Generic Leadership Fine for EHR Implementation in High Acuity, High Risk Areas Such as an Emergency Department?

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

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

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

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

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

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

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

Hello Scot,

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

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

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

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

Thanks,

Amit

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

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

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

Per our testing team:

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

Please let me know if you have any questions.

Thank you,
Joani.

Joani Hughes
Client Services Coordinator
Drummond Group Inc.

These are direct and clear statements.

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

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

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

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

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

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

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

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

-- SS

Note:

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

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

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I argued that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts here and here)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared in yesterday's Wall Street Journal.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.)

The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began,

Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.

Then it stated that the interviewee:

has no such qualms.

The defense of this lack of qualms was heavily based on logical fallacies.

Biased Sample or Hasty Generalization

The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked:

What are the trickiest conflicts of interest to navigate?

The answer was:

Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?

This may be tricky, but is arguably not the most tricky kind of conflict of interest.

The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote ­Risperdal as a safe and effective medication." (See this post.)

Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) biased sample, if not, it appears to be a hasty generalization.

The interview also included a few other choice logical fallacies that went unchallenged by the interviewer.

False Dilemma

The interviewer asked:

What do you tell professors who won't work with drug or biotech companies?

The response was:

I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.

Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative.

The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a false dilemma.

Straw Man

The interviewee worked another argument into the same paragraph:

When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'

I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the straw man fallacy.

Summary

So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies. 

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, here,  here, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

In 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power.

The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just named one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look here). 

She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted here, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche. 

As we noted previously, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world.
- A web-site for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009."
- In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see this Reuters article). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's 2011 proxy statement, she appears to be in line to collect over $250,000 a year in compensation for this position.

It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.]

Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.

True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 "Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail" I provide a link to a probing letter from Darrell Issa, Chairman, US House of Representatives Committee on Oversight and Government Reform to Margaret Hamburg MD, Commissioner of the FDA.

The letter raises the issue that FDA's email monitoring of "whistleblowers" communicating with Congress was illegal ("unlawful, and will not be tolerated"), and the illegality was further compounded by harassment and retaliation against the "whistleblowers."

Many probing "who? why? when?" questions are asked of FDA.

I do not have free text of this letter, just a link to images of the letter. I cannot post the text (no access to OCR of a PDF at the moment), but the letter images are here:

http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf

Worth reading in its entirety.

-- SS

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