Showing posts with label Health IT Hazard Manager. Show all posts
Showing posts with label Health IT Hazard Manager. Show all posts

Tuesday, October 07, 2014

Speculation about EHR role in Texas Ebola debacle vs. real evidence - will it take a lawsuit to know what's real? Probably.

In the past several days the media has been abuzz with stories about the admission, then the following retraction, by a Texas hospital that and EMR "flaw" had caused a man who had been in West Africa and was infected with the Ebola virus to be sent home, instead of admitted and put into isolation.

I wrote about these matters at my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) and the followup October 4, 2014 post
"Dallas Hospital reverses EHR-related explanation for fumbling Ebola case" (http://hcrenewal.blogspot.com/2014/10/dallas-hospital-reverses-ehr-relarted.htm).

A spectrum of the healthcare IT ecosystem seems represented (see http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem).  The technology enthusiasts and hyper-enthusiasts seem to believe the computer could have done no wrong (and usually lack medical and Medical Informatics expertise).

Some people such as myself with specific Medical Informatics experience and who know the failure modes via AHRQ, FDA, ECRI Institute etc. believe the EHR was quite likely contributory or causative of the mistake (see my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

The reason I have written little after my initial two posts is that the only was to resolve the controversy is to actually examine the EHR screens, screen navigation and behavior of the EHR, if possible both before and after the hospital's stated "fix" of the problem, the EHR audit trails (automatically generated EHR accounting logs of user accesses, action taken, time, location etc.) and to examine the EHR in actual operation to evaluate it in context with the clinical setting in which it was installed.

Barring that, everything else is speculation usually biased either by the speculator's own beliefs about either the beneficence or fallibility of information technology in healthcare, and perhaps IT generally, and/or conflicts of interest.

Unfortunately, considering the health IT industry and environment, the only way I believe such an examination of the EHR can come about is via litigation.  I doubt it will come from the traditional regulators of medical devices and healthcare safety.

I do note the following of interest at Politico:

... While all EHRs difficult to use, some are set up better than others.

At Mount Sinai Hospital in New York City, information that a patient was feverish and recently flew in from Liberia would have set off an alarm, with the nurse’s screen flashing yellow and giving instructions to immediately isolate the patient, said Jason Shapiro, an emergency room physician and informatics expert at the hospital.

The nurse entering “fever” into the record would “get a hard stop. They immediately have to enter a response to a travel history question. And if there’s fever and the right kind of travel history, the whole isolation mechanism is supposed to swing into play,” Shapiro said.

... Both Mount Sinai and Texas Health Presbyterian have health records systems they purchased for hundreds of millions of dollars from Epic.


At least some users of EPIC seem to have a system configured to catch such a problem.  In my mind, this speaks the need to industry regulation, to ensure all EHRs meet basic standards of safety and reliability and are not haphazardly designed or implemented from one hospital to the next.

-- SS

10/9/14 Addendum:  

Prof. Jon Patrick of Australia, cited numerous times on this blog, relates this:

"I always talk about data capture and data reuse and the reuse is defined by the data flows required in the design of the system. EPIC might well have allowed for the the data capture but failed to deal with the data flow to properly effect the required reuse."

As may the implementers at the hospital in question also have failed at the flows supporting appropriate and fail-safe reuse in a hectic ED environment.

He adds, for further clarification:

A footnote to this point. We separate data flow from work flow. Data flow is the movement of data from context to reuse in another context, or you collect data on this screen(first context) and then you see it later on another screen (=another context).

Workflow is the route staff team members take in moving from one context to another, that is the movement from using one screen to another screen. Most often triggered by clicking a button that moves you to the chosen screen(next context).

The two are very different things and require close thinking in both cases to not trip up with unhelpful and frustrating system solutions.

Historically, Information Systems development has dealt with these issues both poorly and without adequate separate planning. In the past the focus has been on the data capture and storage, because the notion of reuse and context shifting has been left behind. This has been OK for many business systems where contexts have only small variations and workflow are simple or unimportant.

In medicine that just isn’t the case.

-- SS

Saturday, October 04, 2014

Dallas Hospital reverses EHR-related explanation for fumbling Ebola case

At my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) I questioned a possible role for an EMR-related mishap, including known disruptions of teamwork and suboptimal presentation of information, to have contributed to or led to the release of a man carrying the Ebola virus from a Dallas Hospital.

I then related how the press reported, the very next day, that this was indeed the case.

Now...gee whiz...the hospital changes its tune. "No, it wasn't the EMR after all!" 

See "Hospital reverses explanation for fumbling Ebola case" at http://www.dallasnews.com/news/metro/20141003-hospital-reverses-explanation-for-fumbling-ebola-case.ece. The reversal strains credibility and sounds like redirection, to my ear possibly due to inside attorney and/or EMR company attorney pressure. 

The "new explanation" itself per the new article is that:

... A written statement Thursday said hospital officials identified and corrected “a flaw in the way the physician and nursing portions of our electronic health records (EHR) interacted in this specific case.” That statement implied, without directly saying it, that the flaw left the doctor uninformed about Duncan’s travel history. In Friday’s statement, though, the hospital said, “The patient’s travel history was documented and available to the full care team in the electronic health record.” “There was no flaw in the EHR in the way the physician and nursing portions interacted related to this event,” the statement said.

Again, sounds like redirection and making the doctor (and perhaps the ED doctor's group, if they were contractors) the sole scapegoat.  


"Available to the full care team?"  "Available" in a complex computer system with myriad screens is a very relative term.  The issue seems not "how the physician and nursing portion interacted", it is "how the physician portion made the information readily apparent to the physicians and other team members, or not."
 

The problem here, I believe, still likely amounts to "information hard to find" and "suboptimal support of teamwork (situational awareness)", among others, per the AHRQ hazards taxonomy. 

See, for instance, this.  Either it is true, or not, regarding the travel history:


 (click to enlarge)

I think an impartial investigation is needed to get to the truth.  

What we have now is likely healthcare defense attorney and/or risk management "fog", a phenomenon I have both professional and (sadly) personal experience with.

One also wonders if the EHR vendor had a contractual defects non-disclosure ("gag") clause with the organization, and is now threatening suit, leading to the retraction.  (See http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda for more on that issue, and of corporate "hold harmless" clauses).

Unfortunately, a comprehensive investigation would be likely to only occur in a courtroom via Discovery if others become infected.

If any reader has knowledge of details, my email address is scotsilv AT aol DOT com.

-- SS

Addendum: A medical informatics colleague, Dr. William Goossen of the Netherlands, sent me a reminder about this article on the de-professionalizing aspect of health IT:

Harris BL. Becoming de-professionalized: One aspect of the staff nurse’s perspective on computer-mediated nursing care plans. Advances in nursing science. 1990: 13, 2,  3-74.

Some content of this study - Nurses who participated in this study felt to some degree:
  • De-professionalized: being controlled by the computer, not formally planning individualized care, losing skills to develop NCP's (Nursing Care Plans).
  • De-autonomizing: - control by supervisors - linear operations of the computer and nurses felt to think like that - the system doesn't allow  free texting, - nurses must follow the rules of the computer.
  • De-individualizing: - 'one-size-fits-all' - routinized care - eliminating creativity.
  • De-expertizing: - mindlessness and losing the skills learned in school, the computer does the work.

There is a human aspect to computerization in medicine that is often overlooked, especially by the health IT hyper-enthusiasts (see http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html). 

Perhaps the ED staff at the Dallas hospital needs to be surveyed on these issues.

-- SS

Thursday, October 02, 2014

Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?

[10/3/2014 Note:  my suspicions were correct - see addenda below.]

This story merits special scrutiny in relation to EHR dangers (see for instance http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html):

http://bigstory.ap.org/article/44a12c35649f4f6782fcb3c9f476da09/ebola-case-stokes-concerns-liberians-dallas

Oct. 1, 2014:  Ebola-infected passenger was sent home from ER

DALLAS (AP) — The airline passenger who brought Ebola into the U.S. initially went to a Dallas emergency room last week but was sent home, despite telling a nurse that he had been in disease-ravaged West Africa, the hospital said Wednesday in a disclosure that showed how easily an infection could be missed.

The decision by Texas Health Presbyterian Hospital to release the patient, who had recently arrived from Liberia, could have put others at risk of exposure to Ebola before the man went back to the ER a couple of days later, when his condition worsened.

... The patient explained to a nurse last Thursday that he was visiting the U.S. from Africa, but that information was not widely shared, said Dr. Mark Lester, who works for the hospital's parent company.

"Regretfully, that information was not fully communicated" throughout the medical team, Lester said. Instead, the man was diagnosed with a low-risk infection and sent home.

How could a "failure to fully communicate" information about the man's travels have occurred, at a time when the Ebola issue has been prominent in the press and is causing a worldwide scare?

The Texas Health System hospitals, including Texas Health Presbyterian Hospital Dallas, are EHR users and have been recipients of millions of dollars of federal incentives:

http://www.bizjournals.com/dallas/news/2011/05/24/texas-health-gets-19m-for-ehr-upgrades.html?page=all

May 24, 2011: Texas Health Resources has received more than $19.5 million in Medicare incentive payments for meeting “meaningful use” criteria for installation and use of its electronic health records.

It appears these hospitals are using EPIC. From a July 6, 2009 HIStalk blog interview with the CMIO:

http://histalk2.com/2009/07/06/histalk-interviews-ferdinand-velasco-md-chief-medical-information-officer-texas-health-resources/

What are the most important projects you are working on at Texas Health Resources?
The project is our EHR deployment. We’re an Epic customer. We’re in the middle of deploying the EHR. We’re live now with probably close to three-quarters of our beds. We’re a 14-hospital health system.

EHR's are known to disrupt normal, even mundane channels of medical communication (my mother is dead thanks, in part, to this problem).

Per the Agency for Healthcare Research and Quality (AHRQ) of HHS, possibly relevant modes of disruption in this scenario include:

  • "information hard to find", 
  • "suboptimal support of teamwork (situational awareness)", 
  • "confusing information display", 
  • "design contributed to entry into wrong patient's record", 
  • "lost data", 
  • "excessive workload (including cognitive)" ...

... and other potentially relevant factors (including system outage).

Below is a checklist of such failure modes from the May 2012 AHRQ Health IT Hazard Manager Report (http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf):


 
AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT (click to enlarge)


I've worked in ED's and find this matter puzzling.  While I have no evidence as to any role of EHRs in this seemingly strange, cavalier and incomprehensible medical decision to send this man home, resulting in potential exposure of numerous other individuals to Ebola (and I am certainly not in a position to have such evidence), I believe this possibility needs to be investigated fully.

Yet there does not appear to be a rush for investigation of what transpired in the ED.  See "Health regulators not rushing to probe Dallas hospital’s handling of Ebola patient", Miles Moffeit, Dallas News, Oct. 1, 2014 at http://watchdogblog.dallasnews.com/2014/10/health-regulators-not-rushing-into-probe-of-dallas-hospitals-handling-of-ebola-patient.html/.

Finally, by the way, after all the tens of millions of dollars spent by this organization on EHR's at taxpayer expense and with the awards and accolades heaped on them by the likes of HIMSS, Leapfrog etc., at the very least one might have expected a blatantly obvious case like this to have been recognized as a serious matter. Yet it was not. (One can only imagine what happens with more subtle issues.)

One wonders how much in the real world, as opposed to in the world of EHR marketing and hype, these systems really do help in critical decision making and safety.

-- SS

10/3/2014 Update:

My suspicions were apparently correct.

See:

 "Travel Information Wasn't Communicated In Dallas Ebola Case Due To Electronic Health Record Flaw" (Huffington Post),
http://www.huffingtonpost.com/2014/10/02/dallas-ebola-patient-hospital-error-electronic-health-record-flaw_n_5924698.html

and:

"Dallas hospital blames ‘flaw’ in ‘workflow’ for release of Ebola patient as a more complete picture of his travels emerges" (Washington Post), http://www.washingtonpost.com/news/morning-mix/wp/2014/10/02/dallas-hospital-blames-flaw-in-electronic-record-keeping-system-for-release-of-ebola-patient/

-- SS

More:
  
http://www.wptz.com/health/urgent-ebola-texas-hospital-flaw/28381038

(CNN) -- The Texas hospital treating the first person diagnosed with Ebola on American soil says a "flaw" in its electronic health records prevented doctors from seeing the patient's travel history. Patient Thomas Eric Duncan told the nurse he'd been in Africa, but that information was entered into a document that isn't automatically visible to physicians [apparently even after being filled out with positive information, I note - ed.], Texas Health Presbyterian Hospital Dallas said in a statement Thursday. After discovering this, the hospital says it has changed the system so doctors and nurses will see travel history documentation. "We feel that this change will improve the early identification of patients who may be at risk for communicable diseases, including Ebola," the hospital said.  

Well, yes it will.  Perhaps that could have been thought of sooner?

Additional thought:  this situation might end up being the "Cybernetic Libby Zion case" I've been predicting - where some major debacle leads to serious attention to EHR safety issues.  (On Libby Zion, see http://en.wikipedia.org/wiki/Libby_Zion_Law.)

-- SS

10/4/2014 addendum:

Now...gee whiz...the hospital changes its tune. "No, it wasn't the EMR after all!" 

See "Hospital reverses explanation for fumbling Ebola case" at http://www.dallasnews.com/news/metro/20141003-hospital-reverses-explanation-for-fumbling-ebola-case.ece. The reversal strains credibility and sounds like redirection, to my ear possibly due to inside attorney and/or EMR company attorney pressure. 

The "new explanation" itself per the new article is that:

... A written statement Thursday said hospital officials identified and corrected “a flaw in the way the physician and nursing portions of our electronic health records (EHR) interacted in this specific case.” That statement implied, without directly saying it, that the flaw left the doctor uninformed about Duncan’s travel history. In Friday’s statement, though, the hospital said, “The patient’s travel history was documented and available to the full care team in the electronic health record.” “There was no flaw in the EHR in the way the physician and nursing portions interacted related to this event,” the statement said.

Again, sounds like redirection and making the doctor (and perhaps the ED doctor's group, if they were contractors) the sole scapegoat.   

"Available to the full care team?"  "Available" in a complex computer system with myriad screens is a very relative term.  The issue seems not "how the physician and nursing portion interacted", it is "how the physician portion made the information readily apparent to the physicians and other team members, or not."
 

The problem here, I believe, still likely amounts to "information hard to find" and "suboptimal support of teamwork (situational awareness)", among others, per the AHRQ hazards taxonomy. 

See, for instance, this.  Either it is true, or not, regarding the travel history:



 (click to enlarge)


I think an impartial investigation is needed to get to the truth.  

What we have now is likely healthcare defense attorney and/or risk management "fog", a phenomenon I have both professional and (sadly) personal experience with.

One also wonders if the EHR vendor had a contractual defects non-disclosure ("gag") clause with the organization, and is now threatening suit, leading to the retraction.  (See http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda for more on that issue, and of corporate "hold harmless" clauses).   

Unfortunately, a comprehensive investigation would be likely to only occur in a courtroom via Discovery if others become infected.

If any reader has knowledge of details, my email address is scotsilv AT aol DOT com.

-- SS

Tuesday, June 05, 2012

Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

(Addendum: the AHRQ hazards manager taxonomy report can see seen at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.)

In a July 2010 post "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and an Oct . 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?" I wrote about the postmodern "ready, fire, aim" approach to health IT:

In the first post, I wrote:

... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.
For crying out loud, talk about putting the cart before the horse...

Something's very wrong here...

However, this situation is anything but humorous.

How more "cart before the horse" can government get?

In the second post, I wrote:

... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?

Here we go yet again.

The problem with the AHRQ (Agency for Healthcare Research and Quality, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind.

If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., Health IT and Patient Safety: Building Safer Systems for Better Care, pg. S-2), then health IT is, it follows, an experimental technology.

If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar:

Sent: Tuesday, June 05, 2012 12:23 PM
To: OHITQUSERS@LIST.NIH.GOV
Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET

Agency for Healthcare Research and Quality

Purpose and Demonstration of the Health IT Hazard Manager and Next Steps

June 11, 2012 — 2:30-4 p.m., EST

The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards.

The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers.

... Webinar learning objectives include:

1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing.
2. Explain the process for identifying and categorizing health IT-related hazards.
3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors.
4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities).

In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence.

Have we thrown out all we know about medical research and human subjects protections in face of the magical powers and profits of computers in medicine?

-- SS