Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault

Healthcare IT such as electronic medical records (EMR/EHR) and computerized physician order entry (CPOE) systems are a perfected, safe technology, one might think, from the almost hagiographic and entirely uncritical P.R. about HIT, all the way up to the President of the United States. (Not bad for an entirely unregulated industry. Pharma IT should only have it so well.)

Paraphrasing Capt. Chesley Sullenberger in a recent WSJ article, however, I'm a long term optimist about HIT, but a short term realist. Healthcare cannot be 'transformed' by a technology that itself has major problems and needs transformation. These issues should have been substantially remediated before forced national rollouts, I feel.

That's especially true given the inherent dangers in medicine. You can't be a wishful thinker. You have to know what you know, and perhaps more importantly in medicine, what you don't know (this is especially true both for those in IT who lack formal clinical or biomedical backgrounds, and for those in medicine who lack formal biomedical informatics or computer science backgrounds). You also need to know what your tools can and can't do. Sticking one's head in the sand is no way to approach HIT.




That said, here are some sample voluntary reports on HIT malfunctions from just one vendor, taken from the FDA Medical Devices database, the Manufacturer and User Facility Device Experience (MAUDE) database, links included. These are production systems used on real, live patients, not prototypes:

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.

Emphases below are mine. My comments are in [red italic].

Case 1: (note - added to this post 7/2010)
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.

Case 2:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345
Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities. Defects in the Auto Launch functionality make it possible for a mismatch of patient data. [That is, in radiology reports. The dangers of transpositions is obvious.]

Case 3:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=722614
The issue involves powerchart local access medication administration task, used when certain cerner millennium solutions are not available. At powerchart local access sites that utilize coordinated universal time (utc) functionality, medication administration tasks might be displayed with incorrect times. When a pt download occurs from cerner millennium servers to powerchart local access, and there is no cerner millennium application session active, powerchart local access adds or subtracts the number of hours equal to the time zone difference from greenwich mean time. Scheduled medication administration tasks may show an incorrect administration time and the possibility exists for a pt to receive medications earlier or later than intended. [As just one example of the dangers with this type of defect, an elderly patient with sepsis might get an early dose of aminoglycoside, causing peak levels to rise to nephrotoxic and ototoxic levels - ed.]

Case 4:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706
Patient care delay. The issue involves functionality in cerner millennium powerchart office and powerchart core and affects users that utilize the powerchart inbox and message center inbox. In results to endorse or sign and review, if the user clicks ok and next multiple times in quick succession [e.g., a busy clinician with sick patients, waiting for the computer to respond - ed.] while attempting to sign a result or a document, the display could lag behind the system's processing of the action [that is to say, the human-programmed and supposedly tested and validated computer "system" -ed.], and multiple results or documents could be signed without the user's review. In message center, when clicking ok and next or accept and next, or when deleting or completing messages and moving to the next task, a document could be signed or a message could be deleted without the user's review. Results could be endorsed or documents could be signed without physician review, which could impact patient care. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. [Luck prevailed that no injury occurred - in this reported case. One wonders if that is true of all the users who experienced this problem. Also, I do not recall such errors happening on paper order forms due to, say, a busy clinician tapping his pen on the paper - ed.]

Case 5:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=888215
The issue involves the pharmacy medmanager functionality. If the user performs a modify action on an order with an existing duration and duration unit, the order's stop date might not be recalculated. Specifically, this occurs when only the duration value is changed prior to entering the original duration unit. Pt care could be adversely affected, as medication therapy could be concluded prematurely or could last longer than intended based on the order details prior to the modification. This issue can be avoided if the user performs a renew action instead of a modify action to change an order's duration. If performing a modify action is required, users can manually set the stop date and time during the modify action. Cerner received communication that a pt's surgery required rescheduling as a result of this issue. [Again, was the lack of patient harm due to careful clinicians who at that moment just happened to not be distracted or cognitively overloaded or overworked or exhausted from on-call, or an act of Providence? Were other non-reported users at other organizations less lucky? - ed.]

Case 6:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=920819
The issue involves the results to endorse (rte) inbox functionality in powerchart, powerchart office and firstnet and affects users that use the rte inbox to view radiology reports that have been created in radnet. Radiology results might fail to be displayed in the ordering provider's results to endorse folder in the inbox. Treatment or diagnosis decisions could be delayed if the clinician is relying on the display of a result in the inbox results to endorse folder to initiate patient follow-up. Note: the final results are posted to the flowsheet and are available on the patient's chart. Cerner received communication that a patient's follow-up care was delayed as a result of this issue. [Were any diagnoses of, say, cancer missed by other organizations affected? -ed.]

Case 7:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=700117
The issue involves the direct charting flowsheet and icu flowsheet, used within the powerchart system. When the result details box is accessed for a negative result value in either the icu flowsheet or the direct charting flowsheet in powerchart, either by right-clicking a negative, unsigned result value and selecting chart details from the context menu, or by right-clicking a negative signed result value and selecting modify, the dialog box displays a blank result value. When the user clicks ok in the result details dialog box, the value is changed to zero in the result cell in the flowsheet. [Of all places, health IT in ICU's should be extensively validated before going into production - ed.]

Case 8:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=715963
The issue involves the careadmin medication administration wizard used within the carenet system. When scanning a medication in careadmin, the system fails to recognize mckesson identifiers or other miscelaneous identifiers and properly identify the scanned product, which could result in the documentation of an incorrect dose in the careadmini window. In such situations, the system does not display overdose or underdose or route/form compatibility warnings as it should. Patients could receive an inappropriate dose of medication. Cerner has not been made aware of any adverse patient care events that resulted from this issue. [Thank god for that - but were any unreported by other organizations? - ed.]

Case 9:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029
Microbiology set up a program within the cerner computer system to automate the reporting system for hsv (herpes simplex virus)testing. The system was tested with the assistance of cerner and found to be working appropriately. The new system was operational for approximately 3 weeks when it was determined that the first word of the sentence, "no" was inappropriately dropping off of the following sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2 detected by dna amplification. " as such, two of five patients were incorrectly informed that they had hsv before the error was detected. One had started an antiviral creme treatment. The other three did not have follow-up visits until after the correct results were determined. Cerner has looked at the program and has not provided an answer for the system issue. In the interim, the previous manual review and entry process is being used. [How does the word "no", an essential descriptor in a medical test, simply get "dropped?" Does NORAD's ballistic missile warning system ever do that, i.e., "no ICBM's incoming" reported as "ICBM's incoming"?- ed.]

---------------------------------

Additional reported errors can be seen in a file downloadable by clicking on this link (PDF). Some of these are a bit startling.

---------------------------------

Still others can be seen at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=695436

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=688925

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=996685

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1075747

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=574578

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1288623

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1370640

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=834678

Again, these are reports about just one HIT vendor but this piece is not just about them. Other HIT vendor products have similar issues. Health IT remains an experimental technology.

The MAUDE reports are voluntary, however, so the absence of a report does not mean an absence of a problem. (I note MAUDE queries on a number of major HIT vendors produce no results, or results limited to HIT that is closely associated with physical "medical devices" -- as opposed to virtual ones -- such as radiology systems.) For example, while a query on mfg. "Cerner" brings up hits, a query on another vendor shows this result:

No records were found with Manufacturer: Allscripts Report Date From: 10/01/1998 Report Date To: 09/30/2009

... and this:

No records were found with Manufacturer: Nextgen Report Date From: 10/01/1997 Report Date To: 09/30/2009

... while a broader FDA search on "Nextgen" brings up exactly one relevant hit on "Nextgen EMR - Medical Device" -- without specifics as to the "malfunction" noted under product code "HGM" - which on lookup is a perinatal monitoring system.

A broader search on Allscripts only brings up drug related issues such as this curious 2002 warning letter about the marketing of guaifenesin, a cough medicine, from FDA's Center for Drug Evaluation and Research.

Either these vendors are not reporting HIT problems, or are listed under another name. Rather unlikely is that they have no problems to report (latter hyperlink is PDF). As another example, a search on brand name "Centricity" brings up "hits" mostly on specialized GE products such as PACS.

So, is HIT safe, or can "glitches" affect patient care? Should this industry be entirely unregulated, or its products "certified" by groups with conflicts of interest such as those affiliated with industry trade groups? Should vendors be held harmless for HIT defects that harm patients?

I report, you decide.

-- SS

Fuzzy Math Indeed: Rising Costs in Government's Digital Health Stimulus

Seen in the blog of the Huffington Post Investigative Fund:

Fuzzy Math? Rising Costs in Government's Digital Health Stimulus

Spending Could Be Double The Obama Administration's Public Estimate of $19 Billion

By Fred Schulte
Huffington Post Investigative Fund

15 Oct 2009

Creating digital medical records for every American within the next five years – a key provision of President Obama’s stimulus package -- could cost more than twice the $19.5 billion figure that has been cited by federal officials.

Federal budget documents show that actual spending for the plan, which will use stimulus money to help doctors and hospitals defray the cost of installing high-tech records systems, could hit nearly $47 billion.

The discrepancy between the Obama administration’s $19.5 billion public estimate and the entry in the budget of the U.S. Department of Health and Human Services mostly arises from the government’s calculation that it will recoup some of the cost of subsidizing digital systems through billions of dollars in reduced federal health spending. But many health analysts are highly skeptical that such savings can be accurately predicted.

It's worse. Far worse.

I believe the government is underestimating EHR costs by a factor of 5 to 10, due to implementation failure and remediation costs.

I'm a long term optimist on health IT, but a short term realist. I believe we will be having an avalanche of failed/stalled projects such as this one in years to come: "Another Major HIT Project Setback at UCSF".

The incompetence in this industry is worse than I imagined when I started writing about HIT dysfunction a decade ago. Worse are the coverups of problems that occur in implementation and in use.

At least in the U.S. military, there is transparency about health IT problems (e.g., see here). In the private sector, forget about publicity of what actually goes on in the U.S. (The U.K. has increased its own transparency to some extent.)

A spokesman for the department [U.S. Department of Health and Human Services], Nicholas Papas, said that the $47 billion figure is “undergoing revision and we anticipate it will decrease.” He said the agency expects to generate a “firmer figure” by the end of the year, but declined to say how much it would be.

Papas said there was no attempt to lowball the number for public consumption. Calculating both cost and benefits in the government’s estimate is a sound way to explain the price of the plan, he said.

Unfortunately, these calculations do not factor in the cost of dyscompetence, incompetence and failures created by lack of essential cross disciplinary expertise and talent in the HIT industry.

Many health policy experts agree that electronic health records can cut costs by reducing harmful medical errors and wasteful spending.

I would bet these "policy experts" have never tried to implement clinical IT.

The $19 billion figure has appeared in numerous news articles and been widely picked up and repeated by many bloggers covering the fast-growing health information technology industry. Earlier this month President Obama’s chief technology officer, Aneesh Chopra, mentioned the $19 billion figure twice in a live video cast from the White House.

But it’s “totally hypothetical,” said Sharona Hoffman, a professor of law and ethic at Case Western Reserve University School of Law. She said it counts on savings “with no concrete evidence they will occur.”

It's worse than "totally hypothetical." A major confounding variable is simply missing - the cost of HIT failures, false starts, delays, and remediation. More can be read about those risks here. That site has been online for a decade now, and ironically is nearly the only relevant "hit" on a search engine query on "healthcare IT failure" or similar concept.

Has anyone in government been paying attention?

A slide deck I recently presented entitled "Health IT Promises and Threats" provides a dose of reality on supposed cybernetic miracles. It is at this link (PPT).

-- SS

Data Malpractice on T-Mobile Sidekick: But Don't Worry, Your Medical Data is Safe

One of the promises made about healthcare IT is that your medical data is "safer" in electronic form than in paper form. The Hurricane Katrina example of paper records being destroyed is often used as a poster example of the dangers of paper records.

However, the risk of electronic storage of information, especially the talk of national EMR's stored on the "cloud" (an amorphous term meaning distributed storage "out there" whose physical sites and boundaries are supposedly irrelevant from the user's perspective) has also been under-reported. Excluding frequent reports of data confidentiality breaches, we also have this:

Wall Street Journal, Oct. 15, 2009
Microsoft Recovers Lost Sidekick Data
By ROGER CHENG

Microsoft Corp. said Thursday that it has been able to recover the personal customer data lost from many of T-Mobile USA's Sidekick devices.

The Redmond, Wash., software giant said that most, if not all, customer data was recovered, and that the company would begin restoring data as soon as it has validated it. The company said it will start with personal contacts, and move on to the lost calendar, notes, tasks and pictures as quickly as possible.

The fix comes as Microsoft suffers through a public backlash after mishandling the information found on the Sidekick line of messaging phones, which are popular with teenagers ... Over the weekend, T-Mobile and Microsoft initially warned that the recovery of data would be unlikely, but upgraded their prospects on Tuesday.

They got lucky.

Microsoft blamed a system failure [i.e., an IT system - ed.] for the data loss in the core database and backup system. Microsoft said it had taken steps to strengthen the stability of the Sidekick service and started a more resilient backup process. [More resilient compared to ... what? - ed.]

In IT it's always an apersonal "system failure", not "data malpractice." When medical malpractice occurs, it's the doctor's fault, even if that malpractice occurred secondary to the failure or misdesign of an EMR or other clinical IT by dyscompetent software engineers. When data malpractice occurs, the motto is "We always blame the computer." How about some names of those responsible for this debacle?

... The Sidekick service, run by Microsoft unit Danger [talk about ironic names - ed.], is supposed to be more secure in storing data because it is kept in the "cloud," which involves storing information on the Internet and not one physically vulnerable location, making the temporary loss of data striking.

"Cloud" is a new buzzword du jour to make more appealing a basically bad idea for many fields. Distributing data also distributes risk that some incompetent or careless person or person(s) will cause data corruption or loss (yes, computers are run by people, and either they're in control of their systems, or their systems are in control of them). It also puts organizations storing data on the "internet cloud" at risk of being victims of a network "rainy day" when internet connections might prove unreliable (accidents, sabotage, natural disasters all come to mind).

In healthcare, using the "cloud" for data storage seems to be a bad idea, especially in an era of $99 (retail) terabyte hard drive storage, and corresponding economies in mission critical-grade local mass storage, backup, business continuity and disaster recovery capabilities.

In summary, is electronic medical data more secure when stored electronically than on paper? Only if the underlying CIO's, information stewards, technicians and system administrators are at least as competent and careful as the trained health information management (HIM) personnel in hospital medical records departments and doctors' offices.

Time will tell if that is the case. One mistake, and thousands or millions of records can go *POOF*.

Microsoft and T-Mobile were lucky ... this time.

-- SS

10/26 addendum:

Sometimes, EHR data simply disappears too. At this link is a story of a Canadian clinic that lost two years of electronic health records:

Clinic's medical files vanish

By Ryan Cormier, Edmonton Journal

October 21, 2009

During a recent investigation into whether a patient's confidentiality had been breached at the Fairview Medical Clinic, an investigator asked for a log of who had accessed the complainant's file. When the clinic responded that it had automated his records in 2004 but only had files from 2006 on, alarm bells rang.

"That raised a lot of questions," said Leahann McElveen, an investigator with the office of the information and privacy commissioner.

The clinic had permanently lost two years worth of health files that include patient information on visits, prescriptions, lab reports, doctor's notes and other information. The loss happened when the clinic switched from one electronic medical records system to another.

"They were two similar systems intended to do the same thing," McElveen said. "However, they weren't coded the same way behind the scenes. It's not that the records fall into the wrong hands, they just don't exist anymore."

*POOF* again.

-- SS

Another Major HIT Project Setback at UCSF: Vendor, Client or Both at Fault?

In yet another example of a major health IT project setback, in August I wrote about UCSF's apparent problems with health IT implementation that I learned about through anonymous comments at the HisTALK blog. At "Lessons Unlearned: Health IT Failure, Act 2" I wrote:

I find it remarkable that this resource-wasting scenario (with possible adverse patient care repercussions) can occur:

• In a state that's in a severe economic crisis,
• At an organization that failed severely in a HIT and administrative IT merger ten years ago (in the failed, late 1990's attempted merger between UCSF and Stanford's medical centers, see the 2000 stories "UCSF/Stanford: Marriage was rough; divorce is expensive" here and "A thousand MIS personnel cannot merge two healthcare systems" here),
• With an EHR product, Centricity, that is the descendant of Logician that others have implemented successfully (including myself, speaking from experience),
• With GE, a major global high technology vendor, presiding over this new failure at a major academic medical center,
• With ample preventive material available in books, journals on the web about such failures (e.g., at the many pages and links here and here, as just a few examples).
  

I asked if vendor and hospital executives bother to read such materials.

Here is an update in this poorly-covered mystery:

Friday, October 9, 2009
UCSF halts clinical IT installation
San Francisco Business Times - by Chris Rauber

Dr. Sam Hawgood, newly appointed dean of the University of California, San Francisco's School of Medicine, confirmed that UCSF has put the brakes on installation of a $50 million clinical IT system from General Electric [which had acquired Medicalogic's "Logician" EHR some years ago - ed.]

In late August/early September, the Business Times was unable to reach high-ranking UCSF officials to comment on anonymous reports on the respected HISTalk blog and by sources that UCSF was unhappy with early results of the electronic medical records system installation. An informed insider says GE was “way behind schedule” in writing code, and “UCSF got fed up with the endless GE delays,” and is looking to identify other vendors for a drug order entry system.

“We are taking a pause to evaluate our best options moving forward, and we will be making a decision in the next two to three months, and then moving forward aggressively,” Hawgood said. The delay will not put the IT project behind schedule, he said, because “once we make a decision regarding the vendor, we’ll be back on track for an aggressive installation.” [Unfortunately, that sounds like wishful thinking or spin to me - ed.]

UCSF has brought in consultant Kurt Salmon Associates to help it evaluate the IT project’s woes, which were said to be creating considerable frustration within UCSF Medical Center, and obviously the School of Medicine as well.

This setback is of great concern to me. I believe such scenarios could become commonplace in coming years as healthcare organizations bow to the ARRA-created pressure to computerize "or else" by 2014 - that is, suffer reimbursement penalties for not being "meaningful users" of HIT. (Whatever that somewhat presumptuous term describing a largely experimental technology will ultimately come to mean.)

I have frequently written about the HIT vendors being dominated by those with an MIS (management information systems or "business computing") background, and unshakably and arrogantly deficient in talent management where Medical Informatics expertise is concerned. GE may also suffer from domination by engineers whose primary experience is at the level of capital equipment, PACS etc., much as I wrote about competitor Philips Medical here and here.

Having once worked for a GE competitor myself, Comdisco Healthcare Group, and having asked GE representatives about what a phrase on a banner at an RSNA show stating "GE: Leader in Radiology Informatics" meant -- and getting blank stares and comments that "it has something to do with the computers connected to our xray devices" back in return-- my concern was that the problems are not just UCSF centric but vendor centric as well.

UCSF is a big, complex organization, with a lot of very smart clinicians and lots of politics, and I conjecture that GE bit off more than it could chew regarding development, customization and deployment of major health IT at such an organization. It requires far more than technical excellence.

My concern is that GE, along with many if not most of the other major health IT vendors, lack the Medical Informatics and Social Informatics talent and depth to make our ambitious national EHR plans a reality. The overselling of vaporware and "yes, we can do that, no problem" promises by sales and marketing are also a concern, as I find common in HIT where salespeople promise the world to close a deal. Then, the technical people need to play catch up to the grandiose promises made by their creative sales colleagues.

I fear in a few years we will be in the situation that the UK's National Programme for IT (NPfIT) in the NHS is in now.

If we want to avoid that fate, we as a country must:

• Increase transparency and information diffusion about HIT difficulties and failures greatly. That my website on HIT failures is still nearly unique on the Web after ten years is symptomatic of a true lack of information sharing on real world HIT problems. My monitoring of access patterns to the site as reported in this 2006 AMIA poster (PDF) strongly suggests the demand for such material far exceeds the supply. The AMIA/AHIMA book of which I am an associate editor entitled "H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations" and the new journal "Applied Clinical Informatics" whose Editor-in-Chief is Dr. Chris Lehmann, informaticist at Johns Hopkins, are a start -- but just a start on candid information diffusion about applied HIT realities.

• Health IT vendors need to understand that those in MIS and engineering are, in the context of complex clinical settings where clinician-supportive HIT is to be developed and deployed, often dyscompetent (they fail to maintain acceptable standards in one or more areas of professional practice) or even incompetent (lacking the requisite cognitive and non-cognitive abilities and qualities to perform effectively in the scope of professional practice). Lacking an understanding of medical culture and the nature of medical settings is a highly compromising deficit. It leads to mission hostile HIT devices such as shown here. There needs to be much better talent management in that regard.

• Suboptimal HIT vendor performance, and defective HIT devices, should not be tolerated. Repeat purveyors of such technology should be materially sanctioned for wasting precious healthcare resources. Whether this happens primarily in the courtroom, or in the court of "consumer opinion" by HIT buyers -- based on transparent consumer reports on HIT - remains to be seen.

-- SS

Addendum: a reader familiar with the UCSF situation largely confirms my suspicions as above regarding vendor capabilities and the vendor's biting off more than it could chew, greatly delaying deliverables. They did say, however, that I was not correct (in this case) about the issue of salesperson "promise the moon" behavior, and that this was not a factor in the project stoppage.

Sham Peer Review: Could This Bad Faith Practice Contribute to the Silence About Healthcare IT Problems?

Health IT problems and failures seem to be rarely heard about in the public media, yet almost every physician and student I know, including those actively involved in HIT projects, privately tell me of many mishaps, traps and difficulties they encounter frequently. Some of these problems impact patient care, up to and including some only-by-the-grace-of-god "near misses" - and worse. They also state they do not want to be quoted publicly for fear of reprisals.

While I'd thought that part of this issue was fear of retaliation from vendors and hospital executives for contractual "defects gag clause" violations, another practice that may be uncomfortably common might also be a significant contributor to the general lack of information about bad HIT: bad faith ("sham") peer review.

Sham peer review or malicious peer review is a name given to the alleged abuse of a medical peer review process to punish a physician for personal or other non-medical reasons (Wikipedia).

This practice is really a show trial for physicians deemed by hospital management to be whistleblowers (e.g., on quality issues) or troublemakers. Sometimes it is used as a tool by competing physicians as well.

The article "Tactics Characteristic of Sham Peer Review" (PDF) by Lawrence R. Huntoon, MD PhD of the American Association of Physicians & Surgeons spells out some of the characteristics of this process:

The tactics used by hospitals and others in conducting a sham peer review are remarkably similar throughout the country. The common feature of these tactics is that they violate due process and/or fundamental fairness, and they often represent an attempt to make the incident or event "fit the crime."

Although our legal system is not perfect, it does incorporate sound principles and procedures designed to protect an accused individual's right to due process and fundamental fairness (e.g. an accused person is considered innocent until proven guilty). In evaluating the fairness of peer review, one can often find corresponding principles of due process and fundamental fairness in our legal system.

This article is worth reading in its entirety. It details tactics such as:

• Ambush Tactic and Secret Investigations - unprepared physician is surprised by what amounts to a well-organized interrogation panel

• Depriving Targeted Physician of Records Needed to Defend Himself - bureaucracy and red tape prevent a physician from mounting a timely defense.

• Considering a physician "Guilty Until Proven Innocent" - burden of proving innocence shifted to the accused physician.

• Numerator-Without-Denominator Tactic - cherry picking of cases to unfairly highlight (unavoidable) adverse outcomes.

• Misrepresenting the Standard of Care - hospital administration hires an outside expert who opines that because the targeted physician did not use the same surgical technique or medical treatment that the expert prefers, the targeted physician must be practicing beneath the standard of care.

• Trumped-Up and/or False Charges - "spin" and outright fabrications are deployed.

• The "Disruptive Physician" Label - this deserves full explanation here:

The definition of "disruptive physician" is highly subjective and subject to manipulation and abuse. Recently, the general and vague definition of "disruptive physician" has been fortified with the more specifically vague and subjective descriptions in the "Code of Conduct" as promulgated by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Nonverbal conduct, such as facial expression and body language, can be used to label a physician "disruptive," and no evidence is required beyond how the accuser feels. [Unbelievable - Ed.]

Increasingly, the term "disruptive physician" has become synonymous with "mentally impaired" physician. A physician who is wrongfully labeled "disruptive" because he does not agree with the hospital administration's views, or complains about substandard care in the hospital, can be subjected to inpatient treatment at a facility that specializes in treating "disruptive physicians." "Treatment" at one of these facilities may include treatment with medications, which if the "dissident physician" refuses to take "voluntarily," may result in automatic termination of privileges for failure to comply with the recommended "treatment." Physicians typically emerge from one of these "treatment" facilities with psychiatric diagnoses of narcissistic personality disorder, obsessive-compulsive disorder, or both.

• Dredging Up Old Cases from the distant past to Justify Summary Suspension

• Ex-Parte Communications - although such communications taint the entire hearing process and clearly violate fundamental fairness and due process, hearing officers, hired by the hospital, often allow ex-parte communications.

• Hospital Attorney or Conflicted Attorney Used to Influence the Peer Review Process - Hospitals that employ sham peer review often will use an attorney who represents the hospital or who represents both the hospital and medical staff simultaneously (i.e. a conflicted attorney) to influence the peer review process.

• Bias - e.g., stacking the investigative committee or hearing panel with physicians who have personal animus or bias against the accused physician; allowing the prosecution much more time to review records or present the case than the targeted physician; etc.

Also see the article "Twelve Signs of Sham Peer Review" here by a healthcare law firm.

Also of interest is "Readers' Responses to the Letter by Chalifoux and the Editorial by Bond in Regard to Sham Peer Review" at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1681969
in response to an article by Roland Chalifoux, Jr, D.O. entitled "So what is a sham peer review?", MedGenMed. 2005;7:47 available at Medscape here.

If the threat of sham peer review is being leveraged against physicians who are deemed "complainers" or "troublemakers", to the point of prosecution for facial expressions deemed "disruptive" by others, than it is understandable how physicians might be reluctant to complain about multimillion dollar HIT projects (the outcomes of which hospital executives' reputations and career advancement may depend upon) that have gone awry.

Finally, I should probably ask: does sham peer review contribute to silence about healthcare C-suite mismanagement and malfeasance in general?

-- SS

BLOGSCAN - PharmaLot is Back

PharmaLot, written by Ed Silverman, one of the best blog sources for news and views about the pharmaceutical industry and related issues, is back in operation.

Nemeroff, Seroquel, and ACCME

Nemeroff, Seroquel, and ACCME

Roy Poses has discussed the atypical antipsychotic drug Seroquel (quetiapine) several times on this site, pointing out manipulation of clinical research results to enhance the appearance of efficacy, and suppression of studies with unfavorable results. I call this augmenting the marketed profile of the drug. Daniel Carlat has commented on published Seroquel data here and ClinPsych here.

AstraZeneca, the marketer of Seroquel, has also been busy with continuing medical education (CME) programs that augment Seroquel’s profile. Last December 8, one such program went on line, aired by the provider CME Outfitters. The program’s title was “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The corporate logo for CME Outfitters is Education with Integrity. I will allow readers to decide if the company is meeting its mission statement in this respect.

The key opinion leader engaged by CME Outfitters to discuss Seroquel and other atypical antipsychotic drugs was Charles Nemeroff of Emory University. He was joined by 2 KOLs-in-training, whom I will not name. The corporate sponsor that paid CME Outfitters and, indirectly, these presenters was AstraZeneca. I do not need to rehearse here the ethical issues that have surrounded Dr. Nemeroff for the past several years. Suffice it to say that, as a result of those issues, Dr. Nemeroff is no longer chair of the department of psychiatry at Emory University, he is no longer editor-in-chief of the ACNP journal Neuropsychopharmacology, he was removed from involvement with ongoing federally funded research grants at Emory University, and he was put on a short leash by the Emory administration.

On December 23, 2008 I filed a formal complaint about Dr. Nemeroff’s program with ACCME. My bill of particulars was lengthy, detailed, and backed up by extensive
materials. In due course, ACCME investigated the complaint and found that the program did violate ACCME standards. With respect to content, ACCME determined that Dr. Nemeroff’s program lacked sufficient information about possible adverse effects of treatment with atypical antipsychotic drugs; and failed to emphasize sufficiently the efficacy of alternative treatments. With respect to commercial bias, ACCME determined that bias existed as a result of the absence of contrasting therapy data, and through downplaying the drawbacks related to treatment with atypical antipsychotic drugs in depressed patients.

Following these findings by ACCME, the provider was notified of the violations in early September 2009, and the program was removed from the provider’s website. The sanitized statement of violations determined by ACCME does not capture the nuances of deceit, ineptitude, and deficient educational content in Dr. Nemeroff’s program. One remarkable example was Dr. Nemeroff’s citation of data, from one of his own publications, that were previously retracted. Did he think no one would notice?

A second example involved biased presentation of the sponsor’s data for Seroquel. Two doses of Seroquel (150 mg and 300 mg) were tested. Only the results for the 300 mg dose were statistically significant. Nevertheless, in the video presentation one of the junior presenters stated very clearly that there was “significant improvement in both response and remission with both doses” of Seroquel. That is a falsification of the scientific record. That falsification does not meet ACCME requirements for fair, balanced, truthful, and honest teaching. As moderator, Dr. Nemeroff was required to correct this false statement made by his junior assistant, but Dr. Nemeroff failed to do so.

The negative findings and sanction by ACCME against Dr. Nemeroff’s program are welcome, though I have to say it took ACCME an inordinately long time to complete their work. I also presented ACCME with several follow-on questions, which the Council is now considering. These are:

• Did ACCME notify the presenters that their program violated ACCME policies? If not, why not?

• Will CME credits be clawed back from physicians and other professionals who obtained credits through the noncompliant program? If not, why not? I believe this would be an effective form of negative feedback to the provider and the presenters.

• Does ACCME have a process to require the provider and presenters to ascertain whether any patients were injured as a result of the violations that created biased and deficient information in this program? If not, why not?

• Does ACCME require the provider to notify physicians and other professionals who completed the noncompliant program that the provider was sanctioned for violation of ACCME standards? If not, why not?

• Does ACCME require the provider to furnish corrective materials to such professionals in order to remedy the bias and incompetence to which they were subjected through violation of ACCME standards, and thereby to remove potential danger to future patients? If not, why not?

• Why did ACCME allow the noncompliant program to remain available long after the complaint was filed? I suggest that ACCME needs to place a hold on programs that are subject to active complaint. Had such a policy been in effect in December 2008, the violating program would not have been re-aired by the provider in early 2009, it would not have remained on-line for 9 months, and the damage to the continuing education community would have been contained.

• Will ACCME issue a public listing of sanctions it has enforced against providers and presenters? If not, why not? State medical boards do exactly that in relation to physicians and other professionals who violate standards of practice.

• Finally, I reminded ACCME that its primary constituents are patients, physicians and other professionals, not commercial or academic CME providers. It seems to me that ACCME was altogether too laissez-faire and dilatory in the way it handled this matter. At the time of my initial complaint last December, I requested expedited review precisely because additional airings of this violating program were scheduled.

The good news is that ACCME seems to have got the message that things need to change. As one of their officers wrote to me recently, “We sincerely appreciate the time and effort you have put into participating in our complaints and inquiries process. You have raised important issues that the ACCME will review and address.” I await their next communications on the remaining questions.

As for Dr. Nemeroff, he is yesterday’s news. The adverse findings by ACCME about his program serve as a reminder to corporate sponsors and CME companies that Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark.