for informed consent about the risks, nor opt-out of EHR use in their care - ed.]

In related posts I'd observed such concerns being ignored by hospital management.  See header of the aforementioned post.

Now we have this:  a major system crash.

Healthcare IT News
Setback for Sutter after $1B EHR crashes

'No access to medication orders, patient allergies and other information puts patients at serious risk'

SACRAMENTO, CA | August 28, 2013

The nearly $1 billion electronic health record system at Sutter Health in Northern California crashed early this week, leaving nurses and clinical staff unable to access any patient information for a full day.
he Epic EHR was down Aug. 23 due to a planned upgrade for eight hours during which nurses and other clinical users could read medication orders and patient histories but had to record new data on paper to then be re-entered into the system later, according to reports from the California Nurses Association, part of National Nurses United, the largest nurses union in the U.S.

Then, on the morning of Aug. 26 at approximately 8 a.m., the system crashed completely, at which time nurses, physicians and hospital staff had no access to patient information, including what medications patients were taking or required to take and all vital patient history data. 
 
The Epic EHR went dark at several Sutter Health locations, including Alta Bates Summit Medical Center, Eden Medical Center, Mills-Peninsula Hospital, Sutter Delta, Sutter Tracy, Sutter Modesto and numerous affiliated clinics.

"This incident is especially worrisome," said Bonnie Castilla, RN, CNA legislative director, in a news release. "No access to medication orders, patient allergies and other information puts patients at serious risk.  These systems should never be relied upon for protecting patients or assuring the delivery of the safest care."  [This is no exaggeration.  My mother was nearly killed by such a problem when caused by an EHR defect (link) that I averted at the last minute by happenstance of showing up at the right time, while she recuperating from another EHR-related disaster - ed.]   

Some RNs also reported that Sutter failed to provide adequate support during the blackout and didn't implement adequate backup planning.
 
"All information such as medication administration records and patient histories was outdated by two to three days," said Mike Hill, Alta Bates Summit RN, in a news release. "There were no orders that could be seen of any kind through the day so nurses called for what they needed."

Kevin Sweat, an emergency room RN at Eden Medical Center, a Sutter affiliate, also weighed in on the blackout, saying that in his 12 years as an RN he has never seen a system crash like this. 
  

Worse, clinicians must now serve their Cybernetic Master to perfection, or be whipped (apparently to improve morale):

... "We have been on Epic for 5 months now, and we can no longer have incorrect orders, missing information or incorrect or missing charges. Starting on September 1st, errors made in any of the above will result in progressive discipline," according to another hospital memo sent to staff.

In the setting of dire warnings by the nurses of EHR dangers several months back that were likely largely ignored, if any patient was harmed or killed as a result of this latest fiasco, the corporate leadership has literally begged to be sued for negligence, in my view.

However I'm sure a press release soon will claim that "patient care has not been compromised."

Of course this includes now and moving forward, even with informational gaps all over the place.

-- SS

Aug. 29, 2013 additional thought:

The punishment for not being a 'perfect' user of this EHR is the ultimate "blame the user" (blame the victim?) game, considering the pressures of patient care in hospitals in lean times - partly due to EHR expense! - and EHRs that have not been formally studied for usability and are poorly designed causing "use error" (that is, a poor user experience promotes even careful users to make errors).  Cf. definition of bad health IT:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

The study of usability is getting underway only now via NIST but will likely be done in an industry-friendly way due to health IT politics.

-- SS

Aug. 29, 2013 addendum

There have been numerous comments over at HisTalk (at http://histalk2.com/2013/08/27/news-82813/) defending the outage as not EPIC's fault.   From the point of view of clinicians - and more importantly, patients - it doesn't matter what component of the hospital's entire "EHR" (an anachronistic term used for what is now a complex enterprise clinical resource and clinician command-and-control system) went down. 

Aside from all the EPIC issues the nurses have been complaining about (see earlier July 12, 2013 post linked above), the larger problem is that IT malpractice occurred.  The term "malpractice" is used in medical mishaps; I see no reason why it does not apply to major outages of mission critical healthcare information technology systems.

IT malpractice in healthcare kills.

These are the types of nurses I'd want caring for me and mine.  Letting this kind of snafu go "anechoic" does not promote proper management remedial education on Safety 101 and on health IT risk, two areas of education that management appears to desperately need in hospitals.

-- SS

Patients as lab rats for beta software: have sancrosanct patient's rights been trivialized, while poor software of non-trivial risk been sanctified?

I have noted a class action lawsuit vs. Allscripts and Eclipsys, EHR producers, regarding a merger:

UNITED STATES DISTRICT COURT, NORTHERN DISTRICT OF ILLINOIS, EASTERN DIVISION; BRISTOL COUNTY RETIREMENT SYSTEM, Individually and on Behalf of All Others Similarly Situated, Plaintiff, vs. ALLSCRIPTS HEALTHCARE SOLUTIONS, INC., GLEN E. TULLMAN, WILLIAM J. DAVIS AND LEE SHAPIRO, Defendants.

The Lead Plaintiffs' Amended Complaint is available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf.  It is worth reading, if just to understand the inner workings of an unregulated healthcare device industry on which your well-being and that of your family increasingly depends.

Lead Plaintiffs' Amended Complaint, available here in PDF:  http://securities.stanford.edu/1048/MDRX00_01/2013515_r02c_12CV03297.pdf

The lawsuit is primarily about alleged misrepresentations made to investors by Allscripts and Eclipsys in a merger regarding inability to integrate products, leadership chaos, and materially false and misleading statements and omissions made during the Class period by these companies about their progress.

I note that in a chaotic environment such as alleged, product safety is not likely a big concern.

However, even more ominous are the allegations of deliberate use of beta software on patients without informed consent or any knowledge by patients whatsoever of its use, which apparently did not work out well.  Not indicated is if patient harm occurred.  If the allegations are true, considering the ECRI Deep Dive health IT risk study results of nearly 200 health IT "incidents" in 36 hospitals over 9 weeks voluntarily reported, including 8 harm incidents and 3 possible deaths - see http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html it would not be surprising.

From the Complaint, allegations on software beta testing are as follows.  Emphases mine:

41. CW1 [coded person's name - ed.] explained the different interface integration systems as native integration, disparate integration, and High Level 7 “HL7” interface. The goal of native integration was to have the ability to update patient information throughout the Allscripts’ software offerings. This would allow Allscripts’ Sunrise products to seamlessly integrate with Allscripts’ Enterprise, Professional and MyWay products and allow the products to update patient health records without the use of industry standardized codes. Allscripts branded its native software as ADX. [see Complaint footnote 2.] CW1 described disparate integration as allowing Allscripts software to interface with non-Allscripts software which he described as a Health Information Exchange (“HIE”) software that allowed data to be read and
updated from different software vendors.

42. CW1 said ADX 1.0 was designed to pull and update patient electronic health records automatically and was Allscripts’ native integration software. In approximately July 2011, he learned that Allscripts began a complete reworking of ADX 1.0 because customers were complaining about the lack of functionality and integration, and that it did not allow the user to review and approve changes made in other healthcare settings before being accepted by the hospital or physician practice systems. [If the allegations are true, these problems would be creating on its face significant risk of oversights, confusion and medical errors  - ed.] The upgrade was going to be known as ADX 1.5, but the method and interface for data integration changed. In particular, the interface was changed to allow clinicians to approve changes before they were entered into the system. He also learned from other Allscripts employees that ADX 1.0 was being beta tested [see Complaint footnote 3] at Blessing Hospital in Quincy, Illinois and another place he could not recall, but it was suspended in approximately the middle of 2011 because it failed to perform to expectations. [see Complaint footnote 4] [Remarkable - if the allegations are true, experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations" - and what of the unconsenting meatbags a.k.a. patients it was purportedly tested on? - ed.]

Complaint footnotes:

[2] CW1 described the HL7 interface as using industry standardized codes or language to allow users of disparate software systems to update patients electronic health records.

[3] In software development, “beta testing” generally refers to a testing phase in which a subset of the intended user population tries the product out, in order to see how the product works in real-world conditions.  [What sane patient would consent to such testing of medical IT involved in their care, to 'see how it works in real-world conditions'? - ed.]

[4] See also ¶158 (Defendant Davis’ May 8, 2012 statement “our initial release of our integrated capability...was launched in the middle of last year”); ¶189; cf. ¶76 (CW11’s statement that beta testing at Blessing occurred in late 2011 and was halted in Spring 2012);

Again, I find the allegations of great concern - that experimental software was being beta tested on live patients and was stopped because it did not "perform to expectations."  If true, what of the unconsenting meatbags a.k.a. patients?  They would not have counted for much.

More from the Complaint in Count 50:

50. Consistent with CW2, CW3 said the Helios system was never taken to production while he worked at Allscripts. After he left to join Medicity he had heard that Allscripts delivered a Helios type product for beta testing in the fall of 2011 at the New York Presbyterian Hospitals and it did not go well and that the beta testing of the Helios product at the North Shore Long Island Jewish Community Hospital was scratched prior to implementation.

If the allegations are true, New York Presbyterian Hospitals in the fall of 2011 were performing beta testing of software so bad it was deemed unacceptable for LIJ Community Hospital.  Again, if true, what about the risks patients were subjected to, and ... were any harmed?

Still more in Count 76:

76. CW11 said that Blessing Hospital in Quincy, Illinois was beta testing ADX 1.0 sometime in late 2011, but could not recall specifically when it began. CW11 said he was told that the testing was stopped in early 2012 because the product was not working properly and Allscripts deployed a product development team to Blessing Hospital to develop a workflow which lead to ADX 1.5. As far as CW11 knew, no one went live on ADX 1.0. Blessing Hospital began testing ADX 1.5 in late Spring 2012, and was the first to go live using ADX 1.5 in July 2012 which allowed the integration of patient information seamlessly between Sunrise and Enterprise applications. Components of Helios went into ADX 1.5. ADX 1.5 allowed for integration of patient data relating to PAMI (problems, allergies, medications, and immunizations) but some competitor products allow for significantly more types of data to be seamlessly exchanged and Allscripts was working to increase the types of data that could be seamlessly exchanged between acute care and ambulatory applications.

In effect, if the allegations are true, sancrosanct patient's rights have been trivialized, while poor software of non-trivial risk has been sanctified.

This would be, needless to say, deranged.  Software can be debugged in test environments without putting patients at risk - if one is willing to invest the resources to do so.

The Class Action lawsuit Plaintiffs should perhaps seek to discover if there were patient harms or deaths as a result of the alleged software beta testing - assuming that information was not thoroughly "cleansed" by now.

I also note that even small NIH SBIR/STTR grant proposals involving use of new or modified IT on patients, on whose study sections I am an invited reviewer in the domain of Medical Informatics, are subject to human subjects protection evaluation:

http://grants.nih.gov/grants/peer/critiques/sbir-sttr.htm

... Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 [see http://www.research.uci.edu/ora/forms/hrpp/categories_of_exempt_human_subjects_research.pdf - ed.], the [grant review] committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

In health IT tests in hospital settings, which is most certainly experimentation, there are simply no human subjects protections whatsoever.  Hospital IT deserves no special accommodation regarding Protections for Human Subjects.  There are no justifiable reasons I can think of. 

-- SS

Addendum:  Perhaps I'm wrong about people's generosity and altruism.  I would like to hear from people who would gladly submit, say, their newborns as test subjects for the beta testing of experimental health IT software.

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Add the following from Sutter East Bay Hospitals to nurses' and physicians' complaints at Marin General Hospital (http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html), Affinity Medical Center (http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html), Contra Costa County (http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html), San Francisco Department of Public Health (http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html), and others:

For Immediate Release 
July 11, 2013
Contact-  Charles Idelson, 510-273-2246

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today.

Problems with technology are not unique to health care – pilots of the ill fated Asiana airline that tragically crashed at San Francisco International Airport July 6 told federal investigators that an automatic throttle failed to keep the jetliner at the proper speed for landing, the Los Angeles Times reported July 9.  [What is unique to healthcare IT is the complete lack of regulation - ed.]

In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe.

Patient care concerns included computerized delays in timely administration of medications and contact with physicians, ability to properly monitor patients, and other delays in treatment.  Many noted that the excessive amount of time required to interact with the computer system, inputting and accessing data, sharply cuts down on time they can spend with patients with frequent complaints from patients about not seeing their RN.  [Note: patients are not given the opportunity for informed consent about the risks, nor opt-out of EHR use in their care - ed.]

"EPIC is a system that is so cumbersome to use for nurses and physicians, that we often feel as though we are caring for a computer, not a patient,” said Thorild Urdal, an RN at Alta Bates Summit’s hospital in Berkeley. “It delays care and treatment, the program is naturally counter-intuitive and it was clearly not designed in concert with nurses and physicians." [Clinicians end up caring for an "iPatient", as others have noted - ed.]

"The Epic program developed and implemented by Sutter is neither nurse or patient friendly,” said Alta Bates Summit Oakland RN Mike Hill. “Epic does not enhance my ability to chart instead it takes time away from the bedside and my patients and preventing me from providing the absolute best care that they and I expect from me as a nurse."

Sutter CEO Pat Fry last year told the San Francisco Business Times that Sutter will spend $1 billion on Epic, a system that has sparked controversy at several other hospitals, including a Contra Costa facility where several RNs cited serious medical errors in testimony to county supervisors last August.

At Alta Bates Summit specific incidents directly related to Epic problems included:

• A patient who had to be transferred to the intensive care unit due to delays in care caused by the computer.  [It's happenstance they did not have to be transferred to the morgue - ed.]
• A nurse who was not able to obtain needed blood for an emergent medical emergency.
• Insulin orders set erroneously by the software.
• Missed orders for lab tests for newborn babies and an inability for RNs to spend time teaching new mothers how to properly breast feed babies before patient discharge.
• Lab tests not done in a timely manner.
• Frequent short staffing caused by time RNs have to spend with the computers.
• Orders incorrectly entered by physicians requiring the RNs to track down the physician before tests can be done or medication ordered.
• Discrepancies between the Epic computers and the computers that dispense medications causing errors with medication labels and delays in administering medications.
• Patient information, including vital signs, missing in the computer software.
• An inability to accurately chart specific patient needs or conditions because of pre-determined responses by the computer software.
• Multiple problems with RN fatigue because of time required by the computers and an inability to take rest breaks as a result.
• Inadequate RN training and orientation.

These "incidents" are certainly capable of causing harms or fatalities.  One wonders if hospital executives are providing the usual refrain that these are just "glitches" (http://hcrenewal.blogspot.com/search/label/glitch) and that patient care has not been compromised (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

A bit more background follows:

... Hospitals nationally are spending tens of billions of dollars on technology systems, especially on electronic health records (EHR) programs for which they also receive federal financial incentives.

EHR programs are paraded as a panacea for reducing medical errors and cutting costs, but in life the promise is falling short in both areas.

A RAND corporation analysis earlier this year said visions of savings and improved efficiency in patient care have had what the New York Times called “mixed results, at best.”

The U.S. Food and Drug Administration has acknowledged getting hundreds of reports of problems involving health information technology including numerous patient injuries and deaths.

Some examples seen at hospitals across the country:

• At Marin General Hospital in Northern California, RNs called on the Marin Healthcare District board to delay implementation of their EHR system. "Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," Marin RN Barbara Ryan said in comments reported by the Marin Independent Journal.
• In Chicago, the Chicago Tribune in 2011 reported on a patient death at Advocate Lutheran General hospital after an automated machine prepared an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by a physician.
• At Affinity Medical Center RNs in Massillon, Oh. RNs in June raised multiple objections to the hurried introduction of an EHR system. Subsequently, they have cited medication errors, delays in care, problems with documentation, computers crashing, and other concerns.

I am simply the reporter here.

-- SS

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.

Finally, medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the ECRI Deep Dive Study on Health IT harm at this link), ignores its clinicians over too-rapid deployment of health IT.

Also see newspaper article at http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF.

(The hospital management is extolling the safety of the new Cerner system.  What could possibly go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "MAUDE and HIT Risks: What in God's Name is Going on Here?" at http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html or are familiar with "Medical center has more than 6000 'issues' with Cerner CPOE system in four months" at http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html.  Instead, unpaid bloggers do their work for them to protect patients....)

See this:

-----------------------------

For Immediate Release - June 18, 2013

For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner.

The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.

Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients.

The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems.

Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  [Willful ignorance? - ed.] Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.

Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market.

“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. “The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.”

NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment. 

“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center

Inadequate Staffing

·        Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months.

·        The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.

·        They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.

·        The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.

Lack of training

·        Some nurses have received only one day of training.

·        Super-users have received no education or training in the system beyond what is provided to the other users.

Design flaws

·        Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting.

·        During one education session, the system crashed because 17 users at one time overloaded it.

Failure to consult nurses

·        Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency?

Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights.

The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.

CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission.

Michelle Mahon, RN

National Representative

National Nurses United

mmahon@nationalnursesunited.org

234-207-6706

I believe the nurses should strike if their concerns are not heeded.

I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.

-- SS

6/20/13 addendum:

I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated explicitly that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.

I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?

-- SS

9/2/2013 addendum

The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html) - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.

-- SS

"Computer problems" force docs back to paper charts at Memorial Hospital - From June 11 until at least June 24?

More on the wonders and dependability of commercial health IT, as implemented in hospitals, which are generally an IT backwaters:

Computer problems force docs back to paper charts at Memorial Hospital

Published: June 17, 2013 

BELLEVILLE (Illinois) — Computer problems have caused Memorial Hospital (http://www.memhosp.com/Pages/Home.aspx) staff back to the old days of using paper to chart patients' treatments.

The hospital's computer system, Meditech, went down late on Tuesday, June 11 and is not expected to be fully restored until at least Monday, June 24, according to the hospital. In the meantime, staff will be recording patients' medical records unto traditional paper charts.

"While the duration of this down time is unfortunate, all hospital services continue utilizing the backup process we have in place for occasions such as this," Memorial President Mark Turner said in a prepared statement. "I am extremely proud of the way our employees and medical staff have pulled together to maintain quality care and patient safety."

Once the system is up and running again, the information from the paper charts will be transferred into each patient's electronic medical record. The same standards for patient confidentiality and safety are being met, according to the hospital.

The computer problems are believed to result from upgrades added to the system in preparation for a major upgrade in July.

"The duration of this down time is unfortunate?"  This mission-critical system went down June 11 and won't be fully restored until June 24?  How is this even possible?  What, exactly, were their maximal-uptime, redundancy, disaster recovery and business continuity strategies?  Was there a natural disaster in that area I don't know about?

Regarding the hospital President's statement that:

"I am extremely proud of the way our employees and medical staff have pulled together to maintain quality care and patient safety."

I would translate that to read:

"Our IT incompetence is all on you, clinicians.  You're liable for any patient harm that results in the messy transitions from IT to paper, and back from paper to IT."

-- SS

Addendum - a question I've asked before - if everything is just fine, business as usual, with no safety impediments after reverting to paper due to emergency ... then why spend $100 million+ on EHRs?

Read more here: http://www.bnd.com/2013/06/17/2660472/computer-problems-force-docs-back.html#storylink=cpyA

Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue

- Posted at the Healthcare Renewal Blog on May 30, 2013 -

The following appeared in the Marin County Independent Journal about an EHR system so bad the nurses at Marin General Hospital were publicly complaining, putting their careers at risk (see my May 17, 2013 post "Marin General Hospital nurses warn that new computer system is causing errors, call for time out"):

National critic of health care information technology says Marin General should heed nurses' advice

By Richard Halstead
Marin Independent Journal

Posted:   05/27/2013 04:03:00 PM PDT

The critic is me.   I spoke to the reporter but did not know he would publish:

A nationally known critic of electronic health records has harshly criticized managers at Marin General Hospital for their response to a plea by nurses to hold off on a new computer system to prevent potentially dangerous errors.

"The executives at the hospital should be taking out extra insurance policies because they're setting themselves up for a massive corporate negligence lawsuit," said Dr. Scot Silverstein, an adjunct professor of health care informatics at Drexel University in Philadelphia.

Silverstein, who contacted the Independent Journal after reading about the Marin General situation, doesn't dispute the potential of digital records; but he believes implementation has been rushed. He thinks electronic health records should be regulated by the federal Food and Drug Administration, much like medical hardware or pharmaceuticals.

Or regulated by someone with experience in similar mission critical software, and with regulatory teeth.  Paper tigers and bad health IT are a very poor mix where patients' rights are concerned IMO.

At issue is a new computerized physician order entry system, known as CPOE; doctors place medication orders for patients directly into the system.

At a meeting of the Marin Healthcare District board on May 14, a group of Marin General nurses told the board problems with the new computer system were diverting them from their patients and causing errors, such as sending orders to the wrong patients. One nurse reported that a patient had received a medication to which he was allergic.

That is a very direct calling out of the potential for harm and death by front line clinical personnel.  To ignore it is grossly if not criminally negligent.

Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, assured the board that the hospital was safe, despite "glitches" in the new system. Domanico said he was working to fix the problem.

Glitches = safe?  The Board must be highly gullible if they believe this  See http://hcrenewal.blogspot.com/search/label/glitch for more on "safe" glitches.

Silverstein said, "Glitches are a euphemism for life-threatening electronic health record malfunctions and defects."


"What they need to do is exactly what the nurses are asking for," Silverstein said. "They need to turn the system off and put it through rigorous testing and confirm the thing is going to work properly with no glitches before they use it on patients."

That's not rocket science - its common sense - unless they think their own nurses are lying.

Of course, as computers have more rights than patients, and bonuses might be affected, the system will likely continue in full operation, with patients as guinea pigs, and the nurses punished for informing the public that perhaps they should consider other hospitals while the "glitches" in this enterprise clinician command-and-control system are worked out.

Two days after the Marin Healthcare District meeting, Domanico issued a press release stating, "We have not received any medication error incident reports resulting from the implementation of computerized physician order entry."

On Friday, however, Barbara Ryan, a Marin General registered nurse who serves as the California Nurses Association/National Nurses United representative, said, "I can't understand why that statement was made."

Ryan said nurses have told her of errors, and information about errors appears in "Assignment Despite Objection" forms that nurses have filed since implementation of the computerized order system began on May 7. Nurses file the forms to document formal objections to an unsafe, or potentially unsafe, patient care assignment.

The statement's reason and purpose seems fairly obvious. 

Ryan said Marin General nurses have filed close to 50 such forms so far this month; she said typically 10 to 20 such forms are filed per month at the hospital.

"There are still problems with the system," she said. "There are still mistakes being made." Ryan said the hospital needs to boost nurse staffing ratios during the implementation.

That would increase costs (and probably decrease the pool of money for bonuses).

Jon Friedenberg, Marin General's chief fund and business development officer, said the hospital is in the process of upgrading computer servers and adding memory to work stations to increase the speed of the new computerized order system.

"We completed an upgrade of memory to 200 of the work stations, and 120 of the work stations have been replaced," Friedenberg said.

This reminds me of a similar IT fiasco I faced some years ago, when the brilliance of IT personnel really shone through regarding an ICU monitoring system that crashed regularly.  Their solution?  Add more RAM.  (See "Serious clinical computing problems in the worst of places: an ICU" at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU).

... Silverstein earned a medical degree from Boston University and subsequently completed a two-year fellowship in medical informatics at Yale University School of Medicine. He served as Merck Research Laboratories' director of scientific information in the early 2000s before serving for a time as a full-time professor at Drexel University. Today, in addition to teaching part-time, Silverstein works on [EHR-related - ed.] medical liability cases for plaintiff attorneys. [And the defense too, when asked; I'd rather advise on how to prevent mistakes, in fact, than get involved after the fact when someone's been injured or killed - ed.]

What was not mentioned was that I was a CMIO in a major hospital in the mid to late 1990s.

But of course, I - and similarly trained Medical Informatics experts - "don't have enough experience" to lead (as opposed to being an 'internal consultant') health IT projects, a refrain I've often heard from hospital executives.

Silverstein said he started assisting on the liability cases after his mother died as the result of an electronic health care record error that resulted in her not being given the proper heart medicine. Silverstein said his mother's case was not an anomaly.

For example, he pointed to the results of a recent Emergency Care Research Institute study of 36 hospitals conducted over a nine-week period. Asked to report electronic record problems on a volunteer basis, Silverstein said the hospitals reported 170 malfunctions, including eight incidents that resulted in patient harm, three of which may have contributed to patients' deaths.  Although the federal Food and Drug Administration does not regulate health care information technology, some manufacturers have voluntarily supplied data to the FDA. In February 2010, the FDA reported it had been notified of 260 problem events involving health care information technology in the previous two years that were linked with 44 injuries and six deaths.

See my Feb. 28, 2013 post "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events" at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.  Also see my Aug. 5, 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide" at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html. I merely report what ECRI, AMA and FDA have reported.

Finally:

In his press release, however, [CEO] Domanico stated that "more than 150 studies conducted since 2007 have confirmed that organizations using health information technology, like CPOE, have seen positive outcomes."

I believe he's referring to a highly biased and scientifically defective ONC paper of 154 selected studies: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results."

What an unbelievably cavalier attitude.

My colleagues and I refuted (dare I say trashed) that paper pretty thoroughly here:
http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html.

Even worse, the mention of that paper, or EHR benefits in general, is a diversion, an in-your-face red herring (at best; an inability to reason logically at worst), steering away from the real issue:  an EHR implementation about which nurses are complaining ... in the now.

http://www.nizkor.org/features/fallacies/red-herring.html:  A Red Herring is a fallacy in which an irrelevant topic is presented in order to divert attention from the original issue.

That a CEO of a major hospital relies on one defective paper - one that he most likely lacks the experience and expertise to understand, let alone critically evaluate - and red herrings is a poster example of why medical and medical informatics amateurs should not be running hospitals or clinical IT projects.

-- SS

Marin General Hospital nurses warn that new computer system is causing errors, call for time out

- Posted on the Healthcare Renewal Blog May 17, 2013 -

Of course, the ever-present euphemism for life-threatening EHR malfunctions and defects, i.e., "glitches" are the cause (http://hcrenewal.blogspot.com/search/label/glitch):

Marin General Hospital nurses warn that new computer system is causing errors, call for time out

By Richard Halstead
Marin Independent Journal
Posted:   05/15/2013 04:07:49 PM PDT

Nurses at Marin General Hospital have asked administrators to put implementation of a new computerized physician order entry system on hold until glitches can be worked out and more training provided to nurses and doctors who use it.

Nearly a dozen nurses attended the regularly scheduled meeting of the Marin Healthcare District board Tuesday night at Marin General to voice their concerns. The district board oversees Marin General, but it does not involve itself in the hospital's day-to-day operations.

"Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," said Barbara Ryan, a Marin General registered nurse, who works in pediatrics and the intensive care nursery. "We're not asking you to get rid of it. We're asking you to place it on hold."

Orders passed to wrong patients?  No problem, just a glitch!  Meds people are allergic to?  Just a glitch.  Dangerous?  No way.  It's just a glitch!

But Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, said, "I'm confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."

Where's the data backing up that assertion, I ask?  The actual risks of paper records don't seem to be robustly documented anywhere.

Ryan, who serves as the California Nurses Association/National Nurses United representative, was one of four Marin General nurses who spoke during the public comment portion of the meeting. Ryan said the nurses warned in advance of the system's roll-out on May 7 that nurses and doctors had insufficient knowledge of the system. Ryan said due to problems with the software nurses had been unable to open the program at home to practice using it.

And yet the rollout happened anyway?  That seems to me to be reckless indifference to the concerns of clinicians.

"Lo and behold the problems that we were worried about have happened," Ryan said. "We're looking at two-hour preps for surgery and two- to three-hour discharges; skilled nursing facilities calling back saying, this really doesn't make sense; the wrong meds ordered on the wrong patients and then given to the wrong patients; the inability for nurses to be able to see what the doctor ordered and double-check it."

Of course, I might add, patient safety was not compromised, the other common refrain of EHR glitch-excusers ... see below.

Ryan said nurses have and will continue to file "assignment despite objection" forms due to the system. Nurses file the forms to document formal objections to what they consider an unsafe, or potentially unsafe, patient care assignment.

"We will take patients but we will object to the assignment because it is unsafe," Ryan said. "This system is making it unsafe."

These will be exceptionally helpful in court to any patients injured or killed as a result of these "glitches" and EHR rollout that occurred despite direct warnings from clinical experts.

Marin General nurse Susan Degan said, "This is not about resistance to change. It's about accountability. My most important role is that of patient advocate. I am held accountable when errors are made."

Domanico acknowledged there have been some technical problems with the Paragon system, including making it possible for nurses to open from home. And he said the software is not faster than the old paper system.  [Considering it's acknowledged all the way up to the highest levels of HHS that current EHR's slow physicians down, one wonders if anyone in this organization thought an EHR would actually increase speed? - ed.]

About the "resistance to change" canard, see my essay "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html .

"So yes," Domanico said, "it is causing stress for nurses who have heavy workloads, who are learning how to use it, particularly in areas where we need to speed up the computer."

What?  "Speed up the computer?"  They've spent tens if not hundreds of millions for an EHR, and the computer's too slow?

Actually, I think what this CEO in an obvious display of health IT ignorance is trying to say is that we have to do something about the system's poor usability, which sort of mimics what the Board Chair of the American Medical Assocation just said (http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html).

Also - clinician stress promotes error.

But Domanico challenged the suggestion that patient safety at Marin General had been compromised.

In fact, there is no way the issues described above cannot be compromising patient safety, on its face. (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

"I would have no hesitation about entering this hospital tonight," he said.

As a VIP, of course, this CEO would get special treatment.  Thanks a lot.

I would NOT want to be a patient there under these conditions, unless perhaps I had a 24x7 medically-skilled advocate/bodyguard.

Board member Ann Sparkman, who previously served as in-house counsel at Kaiser Permanente, said nurses at Kaiser struggled at first when a new computer system was introduced there.

Sparkman said, "It's just to be expected."

This seems a rather bizarre appeal to common practice (http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html).

The stunning ignorance of this board member about proper mission-critical IT safety testing and implementation, such as performed in pharma, aerospace, etc. is, quite frankly, shocking.

Further, an attitude that life-threatening "glitches" are "just to be expected" by a member of the Board of Directors, with fiduciary responsibilities regarding hospital operations, is grossly negligent in my opinion, and completely ignores patient's rights.

Unbelievable.

One wonders if any formally-trained medical informatics experts were in leadership roles in this project.

-- SS