An Expensive Healthcare Computing Mistake: $1.5 Million

At my June 2011 post "Babies' deaths spotlight safety risks linked to computerized systems" I reported on a case (case #2) of an infant death in part attributed to HIT (PACS) interference in otherwise simple care processes.

In "Allen-Blake vs. Abington Memorial Hospital", a critical x-ray of a PICC (peripherally inserted central catheter) line placement allegedly was never read due to misdating.

The Allen-Blake case was settled 2/29/12 for $1.5 million, according to the public docket count 78 (link):

2/29/2012

Order

OF 2/28/12 OTT, J PROPOSED SETTLEMENT OF $1,500,000.00 APPROVED CC

That $1.5 million might have paid for a lot of other things, such as provision of better medical care through hiring/retention of more staff. The legal fees for defense incurred must also have been substantial, representing yet more precious healthcare capital down the proverbial drain.

Add cases like this to the "total cost of ownership" of health IT.

-- SS

Stroud v. Abington Memorial Hospital: Is This Why Chart Alteration Might Be Appealing?

As I described in several recent posts on malpractice cases at University of Pittsburgh Medical Center (UPMC) including:

"UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence" (link),

and

"Propofol and Other Drug Questions: Was Michael Jackson a UPMC Patient at the Same Time as Samuel Sweet?" (link),

... electronic medical records may offer certain advantages to someone who is going to try to alter medical records.

No whiteout needed, no physical erasures, a difficult to interpret and/or made-hard-to-get audit trail, etc.

Why, one might ask, would a hospital and/or its clinicians attempt such a maneuver, knowing the penalties are likely to be severe?

Because the penalties might not be so severe after all.

While I am not an attorney, this case I came across seems to be readable by those who understand plain English:

ROBERT STROUD, INDIVIDUALLY AND AS ADMINISTRATOR OF THE ESTATE OF JAMES H. STROUD, DECEASED, PLAINTIFF, v. ABINGTON MEMORIAL HOSPITAL, ET AL., DEFENDANTS (link to memorandum opinion).

Here is a summary of what allegedly happened that led to the suit:

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

... 1. FACTUAL BACKGROUND

James Stroud was admitted to Hospital for a total right knee replacement on October 25, 2004. (Doc. 45 at 11, ¶ 46.) Following surgery, he remained at Hospital under the medical care of various of the defendants and others. (Id. at 11-14, ¶¶ 47-68.) Plaintiff alleges that during that time, James Stroud complained of nausea and failed to have a bowel movement. (See, e.g., id. at 11, ¶¶ 50, 52.) Plaintiff further alleges that, while various of the defendants and others examined and treated James Stroud, they failed to adequately diagnose and treat his emergent medical condition, later found to be a bowel obstruction or ileus. (Id. at 11-14, ¶¶ 51-68.)

Plaintiff specifically contends that Dr. Paul Crispen, a urology resident under the supervision of urologist Dr. Charles ordered an abdominal/pelvic CT scan to be performed on James Stroud on October 28, 2004 to investigate the cause of his lack of bowel movement. (Id. at 12, ¶ 58-59.) Robert Stroud avers that the CT scan revealed "marked dilation of the small and large bowel, representing either an obstruction or adynamic ileus," but that no action was taken in response to this finding of a potentially serious medical condition. (Id. at 14, ¶ 68-69.) Plaintiff attributes this inaction, at least in part, to the failure by the various treating medical professionals to communicate adequately concerning James Stroud's care and the failure by Hospital to have in place and enforce proper policies and procedures for interdepartmental communication. (See, e.g., id. at 19-21, ¶ 105(n), (q), (r), (aa)-(cc).)

That same day that the scan was performed, October 28, 2004, James Stroud was discharged from Hospital to a rehabilitation center. (Id. at 14, ¶ 70.) The following day, October 29, 2004, he complained of abdominal pain and began vomiting. (Id. at 15, ¶ 73.) He was taken to Hospital's emergency room early that afternoon and was subsequently readmitted. (Id. at 15-16, ¶¶ 74-80.) He was examined and additional diagnostic testing, including an abdominal x-ray series, was ordered, completed, and interpreted later that evening. (Id. at 16-17, ¶¶ 81-95.) By about 11:20 p.m. he began vomiting, became unresponsive, and was unable to be revived. (Id. at 17, ¶¶ 96-98.) He was pronounced dead at 12:08 a.m. on October 30, 2004. (Id. at 17, ¶ 98.)

There were allegations of record concealment and withholding and in finding this, the plaintiffs sought additional punitive damages.

The court nonetheless decided (emphases mine):

... Plaintiff's request for punitive damages is premised on two interrelated theories: (1) that the defendants knew that James Stroud was suffering from a life threatening condition, yet failed to take any action in response to that knowledge (Doc. 45 at 59-61, ¶¶ 210-215, 222); and (2) that after the demise of James Stroud, the defendants took actions to cover up their prior negligence, including the deliberate concealment and withholding of relevant medical records (id. at 60-61, ¶¶ 216-221). Plaintiff's underlying substantive claims are, as we know, for negligence, survival, and wrongful death based on the defendants' allegedly negligent care for James Stroud. Plaintiff alleges no underlying claim concerning the defendants' alleged concealment of prior negligence.

This case is thus closely analogous to the case decided by the Pennsylvania Superior Court in Gallagher [v. Temple University Hospital - ed.], which also concerned a medical malpractice action against a hospital. In Gallagher, the Superior Court held:

[Appellants] asserted an independent claim for punitive damages premised upon the allegedly outrageous conduct of altering and withholding the medical records in an attempt to stymie Mr. Gallagher's guardians from successfully obtaining redress for his Injury by tampering with the discovery of the facts necessary for prosecution of his medical malpractice lawsuit. While this conduct is relevant to show after the fact awareness of negligence on the hospital's part, it does not, however, relate to the conduct alleged to have been negligent, which actually caused the injury. While the conduct surrounding the alleged withholding of certain records and the whiting out of portions of other records, if true, is undoubtedly reprehensible, none of these facts, however, relate to the malpractice being litigated. Nor do these facts assert a separate cause of action sounding in tort. 2005 WL 2649868 at *3.

The Third Circuit has similarly held that a defendant's falsification of relevant records and lying at a deposition to conceal his wrongdoing, while reprehensible, is insufficient to establish the culpable mental state of recklessness necessary to impose punitive damages because it does not support the conclusion that the defendant consciously appreciated the risk of the harm he caused. See Burke, 904 F.2d at 183. In so finding, the court reasoned "that punitive damages are intended to deter risky behavior that causes harm; they are not a sanction for obstruction of justice." Id. (citation omitted).

In the Stroud case the court decided and ordered that:

... (3) Moving Defendants' [i.e., hospital and doctors - ed.] motion to dismiss Plaintiff's claim for punitive damages premised on the theory that Moving Defendants "covered up" their prior negligence is GRANTED and Plaintiff's punitive damages claim on this legal theory is DISMISSED WITH PREJUDICE. [That is, it cannot be raised again - ed.]

One might wonder, then, what hospitals and clinicians have to lose, in a malpractice case they believe is likely to be lost on the merits, for records alteration or concealment that they think they might get away with.

There is the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act of 2002 (PDF, see Section 511, "Preservation and accuracy of medical records", pg. 18-19). However, how often is that act enforced, even if a separate complaint (which is non-judicial) about records alteration is made to the PA Bureau of Professional and Occupational Affairs (where large medical centers might have sympathetic friends) and to similar bodies in other states?

The camouflage made possible by EMR's would only add to the temptation to try to alter the case outcome through "reprehensible" records alteration and withholding/stonewalling on the production of EMR screen shots, audit trails and other data.

-- SS

Sept. 30, 2011 addendum:

The court's own use of the term "obstruction of justice" suggests another venue for addressing chart alterations besides civil court:

The crime of obstruction of justice, in United States jurisdictions, refers to the crime of interfering with the work of police, investigators, regulatory agencies, prosecutors, or other (usually government) officials.

Specifically, criminal court.

Sept. 30, 2011 addendum #2:

Apparently a memorandum opinion such as the above "Stroud v. Abington Hospital" does not create precedent (link):

A memorandum opinion or memorandum decision is a judicial opinion that does not create precedent, persuasive or mandatory in some jurisdictions. A memorandum is often brief and written only to announce judgment in a particular case. Depending on the kind of memorandum decision, citation of the opinion as case law may not be accepted.

While there are likely other cases addressing the medical record alteration/withholding issue, to my legally ignorant mind [1], perhaps in addition to criminal charges, "outrageous conduct of altering and withholding the medical records" should be pursued vigorously by plaintiff's attorneys as a basis for punitive damages. This is especially true if the conduct resulted in or contributed to patient harm.

Note:

[1] Perhaps "legal amateur" is a more accurate term in the same way I am a radio amateur or ham (albeit Extra Class) with some technical experience, but not a telecommunications professional who would/should run a mission-critical enterprise telecommunications project -- and in the same way that many in charge of health IT in hospitals are really health IT amateurs with no significant formal training.

-- SS

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 if any type of alert was generated, and if not, why not.

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.)(Sept. 2011 addendum: the hospital has now filed a Motion to Compel Settlement that can be seen as item #67 and downloaded from the aforementioned courts dockets page here.)

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' such as missed findings of importance, subtle or gross findings that could alter the interpretation of later films, etc. - 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 making a decision on what clinicians should and should not look at, thereby acting as cybernetic 'governor' or 'conductor' of care. The machine or, more properly, the algorithms created by its programmers, decided what the humans should or should not look at. This is not uncommon in HIT. Yet, who qualified these machines and their code 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.

(Note:  more on the x-ray foul up in the Phila. Inquirer here.  "Use error" - per NIST, bad IT design that promotes mistakes, as opposed to "user error" i.e., simple carelessness - seems a factor.)

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 attorney 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 a third 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

Addendum: the Allen-Blake case was settled 2/29/12 for $1.5 million:

2/29/2012

Order

OF 2/28/12 OTT, J PROPOSED SETTLEMENT OF $1,500,000.00 APPROVED CC