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The Patient Safety Puzzle
by Karen Stassi
PUBLISHED: September/October 2011
READ PAGE FLIP or READ PDF
A little over a decade ago the Institute of Medicine
(IOM) published a report called “To Err
is Human: Building a Safer Health System.”
The report highlighted the shocking fact that
44,000-98,000 people died in the U.S. each
year due to largely preventable medical errors;
a number exceeding deaths by motor vehicle
accident, breast cancer, and AIDS.
While quality improvement was already a hot topic in healthcare,
the IOM report blew it out of the water, calling for a 50%
reduction in medical errors in the ensuing five years. It was a
catalyst for sweeping change and a myriad of initiatives tightening
the focus on patient safety. Now it is hard to talk about
quality without patient safety foremost in the discussion. It
gets top billing over financial matters in hospital boardrooms
across the country. Healthcare facilities have revamped their
processes and thrown millions of dollars at the problem. Yet,
according to some analysts, the improvements in patient safety
are less than inspiring.
The number of wrong site surgeries appears to have risen. There
are still hundreds of thousands of medication errors annually,
leading to more than 750,000 injuries and deaths. Nearly one
in five Medicare patients discharged from the hospital is readmitted
within 30 days. The Centers for Disease Control (CDC)
estimates that approximately 1.7 million healthcare-associated
infections occur each year and lead to 99,000 deaths. According
to the National Quality Forum (NQF), medical-related harm is
now the third leading cause of death. In a recent Joint Commission
podcast, Jerod Loeb, PhD, Executive Vice President, Division
of Healthcare Quality Evaluation, said, “There is an epidemic yet
of serious and predictable adverse events. In fact the risk of errors
that lead to harm is increasing...”
Not only are the loss of life and disabilities resulting from adverse
events intolerable, they are also costly. The NQF reports that costs
associated with medical harm are estimated to range between
$17 billion to $29 billion when healthcare expenses, lost productivity,
income, and disability are all taken into account. “We spend
$2.7 trillion in this country on healthcare,” said Kenneth Phenow,
MD, Chief Medical Officer at Blue Cross and Blue Shield of Louisiana
(BCBSLA). “That’s twice as much as any other developed
country in the world and our quality does not reflect the amount
of resource we put into healthcare.” So what on earth is going on?
While the experts are still scratching their heads, theories include
the fact that healthcare has gotten more complex and increasingly
fragmented leading to more opportunities for miscommunication
and dropped balls. Tighter time constraints and new
technologies may make us prone to distraction. Others believe
that with so many outpatient healthcare options available to us
now, the patients who actually end up in the hospital are the ones
who are seriously ill and sicker patients are more likely to experience
adverse outcomes. Whatever the reason, the fact remains
that we are failing. Not everyone of course. The Joint Commission
acknowledges that there are pockets of excellence across the
country. In Michigan, for example, central line associated blood
stream infections (CLABSI) were reduced to almost zero in just a
year and a half. Proof that it can be done with the right tools, the
right focus, the right level of commitment.
Patient safety has long been a focus of the Joint Commission.
In addition to providing patient safety measures required for accreditation,
since 1995 the Joint Commission has required that
hospitals report sentinel events, defined as an “unexpected occurrence
involving death or serious physiological injury or the
risk thereof.” The Joint Commission also considers as sentinel
events the 28 “never events” designated by the NQF. Those “unambiguous,
preventable events that result in death or serious
disability” include items such as wrong site surgery, use of contaminated
equipment, medication errors, patient abduction, and
falls. A complete list can be found at the National Quality Forum
website at www.qualityforum.org. What is startling about both
the never events and the patient safety goals provided by the
Joint Commission and reinforced by other organizations and
initiatives is that, for the most part, they seem so intuitive, so
straightforward. And any given hospital will be quick to detail
the changes they have made and continue to make to ensure
their patients have a safe experience. Yet somehow it hasn’t been
enough and we are still tackling the same issues the IOM highlighted
more than ten years ago.
It’s not for lack of effort or desire, said Ken Alexander, Louisiana
Hospital Association (LHA) Vice President of Quality &
Regulatory Activities. “Everybody is trying to give the best care
possible, bottom line. Performance improvement isn’t new to
hospitals. It’s been out there a long time. It’s are we measuring,
are we benchmarking, are we knowing how we are doing? I think
that’s where hospitals to a large extent were–maybe not looking
and focusing and measuring the right things.” The consensus
seems to be that most adverse events stem from process and
system breakdowns in hospitals, not from a lack of skill, education,
or care by providers. However despite all the goals and
checklists being implemented and all the focus on seemingly
common sense practices, errors are still occurring. “The problem
is a lot of those things are so routine that you take them for
granted,” said Alexander. “You just assume you are doing it until
you stop and analyze.” Patient safety goals need to be kept top of
mind and in focus, he urged. “When we get busy with life and all
of that stuff, you may not focus and attack it in that systematic,
process-oriented way.”
While the reasons medical errors have been so hard to eliminate
may still elude us, the fact is, when the numbers of adverse
events weren’t dropping the way they had anticipated, the federal
government started to take notice. In 2007 the Centers for
Medicare and Medicaid (CMS) announced it would no longer
pay for additional costs associated with many preventable errors
including never events. As the largest payer, CMS tends
to serve as a model for other payers, and true to form, many
private insurers, like Blue Cross and Blue Shield of Louisiana,
have followed suit and now do not pay for never events. “What
has happened is without the government and payers being able
to see the kind of widespread results they had been looking for,
they have felt they need to incent or disincent this,” said Richard
Vath, MD, VP of Medical Affairs at Our Lady of the Lake
Regional Medical Center (OLOL). “My personal belief is that
will get the attention of the other players that weren’t really on
board with this idea. It will get them to begin playing hopefully
at the level that we’ve been playing for some time. It’s a little
disappointing that that’s what it took, but I think that’s what
we are seeing right now.” Phenow thinks that while the initial
call to improve patient safety came from academic circles like
IOM, “Over the last ten years the siren has been sounded and
there’s been a lot of work done to try to reduce those medical
errors at the hospital, driven to a large degree by payers,”
said Phenow. Not only are private payers like BCBSLA, United
Healthcare, and Cigna pushing it, but also CMS, said Phenow.
“And now, as we move into the era of managed care in Medicaid,
we’re going to see it in Medicaid as well.”
“It’s difficult to talk about which ones we shouldn’t get reimbursed
for and which ones we should,” said Vath, who explained that
OLOL adopted some best practices that called for contacting
the patients and considering the financial impact when adverse
events occurred. The hospital reviews events on a case by case
basis, said Vath, but, “Now it’s kind of taken out of our hands
because CMS has pretty much laid the groundwork and all the
payers are jumping on board in terms of Healthcare Associated
Conditions.” Phenow confirmed that BCBSLA followed CMS’ lead
in not paying for never events, and is beginning to tie reimbursement
more closely to quality. Last year, said Phenow, BCBSLA
instituted a type of pay for performance program where, when
hospitals ask for increases, they are tied to quality improvement
benchmarks. “We give the hospitals a choice of four different
safety items to focus on: central line associated infections, using
surgical checklists every time they operate, reducing the number
of C-sections performed, and reducing the rate of pre-term
inductions between 37-39 weeks,” said Phenow. “Hospitals have
a choice of which ones they want to take on and they are paid a
certain amount if they are able to show improvement over time.”
While CMS has also tied reimbursement to quality through incentives
and disincentives for reporting, implementing EHRs, reducing
readmissions, etc., they will ramp up those efforts in 2013.
Required by the Affordable Care Act of 2010, CMS’ new valuebased
purchasing program for acute care hospitals will make incentive
payments to hospitals based on their achievement or improvement
on both clinical and patient experience measures. The
intent is to transform Medicare from a passive payer of claims
based on volume of care to a purchaser of care based on the quality
of services beneficiaries receive. The quality measures CMS
proposes to use for the FY 2013 hospital value-based purchasing
program can be found in Figure 1. In 2014, CMS proposes to
adopt three mortality outcome measures, eight Hospital Acquired
Condition (HAC) measures, and nine Agency for Healthcare Research
and Quality (AHRQ) measures for the Hospital VBP program
(Figure 2).
When CMS first started with their core measurement program,
they gave hospitals the option of reporting or not reporting data,
said Phenow. Then they started paying hospitals for reporting.
Now in 2014, hospitals will have to pay for not reporting. It’s a
typical regulatory cycle for CMS and private payers are following
their example. “That’s the way CMS has done it and frankly that’s
the way we’re going to do it,” said Phenow. “We’ve started by offering
a little bit of a bump in their rates if they start reporting this
data and showing improvement. Then over time that program will
become more robust and there will be a greater percentage tied to
performance. Eventually we won’t reimburse them if they aren’t
performing to a certain degree.” Hospitals are going to inherently
listen to the people who write their checks so they can continue
to be hospitals, said Alexander. “It’s not their only focus, the only
thing they’re looking at, because there’s all kinds of stuff they can
involve themselves in, but they are going to make sure that whatever
they are involving themselves in, it’s targeted to whatever CMS
says, because that involves their participation in Medicare, whatever
the state Medicaid program says, because that’s their participation
in Medicaid, and it’s whatever the Joint Commission says.”
This April, with funding from the Affordable Care Act, the U.S.
Department of Health and Human Services (HHS) launched the
Partnership for Patients, a public/private partnership engaging
all stakeholders to work on these common goals:
• Keep patients from getting injured or sicker. By the end of 2013,
preventable hospital-acquired conditions would decrease by 40%
compared to 2010. Achieving this goal would mean approximately
1.8 million fewer injuries to patients with more than 60,000
lives saved over three years.
• Help patients heal without complication. By the end of 2013,
preventable complications during a transition from one care setting
to another would be decreased so that all hospital readmissions
would be reduced by 20% compared to 2010. Achieving this
goal would mean more than 1.6 million patients would recover
from illness without suffering a preventable complication requiring
re-hospitalization within 30 days of discharge.
Achieving these goals will not only save lives and prevent injuries
to millions of Americans, it has the potential to save up to $35
billion dollars across the health care system, said HHS, including
up to $10 billion in Medicare savings, over the next three years.
HHS anticipates that over the next ten years, it could reduce costs
to Medicare by about $50 billion and result in billions more in
Medicaid savings. While the Partnership for Patients is pursuing
the reduction of all-cause harm, there are nine areas of focus:
• Adverse Drug Events (ADE)
• Catheter-Associated Urinary Tract Infections (CAUTI)
• Central Line Associated Blood Stream Infections (CLABSI)
• Injuries from Falls and Immobility
• Obstetrical Adverse Events
• Pressure Ulcers
• Surgical Site Infections
• Venous Thromboembolism (VTE)
• Ventilator-Associated Pneumonia (VAP)
At last count, 2000 hospitals and more than 4000 organizations
had joined the initiative, including the Louisiana Hospital Association
and area hospitals. Some were already working on areas
targeted by the Partnership for Patients and are engaged in a variety
of patient safety initiatives and strategies. One of the biggest,
said Alexander, has been the CMS pilot that most Baton Rouge
hospitals engaged in with eQHealth Solutions, the state’s Medicare
QIO. The project’s goal was to reduce 30-day readmissions
through a coaching program. The project saw substantive reductions
in readmissions during the two-year pilot and won national
acclaim. Now LHA has partnered with eQHealth Solutions to take
the project statewide. In addition, in October, 2010, LHA started a
collaborative to address central line associated blood stream infections
(CLABSI). Now hospitals are starting to implement the tools
and to see improvements. Alexander said they are seeing staff buyin
and excitement that he believes will spread to other areas of the
hospitals. “That’s going to follow through whether you are talking
about a central line infection or hand washing across your facility.
It kind of breeds itself,” said Alexander.
In addition to working with LHA, hospitals are involved in a lot
of patient safety initiatives on their own, said Alexander. For example,
the LSU Health Care Services Division (LSUHCSD) is part
of the National Association of Public Hospitals Patient Safety
Initiative which provides them with resources for patient safety
and allows public hospitals to learn from each other, said Michael
Kaiser, MD, Chief Medical Officer for LSUHCSD. As part of
this initiative each LSU hospital has established a Patient Safety
Committee, implemented the Ask Me 3 campaign, participated in
the annual Patient Safety Week and completed the AHRQ Hospital
Survey on Patient Safety. And in July, 20 Louisiana hospitals
agreed to participate in the Louisiana Department of Health and
Hospitals 39-week Initiative, a voluntary program in which hospitals
agree to establish policies to end the practice of elective,
non-medically necessary deliveries prior to 39 weeks gestation.
Because of their staggering numbers and devastating impact, an
ongoing focus, both nationally and locally, remains on hospital
acquired infections. In Louisiana alone, HAIs affect 29,000 patients
annually and cause about 2,500 Louisianans to die basically
needless deaths, said Phenow. They also increase hospital
stays by 253,000 days and increase healthcare costs by over $400
million. Based on preliminary results from six sample hospitals,
BCBSLA estimated that about 44% of hospital acquired infections
are urinary tract based. Respiratory infections count for
18%, wound 16%, blood borne 12% and GI tract infections 10%.
“Initially we thought hospitals would take care of their own house
and figure this out” said Phenow. “But the data hasn’t shown
much movement, so I think there is a certain amount of concern
that we need to tighten the focus.” BCBSLA recognized that some
hospitals may lack the resources to address their infection rates
at the level of sophistication that is now required, so the insurer
has partnered with an organization called Care Fusion to form
the Louisiana Hospital Quality Initiative. Care Fusion provides
a surveillance program called MedMined™ that identifies patterns
in hospital data and shows where the processes are breaking
down and allowing for infections to occur. BCBSLA is providing
grants to 27 hospitals to participate in a 21-month program using
MedMined™ and participating in educational seminars to help
prevent hospital acquired infections from occurring. “The problem
is just identifying where in the system, because there are so
many processes taking place in a hospital, where in the process
the breakdown is occurring, where these issues of infection are
being introduced, resulting in unnecessary mortality and morbidity,
hospitals stays, and hospital costs,” said Phenow. With Med-
Mined™, hospitals can do this without the massive chart reviews
and data analysis that were required in the past, he said. “I think
CMS is going to get very involved in this,” said Phenow. “I think
Blue Cross is really one of the first to jump on board.”
Technology has been an important patient safety tool for hospitals.
Many have computerized and bar-coded medication systems
to prevent errors. Most have incorporated prompts, safeguards,
and reminders into their electronic health record and bedside
monitors to force providers to stop, think, and focus. For example,
in an effort to address foley catheter infections, OLOL put
prompts into their system to help drive providers to review the
circumstances. “They don’t have to remember all these individual
steps, but as they go about their day-to-day functions we remind
them, is there a reason this device
needs to stay in?” said Vath. An increased
use of technology, particularly
to ensure medication safety, is one
half of the LSU Health System’s two-pronged
approach to patient safety,
according to Kaiser. The other half is
creating a “culture” of safety, one of
the other buzzwords in the patient
safety world.
In fact it is one of three things recently
identified by Joint Commission
President Mark R. Chassin,
MD, FACP, MPP, MPH, and Dr. Loeb
in their new approach to patient safety.
Modeled after strategies used by
other high risk industries like aviation
and the chemical industry, the
concept, called High Reliability, focuses
on consistent excellence over
long periods of time and requires
three changes in healthcare:
• Leadership buy-in. Top leadership must visibly make High Reliability
the top priority.
• Culture of safety. Facilities must create a culture of safety that
emphasizes trust, reporting, and improvement.
• Quality methods. Proven quality improvement tools such as
Lean, Six Sigma, and Change Management must be implemented
to systematically improve processes.
“High Reliability offers healthcare the best hope yet to achieve
and sustain the elusive goal of consistent excellence in safety and
quality,” said Loeb.
For some, The Joint Commission may be preaching to the choir.
Many local facilities have already incorporated those changes into
their way of doing business. For example LSUHCSD has created a
safety council where the seven hospital administrators meet on a
monthly basis to educate themselves about safety tools, create an
open environment, share issues that might be beneficial for other
hospitals, discuss something unexpected, or address something
a regulatory agency identified. At OLOL, the CEO participates in
patient safety rounds with pharmacy heads, the patient safety
chief, medical directors, and other leadership. Patient safety is on
the agenda at all board meetings and retreats. And almost every
local hospital is already using principles of Lean and Six Sigma
to improve their processes and chase the goal of zero errors. But
there is always improvement to be made.
“I think that the patient safety goals in most instances, with most
employees and most procedures, have been fully incorporated and
implemented,” said Dr. Kaiser. “But as with everything, getting
the last little bit, from doing something 97% of the time to 100%
of the time, that’s the challenge.” He said things that were once
being done intermittently, like timeouts, are now the standard. “I
think most of us who have done this work for a long time believe
that if you continue to tweak these processes and you continue
to have the focus of driving it to zero, I think you can get nearly
there,” said Vath. “There are so many variables including what the
patient does in their own home after discharge that we haven’t
really even touched on,” he explained. The key, says Alexander, is
to focus attention on the details, to measure the right things, and
track how you are doing, to take the subjectivity out of it. He does
not believe we will ever be error free, but he thinks we can get very
close. “I can tell you that hospitals are light years ahead of where
they were 20 years ago in focusing on quality and having it integrated
into their culture.” He acknowledges that some of the cultural
and funding issues that Louisiana deals with sets the state
at a disadvantage in rankings, but, “I think as far as dedication to
patient safety, the willingness to work to improve patient safety,
and the desire to improve patient safety, we are on a par with anybody
out there,” he said.
What has been helpful about the patient safety movement in the
last decade, explained Vath, is that it has made clinical quality a
very personal thing. “I think it really became the catalyst to get
all healthcare providers and all healthcare workers interested at
a very personal level in improving the quality of the process to
deliver the healthcare in a quality way and in a consistent fashion,”
said Vath. He said that the Institute for Health Improvement
started 5-10 years ago focusing its efforts on very narrow areas
like central line associated blood stream infections and gradually
added more and more things to create a portfolio on defining patient
safety within an institution. In the last five years that has
evolved and “although we focus on all of these individual things,
it has matured into looking at what happens overall in the institution.”
Vath thinks it’s important to not get caught up in the weeds
of individual safety issues, but to take a broader view. One of his
first roles at OLOL was to “build a foundation of patient safety
as a literal trump card that trumps everything else in terms of
clinical decisions within the organization,” he said.
Another strategy both hospitals and insurers are using is to involve
patients in their own safe care. Some insurers provide tips
to patients before they go to the hospitals. Hospitals have implemented
programs like LSUHCSD’s Ask Me 3, to empower patients
to speak up and question any aspect of their care such as whether
a caregiver washed their hands or if the medication or dose is correct.
However, there remains to some degree an innate hesitancy
to question the doctor or the hospital. “We wouldn’t think twice
at a car repair shop about asking questions about what we are paying
for,” said Alexander. “Yet we often hesitate to question a doctor
or nurse.” He said that hospitals will be doing more and more
to encourage that dialogue and to make patients feel they are a
partner in their care, not only because it has been proven to help
avoid errors, but because under value-based purchasing, hospitals
will be measured not only on clinical indicators, but also the patient
experience through the Hospital Consumer Assessment of
Healthcare Providers & Systems Survey (HCAHPS). Vath agreed
that it is important to continue to build a culture where patients
or their caregivers feel comfortable to ask questions or challenge
something. “The patients or the patients’ caregivers really need to
be able to call the shots on a patient safety or quality issue so they
can get the help they don’t feel they are getting.”
Enhanced communication between caregivers, departments,
and healthcare facilities is also important. Whether it occurs
on the floor or during a handoff, a gap in disclosure can have
tragic consequences. Many hospitals have instituted team huddles
at shift changes and focused renewed efforts on discharge
processes to make sure all pertinent information is passed on.
It is also important that all team members are heard and are
empowered to “stop the line.” Checklists and timeouts only
work if they are used and there can be resistance, particularly
among doctors, to follow them. Kaiser agreed that despite educational
efforts to ensure everyone on the multidisciplinary
team knows their role, some doctors can feel challenged if they
are called out. Conversely, some team members may hesitate
to call a timeout or enforce a checklist if they feel intimidated.
Those breakdowns are something LSU explores in its root
analyses of adverse events and reported near misses, said Kaiser.
It’s not always a conscious decision not to follow the steps,
said Alexander, but it is human nature to become complacent
about routine tasks. Often it is not until it is measured, that it
becomes apparent that you are not following every step.
While it is acknowledged that most hospitals are making concerted
efforts to ensure their patients’ safety, there continues to be a
push by some regulators and payers for increased public reporting.
Some feel that until all adverse events are publicly reported, they
will not get the public attention and outcry that could eliminate
them once and for all. Only 28 states currently mandate public
reporting although it is coming soon to a state near you, said Alexander.
Some providers are still resistant, expressing fears about
variability of data. “Conceptually I am a believer in public reporting
and transparency, but as with all things, it’s all in the details,”
said Kaiser. “The complexity of the patients, the different acuities,
facility differences, different staffing ratios, all those make
apples to apples comparisons very difficult.” For example, he said,
LSUHCSD’s readmission rates may differ from other hospitals,
but the numbers do not take into consideration the types of patients
they treat and what happens when the patient goes home.
“That may affect mortality and readmission more than anything
we did while they were at the hospital. Public reporting doesn’t
cover those nuances very well,” said Kaiser. Public reporting or no,
Blue Cross plans to start providing its customers, brokers, and employers
with more data on hospital performance. “They will, over
time, begin to bring some pressure to bear on hospitals because
nobody wants to pay good money for bad outcomes,” said Phenow.
BCBSLA has started to designate certain hospitals as Blue Distinction
hospitals, meaning they have met very stringent criteria
on certain quality outcomes. “We are going to be getting more
and more information out to our members about what are the
best hospitals when you need a certain procedure,” said Phenow.
“I can tell you there’s a lot of activity in quality these days in hospitals,”
said Alexander. “The majority of that is self-generated from
the hospitals wanting to look for ways to improve how they are
caring for their patients. Some of that is government induced
with the CMS initiatives coming out–what we know as the ‘thou
shalts’. Some of it is financially induced. Nobody likes the regulatory
stick,” said Alexander. “But in a lot of ways it puts a broader
attention on the area of patient safety.” Phenow stressed that he
thinks it’s, “important to recognize that we are working with our
providers and our patients on multiple fronts to try to drive better
value in healthcare, better quality at better cost, and really enhance
the patient’s quality of life.”
Whatever the incentives or disincentives or which initiatives or
collaboratives hospitals choose to embark on, however, the numbers
indicate that challenges remain. “The same big three areas
have always remained and I think will always remain because of
the complexity of healthcare and the number of people involved in
healthcare delivery to an individual patient,” said Vath. In his opinion,
those are medication safety, reducing potential for healthcare
associated infections, and handoff from one caregiver to another,
whether it’s a shift change, doctor change, discharge, etc. Dr. Kaiser
feels the biggest challenge remains one of culture change, of
every team member realizing they need to be aware every time
something didn’t go as it should, regardless of whether there was
an adverse outcome. “When there’s an adverse outcome, I think
that’s pretty well established, but when there’s not, I think that’s
a harder challenge,” said Kaiser. “We still need to work on the culture
so people feel comfortable identifying potential problems.” He
added, “I think we will never be in an era where there are no adverse
events, where things didn’t go as one would have planned or hoped,
but I think we can get to an era where we have all the safeguards
in place to take the human element out of those adverse events. I
think it is a reasonable goal that when a patient comes to one of
our clinics or hospitals we’ve done everything 100% of the time to
make that experience a safe one.”
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