Transcript ADVERSE EVENTS OR… - New England Law Review

Can Hospitals Ever Do No Harm?
Accountability for Adverse Events
New England Law │Boston
October 20, 2011
Barry Furrow
Professor of Law and Director,
the Health Law Program
Drexel University Earle Mack
School of Law
c. 2011
A. THE SCOPE OF THE
PROBLEM
232,442 Medicare potentially
preventable deaths from 2007-09
• more than half associated with four common
hospital diagnoses: Sepsis (41,670); Pneumonia
(31,671); Heart Failure (28,004); Respiratory
Failure (27,404).
• Thirteenth Annual HealthGrades Hospital
Quality in America Study October 2010
BUT IT GETS WORSE
Current rates of adverse events among inpatients
at three leading hospitals are 33.2 percent of
hospital admissions for adults, up to ten times
previous studies.1
Hospitals house patients who are increasingly vulnerable
to harm due to error, and the complexity of the care
hospitals now provide increases the likelihood of those
errors. 2
1. David C. Classen et al, ‘Global Trigger Tool’ Shows That Adverse Events
In Hospitals May Be Ten Times Greater Than Previously Measured, 30
Health Affairs 581 (2011) (uses global trigger tool, a form of chart review that
searches for triggers that mark adverse events.)
2 . Mark R. Chassin and Jerod M. Loeb, The Ongoing Quality Improvement
Journey: Next Stop, High Reliability, 30 Health Affairs 559 (2011)
QUALITY IS SLIPPING:
Infections
•Rates of bloodstream infections increased by 8 percent
between 2008 and 2009.
•Urinary tract infections increased by 3.6 percent .
(Source: National Healthcare Quality Report, Agency for
Healthcare Research and Quality).
•For three of five major types of serious hospital-related
infections, the rate of illness increased in 2009. (Source:
Department of Health and Human Services annual
Quality Report).
QUALITY IS SLIPPING:
Standards
In 2009, less than half of 1,244 hospitals voluntarily reporting to
Leapfrog met Leapfrog's outcome, volume, and process
standards for six high-risk procedures and conditions:
•valve replacement (11.8 percent), abdominal aortic
aneurism repair (36.1 percent), pancreatic resection (33.5
percent), esophageal resection (31.5 percent), weight loss
(bariatric) surgery (36.6 percent), and high-risk deliveries
(29.9 percent).
•[Note: since hospitals report voluntarily, extrapolation to
the entire population of 5,800 non-federal hospitals would
produce lower results.]
WHAT ARE SOME CAUSES
OF ADVERSE MEDICAL
EVENTS?
Failures to Control “Bad”
Doctors
Volume of implantable
cardioverter-defibrillators
(ICDs) in hospital
patients: more than 40%
of the total number of
implanted ICDs not based
on evidence.
Sana M. Al-Khatib et al, Non–
Evidence-Based ICD Implantations
in the United States, 305 JAMA 43
(2011).
Failures to Manage Devices and
Technologies
Faulty device procurement.
Failures to Manage Drug Delivery
Errors
Failures to Provide Coordinated
Teams
Failures to Understood Risks
ILLINOIS WOMAN DIES AFTER CATCHING FIRE IN SURGERY
Friday, September 18, 2009
ST. LOUIS — A southern Illinois woman died after being severely
burned in a flash fire while undergoing surgery, a rare but vexing
problem in operating
rooms.: http://www.foxnews.com/story/0,2933,551361,00.html#ixzz1GifAtwO3
• Failures to Diagnose:
Missed Diagnoses and EHRs
Failure to Update Basic Safety
Functions
►Only 1.5% of hospitals in the United States have
implemented a comprehensive system of electronic
health records.
► Only 9.1% have even basic electronic record keeping
in place.
► Only 17% have computerized provider order entry.
► Physicians-in-training and nurses alike routinely
work hours in excess of those proven to be safe.
► Compliance with even simple interventions such as
hand washing is poor in many centers.
B. THE NEW PATIENT SAFETY
UNIVERSE
►Doctors and hospitals hurt and kill patients.
►The levels of such harms are surprisingly high, and every
new analysis raises the casualty rate.
►The patient safety movement is the new guy in town,
armed with electronics, data, and strategies for tackling
adverse medical events.
Governance to Prevent Harm
19
1. Purpose of Patient Safety
Efforts
• 1. Identify causes of patient injury – whether
“errors” or not.
• 2. Identify, design, test, and evaluate practices
that eliminate systems-related risks and
hazards that compromise patient safety.
• 3. Educate, disseminate, and implement best
practices.
• 4. Maintain vigilance in monitoring and
evaluating threats to patient safety
2. A BRIEF HISTORY OF
PATIENT SAFETY
• 1858. Florence Nightingale--use of
statistics to show effects of unsanitary
conditions in field hospitals; led to standard
statistical approaches for hospitals. Notes
on Matters affecting the Health, Efficiency
and Hospital Administration of the British
Army(1858).
• John Maindonald and Alice M. Richardson, This Passionate
Study: A Dialogue with Florence Nightingale, 12 J. Stat. Ed.
(2004).
www.amstat.org/publications/jse/v12n1/maindonald.html
History continued
• 1917. Dr. Ernest Codman-- ”End result
survey”: every hospital should follow every
patient that it treats, long enough to
determine whether or not the treatment has
been successful, and then to inquire 'if not,
why not?' with a view to preventing similar
failures in the future.” William Mallon, Ernest Amory
Codman: The End Result of a Life in Medicine (Philadelphia:
WB Saunders, 2000).
• Goal: A complete patient record to
evaluate, compare and establish
benchmarks for the performance of
physicians and hospitals.
History continued
• 1966. Avedis Donabedian--his 1966 paper
introduced the concepts of structure,
process and outcome. This way of
thinking about quality and its assessment
has been the foundation of quality assurance
and accreditation of hospitals.
• Donabedian, A. "Evaluating the Quality of Medical Care" The
Milbank Memorial Fund Quarterly, July 1966, (Part 2) 44:166203.
History continued
• 1976. Ivan Illich, Medical Nemesis: The
Expropriation of Health.
• “…[T]he frequency of reported accidents in
hospitals is higher than in all industries but
mines and high-rise construction. …University
hospitals are relatively more pathogenic, or, in
blunt language, more sickening. It has also
been established that one out of every five
patients admitted to a typical research hospital
acquires an iatrogenic disease, sometimes
trivial, usually requiring special treatment, and
in one case in thirty leading to death.”
History continued
• Establishment in 1975 of the Institute for
Safe Medication Practices (ISMP). ISMP
cofounders Davis and Cohen published a
text in 1981 giving a comprehensive
treatment of medication errors.
History continued
• 1981. Steel et al. Iatrogenic Illness on a
General Medical Service at a University
Hospital, 304 N.Eng.J.Med. 638 (1981).
• Study found that more than 36% of the
patients admitted to a hospital developed
iatrogenic illnesses, either a major or minor
complication. Nine percent had major
complications, and 2% of all patients died for
reasons related to the iatrogenic illness.
Exposure to drugs was an important factor.
History continued
• 1984. Anesthesia was plagued in the 80s
by high malpractice premiums, and by a
spate of stories about anesthesia
disasters. [Who says tort suits don’t work?]
• 1984 meeting of the American Society of
Anesthesiologists inaugurated the
Anesthesia Patient Safety Foundation
(APSF): goal was that no patient should
ever be harmed by anesthesia.
• Guidelines issued as early as 1984.
History continued
• 1991. Publication of Harvard Medical
Practice studies -- documented extent and
type of errors in 30,000 hospital
discharges in New York state.
• Replicated since in other populations in
the U.S. and other countries.
http://www.who.int/patientsafety/en/brochure_final.pdf
History continued
• 1996. Meeting of 300 experts held in the
Annenberg Conference Center near Palm
Springs, CA, convened by professional
organizations in response to several errorinduced sentinel events in the mid-1990s.
American Medical Association, the
American Association for the Advancement
of Science, the Veterans Administration,
and the Joint Commission on Accreditation
of Healthcare Organizations.
History continued
• 1997. High level of adverse drug events
in hospitals linked to lack of systems.
See David C. Classen et al., Adverse Drug Events in
Hospitalized Patients: Excess Length of Stay, Extra Costs, and
Attributable Mortality, 277 J.A.M.A. 301 (1997) (ADEs cause
prolonged lengths of stay, increased economic costs, and an
almost 2–fold increased risk of death); David W. Bates et al.,
The Costs of Adverse Drug Events in Hospitalized Patients,
277 J.A.M.A. 307 (1997) (ADE associated with about $2,600 of
additional costs to the hospital, and for preventable ADEs the
figure was almost twice as high); Timothy S. Lesar, Laurie
Briceland, and Daniel S. Stein, Factors Related to Errors in
Medication Prescribing, 277 J.A.M.A. 312 (1997) (risks of
ADEs reducible by improving focus of organization,
technological, and risk management educational and training
efforts).
History continued
• Early 1990s to present. Value
Purchasing. Emergence of large
purchaser coalitions pursing cost and
quality improvements through market-based
strategies, then copied by CMS.
• Value-Driven Health Care: A Purchaser’s Guide
http://www.leapfroggroup.org/media/file/Purchaser_G
uide_Final2-08-07.pdf
• Irene Frasier et al, The Pursuit of Quality by Business
Coalitions: A National Survey, 18 Health Affairs 158
(1999).
History Continued
1996: Joint Commission unveils its Sentinel
Event Policy, requiring accredited health
care organizations to monitor sentinel events
and to rigorously analyze the most serious to
determine the root causes of these events.
.
History continued
1999. Final catalyst:
the IOM Report,
To Err is Human
C. HOW DO WE DEFINE
DAMAGING CARE
EXPERIENCED BY PATIENTS?
Adverse or untoward events, Maloccurrences,
Complications, Medical injuries,
Therapeutic misadventures, Substandard care,
Unexpected outcomes, Preventable deaths,
Iatrogenic injuries, Medical Mishaps,
Errors, Malpractice?
IATROGENIC EVENTS
“ Disorder or illness that a
unintentionally
causes…through
manner or treatment”
physician
diagnosis,
SENTINEL EVENTS
“An unexpected occurrence involving death or
serious physiological or psychological injury, or
the risk thereof." Joint Commission.
The National Quality Forum's Never Events are
also considered sentinel events by the Joint
Commission.
ADVERSE EVENTS
An “unintended physical injury resulting from or
contributed to by medical care that requires additional
monitoring, treatment, or hospitalization, or that
results in death.” Classen et al.
OR… “situations in which an inappropriate decision
was made when, at the time, an appropriate alternative
could have been chosen. …Whether at the time the
particular medical decision was made (knowing the facts
as they were at that moment) the action was
appropriate. “ Andrews et al.
HOSPITAL-ACQUIRED
CONDITIONS
Specific preventable adverse conditions that were not
present upon admission of the patient.
Object left in the patient during surgery; Air
embolism; Blood incompatibility; Catheter-associated
urinary tract infection; Pressure ulcers; Vascularcatheter-associated infection; Surgical site infection, as
mediastinitis after coronary artery bypass grafting
surgery; Hospital-acquired injury due to external
causes such as falls
HEALTHCARE-ACQUIRED
CONDITIONS
CMS Proposed Rule 2.11.2011. Applies HACs to
Medicaid. Each state can adopt its own Medicaid
“never events” for hospitals, even if it is broader than
CMS’s list.
OTHER PROVIDERPREVENTABLE CONDITIONS.
(OPPCs)
OPPCs apply to other health care providers outside of
the inpatient hospital setting. In CMS’ own words,
these never event conditions “can occur in outpatient
hospital, nursing facility, and ambulatory care settings,
and other healthcare settings.”
POSSIBLE LEGAL
REMEDIES
IMPROVE MANDATORY
REPORTING
Create a new federal agency to
♦collect data on medical care,
♦ publish it,
♦ set rules, and
♦ impose penalties.
Analogous to National Highway
Transportation Administration or the Federal
Aviation Administration. Peter Pronovost
USE THREAT OF LITIGATION
THROUGH COMPOUNDING OF
PENALTIES
An intentional failure to disclose a serious adverse event, if
discovered, might impose a federal penalty of up to $1,000 per
day, coupled with a treble damages claim in a malpractice suit by
any patient suffering adverse harm from the event.
Failure to disclose a known or readily discoverable event is
fraudulent concealment, and this both tolls the statute of
limitations and allows for punitive damages.
If an adverse event leads to patient injury, proof of failure to
report creates a presumption of negligence, which shifts the
burden of proof to the defendant to rebut by excuse or
justification.
BAN CONFIDENTIALITY
AGREEMENTS FOR ADVERSE
EVENT CLAIMNS
Most civil litigation ends in settlement and a confidentiality
agreement. These confidentiality agreements little public value.
Tort suits are a major influence on adverse corporate
behaviors. Reducing adverse events, however, requires that such
litigation generates accurate signals to force avoidance of
unnecessary injuries.
1. Visible information about adverse event settlements create
awareness of a provider’s problems and create incentive
effects for providers.
2. Such information is an additional source of data about
errors and adverse events on a provider-specific basis, which
would allow a cross check on adverse event reporting in states
that require it, to the Joint Commission and CMS.
DAMAGE ACTIONS AND
HOSPITAL COMPLIANCE
“Damage actions regulate risky enterprise by inducing
organizations to develop claims management capabilities—that
is, the capacity to process any resulting disputes.”
These claims management practices and staff can “improve
safety, reduce risk, and increase compliance with external legal
requirements.”
See generally Margo Schlanger, Operationalizing Deterrence:
Claims Management (in Hospitals,a Large Retailer, and Jails and
Prisons), 2 J. TORT L. 1 (2008).
SOCIAL BENEFITS OF THIS
LIABILITY SYSTEM: Not so BAD
1.Bolsters regulatory mandates.
Public enforcement may be
weak (witness the Joint Commission, HIPAA by OCR) but
private enforcement can extract standards from the mandates
and “fine” the rule breaker.
2.Articulates corrective justice norms.
We invoke the courts
to enforce ethical and social norms: compensation of victims
by wrongdoers.
3.Deters flawed performance.
The signal is weak, but the
volume can be turned up. Risk management and compliance
are creatures spawned by liability, creating bureaucracies that
focus on adverse events.
HOSPITALSs: RIP
Regiment = narrowing of practice
variation.
Integrate = design integrated systems,
through incentives to create new forms
of managed care.
Price Errors = pain, inflicting costs for
poor performance and bonuses for above
average performance.
MOVE TOWARD WARRANTIES
Brennen and Berwick propose a regulatory
policy that requires providers to guarantee a
safe level of care, with the accompanying
promise of “prompt, easily claimed redress
when that promise is broken.”
The guarantees might encompass “timely
access, information exchange, modernity of
therapy, and outcomes that are well within
the reach of all providers of care.”
MOVE FROM TORT TO
CONTRACT: Warranties
A. Warranties of Performance
1. We promised to achieve these results.
2. We failed.
3. We will absorb all further curative
and remedial health care costs.
B. Warranties of Compensation
1. We injured or killed you.
2. We apologize.
3. We will ensure this never happens
to anyone else.
4. We will offer you compensation.
A NEW LEGAL MODEL FOR
PROVIDERS
Vulnerable patients are to be protected;
Risks are to be reduced with all possible
speed;
Errors are not to be tolerated;
Mistakes will cost money;
Promises will be kept, or else.
A tougher model of patient safety, and the
threat of civil liability is a part of the
pressure.