Quote Of The Year

Timeless Quotes - Sadly The Late Paul Shetler - "Its not Your Health Record it's a Government Record Of Your Health Information"

or

H. L. Mencken - "For every complex problem there is an answer that is clear, simple, and wrong."

Wednesday, March 17, 2021

It Is A Pity That We Don’t See More Balanced Views On Clinical Software Errors.

This appeared las week:

Medical software blamed for fatal anticoagulant double-dosing error

Hospital doctors relying on the Cerner system accidentally prescribed an additional dose of apixaban

11th March 2021

By Antony Scholefield

A hospital software system has been blamed for a fatal anticoagulant double-dosing error after it displayed a prescribing icon so small that it could not be seen on a standard computer screen. 

In 2019, Ian Fraser was admitted to the Sunshine Hospital in Melbourne with an exacerbation of his congestive cardiac failure as well as community-acquired pneumonia.

He had a complex medical history ranging from rheumatoid arthritis and COPD to hypertension, AF and osteoporotic spinal crush fractures, with the result that he was on 14 different regular medications, including anticoagulants.

The 68-year-old eventually underwent a pleural tap. His condition improved slightly and he was restarted on enoxaparin.

During this time however, a respiratory registrar using the hospital’s Cerner electronic medical records system attempted to prescribe Mr Fraser apixaban as a discharge medicine.

He initially made a mistake, inadvertently writing the script as an inpatient order.

The registrar realised what had happened two minutes later and tried to correct it. Thinking that he had been successful, he remained unaware that the inpatient order was still active.

Soon after his pleural tap, Mr Fraser was transferred to the nearby Footscray Hospital for a pleurodesis and decortication.

Since the registrar’s script was in the Cerner system, just before Mr Fraser was due to undergo the procedure he was given an additional dose of apixaban on top of the enoxaparin. 

According to the Victorian coroners court, he subsequently developed a large retroperitoneal haematoma and died two weeks later.

Following the death, a hospital review concluded the incident was a result of the medical software, a system used in multiple public hospitals in Victoria.

The review said the electronic medical record had displayed both the inpatient and discharge medication on the same screen.

However, the icon used to differentiate inpatient from outpatient medications was "too small to be appreciated on a standard computer monitor".

This resulted in the doctor inadvertently suspending the discharge script rather than the inpatient script.

The review also discovered that the Cerner system had no alert to warn that a patient was being prescribed two medications of the same class

It also said the system's terminology was unnecessarily confusing.

"Medications are 'ordered' for inpatients and 'prescribed' for discharge. Medication orders/prescriptions can be either 'discontinued', 'suspended' or 'withheld'."

The Sunshine Hospital originally planned to prevent a repeat of the adverse event by updating its version of the Cerner software and giving more training to doctors on how to use it.

The hospital also said it would ask the Cerner Corporation, a $20 billion US-based company, to fix the problem globally.

But an expert report given to the coroners court said offering more training to doctors implied Mr Fraser’s death was the result of a “user error” when in reality it was a "user interface design induced error".

"Training without addressing the underlying usability issues is relatively ineffective, particularly considering the high staff turnover rate of the public hospital system," the expert report said.

…….


More information: Coroner's findings

More here:

https://www.ausdoc.com.au/news/medical-software-blamed-fatal-anticoagulant-doubledosing-error

It really seems to me that coroners and others are all to quick to blame software for patient harms and deaths without considering that in pretty much every case the cause of a problem is multifactorial.

In this case we have all sorts of factors involved for example.

There are pretty much always user unfamiliarity or training issues found.

There are potentially local system configuration issues which my have affected the display of medication and possibly purchase of less than optimal monitors to display the screens ideally.

There are very often UI design issues which may or may not be important.

As the last line of defence against problems remember someone has to actually administer medications – are they not at least partially for giving two similar medications, without checking.

Any expert who says an issue is “user interface design induced error" as a sole cause of death is not worthy of being called an expert IMVHO.

All this said we need to remember 2 things:

1. Cerner is involved in supporting the delivery of care to 1000’s of patients each year and very few come to harm! Many more errors originate elsewhere in the system.

2. Analysis of each of these sorts of events should be a ‘teachable moment’ for all those involved in software systems so sensible overall incremental improvement can be fostered in a sensible and controlled fashion.

The essential truth to remember is that every software system assisting care has a human telling it what to do!

David.

11 comments:

Anonymous said...

I wonder if this is relevant.

TGA software crackdown
15 March 2021
Francine Crimmins
https://medicalrepublic.com.au/tga-software-crackdown/41788

The Therapeutic Goods Administration recently announced changes to the regulation of ‘software as a medical device.’

The changes apply to software which has a purpose consistent with the definition of a medical device such as diagnosis, prevention, monitoring, prediction, prognosis or the treatment of a disease or disability.

And since the end of February, any products not listed on the Australian Registry for Therapeutic Goods (ARTG) have been prevented from being sold in Australia.

This new guidance clarifies the regulatory landscape for software based digital health products, and will work to distinguish certain products that are considered low risk, from ones that are subject to additional oversight.

Anonymous said...

Talking about software errors....

https://covid-vaccine.healthdirect.gov.au/

This looks as though it has been thrown together by a bunch of high-school students, although that might be a bit rough on the students who could probably do a better job.

The navigation is terrible - there isn't any, not even a Home or About button.

The Department of Health (It's their little logo on the page, not Healthdirect who appear to be hosting it) is continuing its long history of rubbish IT systems.

Anonymous said...

The Department of Health couldn't organise a piss-up in a brewery.

A pity about aged care though. Health have really stuffed that one up and they are continuing to fail considering that the 1b category is for those over 70. There's about 6 million of them who will be eligible from next week.

It's just as well the actual delivery of healthcare is up to the States.

Anonymous said...

Health direct - well they have a new CEO who comes with a record of salvaging stuff ups ( as in her own career resulting from her own doings). Looking up their corporate structure you can see they are more focused on fluffy false titles such as chief people officer than actually delivering value. I can only imagine Friday mornings are lead by “leaders” in kumbaya.

I notice that the department has not excelled in the commencement of the vaccination drive, having not informed GP’s clearly and know show the indifference we have become use to.

https://www.theguardian.com/australia-news/2021/mar/18/what-the-hell-industry-sources-say-government-rushed-launch-of-covid-vaccine-booking-system

Anonymous said...

The Department of Health couldn't organise a piss-up in a brewery.

And things are only just starting - health engine, health direct and the department of health seem to be struggling. I am sure it all sounded so simple at the time and when there was an abundance of time.

Paul Dunn said...

What is striking is that a lot of these failing projects never hit the top 100 government led stuff ups and get the public attention they deserve. Probably why things like aged care went so wrong for so long.

Anonymous said...

Just when when you thought that trust in the government to build and deploy useful IT systems was at an all time low, along comes this debacle.

https://www.theguardian.com/australia-news/2021/mar/18/what-the-hell-industry-sources-say-government-rushed-launch-of-covid-vaccine-booking-system

The Federal Department of Health should stick to what it is good at. If only we could work out what that is. If anything.

Norman Swan's podcast today recommended that Health should have just asked the states to get on with it, after all they are the ones who deliver healthcare, and Health can't organise themselves out of a paper bag (my words not Norman's)

Anonymous said...

@9:50AM Correction. The Federal Department of Health DOES stick to what it is good at - ie. stuffing up.

Anonymous said...

Could someone please explain to me what the Federal Department is supposed to do?

The states are responsible for healthcare delivery, so Health doesn't do that.

Their website says:

What we do
Find out about our work in awareness and education, consultation and engagement, initiatives and programs, grants and tenders, policy, regulation, compliance and research.

Do any of these vague statements justify health getting involved in direct delivery such as health records, aged care, vaccine acquisition and distribution etc.

Health has neither the mandate nor competence to get into these areas. Someone should take a good hard look at the Department of Heath. They seem to be doing more harm than good.

Sarah Conner said...

March 19, 2021 7:38 AM - guessing it would all fall under “initiatives and programs” the depart establishes agencies like ADHA to “implement policy” hence 4 year funding cycles and the return to government agendas. What happens in the next year or two with ADHA is unclear to me. Perhaps service Australia might become a home for MyHR freeing the department up to then run compliance duties.

Only a guess

Anonymous said...

Instead of trying to do stupid things like eHealth and MYHR, they could do a lot worse than copy Chile. We may have also ordered a lot more vaccines than we need, but what counts is getting them into people's arms.

Quick thinking secures vaccines for all
Antonia Noori Farzan

WASHINGTON: Between mass protests over inequality, a push for a constitutional overhaul and one of the worst coronavirus outbreaks in Latin America, Chile has weathered its share of turmoil.

But the country’s virus vaccination campaign is going about as smoothly as anyone could hope.

More than a quarter of Chile’s population has received at least one shot, a feat that only Britain, Israel and the Seychelles have managed to top. Some key factors conspire to explain Chile’s success.

Chile has secured enough doses to vaccinate its entire adult population of roughly 15 million – twice.

That’s because it signed contracts with as many manufacturers as possible, often before safety and efficacy data became available, and volunteering to host clinical trials.

The strategy paid off: Pfizer-BioNTech, AstraZeneca and Johnson & Johnson are all supplying millions of doses.

Millions more doses are coming from Chinese maker Sinovac. But experts say that Chile’s swiftness can’t be attributed solely to a willingness to buy any vaccine on the market.

The country already had a national immunisation program that distributes flu shots and childhood vaccines every year, so the innoculation infrastructure didn’t have to be built from scratch.

‘‘We’ve been doing this for a long time,’’ said Soledad Martinez, an assistant professor of public health at the University of Chile.

Having a centralised system means that each time a new group becomes eligible to get the vaccine, the government knows how many doses each community needs, and whether a mass vaccination site should be set up.

No appointment is necessary. Instead, the government reserves each day’s injections for a specific group of people.

All you have to do is wait for your day to come up.

On March 1, for instance, every 64-year-old in the country could get vaccinated.

The Washington Post