Transcript MedicoLegal Concerns in Ultrasound Today

Malpractice, Health
Care and “Me”
Cindy Allen, MSHS, RT-R, RDMS, RVT
Clinical Applications Specialist, SonoSite, Inc.
Consultant, GCUS
“There are no facts,
only interpretations."
Friedrich Wilhelm Nietzsche
1844 – 1900
Healthcare Cost
Containment
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Estimated > 2.4 Trillion dollar industry
Hospital charges were $873 billion in 2005,

$943 billion in 2006, $70 billion change in 1-year!
Agency for Healthcare Research and Quality, 2008
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45-47 million uninsured in the US (estimated)
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≥ collective population of GA, SC, NC, TN, VA,
KY, MD, DC (estimated 2008)
Objectives
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Define liability, negligence and malpractice.
Review the etiology of malpractice
Identify statistics from the government and
research articles
Recognize areas of risk for ultrasound
Suggest improvements in day-to-day flow
Malpractice
 Professional
misconduct encompassing an
unreasonable lack of skill or
unfaithfulness in professional or fiduciary
duties.
Malpractice Liability
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Has grown much faster than overall health care
inflation.
Most Common Targets:
Obstetrics
 Neurology
 Emergency room care


Konig, Health Care News, January 2006
Bureau of Economic Analysis
1929 – 1945 Household
Budget - 23% food

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“Ready to eat” - luxury.
“Eating out” - rare.
Staples - “Groceries”
(flour, sugar. etc.)
Health care – 4%
1955 - 2005 Household
Food ↓ 22% to 10%
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“Eating out” - taken for
granted.
“Ready to eat” - normal.
“Staples” hold paper
together.
Spending on health care
quadrupled 5% to > 20%
Medical Negligence
 Medical
negligence is a breach of duty
to behave reasonably and prudently
under the circumstances that causes
forseeable harm to another.
Errors in Medicine
 Define:
“the failure of a planned
action to be completed as intended or
the use of a wrong plan to achieve an
aim”

To Err is Human: Building a Safer Health System.
Washington, D.C.: National Academy Press, 1999
Malpractice Insurance

Tort law is the name given to a body of law that
addresses, and provides remedies for, civil
wrongs that do not arise out of contractual
duties. Malpractice Insurance has been referred
to as a “Tort Tax.”

A person who is legally injured may be able to use tort
law to recover damages from someone who is liable, for
those injuries.
Torts cover intentional acts and accidents.

Health Care Costs
Physicians spent $6.3 billion dollars last
year on malpractice premiums.
 The estimate of savings from limiting
unreasonable awards for non-economic
damages could reduce healthcare costs 59% per year.

 This

would cover 2.4-4.3 million Americans.
http://aspe.hhs.gov
Medical Claims
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Only 1.53% of those injured by medical
negligence file a claim.
 Estimate: 98,000 deaths/year
57-70% of claims result in no payment to the
patient.
Cost to defend a claim on average: $24,669
Jury trials: average $4.7 million
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http://aspe.hhs.gov
Student Doctory Network
Liability ED
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A 15-year Emergency review
Causes/missed diagnoses: appendicitis, myocardial
infarction, fracture, infection, aneurysm, and
cerebrovascular disease. Ann Emerg Med 2007;49[2]:196.
Failure to order indicated tests: 58 %
Incorrect interpretation of tests: 37 %
Most of the missing tests were imaging, such as
ultrasound, radiographs, or CT

Glauser, Jonathan MD, MBA. The Etiology of Malpractice. Emergency
Medicine News. Volume 30(7), July 2008, p 6–7
Contributing Factors
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Excessive workload - 23 percent of cases
Handoffs - 24 percent of cases with error and bad
outcome.
Lack of supervision
Fatigue
Patient-related factors
In one of six missed diagnoses, test results did not
reach the correct clinicians.

Glauser, Jonathan MD, MBA. The Etiology of Malpractice.
Emergency Medicine News. Volume 30(7), July 2008, p 6–7
Liable for Medical Negligence
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Duty – to provide care
Deviation from the Standard of Care
Damages - forseeable harm
Direct correlation - damages must occur from
the breach of the alleged standard of medical
care.
A liability of malpractice
Physician-patient relationship
 Breach of Standard of Care
 Most often contested
 Negligent Act must have cause injury
 Proximate cause
 Patient must have sustained an injury

Standard of Care /Three Words

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Reasonable – not extreme, not excessive, moderate,
not demanding too much possessing good sound
judgment, well balanced sensible
Ordinary – common, lacking in excellence, not
distinguished in any way from others, not above but
rather below average, somewhat inferior level of quality
Average – typical, usual, a representative type,
mediocre, run-of-the-mill, so-so, midway between the
extremes, lack of distinction.
Insurance for the Sonographer
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SDMS 1M/6M
$20 Student
$98 Full Time
Employed
$190 Part-time
Employed
$293 Self-employed
ASE – no current
offering
 SVU
 $29.50
1M/3M
Student
 $90.00 Full-Time
Employed (W-2)
 $90.00 Part-time
Employed (W-2)
 $176 SelfEmployed (1099)
Apology Law
 Allows
health care providers to
apologize and offer expressions of
grief without their words being used
against them in court.
 Goal: encourage communication
 Disadvantage: court system
 Virginia has an apology law.

http:www.sorryworks.net/lawdoc.phtml
Apology Law

More than 30 states have enacted laws making
apologies for medical errors inadmissible in
court. Patients may still sue for malpractice; they
simply have to make their case without bringing
up the apology.

American College of Physicians Ethics Manual, 3rd ed.
American College of Physicians, Philadelphia. 1993,
and “Doctors who say they're sorry.” May 22, 2008.
New York Times [editorial].
Review the etiology of
malpractice
Objective 2
Etiology of Malpractice
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Battery – injury by assault or inadequate care
Negligence – below standard of care
Wrongful Death
Loss of a Chance of Recovery or Survival
Res ipsa loquitur (the thing speaks for itself)
Lack of Informed Consent (considered battery)
Etiology of Malpractice
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Abandonment
Breach of Privacy and Confidentiality
Breach of Contract or Warranty to Cure
Products or Strict Liability for Drugs and
Medical Devices
Actions of Health Care Providers
Etiology of Malpractice

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Negligent Referral
False Imprisonment (Restraints)
Defamation
Failure to Warn or Control (Safety)
Negligent Infliction of Emotional Distress
Etiology of Malpractice

Failure to Report
Infection control
 Battered children
 Elder abuse
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Fraud and Misrepresentation
Loss of consortium
Defensive Medicine

A 2005 survey of 844 physicians:
 88%
have been sued (National Ave: 25%)
 92 % have ordered tests, performed
diagnostic procedures or referred to specialist
for the sake of assurance
 33% reported using imaging technology in
clinically unnecessary circumstances.

http://www.healthblog.org/2008
Specific to Sonography
Average pay-out $300,000 (1990)
 Abnormal finding. In 40% of the cases, an
abnormality was found at delivery
 Sonography report inaccurate- 67%
 Image quality problems – 30%
 Not following ACR guidelines – 10%
 Incorrect patient demographic – 5%
 Radiologists

held liable - 60%
Brennan, AJR, 1998
Examples of When a Sonographer is
Liable
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Physically molesting a patient.
Letting a patient fall, causing injury.
Giving the patient or accompanying doctor a wrong
diagnosis
Revealing confidential information about the contents
of the sonogram or disclosing any information that has
adverse affects on the patient.

Clinical Sonography. Roger Sanders and Tom Winter. 2007
Recognize areas of risk
Specific to Ultrasound
Objective 3
Shortage
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Shortage of physicians and personnel
 ~6% imaging personnel
Shorter exam time expectations
Residents are specializing in higher
reimbursement areas
 Demand for primary care physicians
Retiring physicians creating need
Demands on
Physicians/Providers
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Less time per patient
Driven by reimbursement basis fee per service
(office and outpatient)
Learning new computer systems
Computer Order Entry Systems
 Electronic Medical Records
 PACS
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Matrix for standard of care
Changes to Residency Programs
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July 1, 2009: patient load restrictions
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In 2003, work hours were capped
Cost of hospital care and hospital medicine
groups (HMG’s) expected to increase
Hospitalist to see more patients
Experience level of new graduates expected
to diminish
No additional reimbursement planned
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Resident Restrictions. Hospitalist. 2009; 13(1) 23-24
Traditionally

As a delegated, supervised agent, sonographers
malpractice risk was lower:
 Not considered an independent provider
 NP,
PA, MD, DO, PT
 “Supervised”
by licensed person  insulates
risk
 Implication is the employer is responsible if
employer is named.
As professional image increases:
Reduction in supervision/requirements
 Revision from direct to general supervision
(Medicare)
 Focus and attention increases
 Expectation increases
 ↓ supervision, ↑ risk
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Decisions on Image, not on
Interpretation
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Increased reliance on the Ultrasound Image
Digitized world
 Interventions based on Ultrasound image
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Ultrasound more frequently used in guidance or
interventional procedures
No “fail-safe”
Preliminary Reports
A Preliminary Report
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Is not considered legally hazardous as long as the
sonographer does not attempt to make a diagnosis.
If working with a sonologist, the sonologist is
responsible for correcting the sonographer
film/techniques: gallbladder sludge,
pseudohydronephrosis, missing pathology – not
moving patient, missing pathology due to transducer
frequency.

Clinical Sonography. Roger Sanders and Tom Winter. 2007
Areas of Risk – Preliminary
Reports AIUM on OB-GYN
A
preliminary report is a written
or verbal report released prior
to being signed by the physician
responsible for giving the final
interpretation.
Prelim: OB-GYN
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Preliminary reports for fetal biometry,
biophysical profiles, and viability can be
given by a sonographer who is ARDMSregistered in that specialty, if the results are
normal and the final report is complete
within 2 hours;
AIUM on OB-GYN Prelims.
 The
preliminary report is equivalent
to a worksheet. Limitations:
Cannot have recommendations/
impression.
Labeled "Preliminary Report."
AIUM on OB-GYN Prelims.
A
written policy for communicating
the differences and changes that
arise between the preliminary and
final report must be in place.
 Verified final reports must be
available within 24 hours of
completion of the exam.
Preliminary Reports – ICAEL
 The
ICAEL strongly discourages the
use of sonographer prepared
preliminary reports, worksheets or
verbal reports that would be used for
the purpose of clinical management.

The Newsletter, September 2004, Volume 7, Issue 2
Preliminary Reports – Vascular
 Vascular
technologists frequently
report critically important data that
they have collected directly to treating
physicians for their use in the care and
treatment of patients.

Society of Vascular Technologist and Society of
Vascular Surgery
Requested changes to Bureau Labor
and Statistics for Vascular
 SVU
and SVS
 For 2010 Outlook revision
 Separation from Cardiovascular
Proposed Description of Vascular
Technologist Occupation
Conducts tests, using judgments formed from a
review of the images and data obtained through
the testing modalities, to maximize the utility of
the diagnostic tests. The testing consists of
noninvasive ultrasound procedures, performed
to provide diagnostic information regarding the
physiology and functioning of the patient's veins
and arteries for diagnostic purposes. Completes
patients' medical histories, performs a limited
physical examination, and provides a summary
of findings to aid the physician in diagnosis and
treatment.
http://www.svunet.org/advocacy/comments/7-15-08-SVU-SVS.pdf
Identify statistics from
the government and
research articles
Objective 4
Costs of HealthCare
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In 2008, health care spending in the United
States reached $2.4 trillion.
 Keehan, S. et al. “Health Spending Projections Through 2017,
Health Affairs Web Exclusive W146: 21 February 2008.
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Health care spending is 4.3 times the amount
spent on national defense.

California Health Care Foundation. Health Care Costs 101 -- 2005.
02 March 2005.
Gross Domestic Product
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In 2008, the United States will spend 17 percent
of its gross domestic product (GDP) on health
care.
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Keehan, S. et al. “Health Spending Projections Through 2017,
Health Affairs Web Exclusive W146: 21 February 2008.
Comparison:
 10.9 % - Switzerland
 10.7 % - Germany
 9.7 % - Canada
 9.5 % - France
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Organization for Economic Cooperation and Development.
The Uninsured
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Although estimated 46 million Americans are
uninsured, the United States spends more on
health care than other industrialized nations,
and those countries provide health insurance to
all their citizens.

California Health Care Foundation. Health Care
Costs 101 -- 2005. 02 March 2005.
Expensive
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National surveys show that the primary reason
people are uninsured is the high cost of health
insurance coverage

The Henry J. Kaiser Family Foundation. Employee
Health Benefits: 2008 Annual Survey. September
2008.
Employers Expense
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Health insurance expenses are fastest growing
cost for employers.
Increased health costs correlate to drop in health
insurance.
25% of housing problems attributed
1.5 million foreclosures on homes /year
Cost to Employees
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Workers pay $1,600 more in premiums annually
for family coverage than they did in 1999.
The annual premium a health insurer charges an
employer for a health plan covering a family of
four averaged $12,700 in 2008.
 Workers contribution average: $3,400.
 12%

more than 2007.
The Henry J. Kaiser Family Foundation. Employee Health Benefits:
2008 Annual Survey. September 2008
The Self-insured
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Approximately 17 million Americans.
Individual policy applications rose 18% in
fourth quarter 2008 with ehealthinsurance
(compared to 2007).
Individual insurance companies are increasing
rates nationwide 8%-56%.

Julie Appleby, USA Today Friday February 20, 2009
Medical Expense and Bankrupcy
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A recent study by Harvard University
researchers found that the average out-of-pocket
medical debt for those who filed for bankruptcy
was $12,000.
 68 % had health insurance.
 50 % of all bankruptcy filings were partly due
to medical expenses.

Himmelstein, D, E. Warren, D. Thorne, and S. Woolhander, “Illness
and Injury as Contributors to Bankruptcy, “ Health Affairs Web
Exclusive W5-63, 02 February , 2005.
More costs to physicians - ICD-10
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Implementation moved to 2013
Requires adoption of 5010 electronic
transaction standards under the Health
Insurance Portability and Accountability Act.
Estimate: average cost of moving to ICD-10 for
a three-physician practice will be $84,000
Medicare – two tier payment

Technical Component - Usually the larger of
the two components
Performing an imaging study
 Usually the larger of the two components
 Equipment, Supplies
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Professional Component
Interpretation/Report
 Supervision
 Liability
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Payment – Direct Cost

Direct cost is the basic cost of performing the
procedure
Non-physician clinical staff
 Medical equipment
 Medical supplies
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This is a major determinant in how much
doctors are paid for specific procedures.
Direct Cost
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When direct cost is high
(CT, MRI) due to cost to
buy, maintain and use,
doctors get paid more to
use it
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Other variables:
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Time
Effort
Skill
Stress of a procedure
Liability insurance
expenses
Independent Diagnostic Testing
Facilities, IDTF (CMS)
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Designed to limit unnecessary utilization of
imaging services
Required a supervising physician on site with
proficiency in the test being performed
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Interpreted by many as supervised by a radiologist.
Was not implemented, October 2008.
Three No-Cover Events
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Jan. 15 2009
The Centers for Medicare & Medicaid Services
End pay for surgeries involving three major
errors.
Incorrect patient
 Incorrect body part
 Incorrect surgical procedure

Complications – 2006
 Complication
of device, implant or
graft 27.4 million, 2.9% of nations bill
 Complications of surgical procedure
or medical care 14.5 million, 1.5% of
nations bill
Implication – Hospitalizations 2006
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Most expensive conditions/percentage of
national bill:
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Coronary artery disease (5.6%)

1.2 million stays, $53 Billion
Acute Myocardial infarction (3.7%)
 Congestive heart failure (3.5%)
 Pregnancy and delivery (5.1%)
 Newborn infants (4.0%)
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http://www.hcup-us.ahrq.gov/reports/statbriefs/sb59.jsp
American Recovery and
Reinvestment Act of 2009.
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Provision of $20 billion in health IT adoption incentives.
Expected transformation of the practice of medicine if
implemented properly.
Establishment of a system of Medicare/Medicaid
bonuses/penalties to encourage health IT adoption
Incentives for health professionals, including physicians, who use
health IT to a sufficient degree and who see a relatively high
volume of patients.
Goal is to develop health IT standards to improve health care
quality, efficiency and consistency.
Deadline: 2014
Radiation Exposure Concerns
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Informed Consent
Risk not mentioned – Expert knows best
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Radiation risk understated
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unheard (by the patient) and unspoken (by the
doctor)
Equivalent of 500 chest X-Rays (64-slice Cardiac
CT)
Full Disclosure
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Comparision to background radiation for year
Institute for Energy and Environmental Research (IEER)
Recommending New Guidelines
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Women are 52% more likely to get cancer from
the same amount of radiation dose compared to
men
A female infant has about a seven times greater
chance, according to Arjun Makhijani, Ph.D.

AuntMinnie.com January 13, 2009
Radiation Exposure
Natural Radiation – such as radon
 Average person in the US receives 3 mSv of Natural
Radiation
 Chest X-Ray 0.1 mSv or 10 days of natural
 Mammogram 0.7 mSv or or 3 months
 Cardiac CT for calcium scoring 2 mSv or 8 months
 An abdominal/spine CT is 10 mSv or 3 years
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Millisievert: One thousandth of a sievert, the unit for
measuring ionizing radiation effective dose, which
accounts for relative sensitivities of different tissues and
organs exposed to radiation.
(http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray)
Non-Clinical Criteria Influencing
Hospital Choice
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Keeping patients informed about treatment
both during and after visit (77%)
Conducting scheduled appointments on
time(75%)
Room appearance (66%)
Ease of scheduling appointments (64%)
Food and entertainment options in room (63%)
Value for the money (62%)
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http://healthcare-economist.com
Pending Legislation
That I found….
Oregon
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H 2245 (Hunt) Medical Imaging
Changes name of Board of Radiologic
Technology to Board of Medical Imaging;
changes name of Board of Radiologic
Technology Account to Board of Medical
Imaging Account; defines medical imaging
modality and related terms; creates categories of
medical imaging modalities; revises various
provisions relating to medical imaging licensees
and limited X-ray machine operator permittees.
1/16/2009 - Introduced.
New Mexico
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H 498 (Steinborn) Health Care
Relates to health care; charges the New Mexico
medical board with promulgating rules for the
provision of technical services for medical
imaging examinations and radiation therapy
treatments.
02/02/2009 - Introduced. Referred to the House Committee on Health And
Government Affairs, then to the House Committee on Judiciary.
The language of this bill creates a second regulatory agency on medical
imaging without repealing the authority of the existing agency. Additionally
grants blanket exemptions to other allied health practitioners.
Connecticut
Connecticut
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H 5635 (Widlitz) The Administration of Ultrasound
Procedures
Concerns the administration of ultrasound procedures;
eliminates the administration of ultrasound procedures
by nonmedical commercial operations.
01/22/2009 - Introduced. Referred to the Joint
Committee on Public Health.
This bill would prohibit ultrasound for entertainment
purposes.
Virginia – RA House Bill
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H 1939 (Peace) Radiologist Assistants
Provides for the licensure of radiologist
assistants as individuals who have met the
requirements of the Board of Medicine for
licensure as advanced-level radiologic
technologists and who are authorized to assess
and evaluate the physiological and psychological
responsiveness of patients undergoing
radiologic procedures.
01/14/2009 - Introduced. Referred to the House Committee on Health, Welfare and Institutions.
01/26/2009 - ***Passed by the House. Engrossed. To the Senate
01/28/2009 - Referred to the Senate Committee on Education and Health.
Virginia – RA Senate Bill
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S 968 (Blevins) Radiologist Assistants. Duplicate of H 1939.
Provides for the licensure of radiologist
assistants as individuals who have met the
requirements of the Board of Medicine for
licensure as advanced-level radiologic
technologists and who assess and evaluate the
physiological and psychological responsiveness
of patients undergoing radiologic procedures.
01/14/2009 - Introduced. Referred to the Senate Committee on Education and
Health.
02/03/2009 - Passed by the Senate. *****To the House.
Washington
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H 2105 (Cody) Diagnostic Imaging Services
Concerns diagnostic imaging services; directs
the speaker of the house of representatives and
the majority leader of the senate to convene a
work group to analyze and identify nationally
accepted best practice guideline or protocols
applicable to advanced diagnostic imaging
services and any decision and support tools
available to implement the guidelines or
protocols.
02/10/2009 - Introduced. Referred to the House Committee on Health Care and Wellness.
This bill creates a group to study best practices and develop recommendations for practice guidelines protocols
for computed tomography, magnetic resonance, positron emissions tomography and cardiac nuclear medicine
services. These guidelines and protocols would apply to these imaging services paid for by state purchased
health care plans.Work group composition does not include a radiologic technologist.
Suggest improvements in
day-to-day flow
Ultrasound is a great place to be!
Objective 5
Forbes.com

In Pictures: “Jobs That Can Earn More
Than $100,000 Without College”

Author: Klaus Kneale
Ultrasound Technologist
 90th Percentile Income: $110,000
 75th Percentile Income: $82,500
Ultrasound reduces costs

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Limitation to unreimbursed care will encourage
growth, shying away from $$$ procedures.
Needle guidance procedures
Biopsy guidance
 Central Line Placement/complications
 Reducing amount of anesthesia for nerve blocks

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Foreign body visualization
Frees more expensive imaging equipment
Quality vs. Cost

Instant decision on patient care
 “Modern
day stethoscope”
Scarce resources
 Expensive test overuse, abuse
 Consumer awareness of radiation
exposure/use
 Lawsuits over radiation exposure (peds)

Best protection
 Imaging
equipment performance
should be evaluated regularly to ensure
good image quality.
 Image
phantom checks as suggested.
 Safety check all cords.
 Follow manufacture recommendations
for transducer care.
Best Practices
Document!!
 For reimbursement consideration: all
exams require:
 Documentation
 Completeness
 Medical necessity

Documentation

Edits/Additions appropriately for your
institution
 Single line to cross out
 Add/edit
 Why
 Date
 Initial
Best Protection
 Follow
your hospital/departmental
protocol for the procedure/exam you
are doing.
 Perform in the manner in which you
have been trained.
 If you have not been trained….
Support Professional Organizations

Thank the organizers of professional
conferences! Support them.
Further Reading
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Berlin, L. Radiologic errors and malpractice: A
blurry distinction. American Journal of
Roentgenology. 189:5:517-522.
Health Care News
www.sorryworks.com
www.healthblog.org
Student doctor Network
www.healthcare-economist.com
Thank you!
[email protected]
[email protected]