1 todd r. bartos, esquire healthcare litigation group rewarding excellence and protecting your...

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Todd R. Bartos, EsquireHealthcare Litigation Group

Rewarding excellence and protecting your

Bariatric Surgery PracticeNew Informed Consent for Bariatric Surgeons

and a Fresh Look at Post-Adverse Event Communication

STEVENS & LEEHealth Care Litigation and Risk Management Group

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Agenda

The Liability Landscape…

Impacting Risk in Bariatrics

Five Star Components Second Generation Informed Consent Post-Adverse Event Communication

A Case Study…NOVUS


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The Liability Landscape in 2010-2011

What you know you can better control...


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New Data – Frequency Increasing

From the Press Release...

STEVENS & LEEHealth Care Litigation and Risk Management Group Personal and

Confidential

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Severity

Severity continues to be on the rise!

Why isn’t it going down?

Psychologists/Jury consultants help us understand

How it is…

How it should be…

And for some...how it is!


National Median Medical Malpractice Verdict TrendsSource - Jury Verdict Research

$0

$200,000

$400,000

$600,000

$800,000

$1,000,000

$1,200,000

$1,400,000

$1,600,000

2001 2002 2003 2004

Year

Ver

dic

t A

mo

un

t

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Selective cases being pursued

Consolidation of counsel

Psychodrama Still in 2010...

Complications coupled with a “plus”


Severity Drivers

7 STEVENS & LEEHealth Care Litigation and Risk Management Group

Psychodrama to the next level

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Changing Environment

Never Events

“Never events cause serious injury or death to beneficiaries and result in unnecessary costs to Medicare and Medicaid due to the need to treat the consequences of the errors,” said CMS Acting Administrator Kerry Weems. “The steps taken today reflect our strong conviction that these events, in fact, should be prevented, and our commitment to protecting Medicare and Medicaid patients from them.”


Surgical site infection following bariatric surgery

for obesity

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Benchmarking and Ratings


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What’s being said on the web?


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Zagat Surveying in Healthcare

Hospitals & Health Networks, December 2007


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The Environment Keeps Evolving...

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It’s Getting Louder!

Healthcare reform Continued focus on quality and cost


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The combination

POWERFUL RESULTS

Continue to Change the Liability Equation

Being aggressive- using the evidence

$$

RiskMitigation

Risk

EventManagement

Event

Control of the Process

Claim

A Different Defense

Lawsuit

$$ $$ $$

Infrastructure

Baseline assessmen

ts

Create positive evidence Build the

foundation


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Understanding Cause of Our Bariatric Risk


Post-operative leaks

Pulmonary embolism

Vitamin deficiency

Pre-surgery education(true/false test)

Bariatric informed consent

Post-surgery compliance

Leak Guidelines

Clinical Clusters Professional Liability

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So Why Are Bariatric Claims Filed?

In the first instance...a clinical cluster Post-op leaks (esophageal, anastomatic,

and stomach pouch) Failure to recognize sx Staple misfire Delay in diagnosis Delay in surgery to fix leak Left shift

PE Failure to recognize symptoms Delay in diagnosis Delay in or failure to treat Fail to take preventive measures

Vitamin deficiencies Failure to detect and treat thiamine

deficiency Untreated vitamin deficiency

Coupled with a professional liability plus factor

Lack of service excellence/communication

Lack of service recovery/post-adverse event management

Lack of relationship Unmanaged patient expectations

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It’s Turning Out to Be So...

Medicolegal analysis of 100 malpractice claims against bariatric surgeons1

69% of events occurredon day of surgery

Co-morbidities Diabetes – 31% Obstructive Sleep Apnea – 38%

Death occurred – 53% Post-operative leaks – 53% Bowel obstruction – 18% 42% involved surgeon < one

years experience in bariatrics

BACKGROUND: Very few studies have addressed malpractice litigation specific to bariatric surgery. This study was designed to analyze litigation trends in bariatric surgery to prevent further lawsuits and improve patient care. METHODS: A total of 100 consecutive bariatric lawsuits were reviewed by a consortium of experienced bariatric surgeons and an attorney specializing in medical malpractice. RESULTS: Of the 100 lawsuits, 45% were reviewed for defense attorneys. The mean patient age was 40 years (range 18-65), 75% were women, 81% had a body mass index of <60, 31% were diabetic, and 38% had sleep apnea....

1 Cottam D., Lord J., Dallam RM, Wolfe B., Higa K., McCauley K., and Schauer P. “Medicolegal analysis of 100 malpractice claims against bariatric surgeons.” Surg. Obes. Relat. Dis. 2007 Jan-Feb;3(1):60-6. Epub 2006 Dec 27.

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An Element of Five Star:New Informed Consent


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Second Generation Informed Consent

Patient accountability too! Use in pre-event discussions Use a procedure-specific form

Enhance patient education

Expectation management Documents patient understanding Then use it in post-adverse event

discussion

Additional Strategies Spousal consent Copy of form to the patient


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Introductory language

INFORMED CONSENT TO SURGICAL PROCEDURE

It is very important to [insert physician, practice name] that you

understand and consent to the treatment your physician is rendering and any

procedure your physician may perform. You should be involved in any and all

decisions concerning surgical procedures your physician has recommended.

Sign this form only after you understand the procedure, the risks, the

alternatives, the risks associated with the alternatives and all of your questions

have been answered. Please initial and date directly below this paragraph

indicating your understanding of this paragraph.

_________________________________Patient's Initials or Authorized Representative


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For Example, Informed ConsentWitness attestation


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In Your Informed Consent Form?

“In the unlikely event that one or more of the above inherent complications may occur, my physician(s) will take appropriate and reasonable steps to help manage the clinical situation and be available to me and my family to address our concerns and questions.”


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Where the Rubber Hits the Road:Post-Adverse Event Communication


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Prevent the Ultimate Plus Factor

Emotions running high High during adverse events For Patients, Family and You!

Perceived cold demeanor Conclude you are uncaring Or worse...covering it up!

Must have set the table

(that’s why…5 Star!)


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Creating The Relationship

Event management Creating appropriate and favorable

evidence QA opportunity Platform for disclosure

Disclosure of adverse events to promote patient safety and reduce liability risk


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Effective Post-Adverse Event Communication

The key to getting comfortable is: Understanding what “it” is Understanding empathy v. responsibility

An adverse event can be A complication – a known risk of the

procedure A medical error – generally, a preventable

adverse outcome


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First and foremost empathize!

Objective facts – what is known What happened, why If not yet known, say so...but follow up

Discuss what is being done to reduce further harm If not clear about what caused injury, say so

Extension of informed consent discussion*

Answer questions you know they must have

When It Is a Complication


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When It Is a Medical Error

Investigation reveals responsibility... The hardest Takes planning, coordination, preparation Involve legal counsel

Same advice as complications... Empathy Objective, known facts What happened and why Discuss what is being done to reduce further harm

...and Accept responsibility


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A Real Case Study…

Disclosure

First 30 Seconds Sets the Tone

Creates Relationshipor Not

Procedure SpecificInformed Consent

Unfortunate Event


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NOVUS – Putting it all together

Understanding and evaluating bariatric surgery Researched specific root cause of frequency and severity with an

Ethicon grant

Formal endorsement from ASMBS – August 2005

Comprehensive loss control program infrastructure which has been accepted!

Bariatric surgeons across the country ARE changing the way they practice


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ASMBS

Endorses NOVUS (since 2005) Vision: Improve public health and well-being by lessoning the

burden of the obesity disease and related diseases. Founded in 1983, the purpose of the society is to encourage its

members to: Improve care and treatment of the obese and related diseases Advance the science and understanding of metabolic surgery Foster communication among healthcare professionals Be the recognized authority and resource on metabolic and bariatric surgery Advocate for health care policy that ensures patient access to high quality prevention

and treatment of obesity Be a highly valued specialty society that serves the educational and professional

needs of our diverse membership


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Surgical Excellence, LLC

To help general and bariatric programs, surgeons, hospitals, and centers enhance quality of care and patient safety while reducing professional liability risk

To respond to the growing need for supporting bariatric and general surgeons, and their programs from both a clinical and risk management perspective

A complimentary program to NOVUS Helping doctors become COE Insurance proficiency evaluations


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What is Surgical Excellence?

Surgical Excellence’s goals include Moving more bariatric surgeons and bariatric programs to full Center of

Excellence status Increasing quality of care and safety Reducing liability risk Providing peer review services specific to the needs of bariatric and

general surgery programs Helping the start-up of new bariatric surgery programs Reducing morbidity and mortality in bariatrics


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Centers of Excellence

To survive in today’s environment, it is a must have Eligibility is a comprehensive process that includes

Documented comprehensive program Emphasis on results of safety

Process is Time-consuming Benefit from our experience

SE provides support Becoming a COE Mock COE site visit

SE provides a program for COE

The Advisory Board Company – Horizon Scan, February 2009 STEVENS & LEE

Health Care Litigation and Risk Management Group

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Take Home Points

The Liability Landscape keeps evolving

You can impact your risk in Bariatric Surgery

Simple, tested techniques have already worked Second Generation Informed Consent Post-Adverse Event Communication

And...the data supports it NOVUS SRC Surgical Excellence


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Stevens & Lee’s 225 lawyer and non-lawyer professionals assist health care providers and organizations meet the challenges they face in a changing and consolidating industry. Our Health Care Department is comprised of approximately 31 professionals – including 25 attorneys whose exclusive practice is in health care – who serve as general counsel to acute care and specialty health care organizations, health systems, long-term care providers and physician practices and regularly litigate cases in state and federal court.

Stevens & Lee’s health care litigation and risk management team has designed customized risk reduction programs focused on both risk reduction and economics. Some of those programs include “Five-Star Service Excellence”, Disclosure Training, Risk Assessments, as well as the new EMR risk reduction program. Specialty specific programs are available as well. All programs combine education, training, communication, as well as documentation services.

STEVENS & LEE51 South Duke Street

P.O. Box 1594Lancaster, PA 17608-1594

[email protected]

For more information, please contact Todd R. Bartos:
