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Babies' deaths spotlight safety risks linked to computerized systems

Two new tragic cases. (A third, earlier case of infant death was posted in March 2011 here).

Case #1. See Baby's death spotlights safety risks linked to computerized systems by Judith Graham and Cynthia Dizikes in the Chicago Tribune.

A baby died at Advocate Lutheran General Hospital due to an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by the physician. The authors write:

Although a series of other errors contributed to the tragedy, its origin — a piece of data entered inaccurately into a computer program — throws a spotlight on safety risks associated with medicine's advance into the information age, a trend being pushed aggressively under health reform.


One wonders - what happened to the alerting features, for the tens or hundreds of millions of dollars the hospital spent on health IT?

I've also left a number of comments to the Chicago Tribune story in its comments section, in response to the usual pro-health IT-at-all-costs posts.

Case #2. There's also been a baby death locally to me that is allegedly due to HIT (PACS) interference in otherwise simple care processes.

See "Blake vs. Abington Memorial Hospital" at this link. The Complaint in the latter case, a public document, is available as a .tif image at this link (1 MB; you may need to use IE to download beyond the first page).

(July 8 addendum: since this blog post was published, I've noted multiple "hits" on it from the IP of the hospital involved, 65.216.195.x , at different times of the day, as well as on my Drexel website on HIT failure. Clearly they are aware of the issues noted herein.)

A critical x-ray of a PICC (peripherally inserted central catheter) line placement allegedly was never read due to misdating. See for example counts 17 - 25, and 39 - 45. It was dated several days earlier than it was taken.

Counts 39-49 (emphases mine):

39. Defendants also described that the February 27, 2010, x-ray was digitally transmitted to radiology, and the technician attempted to match the image to doctors’ orders, and then put all the identifying information on the film, including the patient’s name, date of birth and date of study.

40. Defendants told Plaintiffs that the radiology technician picked the wrong name and put it on the x-ray, and then later realized it was the wrong name and then somehow changed the information on the image.

41. Defendants told Plaintiffs when the technician changed the information on the image, she typed the date of birth where she should have typed the date of study. [Puzzling; my $99 Canon camera embeds date information in the image itself, as do PACS systems - ed.]

42. Defendants told Plaintiffs that the incorrect date on the image caused the x-ray not to be read by a radiologist in the night the image was taken, and that if the image had been correctly dated February 27, 2010, it would have been reviewed by a radiologist immediately, who would have alerted Defendants that the PICC line was improperly positioned and had to be moved back to a safe position. However, since the film was incorrectly dated February 23, 2010, the film was classified as “old” and was not put in line for immediate review, and was not reviewed in time to prevent injury to Plaintiffs Decedent.

43. The Defendants told Plaintiffs that an older x-ray has less significance than a newer image and is, therefore, not as critical to review. [This is exactly the reverse of good radiological practice. 'Old' - but never officially read - means 'potential danger' - ed.]

44. The Defendants told Plaintiffs that the x-ray was reviewed by Dr. Griffith on the morning of February 28, 2010. At that time, Dr. Griffith, thinking that the image was from the 23rd, compared it to the next most recent image, which was from the 25th In reviewing these x-rays, Dr. Griffith reportedly concluded that the PICC line shown in the image she believed was from the 23rd had been removed by the 25th. [Gevalt - what a tragic error. In healthcare, critical attention to detail at all times is required, or your patient's dead. There is no room for computer fritter. - ed.]

45. Defendants told Plaintiff that the x-ray from the 27th, which was mislabeled as being from the 23rd, would have been reviewed by the neonatologist on duty on the morning of the 28th, but this did not happen because the computer which places films in line to be reviewed would have ignored such an “old” film.

[Note the accusation of the computer acting as cybernetic 'governor' or 'conductor' of care, deciding what the humans should or should not look at. This is not uncommon in HIT. Yet, who qualified these machines to play this role? More on this critical issue
at this link. - ed.]

46. The Defendants told Plaintiffs that the next 24 hours were uneventful, but late in the day on Monday May 1, 2010, Destinee’s condition began to deteriorate rapidly.

47. The Defendants told the Plaintiffs that the during the efforts to reverse Destinee’s deterioration, they discovered that the PICC line was in the wrong position, and that they confirmed this by sampling the fluid from around the heart, which was found to be full of hyperalimentation fluid, and then pulled the line back from its incorrect and dangerous position in the heart.

48. The Defendants told Plaintiffs that they did not know if the PICC line caused a hole in the heart, but that just having the line in the heart was enough for it to push the hyperalimentation fluid into the pericardium.

49. As a direct and proximate result of Defendants’ negligence, Plaintiff’s Decedent’s suffered injuries, including but not limited to: [numerous catastrophic complications followed by death - ed.]

If these counts are accurate, I ask the same question as in case #1: if an x-ray was accidentally dated five days or so before it was taken (how can that even happen?), why was an alert not triggered that an "old" (and unread) x-ray needed an official radiologist reading ASAP?

What are hospitals getting for their tens to hundreds of millions of dollars they are throwing at clinical IT?

This latter story really disappoints me if true. I was a Resident in Internal Medicine in this hospital in the mid 1980's and used my knowledge of radiology, in which I spent a year of formal postdoctoral education, and of computing to fix a CT scanner in the middle of the night and save a young man's life (as documented in a letter from my former Residency Director, now the Chief of Staff here and here , pgs. 1 and 2 respectively).

Ironically, even after all these years, I probably could have read that PICC line placement x-ray.

Technology can be a great blessing in medicine. I am alive and healthy in 2011 thanks to it. The medical condition referred to in the aforementioned letter was in fact cured as a result of advances in cardiac electrophysiology science, as here and here, pgs. 1 and 2).

However, technology cannot be applied cavalierly, lawlessly (per Sharona Hoffman), experimentally, without regulation, and without informed patient consent as is often done in the world of HIT.

-- SS

June 27, 2011 addendum:

In further review of the dockets in case #2, I find there seems to be a wee problem getting the hospital's Chief of Staff Jack Kelly to a deposition.

In a motion filed June 10, 2011 by the plaintiffs, "BY ADMINISTRATOR ERICA L ALLEN-BLAKE; RICARDO BLAKE; ESTATE OF DESTINEE LOTOYA BLAKE DECEASED MOTION TO COMPEL DEPOSITION OF DR. JACK KELLY" (.tif file at this link), in Exhibit "J" the plaintiff's attorney writes to the defendants' attorney (emphases mine):

I received your faxed letter of May 2, 2011. I don’t agree with any of your sophistry, and want to depose [Chief of Staff] Dr. Kelly. I remind you that you objected to the Complaint, claiming the meeting with the Plaintiffs had a specific purpose under MCARE (which never made any sense, but you wrote it, not me). Your objection raised issues of fact. If you don’t want to back them up, or can’t, then withdraw the objections.

If you’d like to ask the Plaintiffs one question at a deposition taken pursuant to your pending objections - i.e., whether they were told by your clients that MCARE written notice was purpose of the meeting or not - I’d agree to let you do that. I can represent to you that their answer will be "no.”

Be advised that I am tired of Abington’s dilatory tactics in this clear liability case in which an infant was killed by, among other things, some of the most egregious professional malpractice imaginable. On top of that, Abington refused to provide the name of the radiology technician until suit was filed. Now, you’re playing ticky-tack games about depositions, and my clients are understandably not impressed.

Under cover of separate letter you will find a Notice of Deposition for Dr. Kelly for this Friday, May 6, at 2 pm in my offices.

Wow.

A motion to compel was filed on 6/22/2011 so apparently the May 6 deposition did not take place.

I add the the MCARE Act of 2002 ("MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR ACT") in Pennsylvania (PDF at this link) states:

MCARE Section 308. Reporting and notification.

... B. Duty to notify patient.--A medical facility through an appropriate designee shall provide written notification ['written' - this word would appear to mean "in writing" - ed.] to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee within seven days of the occurrence or discovery of a serious event. If the patient is unable to give consent, the notification shall be given to an adult member of the immediate family. If an adult member of the immediate family cannot be identified or located, notification shall be given to the closest adult family member.

Allegedly from the June 10 Plaintiff's Motion, as it appears to me, the hospital seems to be trying to claim a verbal meeting with the family satisfied the MCARE Act's notification requirements even though nothing in writing was apparently given, but that the information exchanged in that family meeting is not admissible in court.

It seems hospitals (perhaps pushed by their insurers) attempt to play legal games to try to avoid culpability for their "computer-anecdote" patients, some who end up as roadkill on the experimental racetrack of health IT.

Again, this is doubly disappointing if accurate, as I knew some of the principals on the defendants' side two and a half decades ago.

Also see another case at my aforementioned March 2011 post "Thanks to the wonders of EHR, this premature baby went to the grave, prematurely" at this link, from an Oct. 2010 story in Virginia Lawyers Weekly ("Failures in care alleged after premature birth - $1,000,000 Settlement"). A PICC line was also involved.

-- SS

My mother passed away

My mother, affected catastrophically by an EHR error last year, passed away yesterday evening.

In her memory, a photo of her and me from 1957 I found in her possessions.

Betty Silverstein, 1925-2011

Her children were always Number One.

May she rest in peace, and may my efforts result in others not having to suffer similar mistakes at the hands of IT.

-- SS

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE (Manufacturer and User Facility Device Experience) database below.

From FDA's description of MAUDE:

  • MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
  • The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
  • MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

I somehow missed the following case when I wrote the Oct. 2009 post 'Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault' but I have added it there as well:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460
CERNER MILLENIUM POWERCHART CPOE
Event Date 11/19/2006
Event Type: Death
Patient Outcome: Death

The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified.

Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol.

This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors.

The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data.
[Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner.

The professionals need to hunt for it. As such, the user unfriendly screens [see this link on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.

How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide?

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT",
nobody really knows; these devices are unregulated with no requirements for reporting.

However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers like these.

We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "The 'Meaningful Use' Regulation for Electronic Health Records", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

[Except for those who
haven't - ed.]


And our government's called BP Energy Company cavalier?

I offer no additional comments.

-- SS

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