Can Hospitals Ever Do No Harm?

Accountability for Adverse Events

New England Law │BostonOctober 20, 2011

Barry FurrowProfessor of Law and Director,

the Health Law ProgramDrexel University Earle Mack

School of Lawc. 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

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)

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

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 SURGERYFriday, 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

►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.

Failure to Update Basic Safety Functions

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) 44:166-203.

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 error-induced 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_Guide_Final2-08-07.pdf

• Irene Frasier et al, The Pursuit of Quality by Business Coalitions: A National Survey, 18 Health Affairs 158 (1999).

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

History continued

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 physician unintentionally causes…through diagnosis, manner or treatment”

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.

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.

ADVERSE EVENTS

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; Vascular-catheter-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 PROVIDER-PREVENTABLE 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 CLAIMNSMost 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).

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.

SOCIAL BENEFITS OF THIS LIABILITY SYSTEM: Not so BAD

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 Performance1. We promised to achieve these results.2. We failed.3. We will absorb all further curative and remedial health care costs.

B.Warranties of Compensation1. 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.