Gatling Gun

At my Feb. 16, 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'" I established that buyers and users of EHR systems do so at their own risk with regard to implementation problems or outright defects resulting in patient harm.

As I've also written at my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a Political Hot Potato; Demurs", FDA has admitted health IT is a medical device that they shy away from regulating because it's politically expedient not to do so. (The area is a "hot potato" per the Director of FDA's CDRH, the Center for Devices and Radiological Health, so FDA stays away.)

Yet FDA knows of the stakes. As I observed at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks" and elsewhere, patient harm is occurring due to these devices and FDA is aware. Due to admitted impediments to information diffusion, however, even FDA, IOM, The Joint Commission (due to a "dearth of data" as in their 2008 Sentinel Events Alert On Healthcare IT) and others do not know the true magnitude of the problem.

From the FDA internal memo at the preceding FDA memorandum link:

Limitations of the MAUDE [Manufacturer and User Facility Device Experience database] search and final subset of Medical Device Reports (MDRs) include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.

2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.

3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.

4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.

5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

... The results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

Finally, as I pointed out in my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership", the Office of the National Coordinator for Health IT at HHS (ONC) had published the following with regard to the qualification of those who could "lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States":

Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.

Here, though, is a more typical reality in today's hospitals, the background of an EHR deployment leader in one of the most risk-prone and difficult environments in healthcare, the Emergency Department (ED) in a large hospital of which I am aware:

Clinical Systems Analyst

January 2004 – Present

Project manager for implementation of an ED EHR [vendor name redacted]
Responsible for all aspects of implementation including build and process design, report build, testing, training, and go-live support.
Extensive knowledge ADT processes, HL7, and CPOE.
Manage software patches and upgrades.
Experience in HTML, SQL and SAP.

Financial Systems Analyst
November 2001 – January 2004

Project Team Lead for implementation of Patient Accounting system.
Responsible for system development and system build, training, testing, and reporting.

Education

[Regional university in the lower 50% of US News rankings in the region, name redacted]
B.S., Management Information Systems
2000 – 2003

[Name redacted] Community College

Associates Degree, Business Administration

So, ED physicians (with many years of doctoral and post-doctoral training and experience, boards testing their competence, etc.) may be placing the lives of patients and their careers in the hands of:

An experimental medical device,
unregulated by anyone,
in a field whose qualifications for leadership are unregulated by anyone,
devices known to be risky,
but without anyone knowing the magnitude of that risk,
whose implementation is led by a generic 'clinical' systems analyst "responsible for all aspects of implementation" with a Bachelor's degree in MIS from a second-tier institution, an Associates degree from a community college, and no medical or Medical Informatics education or experience whatsoever.

Further, that project lead jumped from financial systems analyst to 'clinical' analyst/leader of an ED EHR implementation.

One should also ask

Who was the hiring manager who hired such a person and put them in the role?
On what credentials and experience was the decision based?
What were the hiring manager's own credentials?

I leave it to the reader to decide if this is an appropriate arrangement, and if they would place their trust in an ED whose activities center around a cybernetic system implemented in this manner.

-- SS

Feb. 17, 2012 Addendum:

At least in this case the person has degrees.

Per several prominent healthcare IT recruiters in the past in the article "Who's Growing CIO's" in the journal Healthcare Informatics, as mentioned at my Sept. 2009 post "Correcting historical information from the recruiter component of the Health IT Ecosystem", the School of Hard Knocks was plenty good for health IT leadership roles:

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

-- SS

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

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Death at Birth: A Tragedy Caused by Overwork and Undertraining - and Technology

As a result of my recent post "Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients", a malpractice attorney, Patrick Malone in Washington, D.C., sent me a link to a tragic summary of a case his firm handled.

The story illustrates the toxic effects that health IT and other technology, especially when not "done well", can have on patient care.

I present it below with just a bit of comment, with permission of attorney Malone. Emphases also mine:

Death at Birth: A Tragedy Caused by Overwork and Undertraining
The Patrick Malone firm represented the family of Keren Kipoliongo, a baby girl who died in her mother’s womb just minutes before the successful Cesarean section delivery of her twin sister Gabrielle.
This tragedy occurred at Virginia Hospital Center in Arlington, Virginia in July 2008. At midnight one evening, Mrs. Kipoliongo and her husband presented to the labor and delivery unit at the hospital, as scheduled per their obstetrician’s instructions. The plan was to induce labor with the drug Pitocin (oxytocin) and monitor both babies during the labor with fetal heart monitors, to make sure they could withstand the contractions and be safely delivered by the normal vaginal route.
This was the first pregnancy for the couple, and they were excited about the prospects of having twins. They had set up their home in northern Virginia with a nursery with two cribs and two of everything else they would need.
The obstetrician whom Mrs. Kipoliongo had seen regularly throughout her pregnancy checked them into the L&D unit and then went to sleep in the doctors’ lounge. He instructed the nurse and a resident physician (doctor in training) to call him if needed.
Mrs. Kipoliongo was left alone for large stretches through the night. It wasn’t until a nursing shift change at 7 a.m. that she started to get close attention from the nurses. By that time, baby Keren was in bad shape as shown by fetal monitor patterns in which her heart beat was slowing ominously with the mother’s contractions. She had already shown throughout the overnight period a flattening or lack of variability from beat to beat. (The flattening of the heart rate often means the baby is not getting enough oxygen.) [Why was this not noted and acted upon promptly? Read on - ed.]
They finally brought the obstetrician in, and he decided around 8:15 a.m. to do a Cesarean section. Baby Keren was still alive at that point. Unfortunately she died some time over the next hour, because when the doctor finally cut into the mother’s womb after 9 a.m., he found that she was dead, with the umbilical cord wrapped tightly around her neck.
When our law firm investigated what had happened on behalf of the family, we found several disturbing facts. These included:
Despite the lack of reassuring signs on baby Keren’s heartbeat, the nurses failed to do any of a number of standard things that can improve the baby’s condition, such as turning the mother, giving the mother oxygen, and giving extra fluids.
The hospital overworked the nurse assigned to Mrs. Kipoliongo’s labor, giving her a second patient for whom she was also primarily responsible. Standards require one-on-one nursing during a labor that is as involved as hers was. The stimulating drug Pitocin requires close monitoring. In addition, Keren was under-sized (a condition called “intrauterine growth restriction”), and that is why they were proceeding with a scheduled birth rather than wait for labor to start on its own. (At autopsy, Keren was found to have completely normal body organs; her only issue was being small.) [I note that the overwork might have included having to interact with an EHR presenting a mission hostile user experience, as I've seen in critical care environments and have worked to specifically avoid when I was in charge as here - ed.]
Inspection of the computerized hospital record showed that this nurse, Julie Bates Gilpin, made most of her entries in the record hours after the purported observation time, including a whole series of entries after her shift ended. [I have seen this phenomenon myself; some EHR's allow entries even without a time stamp, and the only way to ascertain when entries were made is via discovery of metadata (automatically generated audit trails and other data that shows who manipulated data, and when. Hospitals often resist providing full metadata, despite Federal Rules of Civil Procedure (FRCP) governing e-discovery enacted almost 6 years ago - ed.]
We asked the nurse at a deposition why her entries showed such regular times of observation, at exactly 15 minutes after the hour, 30 minutes, 45 minutes, etc. She told us that was because she “rounded” on her patients every 15 minutes. But later we discovered – after winning a “motion to compel” in which the judge required the hospital to turn over records of the other patients Ms. Gilpin was monitoring that night (with names blacked out) – that she was also recording the same exact pattern of observations on her other patient, at 15 past the hour, 30, 45, and so on. So when we compared our client’s record with the other patient, it was clear that Nurse Gilpin was making computer entries showing that she was in two places at once. Again, most of these entries were made hours later and back-timed. [I also wonder, during the actual clinical encounter time was the nurse treating the actual patients or the e-Patient, i.e., the 'virtual patient' represented by the computer screens? - ed.]
We also wanted to know why the alarm on the fetal monitor went off 12 times during the night but was answered only one of those times by Nurse Gilpin. We discovered that these monitors have alarm reset buttons like a snooze button on an alarm clock. You can hit the button and turn off the alarm without doing anything else for the patient. Most of the time, the “snooze button” was hit by a nurse at the nurse’s station. What did this mean? The monitor was supposed to be tracking two separate twin babies. [Not exactly what I would call a "state of the art" alert design - ed.] The alarm would go off when the signal was lost for one baby. The nurses are supposed to reposition the patient so they can pick up the signal again. They didn’t do that for most of the times that the signal was lost. So it turned out that hours went by during the night when nothing was tracked on baby Keren’s heartbeat.
Even worse, we found out that when we took Nurse Gilpin’s testimony, she no longer remembered how to do her job on the labor and delivery unit even though she had worked there up until a few months before the time of her deposition. We asked her how a nurse reads the fetal monitor and what are bad signs for the baby, and she said she didn’t know.
And even worse than that (the wrongdoing kept piling up in this case as we continued our investigation), the resident doctor, whose name was Dr. Sahardat Nurudeen, and who was the only physician monitoring our client’s labor progress for nearly eight hours, also claimed at her deposition that she couldn’t read a fetal monitor tracing even though she was in training to become an obstetrician. (In fact, she had completed her full obstetric residency and was preparing for her board certification test at the time of her deposition.) We say “claimed,” because it could be that she just wanted to avoid answering tough questions at the deposition about individual segments of Keren’s monitor strips. Either way, it wasn’t good for high quality, accountable patient care.
We finally concluded that there were many chances during that night to save Keren’s life, but the understaffing and overwork and apparently poor training (how could a nurse or a young doctor forget how to read a fetal monitor, a basic part of their training?) [and the toxic effects of ill-conceived and ill-implemented technology - ed.] led to an unnecessary tragedy.

This story should give pause to technophiles in medicine who ignore technology's possible downsides, and the clinicians who are compelled to center their clinical lives around such technology (while the purveyors of that technology are often held harmless by hospital executives in violation of the latter's fiduciary responsibilities).

-- SS

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