Monday, May 09, 2016

YUVGE Disappointment

Our Universal Disappointment has been updated to the latest and greatest, Version 6.x. I should have been more wary, as a certain other Version 6.x has led to a lot of Pain And Constant Suffering. But no, I was optimistic. After a YEAR of having to reopen examinations four and five times to make all the images load, lo and behold, the New and Improved Universal Disappointment did indeed fix the problem. And even more exciting to us, it seemed to be more generous about showing saved measurements as well. We thought we were back in business.

Now, that's not to say that UV6 fixed everything. We still have windows covering over windows, and the measurement tool and the scrolling tool do not play nicely together. We could have lived for another year with that, if we really had to. But, no, we had to find another, far worse problem.

Last week, the second week of UV6 deployment, things started drifting downhill. We would get an occasional presentation state error when loading old PET's for comparison. No big deal.  But today, things took a nose-dive. We can no longer load ANYTHING, new or old. We get these rather cryptic messages instead:



Someone want to tell me WHO the F... Dakota might be? Are we talking about Dakota Fanning? What would she have to do with my PACS? North Dakota? South Dakota? Is that where GE keeps its cloud? Must be raining up there.

We are dead in the water, once again proving Dalai's First Law:  PACS IS the Radiology Department. No PACS, no exams, no patient care.

GE, you should be ashamed. You made us wait a YEAR for this update that fixed a "coding problem" that should have been fixed 51 weeks ago with a minor hotfix. NOW you deploy a faulty upgrade that has taken us down completely? Really? Don't you boys and girls ever even test your software before unleashing it on the masses?

GE took a fantastic product, Dynamic Imaging's IntegradWeb, and ran it into the ground. I can promise this particular site will NEVER purchase anything from GE again, and if anyone asks me in my waning years about GE products, I won't have much nice to say.

UV now earns the dreaded Dalai Do Not Buy designation. No surprise.


ADDENDUM...

We're back up. The problem was "a setting got changed that made the system look in the wrong places for things." Perhaps it was checking Fargo and not Rapid City.

Friday, May 06, 2016

Siemens Health-Imagineers

From Siemens comes this press-release:
Today Siemens Healthcare unveiled its new brand name Siemens Healthineers. The new brand underlines Siemens Healthcare's pioneering spirit and its engineering expertise in the healthcare industry. It is unique and bold and best describes the Healthcare organization and its people – the people accompanying, serving and inspiring customers – the people behind outstanding products and solutions.

"We have an exceptional track record of engineering and scientific excellence and are consistently at the forefront of developing innovative clinical solutions that enable providers to offer efficient, high quality patient care. Going forward as Siemens Healthineers, we will leverage this expertise to provide a wider range of customized clinical solutions that support our customers business holistically. We are confident in our capability to become their inspiring partner on our customers' journey to success", explained Bernd Montag, CEO of the company. "Our new brand is a bold signal for our ambition and expresses our identity as a people company – 45,000 employees worldwide who are passionate about empowering healthcare providers to optimally serve their patients."

As part of its Vision 2020 strategy Siemens AG announced nearly two years ago that its healthcare business would be separately managed as a company within the company with a new organizational setup. Siemens Healthineers will continue to strengthen its leading portfolio across the medical imaging and laboratory diagnostics business while adding new offerings such as managed services, consulting and digital services as well as further technologies in the growing market for therapeutic and molecular diagnostics.

The name of the legal entities will remain unchanged.
I heard about this new moniker a few days ago, from a friend high up in the Siemens hierarchy. It took me a moment to place the term, and then I realized why it sounded familiar...From the Disney Imaginations website:


About Imagineering
Walt Disney Imagineering is the unique, creative force behind Walt Disney Parks and Resorts that dreams up, designs and builds all Disney theme parks, resorts, attractions, cruise ships, real estate developments, and regional entertainment venues worldwide. Imagineering’s unique strength comes from the dynamic global team of creative and technical professionals building on the Disney legacy of storytelling to pioneer new forms of entertainment through technical innovation and creativity.

The name “Imagineering” combines imagination with engineering. Building upon the legacy of Walt Disney, Imagineers bring art and science together to turn fantasy into reality and dreams into magic.
I really think this is an incredible way to view healthcare software, although maybe a little difficult to roll off the tongue. Still, I predicted a cooperative effort of this sort way back in 2008...

It's far better than someone else's motto..."ImaGinE It Works..."

Wednesday, April 13, 2016

Gomerblog On EHR's...

Gotta love Gomerblog. In fact, I urge all of you to subscribe for a dose of medical humor far more sophisticated than what I provide here.

Today's entry follows upon the heels of the wishful thinking April Fools' Day post. (I do have it on good authority that Apple really IS working on medical software, but my source would have had to kill me had he elaborated.)

The dirty little secret seems to be that the EHR programmers didn't know their software would be used on real, live patients!  Wow...

From Gomerblog:

EMR Developers Shocked to Learn How Their Software is Actually Used

By Gomerblog Team on Apr 12, 2016 07:00 pm
Several developers of widely-used electronic medical record (EMR) software were invited out of their cubicles last week for a much-hyped tour of the real-world health care system.
2341821_mA volunteer team of medical office managers showed the visiting programmers around inpatient hospital wards and outpatient clinics yesterday, carefully coordinating the visits so the programmers could witness physicians in the full swing of patient care.  Seeing their products being used in actual clinical settings for the first time, the general response of the developers was shock.
“Wait, wait, wait,” said Bingo “Bozz” Murdoch, developer of MediQuickChart Systems.  “They’re actually using our software to, like, keep track of real patient records,” he noted.  “And they’re trying to enter the data real-time.”
Murdoch simply shakes his head when asked about the many levels of inputs and multiple levels of exhaustive drop-down menus.  “You just can’t get all of medicine into a dropdown menu,” he said incredulously.  “It would just be impossible.  That’s why we just picked a handful of interesting diagnoses and codes to include in the system.  These systems were never meant to be comprehensive.”
EMR software has long been a source of headache and delay for physicians and associated health personnel alike.  Along the way, many have wondered what the heck the developers were thinking.
“Why would you list 63 different ophthalmology exam findings on this drop down menu, and yet require us to free-text ‘enlarged tonsils’ every single time?  It’s supposed to be a primary care EMR, for gosh sakes,” said Dr. Goodforyou, a physician who was noted to be running 90 minutes behind at the time of the interview.  “Ever since moving to electronic medical records,” he added, “my charting has bitten the big one.”
Patients and physicians have also been critical of the need for computers in the exam rooms, complaining that the screens introduce a barrier to personal communication.
“It’s like talking to my teenager,” complained patient Mandy Mayhow, when asked about her impression of EMRs.  “I feel like the doctor isn’t even there any more.  I’m just talking to the back of a screen.”
Dr. Goodforyou was no longer available to respond to Mayhow’s comment.  His office manager, however, noted that he probably feels the same way.
Again, the software developers were at a loss.  “We were never asked to consider doctor-patient interaction or clinic flow in our product development,” said Murdoch.  “We thought the goal was simply to try to maximize required visit documentation.  It was all supposed to be a game.”

Wednesday, March 30, 2016

PACS Tidbits

New stuff in PACS seems to be overwhelmed somewhat by the Trump-like stampede of EHR data. Still, I've got a couple of items which might interest my loyal readers, all four of you.

Let us start with GE. Our Universal Disappointment Viewer should be updated to the next version sometime in the next few weeks. For those who haven't heard, our current UV has a number of problems, not the least of which involves not displaying one or more slices from a CT series when scrolling through. Fortunately, we do see a blacked-out pane with the phrase "0% loaded..." to let us know that we might be missing something. That is a major step up from our earliest go-round with Centricity 2.x years ago, which would skip images and not be kind enough to tell us it had done so.

As it stands, the "0%" thing happens on nine out of ten CT's, forcing us to close and reopen the exam, sometimes three or four or five times.

So...let's run some numbers. It adds 30 seconds to the exam each time we have to go through the close-and-reopen cycles. The busy site has maybe 40 CT patients per day (I'm underestimating), and for simplicity's (not Centricity's) sake, let us say they operate 5 days per week, and 50 weeks per year. That would be 10,000 patient-exams per year. So that's 9,000 exams that need to be reopened, wasting 4,500 minutes or 75 hours wasted for this year of Universal joy. At $200/hour (EXTREMELY reasonable rate), that would be $15,000 blown because of this poor coding.

I am hereby submitting a bill for this amount, $15,000.00, to General Electric for our professional services and time lost. I would urge all other departments experiencing this sad software error to do the same.

GE, please contact me for the address to send the check. I'll let everyone know when it arrives. Or if it doesn't.

While we are waiting on the check that's certainly in the mail by now, let us turn our attention to Agfa. You haven't heard much from me about our situation there, and you won't for a while. But in my search for an image-sharing solution (I still favor lifeIMAGE for this purpose) I stumbled across the fact that Agfa has an offering in that realm. Which has been deployed exactly never. I've learned not to beta (or alpha) test when patients are involved, thank you. Also, I'm hearing that Agfa plans to standardize and unify all of its installations onto one uniform platform. I'll assume this platform will be Agility, but I have no confirmation of that as yet. Good luck.

Onward and upward. Apparently Fuji has released Version 5.0 of Synapse PACS, and in an article on ImagingBiz.com, (which was sponsored by Fuji and written by Fuji USA V.P.'s), it was the "hit" of RSNA 2015. I must have missed that somehow, perhaps because I rarely wander over to the Fuji booth. But the Veeps do make the new version sound quite intriguing.

Our latest Synapse PACS has beefed-up archival and worklist/workflow-engine capabilities—from unique sharing features to EHR interoperability tools to workflow-optimizing options that take integration beyond the enterprise, into the cloud and, from there, wherever collaboration is happening—or should be happening.

In a nutshell, the need today is for a diagnostic-level PACS workstation that extends through the PACS to any desktop that a PACS might touch. That’s why the Fujifilm team came up with the Synapse 5 PACS viewer. It’s designed to help users keep up with the changes that have already taken place and, more importantly, to help them stay out ahead of what comes next.

Nice to hear this from the company that has the reputation of taking years to update things.

When I first saw Synapse in action in the early 2000's, I was told that the local group had insisted on three-second transmission times for any study. Of course, it turns out that the group itself figured out how to accomplish this without help from Fuji. But speed is indeed an important factor today:

Going into the Synapse 5 PACS design phase, our team knew the only way to achieve sub-second image access while also virtually caching large datasets and enabling reads from wherever, whenever—including with 3D—was to approach server-rendering technology in a whole new way. That’s why we came up with not just a new viewer but a next-generation viewing application, one combining architecture changes as well as technology advancements.

With the new Synapse 5 technology, there’s no client at the desktop, and the image rendering occurs on the server. This allows the technology to be far less dependent on the viewer side, and it allows users to simply log in and choose their interface as well as their screen—Explorer or Firefox or Chrome, desktop or smartphone or tablet—or work with any combination of preferences.

Yup. Server-side rendering and a zero footprint client. Nothing novel, but Fuji is the first of the big-iron companies to implement this on this scale. I think it's a good idea if done right.

One of our favorite aspects of Synapse 5 PACS is its brilliant simplicity. Like most cutting-edge websites and more than a few apps, it uses HTML5 and was largely inspired by what you’ve seen in the world of e-commerce. It’s got a user-friendly, intuitive GUI, with high performance, limitless scale and strong security.

Can you say "Hyperbole?" I knew you could.

Here’s another reason we were so busy answering questions at RSNA 2015: As “disruptive” a technology as Synapse 5 is, it’s barely a disruption at all for existing customers. It’s not a forklift of a database or a migration or a platform change. It’s just an upgrade to our current Synapse 4 platform. Current Synapse users will be able to light up an entirely new viewer that will work off of the existing database they already have.

An upgrade? Definitely. I'll bet money it is a HARDWARE upgrade, requiring a new server (or more likely many servers) added to the back end. I could be wrong.

We haven’t forgotten to take what we’ve heard from radiologists and apply it. That means, among many other things, that our new viewer makes it easy to look at a screen for eight hours a day. We’ve thought through ergonomic implications, right down to details like minimizing wrist strain, and we’ve geared everything toward greater efficiency and productivity.

Oh, still my beating heart! Someone cares about us poor rads? That would be nice...

But now a thinly-veiled slap at our competitors...

There’s been a lot of talk lately about “deconstructing PACS” in order to free it from silo-ed systems. Customers want fast image viewing, diagnostic integrity, flexible worklist, integrated 3D, platform independence and information lifecycle management. Legacy PACS does not perform all of these functions well, which is why Synapse 5 is so different.

Synapse 5 PACS inherently does what PACS deconstructors would do if they could: It helps transform healthcare organizations as they enhance collaboration and optimize workflows across the enterprise.

I'm not seeing anything that says Visage and TeraRecon can't do all that, too. In fact, Fuji's non-deconstructed PACS sure sounds a lot like Visage's deconstructed PACS. But I'm sure there are differences.



Remind me to stop by Fuji's booth next RSNA. If I'm still in the business, that is.

Sunday, March 27, 2016

Lingering Frustration And Bad Design



Mrs. Dalai loves HGTV, and so I end up watching it quite a bit. I think I've even become somewhat of a house connoisseur after all this time.

So let's look at a house, pictured above. Wouldn't you love to live in this house? It's a great house! 4 bedrooms, 3 bathrooms, gourmet kitchen with granite countertops, stainless steel appliances, the whole nine yards! The house contains every gadget you could possibly want.

But there's a problem. The house was designed by someone who lives in a cave and doesn't drive a car. It is part of, well, a rental community, owned by an absentee landlord who will never set foot in the neighborhood, living in a corner office suite in some skyscraper somewhere. Can you see what's wrong? Hopefully, you did before you moved in. Because once you're in, it's too late.

My metaphor might be a bit stretched, but I think it is clear nonetheless. It is all too easy to design something wrong when you don't know anything about those who will use your product, and when the end-users aren't even the targets of your sales pitch.

So it is with PACS and EMR's, and so I've been saying here and elsewhere for a very long time. But it seems that with the greater penetration (government-mandated or not) of EMR's has come a deeper understanding and acknowledgement of just how flawed they are from the user's standpoint, the only one that counts.

This graphic from Gomerblog nicely outlines the problem:

And I will shout about the problem as loudly as I can:

THE PEOPLE THAT CREATE THESE PRODUCTS AND THE PEOPLE THAT BUY THESE PRODUCTS ARE NOT THE PEOPLE THAT USE THEM!!!

Moreover, there seems to be very little interest in correcting this.

But wait, the world is beginning to feel our pain, and attention is coming from a very unlikely source: the government! Read this article, "Frustrations linger around electronic health records and user-centered design" in Healthcare IT News, and be encouraged. At least some in relatively high places seems to get it:
In a provocative prime-time speech, meanwhile, Acting CMS Administrator Andy Slavitt threw down the gauntlet: "I'm certainly not bashful about what we need to do better, and I'm not going to be bashful here, even in the face of some very good reasons for optimism, about ways we need to take our game up across the board.”

The health IT industry has done very well in the years since the HITECH Act, said Slavitt. "But we're still at the stage where technology often hurts rather than helps physicians providing better care."
Wow. Someone from the government is here to help us!  He actually said out loud what I've been saying for years. These poorly-written, outlandishly expensive software extravaganzas can HURT patients. Yowza!

Mr. Slavitt, my new governmental hero, continues my, I mean his, rant:
To bolster his case, he rattled off a series of actual quotes from frustrated clinicians. One complained that in his EHR, "to order aspirin takes eight clicks; to order full-strength aspirin takes 16."


Slavitt said CMS is newly committed to taking a "user-centered approach to designing policy." He asked vendors to do the same, with a similar spirit of empathy: "Step back and look at what you don't think is working, and make it better."
This, from CMS? Someone pinch me...

Perhaps the additional attention comes from the fact that more and more physicians have become disgusted with the status quo:
That dissatisfaction is getting worse, not better. A study published this summer by the American Medical Association and the American College of Physicians found that physicians are more frustrated with EHRs than they were five years ago.

Forty-two percent of respondents said their EHR system’s ability to improve efficiency was "difficult or very difficult." Some 72 percent said the same about its ability to decrease workload.

We saw similar feedback in Healthcare IT News' first-ever EHR Satisfaction Survey this past fall. In addition to numerical scores, we also asked for anecdotal feedback from more than 400 people who took the poll. Opinions such as "not very intuitive," "cumbersome" and "too many clicks" cropped up over and over again.
So what's the problem? As usual, that can be stated with two little letters:  I and T. The article continues:
In his landmark book, The Design of Everyday Things, Don Norman, director of The Design Lab at University of California San Diego wrote:

"The reasons for the deficiencies in human-machine interaction are numerous. Some come from the limitations of today's technology. Some come from self-imposed restrictions by the designers, often to hold down cost. But most of the problems come from a complete lack of understanding of the design principles necessary for effective human-machine interaction. Why this deficiency? Because much of the design is done by engineers who are experts in technology but limited in their understanding of people."

Of course, in healthcare IT there are other challenges. EHR vendors would probably love to have all their products look as sleek and intuitive as the latest iOS release. But they also have to ensure they check all the boxes to comply with certification criteria from the Office of the National Coordinator – all 560 detailed pages of the 2015 Edition.

"I know some people inside big EMR companies who want to do excellent design, but in an organization that's owned by IT, it's difficult for even a design advocate to have their voice heard and affect the process," Amy Cueva, co-founder of the design-centric Health Experience Refactored conference, told Healthcare IT News in 2013.
I have been saying this in reference to PACS for much of my career, and it applies equally to the superset of EHR's. Let me emphasize these very important statements:

Why this deficiency? Because much of the design is done by engineers who are experts in technology but limited in their understanding of people.

(B)ut in an organization that's owned by IT, it's difficult for even a design advocate to have their voice heard and affect the process...

There is some light at the end of the tunnel, but...
That's changing, thankfully, as more and more efforts are being made industry-wide to make EHRs easier to use and perhaps a bit better-looking. One of those ONC certification criteria, after all, is that vendors employ a user-centered design process when developing their tools, and report the results of usability testing.

A study published this past November in the Journal of the American Medical Informatics Association took a look at UCD processes at 11 unnamed vendors, seeking to understand the challenges and opportunities for better design practices.

"Our analysis demonstrates a diverse range of vendors’ UCD practices that fall into 3 categories: well-developed UCD, basic UCD, and misconceptions of UCD," wrote researchers from MedStar Health's National Center for Human Factors in Healthcare, noting that the latter category might refer, say, to the mistaken belief that responding to end-users' requests and complaints qualifies as user-centered design..."
But we aren't there yet...
Dishearteningly, the researchers found some respondents still didn't see the business case for investing in UCD processes. It even found that some smaller EHR vendors didn't even have any usability experts on their staff.
And this is the bottom line. As with PACS, in most places, IT controls every facet of the EHR. Software wonks create these jumbled messes while insulated from the actual users. IT folks buy the stuff while equally removed from the wants and needs of those who have to use it. It needs to be reiterated...physicians use EHR's (and PACS) to take care of patients. What a concept. Healthcare IT is used for HEALTHCARE! This isn't some app for your iPhone that won't hurt anyone if it fails or if it isn't usable. This is life and death, people. That's not an exaggeration. It has to work and work well. And today, it doesn't. It gets between physician and patient, impairing instead of facilitating that sacred relationship.

We just aren't there, yet. But maybe someday...

Sunday, March 06, 2016

Cinders, EHRs, and Other Disappointments

I admit to being addicted to new technology. I love gadgets of all shapes, sizes, and sadly, prices. If there's some technological toy out there I'm missing, let me know and I'll run right out and buy it.

The crowd-funded sites, Kickstarter and Indiegogo, are the perfect trap for suckers people like me. Here, we find a plethora of inventions that one just has to have, requiring only a small investment for a piece of the future. Dangerous places, these.

Sometimes, the invention is so outlandish that it doesn't get funding, but some creations are so tempting and apparently within the realm of possibility that the rubes like me line up to part with their hard-earned cash. I've fortunately only gone down the tubes once, that on a pre-Apple Watch smartwatch wherein the inventor collected funds but never actually made a working copy of his invention. Fortunately, I didn't lose much on that one.

A more frustrating situation arises when the invention sort-of works but doesn't really. Such was my experience with Cinder, a screen protector for the iPhone 6 series.


The enticing property of the Cinder that made me dump a perfectly good Rhino-Shield was the curve...curved edges, that is, as you can sort of make out in the picture above. And why do we need this? Just ask Cupert, the makers of Cinder:
We created CINDER - the picture-perfect, seemingly invisible, ultra-thin glass screen protector with a form-fitting, edge-to-edge wrapped screen design, providing the ultimate user experience.

Unlike dull and ordinary flat screen protectors, CINDER beautifully combines flawless form with practical functionality in a precision-fitted, curved glass screen protector with specially-developed nanotech adhesive to ensure easy installation and reusability.

{snip}

Engineered to be the most elite, user-sensitive screen safeguarding accessory, CINDER protects your iPhone 6 or iPhone 6s at the highest possible level without compromising design or functionality. Real curved glass edges seamlessly wrap around the iPhone 6 and 6s Series screen - no gaps or hard edges to chip. Just impeccably beautiful, iPhone-flattering protection that’s practically invisible.
Nice idea, but for the majority of users, per Amazon.com reviews, the Cinder just didn't work. It was not washable as claimed, it was very fragile, often breaking when installed, and it was not made from Corning Gorilla Glass as had first been claimed. For me, the problem was that it did not snugly fit around the glass of the screen, and thus, it was dislodged by the iPhone's protective case, and you MUST use a case to cocoon your iPhone should it fall to the floor. When I informed Cupert that every single case I tried knocked their stupid Cinder off the screen, they simply said, "Try another case." No refund, no nothing. So instead of the damnable Cinder, my iPhone now sports a Thule case with built-in screen protector, and I'm pleased with it. But I now have about $100 of unusable protectors and cases sitting in my drawer, thanks to my infatuation with a concept that just wasn't properly produced.

There are probably a million other similar product design missteps like the Cinder. Even Big Companies like Fiat-Chrysler can go down the tubes on a foolish idea. Take something as mundane as a gear-shift lever:
Image courtesy FoxNews.com
You would think it hard to bung that up, but you would be wrong. From FoxNews:
Electronic gear shifters on some newer Fiat Chrysler SUVs and cars are so confusing that drivers have exited the vehicles with the engines running and while they are still in gear, causing crashes and serious injuries, U.S. safety investigators have determined...

Agency tests found that operating the center console shift lever "is not intuitive and provides poor tactile and visual feedback to the driver, increasing the potential for unintended gear selection," investigators wrote in the documents. They upgraded the probe to an engineering analysis, which is a step closer to a recall. NHTSA will continue to gather information and seek a recall if necessary, a spokesman said...

In the vehicles, drivers pull the shift lever forward or backward to select gears and the shifter doesn't move along a track like in most cars. A light shows which gear is selected, but to get from Drive to Park, drivers must push the lever forward three times. The gearshift does not have notches that match up with the gear you want to shift into, and it moves back to a centered position after the driver picks a gear.
And so it is with EHR's. These gargantuan and hideously expensive systems have great potential to improve health care, but unless they are well-made, and programmed for success, they can do just the opposite. And they do.

I hope you are already a fan of ZDoggMD, a physician-rapper (much funnier than a physician-blogger). ZDogg has encapsulated the frustrations with today's EHR's in this painfully hilarious video:


You will find the lyrics and background information on ZDogg's website.

His bottom line is this:
Simply put, the Tower of Babel of existing EHRs may not ever talk to one another, but they do share one thing: they come between us and our patients. Staring at a screen to click boxes and satisfy quality measures while figuring out the seventeenth digit for an ICD-10 code—this nonsense robs us of precious time and attention that should be spent on and with patients. I would never advocate going back to paper. Ever. But we need to demand technology that binds us closer to those we care for, technology that lets doctors be doctors. And nurses, and RTs, and case managers, and dietitians, and scrub techs—[insert crucial care team member here].
Which is what I've been saying for YEARS about PACS. The damn things work just enough to justify their existence, barely. They are clearly designed by people who do NOT understand our workflow, and they get between us and our patients, or their images, anyway. This is not how it should be. So why are EHR's so hard to use? Easy. Poor design, poor testing, and no real incentive to change.

As with PACS, EHR's are sold not to the end-users, but to the IT department and the CTO/CIO, who probably have absolutely no idea how it should work. Their criteria will be some combination of the following:

  1. Which product is cheapest?
  2. Which product is most expensive? (If it costs more it must be better!)
  3. Which is the Big Name Company that everyone thinks you have to have?
  4. Which company will do the maintenance and let IT off the hook?
Notice that having the thing actually work in the hands of those who use it is not on the list. 

A comment on ZDogg's page from someone who claims to work for THE Big Name in the EHR business is quite revealing:
People wonder, "why aren't EHRs designed with providers in mind?" I've worked at Epic and can tell you why not:
  1. Physicians were on staff, but hard to reach. They were technophiles and barely practicing as others mentioned.
  2. It really is a billing platform with some patient stuff tacked on. Everything useful you see is probably a workaround and one level away from not working at all.
  3. Quality Assurance (manual testers) are supposed to be a surrogate for users, as there is no beta testing. They are intentionally hired without CS background and maintained as laymen with a very lite, monkey-see-monkey-do training. However if they are not lickety-split quick to master the software, they are fired. Quality Assurance ends up being more like Self-Reassurance.
  4. There is absolutely no testing of interoperability. There is however plenty of testing for the several convoluted ways of sharing data between Epic servers.
And in fact, interoperability is another HUGE bugaboo with EHR's. As ZDogg rapped, er, said in the video, "Bought the new software, and though we use it here, I can’t use it over there, different systems everywhere!" In fact, Epic has been charged with overtly blocking data from other systems. Rather ominously, the original piece from ihealthbeat.org has been taken down, or at least yields a 404 error. But what happens in Vegas stays on the internet, and so the cached version is still accessible:

Thursday, November 5, 2015

Connecticut reportedly has launched an investigation into several hospital networks and Epic Systems over their information sharing practices after a state law (S 811) took effect last month, prohibiting the use of electronic health records to block the flow of health data, Politico reports.

Background on Law

The law, which was passed in June and took effect Oct. 1, makes information blocking an unfair trade practice and subjects violators to penalties. According to Politico, the law based its definition of information blocking on the one used in the Office of the National Coordinator for Health IT's April information blocking report.

In addition, the law aims to slow the rate of health care network consolidation.

State Investigating Complaints

According to Politico, the Connecticut Attorney General's Office is reportedly investigating complaints under the law, including those against Epic and health systems in the state (Allen, Politico, 10/30).

The investigation stems from independent medical groups' allegations that hospital networks are using EHRs to dictate patient referrals and bring patients back to their networks (Walsh, CMIO, 11/3).

Critics allege that Epic -- which holds more than 50% of the state's hospital EHR market -- is unfairly collaborating with certain health networks against smaller physician practices.

For example, state Sen. Len Fasano (R), who co-sponsored the new law, said he heard anecdotes about physicians struggling to access patient information recorded at large hospitals, in particular Yale-New Haven Health System.

He said, "It was impossible for them to gain access to a patient's full medical record unless they were associated with the hospital," adding, "Independent doctors cannot properly care for their patients if they are denied access to full medical histories."

Meanwhile, state Senate President Martin Looney (D) said Epic was being used "as both a coercive tool to shut out nonparticipating practices and, in some cases, force them to be sold to larger health care networks."

Epic's Response

Epic spokesperson Eric Helsher said the vendor is not responsible for creating the conditions that led to such complaints, noting that the health care landscape is changing.

He said, "Physicians are aligning with health systems to reduce costs and improve patient outcomes," adding, "Epic enables this alignment by providing deep integration around a single patient record, a robust patient portal to increase patient engagement, and population health management and analytics tools that drive coordinated care" (Politico, 10/30).
So...Epic admits no responsibility although it created a proprietary system in a space that should be trying to integrate. Heck, even the majority of dysfunctional PACS can talk to each other, at least to some degree. Epic's stance is tantamount to Apple saying that from now on, an iPhone can only call other iPhones, but why would you want to communicate with a filthy, stinkin' Android anyway? Not cool, and at least in Connecticut, not legal.

And this unbelievable combination of hubris, arrogance, and indifference to the real needs of the patients, let alone those of us striving to take care of them, sets a rather nasty tone for the future.

I have said repeatedly on this blog and elsewhere for the past eleven years that PACS is a critical, life-saving creation. Dalai's First Law, in fact, states that PACS IS the Radiology Department. And as it is used today, the EHR the patient's entire record, and his connection to healthcare. Nothing happens in an electrified hospital that doesn't pass through the EHR. If it works, great. If it fails, people die. You might recall the little Ebola episode in Dallas from 18 months ago, and the Epic Fail that contributed to the near-disaster. (I say "near" because "only" one person died that time.) What I said then is still true:

Do you sense a familiar refrain? (Lawyers please note...THIS IS ALL MY VERY OWN HUMBLE OPINION, as is every other word that I have ever written or ever will write, unless quoted from someone else, and worth every cent my dear readers paid for it.) Once again, here in the Health Care Field of Dreams, we have badly written, badly designed software, created with minimal input from those who have to use it, selected and then implemented by IT types who also don't have to use it and don't understand enough about those who do to get it done right. This has to stop. Right. Bloody. Now. Hit CNTL-ALT-Delete and start over.

With Epic and the government having their hands deep inside each others' panties, we may well be stuck with these unusable systems for the foreseeable future. (And as an aside, if you deconstruct the Meaningful Use rewards and penalties, doctors are being bribed to buy EHR's that have the certified and confirmed ability to transmit data to Washington, D.C., so again, we won't expect the government to do anything about anything.) But, the demise of Mr. Duncan, and no doubt dozens if not hundreds more that he inadvertently infected between his two ER visits may level the playing field.

It is clear that Epic's epic Dallas fail (which might not really be totally attributable to Epic per se, but rather to the way the product was set up in the field, not passing that one lil' bitty critical entry to where it should go), contributed to Mr. Duncan's being released when he should have been locked up in the local version of Wildfire. It is possible, just barely possible, that this tragic episode will awaken the public to the dangers inherent in the IT-controlled medical software industry and its acronymbysmal spawn, EHR's, CPOE's, and the occasional unruly PACS. Get enough people upset about this, and they will call their congressmen, and more importantly their lawyers. (I would submit that more gets done by class-action suit in this country than by Congress.)

I realize that replacing these huge legacy systems which were outdated before they were even conceived would cost somewhere in the trillions of dollars, and so I'm not holding my breath that this will ever happen. But maybe a few million and billion dollar suits and fines would get the attention of the Epics, the Cerners, McKessons, and all the others who create these nightmares. Or maybe, just maybe, the execs will read this, and the other rebellious propaganda we are starting to see online, and realize that they are causing damage rather than progress, and be inspired to turn it all around. I'm a staunch believer in the electronic record, PACS, computers, iPhones, Apple Watches, and anything else technical. This is the future, without question. But it has to be done right, and so far that hasn't happened.
And don't underestimate the power of the individuals. Go to ZDogg's site, letdoctorsbedoctors.com, and express your opinion about EHR's. It's a start.

This sorry state of medical software cannot go on. The time has come to fix it. Now.

Wednesday, February 24, 2016

Merge CEO Leaves To Run Tribune Publishing

Is it me? Is it something I said?

I keep having to break in new CEO's at Merge Healthcare, and AMICAS before that.

Back in the AMICAS days, I apparently chased out Hamid Tabatabaie. Then Peter McClennen. Then Steve Kahane. Then Merge came on board, and I thought I had a keeper with Justin Dearborn. But alas, he too has seen the light.

I'm kidding, of course, about me having much of anything to do with anything at Merge, but it is true that Justin Dearborn is leaving Merge to become the CEO of Tribune Publishing. From the Chicago Tribune, one of the papers TP manages, comes this article, dateline yesterday:

Three weeks after welcoming Michael Ferro as the largest shareholder and nonexecutive chairman of Tribune Publishing, Jack Griffin is out as CEO.

Griffin, who has guided Tribune Publishing since its August 2014 spinoff, has been replaced by technology executive and longtime Ferro associate Justin Dearborn, the Chicago-based newspaper company confirmed Tuesday.

Dearborn, 46, had been CEO of Merge Healthcare, a Ferro-controlled medical technology company that was acquired by IBM in October.

"Although this is a different medium than my last technology company, it has the same challenge on how to create the highest value for our content," Dearborn said in the news release.

Michael Ferro, as my readers know, bought the scraps of Merge years ago, and then purchased AMICAS to give the reborn company a working PACS.

Tribune Publishing owns the Chicago Tribune, Los Angeles Times and other major newspapers. When Ferro's acquisition was announced, Griffin called Ferro "a tremendous admirer of our brands at the Tribune … so it's a winning combination for our company."

{snip}

Dearborn, who has no media experience, takes the helm of the legacy newspaper company as it struggles to reverse years of industrywide revenue declines and transition to a digital-first medium. He has a long track record with Ferro, the two having worked together on Internet software company Click Commerce, investment firm Merrick Ventures and most recently Merge Healthcare, a Chicago-based medical software company that was sold to IBM for about $1 billion, including the assumption of nearly $198 million in debt, according to Dealogic.

In June 2008, Merrick Ventures bought a controlling stake in Merge, which had been reeling from an earlier accounting fraud scandal, for $20 million, including a $15 million loan. Dearborn was installed as Merge CEO the following month.

Although Merge didn't turn a yearly profit under Ferro's and Dearborn's leadership, the development of an artificial intelligence initiative to analyze medical diagnostic records caught IBM's eye last year, leading to the sale of the company.

Merrick's 23.5 percent stake in Merge was valued at nearly $190 million in the IBM transaction.

Congratulations to Mr. Dearborn. He is incredibly capable, and I'm sure Tribune will thrive under his leadership. Perhaps with his connections, we will see Watson trained to read the various newspapers and provide commentary. That would be about the only column I would pay to read.

In the meantime, I'm waiting to find out something very important to us customers...Who will take the helm at Merge?

Sunday, February 21, 2016

My New Workstation

I sit on my backside most of the day, staring at a workstation monitor. At some sites, I have the Herman Miller Aeron chair, which is OK, but there has to be a better way to sit and think and interpret, and whatever else it is I do all day.

And here it is:







The Altwork Company has come up with a better way, a "new way to work," the Altwork Station. Look at the pictures and watch the video, and I think you'll agree, it has got to be better than what most of us do now.

This next step in workspace evolution is fairly reasonable as such things go...
As an early adopter, you’ll be one of the first people on Earth to have a workstation that works with you.

The list price for an Altwork Station is $5,900, but for our early adopters, we’re offering significant discounts.

Our early discount program will provide a forum for you to get to know us, and for us to get to know you as we build, deliver, and support a workstation that will change the relationship between you and your work.

There are two options for Altwork early-adopter discount customers:

Buy Now – $4,900 or $3,900

Signature Altwork Station – $4,900 includes:

Lock-in early adopter discount of $1,000
Choose from 10 custom upholstery colors, 3 frame colors, 4 desk and accent colors
Engraved commemorative plate with unique serial number
Priority manufacturing and shipping (you’ll be the first on your block)
Limited quantity available
Price does not include shipping

Altwork Station – $3,900 includes:

Lock-in early adopter discount of $2,000
Choose from 2 pre-configured color palettes
Priority manufacturing and shipping (you’ll be the second coolest kid on your block after Signature series, which is still pretty cool)
Limited quantity available
Price does not include shipping

I think I could do without the Signature Version. On second thought, why not go all the way?

I think my backside is worth it!

Saturday, February 20, 2016

Brother, Can You Spare A Dime ($0.10 CAD) For A PET?

The Canadian healthcare system has been touted as the most wonderful thing since sliced bread, the epitome of the Single-Payer model, the Way It Should Be Done, the ultimate, logical manifestation of where we are headed. The Affordable Obama Care Act is, of course, just a brief bus-stop on the highway to Canada.

But wait just a moment, eh? All is not perfect in the land of the frozen. How many Americans (or Saudis or potentates of various small nations) go to Canada for esoteric, life-saving surgery? Conversely, how many Canadians cross the border (no wall as yet) for their care? (Answer: Depending on the source and the year, upwards of 50,000.) Yes, drugs are cheaper Up North, because the Canadian government artificially caps the prices, forcing us hosers in the U.S. to pay the difference.

It seems that some procedures might require a wait. A long wait. In fact, wait times are so much a part of the Canadian healthcare culture that there are official websites devoted to telling our Canuck friends just how long they'll have to wait. Here's the link from the Ontario Ministry of Health and Long Term Care, for example.

If you should happen to check Diagnostic Scans, you'll be able to chose CT or MRI. Let's pick MRI, and then select a nice town in Ontario called Sudbury, which yields:


Diagnostic Scans
Magnetic Resonance Imaging (MRI)Target:28 days
[Oct-Nov-Dec15]
Hospital Name
Location
Wait time (days)
Provincial Wait Time
(9 out of 10 patients complete their procedures in this time)
101
Hôpital régional de Sudbury Regional HospitalSudbury83
Northeast Mental Health CentreSudburyNR/NS




Can you imagine the b*tching and moaning you would hear if you told an American he/she would have to wait over three months for an MRI? Yanks get upset if they can't get their scan the day it's ordered.

The site above doesn't mention PET/CT scans, and there's a reason for that. There are 12 (give or take) PET/CT scanners in all of Ontario, and utilization is, well, a bit different than we see here in the States:
The volume and percentage of PET/CT scanning across the province in 2013 remained steady in relation to the previous year (Figures 2 and 3). The number of completed oncology-related PET/CT scans per million population increased from 510 in 2011 to 671 in 2013, which may be a result of an increase in the population of the province and of rising cancer incidence rates (Figure 2). The increase also might be attributed to some head and neck cancers becoming part of the insured indications for PET/CT scans in April 2012.

That would be just under 700 PET/CT scans per million, yes? In the US, that figure is 5,000 per million population. In fact, here is a breakdown of scanner distribution and utilization in some of my favorite countries, although some of the numbers are a little older:


Which brings us to the PET/CT status of Sudbury, Ontario, which is either heartbreaking or heartwarming, depending on your point of view. It seems that the citizens of Sudbury themselves have been asked to pay for the regional scanner themselves. The following quotes are all from the Canadian Broadcast Company (CBC):
Sudburians have spent years trying to raise millions of dollars to buy its hospital a PET scanner. A Positron Emission Tomography (PET) machine uses a type of sugar to detect cancer, cardiac issues and even dementia.

The Ministry of Health and Long-Term Care has told the city it's up to residents to raise the money needed to buy the region's first machine, which is estimated to cost as much as $5 million dollars.
The machines are cheaper than that, but you have to have a shielded room in which to put them, and a great deal of additional infrastructure, so the price is probably not far off the mark. Or the CAD. But this sure sounds unusual. Making the patients pay for the scanner? I knew this sounded familiar, and in fact, another Ontario hospital, Seaforth Community in East Huron, had to hold a radiothon to pay for its PACS in 2007. Again, the money just isn't there for a critical service. Well, we assume the money just isn't there, eh?
A Sudbury doctor says his community's struggle to get an important piece of cancer detection equipment is another example of the provincial government's attempt to block the technology...

The Ministry of Health and Long-Term Care has told the city it's up to residents to raise the money needed to buy the region's first machine, which is estimated to cost as much as $5 million dollars.

Dr. Dave Webster says asking the community to foot 100 per cent of the bill is a way for the ministry to purposefully slow down the introduction of PET technology across Ontario.

"It's quite simple. They don't want to pay for it," he said.

Webster, a nuclear medicine doctor who has fought for decades to bring more PET scans to the province, said the machine can accurately detect cancers that MRI and CT scans cannot.

"You have patients that would have survived their cancer had they had a PET scan at an appropriate time," he said. "And similarly, there are people that are told therapy is not possible and the PET scan shows they are."

"People in Ontario are more likely to die simply because they will not have access to what has simply been the standard of care on following up with cancer patients for more than a decade," he said.

Windsor doctor Kevin Tracey was a founding member of a ministry-backed committee set up more than 15 years ago to bring PET technology to Ontario.

He said he resigned in protest because the government was purposefully slowing down access to the scan.

"Basically, we're holding the number of patients down that need scans done. I'm sure there's monetary reasons why that's done," he said.

Tracey said Ontario is doing fewer PET scans than just about anywhere in the western world.

Ontario performs 11,000 PET scans per year, according to Cancer Care Ontario, while Quebec performs nearly four times that number, more than 40,000 scans annually, with a much smaller population.
There is a very personal facet to this particular PET tale:
(The decision to fund PET operations) was an early Christmas present for the family of Sam Bruno, a man who spent the final years of his life trying to bring a PET scanner to Sudbury...

Since his death five years ago, Bruno's family has spent years raising money for a PET scanner in Sudbury — and on Tuesday were one big step closer to realizing their dream.

The province has agreed to spend $1.6 million each year to operate the machine.

The community needs to raise $2 million more to make it a reality. A total of $1 million has been raised so far.

Hoskins said he hopes his ministry's funding commitment will be a shot in the arm to fundraising efforts.

Having a PET scanner in Sudbury to service northeastern Ontario patients means people like Bruno will no longer have to travel to Toronto for tests.
You might think Sudbury is too small for a PET/CT. You would be wrong. Sudbury has over 160,000 citizens, not much smaller than my little town in the Deep South. And we have three PET/CT's here. Sudbury has an-otherwise state-of-the-art oncology facility, lacking only PET/CT.
"We should have had it a long time ago," said Wayne Tonelli, co-founder and president of the Miners for Cancer charity. "We have a world-class facility here in Sudbury with our cancer centre. Let's get some world-class equipment here."
I'm assuming the "Miners for Cancer" actually favor a cure for cancer.

Editorial time. Forgive the somewhat jingoistic language to follow.

The healthcare here in the United States is good. Really, really good. People who can afford to do so come HERE to be diagnosed and treated. Those who can afford to come HERE do NOT go to Canada. Or Germany. Or Switzerland. Or Sweden. Or India. Or Anywhere Else. I'm not saying I contribute much, if anything, to it, but the best medicine in the world is practiced in the United States.   Now I don't think our system is perfect, and I have called for massive reforms, dumping Obamacare, Medicare, Medicaid, and revamping the whole thing including a huge revision of the laws governing the Third-Party Payers, our beloved insurance companies. Ours is a dysfunctional system and it has to be revised. But even with its blemishes, ours produces some of the best medicine in the world.

And yet, in our inexorable march toward Socialism, led by demagogues who would have us trade everything that makes America America for "free stuff", American health care stands to be crippled in the process of making it "free". And by the way, nothing is "free". Someone has to pay for the "free stuff".

We need to look at the case of Sudbury's PET/CT and understand the implications. There isn't enough money in Ontario to provide "free" PET/CT for Sudbury, and in fact, funds for this life-saving technology are limited province-wide. Thus, the fine people of Sudbury will have to fund the purchase themselves. That they are willing to do so to help their fellow citizens is the heartwarming part of this story. The heartbreaking aspect is that they have to do so. I see this as a huge crack in the perfect facade of Canada's single payer system. It FAILED the people of Sudbury. And it fails the people of Ontario, and indeed all of Canada by limiting resources and thus rationing their care.

In response to my East Huron Radiothon post of 2007, a (probably former) reader commented:
As a personal friend, and former patient of Dr. (mentioned in article), I need to comment!

Our healthcare is NOT free, but our taxes allow us wonderful healthcare, and an above-average level of access to all kinds of medical tests etc. What we need, we get. It's easy to stand in the U.S. and throw stones, but around here (Southern Ontario) we decide how many kids to have by deciding how many kids we WANT to have, rather than by how many our insurance (or lack thereof) will pay for! We take our kids to the doctor when they NEED to go, not when we have enough money to pay a co-pay!

My son was special-needs...yes, born at Seaforth Hospital. He received first-rate care, with swift and appropriate transport to Children's Hospital. On day 3, I heard a PCCU nurse say of my son "Well, there's a million dollar boy!", meaning his cost of care had already topped the million dollar mark. Had my husband and I NOT lived in Canada, our grandchildren would still be paying off the cost of that hospital stay...let alone the other numerous hospital stays our son had through his life.

We don't have a problem donating for good causes...we're neighbours. That's what good neighbours, and good citizens do.
It's hard to argue with this statement, but read it again. Maybe twice more. "What we need, we get." Sounds a little bit too close to "From Each According to Their Abilities, to Each According to Their Needs". But then maybe I'm biased.

The profit motive has brought an overabundance of expensive CT, MRI, and PET/CT scanners to the United States, with the inherent likelihood of over utilization. Contrast this to the neighbourly situation in Ontario which requires the citizens themselves to raise money for life-saving technology that the government, even using the generously given tax-dollars (CAD) cannot provide. Better to over-utilize, or better that ". . .(p)eople in Ontario are more likely to die simply because they will not have access to what has simply been the standard of care on following up with cancer patients for more than a decade..."? You tell me.

"Free stuff" can have a very high price-tag.

Thursday, February 18, 2016

Hostage Data

I was first alerted to the situation by my friend Stacey, who directed me to the story on the Daily Kos. I tend to avoid that site like the plague, but I had to read this story.  Fortunately, the author, "Medical Quack", has the information on his own blog, and the story has since been picked up by many other news outlets, including Fox.

Here are the facts from Medical Quack:
A Southern California hospital was a victim of a cyber attack, interfering with day-to-day operations, the hospital's president and CEO said.

Staff at Hollywood Presbyterian Medical Center began noticing "significant IT issues and declared an internal emergency" on Friday, said hospital President and CEO Allen Stefanek.

A doctor who did not want to be identified said the system was hacked and was being held for ransom.

There is no information that any patient or employee information was compromised, but the hospital called in computer forensics experts, and the FBI and the LAPD to investigate.

The hospital's emergency room have been sporadically impacted since Friday, Stefanek said.

The unnamed doctor said that departments are communicating by jammed fax lines because they have no email and that medical office staff does not have access to email.

9000 bitcoins is the price demanded to give the hospital back the “key” codes to open the system back up. 911 patients are being diverted to other hospitals.

The hospital seems to be keeping it pretty quiet and I guess really what else can they do as paper back up files come out as they always do in times when the EHR goes down.

This disruption is raising havoc with getting access to all the patient information needed at times. Radiation and Oncology has been shut down and they are not allowed to turn on their computers.
The Daily Kos quoted all this directly, but revealed the EMR vendor in the title of the piece:

Hollywood Presbyterian Medical Center McKesson EHR Hacked And Hospital Data Being Held for Ransom..

If you prefer a little less innuendo and speculation, here's the FoxNews version:
A Los Angeles hospital paid a ransom of nearly $17,000 in bitcoins to hackers who infiltrated and disabled its computer network because paying was in the best interest of the hospital and most efficient way to solve the problem, the medical center’s chief executive said Wednesday.

Hollywood Presbyterian Medical Center CEO Allen Stefanek said the hackers demanded a ransom of 40 bitcoins, currently worth $16,664. The FBI is investigating the attack, which began on Feb. 5.

Authorities said this kind of attack is called “ransomware,” where hackers encrypt a computer network’s data to hold it “hostage,” providing a digital decryption key to unlock it for a price.

"The quickest and most efficient way to restore our systems and administrative functions was to pay the ransom and obtain the decryption key," Stefanek said. "In the best interest of restoring normal operations, we did this."
This implications of this sad situation are staggering. Some little twerps, most likely operating from outside of the United States, brought a hospital to its knees, forcing it to pay a ransom to continue operations (and surgeries too, we assume.) I'll bet this has happened before, but hasn't been reported by the IT and IT Security folks affected. I'd be embarrassed too. That the little miscreant involved settled for "only" $17,000 in untraceable Bitcoins suggests that he is but a lowly amateur. And that is even more frightening. If some high-school kid in an Internet cafe can do this, what could government-backed (and you know which governments I mean) hackers accomplish? What could ISIS-owned hackers do to us?

Everything we associate with daily life is hooked into the Internet somehow. Communications, entertainment, health-care, power plants, missile launchers...pretty much everything. Now I'm a firm believer in individuals, companies, enterprises, etc., taking reasonable precautions against hackers. Cybersecurity is big business and rightly so. But the relatively minor incident in California is a HUGE wake-up call, not that we really need it. Hacking our infrastructure via the 'Net is a huge national security issue. We are in just as much danger from the hackers as we are from the crazy kid in North Korea with the bad haircut and shiny new intercontinental ballistic missiles. With a few key-strokes, a hospital was taken down (proving Dalai's First Law in the process: PACS IS the Radiology Department). With a few more, a nuclear power plant could shut down. Or melt down. That's no exaggeration.

We the People need to be protected from this sort of thing, and it is our government's job to do so. Yes, they are trying, half-heartedly, without adequate time, money, or effort, to fight against a hidden enemy. I've been told by execs from phone companies that the telemarketers hacking and spoofing their systems have better software and better technology than we do. If they can bollux our phones, if we can't defend our communications networks, we're sunk.

Our administration, in its infinite wisdom, will be turning over control of the Internet to the UN. Great. Most governments of Third World nations, not to mention quite a few Second World countries,  ISIS, and other nice folks, either ignore illegal Internet activity, or actively encourage and participate in it. And there are no consequences from us. Zero.

How to solve this? Somehow we have to let our "friends" overseas know that we won't tolerate this anymore. Do we have to sever the Internet backbones? I hope not but unless the rest of the world will police their own vermin, we will have to do it for them, or at least isolate ourselves from the infection. There need to be sanctions, fines, treaty revocations, and I don't know what else to put a stop to this.

As for home-grown United States-based hackers, we have to institute some VERY severe punishments. Up to and including capital punishment for anyone whose illicit activity leads to the death of innocents. And we have to have a moon-shot level program to boost our technology to surpass that of the criminals.

I'm mad as Hell about this. Our government has failed to protect its citizens, and that has to change.

NOW.

Saturday, February 06, 2016

The Measure Of A Company



The measure of a man cannot be whether he ever makes mistakes, because he will make mistakes. It's what he does in response to his mistakes. The same is true of companies. We have to apologize, we have to fix the problem, and we have to learn from our mistakes.

Wil Shipley

Software, being written by humans (until Watson gets the hang of it, I suppose) is going to contain errors. When the program has something to do with the medical field, those glitches could cause devastating effects.

Now being human as well, and having made my share of mistakes in interpreting images over the years, I'm not really trying to throw stones at the software folks. But when a glitch is found, there are ways to deal with it, and ways NOT to deal with it.

The latter is easy to recognize. Say one has a shiny new PACS system that skips CT slices intermittently. Telling the customer that it's an issue with the code, and the next fix will come roughly a year after the software went online is probably NOT the best approach. Having a PACS that sometimes doesn't inform the user that there are prior issues, and spending lots and lots of time backpedalling and outlining how the issue was bounced back and forth and back again within the corporate structure is definitely NOT how I want things handled.

So how should our friends in the medical software market do their mea culpa's? An excellent question. Here is how Merge Healthcare did it with two recent letters to their customers.

These two notices arrived January 27, 2016:

URGENT: MEDICAL DEVICE RECALL
Recall #2016-012
January 27, 2016
Dear Radiology Manager or PACS Administrator,
This is to inform you of a product recall involving:
Product:
Merge PACS™ V6.0.2.0 MR2 and earlier. We shipped these products May 2006 through June 2010, or earlier from Amicas. 
Issue:
This recall has been initiated due to an issue in which the patient name in the Halo title bar may not update to match the name on displayed images due to the JAVA running out of memory.
Potential Harm:
Use of this product may result in a mismatch of the displayed patient name on the Halo title bar and the displayed images. 
Product Containment:
A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. The use of Merge PACS does not need to be discontinued.
Instructions:
An upgrade for Merge PACS is available for this issue. Call Merge Customer Service at (REDACTED) to schedule the upgrade. 
If you decide to decline this maintenance release, please complete (REDACTED)
  
Please ensure that all users of the product are provided with this notification. Your assistance is appreciated and necessary to prevent patient harm.
If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide. If you have any additional questions, call Merge Customer Service (REDACTED)
This recall is being made with knowledge of the Food and Drug Administration.

And...

URGENT: MEDICAL DEVICE RECALL
Recall #2016-012
January 27, 2016
Dear Radiology Manager or PACS Administrator,
This is to inform you of a product recall involving:
Product:
Merge PACS™ V6.0.2.0 MR2 and earlier. We shipped these products May 2006 through June 2010, or earlier from Amicas. 
Issue:
This recall has been initiated due to an issue in which the patient name in the Halo title bar may not update to match the name on displayed images due to the JAVA running out of memory.
Potential Harm:
Use of this product may result in a mismatch of the displayed patient name on the Halo title bar and the displayed images. 
Product Containment:
A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. The use of Merge PACS does not need to be discontinued.
Instructions:
An upgrade for Merge PACS is available for this issue. Call Merge Customer Service at (REDACTED) to schedule the upgrade. Reference this recall #2016-012.
If you decide to decline this maintenance release, please (REDACTED)
  
Please ensure that all users of the product are provided with this notification. Your assistance is appreciated and necessary to prevent patient harm.
If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide. If you have any additional questions, call Merge Customer Service at (REDACTED)
This recall is being made with knowledge of the Food and Drug Administration.

You get my drift. Face up to the glitches, let the customers who haven't yet found them know they exist, and FIX them. Sounds like a plan. A plan other vendors need to follow a bit more religiously.


Monday, January 25, 2016

Reporting In

A few weeks ago, I received this message from one of the top Merge execs (emphasis mine):

Notification of Enhanced FDA Reporting Methodology

Dear Valued Customer,

As part of our commitment to ensure compliance and driven by our objective to deliver high-quality medical devices, we want to inform you of a change in our quality management processes to provide greater transparency to our customers and raise the bar on delivering quality in the medical device industry. I also want to take this opportunity to reiterate Merge Healthcare's commitment to implementing corrective actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and all regulatory requirements. Merge's executive management team takes the FDA’s observations seriously, and we have been fully cooperating with the FDA to resolve any questions or concerns expressed by the FDA.

Merge Healthcare has enhanced its FDA reporting methodology to report to the FDA product corrections and removals including those that may be classified by the FDA as Class III recalls. For clarity, Class III recalls signify the lowest potential risk situations, representing minimal impact to patient care. In this context 'recall' can be a form of communication and should not be interpreted as always requiring an update to a product. This change in policy will also increase transparency and notification to the FDA of Corrections and Removals associated with our medical devices. As a result, it is very possible that you will see an increased number of reported events on the FDA website. You will also see an increased number of messages from us, explaining the details around the event and any required action that may need to be taken.

So what does this mean to you? It means that we will continue to provide timely and comprehensive communication and information about the use of our products and overall product quality. It also means we will continue to deliver solutions you can trust and that help you provide the best patient care possible. And lastly, it means we will continue to provide world class support of those solutions and provide the opportunity for you to take advantage of our latest product advancements.

Merge Healthcare intends to advance the delivery of quality, patient-centric solutions in healthcare. We thank you for your continued partnership with Merge Healthcare and look forward to continuing to serve you for your current and future needs.

If you have any questions or would like to discuss this matter further, please feel free to reach out to me at your convenience.

I am gratified to read this; it is an upstanding and even courageous stance.

Software, being written by human beings, always contains some mistake or glitch or something. The PACS created by Merge, and its predecessor AMICAS, are no exceptions. THIS LINK takes you to the 11 complaints I could find about Merge PACS. THIS LINK shows a few more, older complaints when AMICAS ran things.

By the way, MAUDE in the list of problems stands for: "Manufacturer and User Facility Device Experience". I guess that could be positive or negative.

Having a problem? Your government is here to help you. Search for it at: