HIStalk Quotes
Do We Need an Institute for Safe Clinical Information Systems?
We've had good discussions here recently about vendors and their products: documentation, database design, testing, and human interface design. Many of us believe that clinical system vendors could (and should) do a better job designing software products that are easier to use for clinicians and safer for patients, although it's naive to think that will happen without motivation and without additional cost (dollars or opportunity.) Currently marketed products are often poorly and inconsistently designed, have logical and technical flaws or inconsistencies that may harm patients, and are marketed beyond their actual capabilities. The competitive bar is set rather low and risingly only occasionally and slightly.
I'm reminded of the early days of the Institute for Safe Medication Practices (ISMP.) When it was founded, drug companies did pretty much whatever they wanted. Drug names and labels caused mistakes. Hospitals didn't share their error experiences, meaning patients kept getting harmed by known problems such as confusing labels or inadequate instructions. Medication errors weren't reported, acknowledged, or discussed as a topic of interest for most hospitals. They weren't even on JCAHO's radar. Everyone knew that patients were being harmed, but no one stepped up as a patient advocate to insist that the industry could do better.
Mike Cohen made it his life's work to improve this sorry situation. He founded ISMP to serve as a clearinghouse for information, to nudge the drug industry constantly, and to establish standards (voluntary or otherwise) to reduce patient harm from medication mistakes. He brought medication errors out of the closet and saved countless patients in the process. ISMP even got involved with sofware topics, such as their excellent Field Test to assess the clinical capabilities of medication systems. It didn't take academic committees, government regulation, or endless strategic posturing. It took one guy with an unrelenting desire to right an obvious wrong.
Here's my conclusion: we need an organization like ISMP for clinical information systems. We don't necessarily need or want FDA oversight for software. Healthcare IT has always been a small industry where everyone, vendor and provider alike, knows each other. Why can't we form our own independent and nonprofit organization like Mike Cohen did? Why can't we create an Institute for Safe Clinical Information Systems?
What could a group like this accomplish?
- Assess and certify the potential of a given software application to cause patient harm through errors, confusing design or likely inappropriate use by clinicians.
- Publish findings of these product evaluations to guide prospective customers and alert existing ones..
- Review and publicize known issues with clinical applications that may cause patient harm.
- Collect, evaluate, and distribute information on clinical errors due to software.
- Design testing scenarios and tools for general use.
- Develop usability standards, terminology, and metaphors for common clinical tasks: ordering, reviewing lab results, etc.
- Serve as a clearinghouse for clinical rules, order sets, protocols, and standards.
- Publish best practices.
Sometimes I say something controversial here just to spur discussion, but I'm serious about this idea. Vendors are not doing a good job and neither are their customers. Patients deserve better.
Am I nuts? Should I pursue this idea? Who's with me?
Tim, I'm with you. Count me in on the new Institute.
As HIT vendors look to more tightly integrate with medical devices - to the
point of interoperability - ensuring good practice is critial. Networked
medical devices might also benefit from this kind of oversight. It just so
happens that I'm at a 2 day study group to consider regulatory oversight
for networked medical devices, so your "modest proposal" is most timely.
I agree with the statements completely. The FDA is too bureaucratic,
however, I could see another organization like HIMSS or JCAHO trying to
control a group like this. There are so many pseudo-political or vendor
controlled organizations, of similar veins, in healthcare now that I'd fear
this could turn into a similar situation if not chartered correctly and
infused with a continual dose of strong provider-side leaders and experts.
i know it doesn't seem like it will change a thing, but CCHIT, having
adopted the work of the EHR TC within HL7 may have at least some inpact on
creating better software.
What does IHC have to say under their article of "Picis Revenues do not add
up?"...It is an interesting headline for a company who has a new board
member that for now anyway "does not have a chip on his shoulder!" - but
probably should to avoid any more bad press!
Oh Boy..here we go again..It has been a while since we heard from
Milwaukee's best. I am waiting for the Picis response and the certain
misinformation that will be coming at us... back and forth
especially...this time of the year!
I think you're right. Vendors and their clients do need to do a better
job. It's so comical as to what the vendors sell and subsequently
implement (which maybe different due to actual software limitations). The
software implementation discussion (previousdiscussion) is so true. It's
frustrating from having been a vendor analyst to say "yup, seen it. No,
don't know when it will be fixed. No, I don't control the process. Don't
know why we don't publish a list..." Subsequently, the client that has
trouble implements systems needs to do a better job in making changes to
maximize the systems capabilities as well as properly getting buy in and
input from the clinicians (how many times have we heard from less than
successful implementations that the first time the clinicians saw the
system was just before go-lives?). Finally, a point that's minimalized by
all parties, even after a go-live it takes a few years to shake out the
system as well as get all parties comfortable enough to be able to properly
utilize the given systems capabilities. Even then, you will have to
contend with humand being humans (and making mistakes).
I completely agree on a governance body for HIT. We can hope for
regulatory changes, but it's taking too much time and it's putting patients
at risk....bottom line. As a vendor, I can tell you the issue runs deep
into our organizations. I have worked to several large and small HIT
software development companies and the issues tend to be the same. Internal
issues with development, implementation and support are the norm. I see
this as the biggest factor in the issues with the end product. This is one
of the reasons I created the healthcare it forum (www.healthcareitforum.com
plug – plug;). I know it's an odd stance for a vendor, but I want all
software, implementation, and support issues out in the open for all
vendors. This puts incredible pressure on us to do the right thing and get
our house in order. Because….this directly affects the bottom line when
people do not buy because of known issues. Another body to audit the
software puts the added pressure to release a great product. My two cents…
