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So, you've heard about the institutional review board and our case study with
the Michigan project and I would now wanted to talk just about some other things
that we really need to be aware of when
we're doing quality improvement in patient safety work.
I'm going to call this risk and rights and we're
going to talk a little bit about what risk management can do for
you and also what the Institutional Review Board does for
any contracts that you have and
including any grants that you may receive to support your work.
Okay, so our objectives for today are to
understand the role of risk management and quality improvement.
There are lots of different departments in
litigation and legal work at each hospital that I've ever been to.
So to make sure you know what you need to seek
their approval for and you need to get consent as well,
but also an opportunity to look at some of the opportunities that
you have as a quality improvement or patient safety expert as
you move forward to see what we need to do before we make sure that
the information that we're putting out there does not put
us or the hospitals' intellectual property at risk.
We'll get started with in the US health care,
I think many of you already know this about from
the Harvard study about the number of deaths per year.
And actually, as you probably also know,
many people believe that this is
a significant low ball figure compared to what we actually see.
And as long as I've been working in patient safety and quality,
we've seen preventable harm which when I first began
working in this area wasn't even something that was really talked about or recognized,
but it is the third leading cause of death in the United States.
Meaning that all of those infections that we can prevent,
those falls, those decubitus,
and all the things that our patients
have that we used to just consider hospital sequelae,
most of them are preventable.
And in the US, three in 10 patients suffer a preventable harm,
which is quite significant if you're looking at 30 percent of the patients,
and the more things that you have done to you,
like if you're an ICU patient or you're having an operation,
the more procedures that you have,
the more likely it is that you have an adverse event.
The same with length of stay,
the longer that you stay in the hospital,
the greater your risk for an adverse event.
I think that what is also important is that up to
six of 10 patients report that they were not respected or heard.
And I think that this is a different kind of patient harm.
We're moving towards patient-centered care meaning that we want to know
the patient's opinion and we respect and
we include them as one of the health care team members.
Further, we're talking about
not only the physical harm but a lot of the cost that's associated with this so
nearly $1 million or $9,000 per
United States household are
spent annually on mistakes that we've made that are preventable.
So, very significant especially as we look to reduce costs of health care.
And we're looking to not only optimize
health care but being able to provide it to as many people as we can.
So as I said, when we started off,
every hospital legal department usually has multiple different groups of providers.
And I think that the list that I put here is
pretty much standard and the whole goal is to make sure that we are supportive,
our work is supported,
that we have strategic priorities that we're able to meet.
But also, that we are covered when we're out there doing our works,
and not only do we worry about litigation
and we have a general counsel and claims in litigation,
but we also have business transactions and those are often with either contractual,
whether it's somebody that we're hiring or when we hire our services.
And at the Armstrong Institute,
we have participated as an outside vendor numerous times in
both primary and secondary contractors for both statewide and federal work.
And there's many, many pages of reading that need to go into that.
There is also many opportunities for you to miss very important things.
The things that I worry about not only the scope of work but,
do they estimate the number of FTEs to do the work at an appropriate level?
Is there adequate compensation?
And is any of the work already out
there that may put you at risk where your program at risk?
And who is actually attending in the transaction?
Who are you training to make sure that you really understand your audience?
So, those are things that are very important.
Things that also can fall into that area are
how slides have to be labeled or how online education needs to be labeled.
So, just about anything that can
happen when you're a contractor really needs to be evaluated.
And we send everything to
not only our business transactions but also our institutional review board
who looks at it to make
sure that it falls in line with the requirement for the work that's being done.
There's also labor and employment for disputes with
employees whether they be unionized or non-unionized,
working hours for instance, vacation time,
time off, and then technology for commercial transaction I think is also very important
because a lot of what you develop as a quality improvement or
patient safety expert or even if you are primarily a clinical researcher,
if you develop something that has the potential to improve
patient care or diagnose something faster,
these are things that
the hospital legal department can
actually assist you in making sure that it's copyrighted
appropriately and then put out there on the market
and even offered for purchase sometimes by the second and third party vendors.
So, our focus today though is more about
risk management and what we expect from risk management in quality and safety.
So, risk management in general provides us legal advice for how we manage our patients,
on how we manage our medical staff.
If there are ethical issues, oftentimes,
we feel that there are things that we
do that might not be necessary but we're doing them because
maybe there is an opportunity for a better diagnosis
or maybe it's because the provider is
also afraid that if he doesn't order a significant tests,
it will open them up to litigation.
So, there are lots of different issues that we have risk management participate.
The other thing is, as I mentioned,
was the IRB attorney that looks over the contract that we're working with.
And they pretty much,
just like the business attorneys,
when they look at that, they look at the contractual work that we're
set to do and make sure that it's in our scope of work.
They also provide advice as to whether or not it
should be submitted to the IRB and almost always,
we take the opportunity that if we
think that there's going to be a publication out of it,
we do send it to the IRB.
And we submit it as either quality improvement or
non-human subjects which you would have heard Dr. La Marche talking about.
And depending on your quality improvement project,
it's a good idea to consult with your IRB especially if
there is a grant funded and you know that there's going to be publications,
if you lose copyright when the research is over,
and I think that what's important to know is that even though it's quality improvement,
sometimes we do call that quality improvement research because we do have baselines and
we have our baseline numbers and then we have our metrics that we
follow after the implementation.
And we look to see whether or not we made
a significant change either in a patient outcome such as length of stay,
mortality, and/or cost of care.
So, all of those things are really important.
In quality improvement, I think that
because we've always been taught that we shouldn't be competing on patient safety,
there's a lot of opportunity for sharing.
So I just wanted to go through some of the things that
have been pointed out to us in the many years that we've been doing
quality improvement for the last 15-20 years that I think were really important
to share with you so that you're making
sure that you're on the same page with risk management,
you have their support when you do share something,
and that there are some things that the hospital will limit your ability to share.
So, those stories that we tell to engage patients,
we have to also make sure that it's a story that's
ready to be told and won't put us at additional risk.
David Thompson DNSc, MS, RNAssociate Professor
