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Selasa, 07 Agustus 2012

Massive Health IT Outage: But, Of Course, Patient Safety Was Not Compromised

Having been 'Down Under' in Sydney addressing the Health Informatics Society of Australia on the need to slow down their national health IT program - and on the need to think critically about HIT seller public relations exaggerations and hubris - and being very busy, I missed this quite stunning story of a major health IT outage.

Just a typical "glitch":

Some lessons from a major outage
Posted on July 31, 2012
By Tony Collins

Last week Cerner had a major outage across the US. Its international customers might also have been affected.

InformationWeek Healthcare reported that Cerner’s remote hosting service went down for about six hours on Monday, 23 July. It hit “hospital and physician practice clients all over the country”. Information Week said the unusual outage “reportedly took down the vendor’s entire network” and raised “new questions about the reliability of cloud-based hosting services”.

A Cerner spokesperson Kelli Christman told Information Week,

“Cerner’s remote-hosted clients experienced unscheduled downtime this week. Our clients all have downtime procedures in place to ensure patient safety.  [Meaning, for the most part, blank paper - ed.] The issue has been resolved and clients are back up and running. A human error caused the outage.  [I don't think they mean human error as in poor disaster recovery and business continuity engineering - ed.]  As a result, we are reviewing our training protocol and documented work instructions for any improvements that can be made.”

Christman did not respond to a question about how many Cerner clients were affected. HIStalk, a popular health IT blog, reported that hospital staff resorted to paper [if that was true, that paper was OK in an unplanned workflow disruption of major proportions, then why do we need to spend billions on health IT, one might ask? - ed.] but it is unclear whether they would have had access to the most recent information on patients.

One Tweet by @UhVeeNesh said “Thank you Cerner for being down all day. Just how I like to start my week…with the computer system crashing for all of NorCal [Northern California].”

Tony Collins is a commentator for ComputerWorldUK.com.  He's quoted me, as I wrote in my May 2011 post Key lesson from the NPfIT - The Tony Collins Blog.

This incident brings to life longstanding concerns about hospitals outsourcing their crucial functions to IT companies.  

Quite simply, I think it's insane, at least in the foreseeable future, as this example shows.

It also brings to mind the concerns that health IT, as an unregulated technology, causes dangers in hospitals with inadequate internal disaster and business continuity functions aside from fresh sheets of paper.  Such capabilities would likely be mandatory if health IT were meaningfully regulated.

The Joint Commission, for example, likely issued its stamp of approval for the affected hospitals, hospitals who had outsourced their crucial medical records functions to an outside party that sometimes went mute.  If someone was injured or died due to this outage, they would not care very much about the supposed advantages.

There's this in the article:

... “Issue appears to have something to do with DNS entries being deleted across RHO network and possible Active Directory corruption. Outage was across all North America clients as well as some international clients.”

Of course, patient safety was not compromised.

Finally:

Imagine being a patient, perhaps with a complex history, in extremis at the time of this outage.  

I, for one, do not want my own medical care nor that of my relatives and friends subject to cybernetic recordkeeping unreliability and incompetence like this, and the risk it creates.

-- SS

Aug. 8, 2012 addendum:

The Los Angeles Times covered this outage in a story aptly entitled "Patient data outage exposes risks of electronic medical records."

They write:

Dozens of hospitals across the country lost access to crucial electronic medical records for about five hours during a major computer outage last week, raising fresh concerns about whether poorly designed technology can compromise patient care.

My only comment is that the answer to this question is rather axiomatic.

They also quote Jacob Reider, acting chief medical officer at the federal Office of the National Coordinator for Health Information Technology, who said:

"These types of outages are quite rare and there's no way to completely eliminate human error"

This is precisely the type of political spin and misdirection I cautioned the Australian health authorities to evaluate critically.

Paper, unless there is a mass outbreak of use of disappearing ink, or locally hosted clinical IT, do not go blank en masse across multiple states and countries for any length of time, raising risk across multiple hospitals greatly, acutely and simultaneously.  (Locally hosted IT outages only cause "local" mayhem; see my further thoughts on this issue here).

-- SS

Malpractice Attorney Puts ONC-Authorized Testing and Certification Bodies (ATCBs) at Risk of Litigation?

I am jet-lagged after returning from Sydney, Australia, where I delivered one of the keynote addresses at the Health Informatics Society of Australia annual conference, HIC 2012 (http://www.hisa.org.au/page/hic2012/).

My theme in a talk entitled "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step" was health IT trust and safety.  I was actually invited in 2011 but could not attend; I was helping care for my mother, who was severely injured due to a HIT-related mishap in 2010.  Her death in 2011 allowed me to attend now on re-invitation.

More on my presentation later.


A beautiful view of the Sydney Harbour Bridge and Opera House, taken with a mere Canon SX110IS.  Click to enlarge.


In the meantime, I returned to the U.S. to find that the defense attorney for the hospital where my mother was severely injured, and then died as a result, is once again raising an absurd issue in objections to the medical malpractice Complaint that was refiled within the Statute of Limitations for technical reasons.   The President Judge of the county where the case is filed had dismissed this complaint (among many others) some time ago:


(ii) Plaintiffs Software Design Defect Claims are Preempted by the Federal HITECH Act

... To the extent Plaintiff attempts to bring a common law product liability claim against [name redacted] Hospital for required use of EMR software, such a claim is barred due to Federal Preemption of this area with the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act. 42 U.S.C. 201, 300, et seq.

Specifically, the design, manufacture, specification, certification and sale of EMR in the United States is a highly regulated industry under the jurisdiction of the Department of Health and Human Services (HHS). The HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH act as amended. Id.

The Supremacy Clause of the United States Constitution, article VI, clause 2, preempts any state law that conflicts with the exercise of federal power. Fid. Fed. Say. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014 (1982). “Pre-emption may be either express or implied, and ‘is compelled whether Congress’ command is explicitly stated in the statute’s language or implicitly contained in its structure and purpose.” Matter of Calun Elec. Power Co-op., Inc., 109 F.3d 248, 254 (5th Cir. 1997) citing Jones v. Rath Packing Co., 430 U.s. 519, 525 (1977).

In this case, to impose common law liability upon [name redacted] Hospital for using certified EHR technology, which was in compliance with federal law and regulations for Health Information Technology, would directly conflict with Congress’ statutory scheme for fostering and promoting the implementation and use of EHR 

I really don't think Congress intended HIT to maim and kill patients with impunity.  In any case, this assertion was thrown out in its entirety several months ago, but here it is again in a new set of objections.  I find its reappearance remarkable.  I also wonder if the industry is behind it.

As per numerous posts in this blog, such assertions are false - and likely knowingly so in this situation.  (In that case, this would be an even more serious matter.)

For example as I pointed out at my Feb. 2012 post Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified", ONC-Authorized Testing and Certification Bodies (ATCB's) answered my questions about safety, legal indemnification etc.  Their work has nothing to do with certifying HIT as safe by their own admission.

Also, as in my April 2011 post FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs and my Nov. 2011 post IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care, the HIT industry is unregulated.

On the HIT regulation issue, IOM has itself stated in no uncertain terms that HIT is non-regulated (not "a highly regulated industry") in their report to HHS.  For instance, in the aforementioned 2012 report they state (as one example):

... If the Secretary [of HHS] deems it necessary for the FDA to regulate EHRs and other currently nonregulated health IT products, clear determinations will need to be made about whether all health IT products classify as medical devices for the purposes of regulation. If FDA regulation is deemed necessary, the FDA will need to commit sufficient resources and add capacity and expertise to be effective.

I won't even address the claim that the HITECH Act represents or intended to represent Federal pre-emption of state common law rights.   It's without merit, and actually absurd.

Worst of all, statements in legal dockets that "HHS draws its statutory authority to design and certify EMR as safe and effective under the HITECH Act" (in reality, private non-governmental ONC-Authorized Testing and Certification Bodies or ATCB's are appointed by ONC to "certify" HIT features and functionality to be compliant with "Meaningful Use" guidelines and do not test for safety or efficacy) potentially puts those private ATCB's at risk for being named defendants in lawsuits where HIT was found unsafe and/or ineffective if upheld.

I am sure the ATCB's and ONC would not be happy about that.

-- SS

Super High Fat Ketogenic Diets v. Paleolithic/Ancestral Nutrition

As the trend towards even higher fat diets continues in a faction of the community, it should become ever the more clear to those not engulfed in dogma that this is not consistent with our evolution.  There is no way, repeat NO way, that our ancestors could have eaten a diet of the 80-10-10 variety -- as in 80% fat, and 10% protein, 10% carbs ... or any of the various higher fat lower carb ratios, perhaps allowing for an extra couple few percent of protein.  

One would have to believe that humans evolved in an environment of such abundance where killing was accomplished with such ease, that they would kill another animal to eat just its fatty parts before consuming the meat.  Does that sound plausible to you?  Or that humans foraged for only fatty plant stuffs like nuts and fatty fruits like avocados and left the sugary and starchy stuff they may have happened upon in the process alone.  Sounds right, eh?  We're to believe that cultivation of plants has altered their sugar and starch content vs. the days of old, but domestication of animals and even "wild life" existing on the fringes of human developments has not altered the composition of said same ... even if fed a "natural diet" (e.g. grass fed beef).  Your fatty fish are mostly around 60% fat or less.  Are all these paleo lipophiles having seal oil and whale blubber shipped in from the Arctic?  
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just a reminder.....

4 jenis Jjigae (sup) lezat asal korea



     Jjigae adalah sebutan untuk berbagai macam masakan Korea berupa sup yang dimasak dan dihidangkan di dalam panci kecil untuk porsi satu orang. Isinya bisa berupa makanan laut, sayuran, daging, atau tahu. Dibandingkan dengan sup dalam kebudayaan Barat, jjigae memiliki kuah yang lebih sedikit.

     Makanan ini rasanya pedas karena diberi bumbu cabai. Jjigae biasanya disajikan panas-panas sebagai hidangan di musim dingin. Jjigae berbeda dari jeongol dalam ukuran panci yang digunakan. Jeongol dihidangkan di dalam panci besar, dan diletakkan di tengah-tengah meja untuk dimakan bersama oleh beberapa orang.

     Bahan utama atau bumbu yang dibuat sup menentukan nama masakan, seperti saengseon jjiage (sup isi ikan), dubu jjigae (sup isi tahu), dan gochujang jjigae (sup berbumbu gochujang). Dan inilah 4 jenis Jjigae yang terkenal:

1. Kimchi jjigae


     Kimchi jjigae berupa sup pedas yang direbus di dalam panci bersama kimchi dan air cabai dari kimchi. Sup ini berisi sayuran (sawi putih, daun bawang), tahu, dan makanan laut atau daging babi.

     Kimchi jjigae merupakan masakan yang sering dibuat orang Korea di rumah sebagai lauk teman makan nasi. Bahan-bahan untuk sup mudah didapat, dan membuatnya tidak sulit. Kimchi yang sudah masam menghasilkan sup dengan aroma yang kuat dan biasanya menjadi lebih enak. Penjual kimchi umumnya membedakan antara kimchi baru dan kimchi masam yang sudah lebih lama terfermentasi.

     Sup ini dihidangkan di tengah-tengah meja bersama pancinya dengan pelengkap sejumlah banchan. Panci biasanya berukuran cukup besar untuk memuat sup yang cukup untuk dimakan bersama oleh dua orang atau lebih. Di rumah makan, sup ini juga disajikan dalam panci keramik berukuran kecil (ttukbaegi) untuk porsi satu orang.

2. Sundubujjigae



     Sundubujjigae adalah jjigae yang bahan utamanya adalah tahu sutera. Bahan sundubujjigae adalah tahu korea, kerang, jamur, jeotgal dan telur, direbus dengan kuah yang dibumbui kecap asin dan disajikan panas-panas di dalam ttukbaegi.

     Variasi bahan lain bisa kimchi dan berbagai jenis makanan laut. Sundubujjigae lebih banyak disukai orang tua karena tekstur tahu sutera yang lembut saat dikunyah.

3. Budae jjigae


     Masakan ini bermula pada saat berakhirnya Perang Korea ketika rakyat kekurangan bahan pangan. Pada saaat itu rakyat yang tinggal di Uijeongbu, provinsi Gyeonggi, memanfaatkan kelebihan bahan makanan dari pangkalan militer AS yang berupa daging kalengan dan ham. Mereka mengkombinasikan bahan-bahan ini dengan kuah masakan Korea yang berbumbu gochujang yang pedas dan merebusnya dalam panci besar. Lama kelamaan masakan baru yang sederhana dan mudah dibuat ini menjadi terkenal dan sering diasosiasikan dengan kota Uijeongbu sehingga disebut juga dengan uijeongbu jjigae.

     Pada saat ini masakan budae jjigae sangat populer di Korea Selatan. Banyak restoran yang menyajikan hidangan ini dengan variasi-variasi baru dengan menambahkan bahan-bahan sayuran, jamur, mie instan ramyeon, tteok, kimchi, makaroni, keju dan sebagainya.

4. Doenjangjjigae


     Doenjangjjigae merupakan jenis jjigae yang bahan utamanya adalah doenjang. Doenjangjjigae dimasak dengan bahan yang berbeda-beda menurut musim. Pada musim panas, biasanya doenjangjjigae ditambah jamur dan pada musim dingin ditambah daun lobak. Bahan-bahan lainnya adalah potongan cabai, ketimun dan tahu yang direbus dalam ttukbaegi dan langsung disajikan selagi panas. Doenjangjjigae memiliki kandungan protein tinggi dan mudah dicari di restoran di Korea karena harganya terjangkau. Sup ini berciri khas rasa yang kuat karena doenjang, juga asin dan pedas. Doenjjangjjigae merupakan salah satu masakan favorit masyarakat Korea.

 

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