Medical-Legal Issues in Sonography

1. Medical-Legal Issues in Sonography Hholdorf.wordpress.com

3. Objectives • 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

4. Malpractice • Professional misconduct encompassing an unreasonable lack of skill or unfaithfulness in professional or fiduciary duties.

5. Malpractice Liability • Has grown much faster than overall health care inflation. • Most Common Targets: • Obstetrics • Neurology • Emergency room care • Konig, Health Care News, January 2006

6. Medical Negligence • Medical negligence is a breach of duty to behave reasonably and prudently under the circumstances that causes foreseeable harm to another.

7. 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”

8. 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.

9. Medical Claims • 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 • http://aspe.hhs.gov • Student Doctory Network

10. Liability ED • 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

11. Contributing Factors • 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

12. Liable for Medical Negligence • Lack of Duty – to provide care • Deviation from the Standard of Care • Damages - foreseeable harm • Direct correlation - damages must occur from the breach of the alleged standard of medical care.

13. A liability of malpractice • Physician-patient relationship • Breach of Standard of Care • Most often contested • Negligent Act must have caused injury • Patient must have sustained an injury

14. Standard of Care /Three Words • 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.

15. SDMS 1M/6M $20 Student $98 Full Time Employed $190 Part-time Employed $293 Self-employed ASE – no current offering SVU 1M/3M $29.50 Student $90.00 Full-Time Employed (W-2) $90.00 Part-time Employed (W-2) $176 Self-Employed (1099) Insurance for the Sonographer

16. 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

17. 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].

18. Review the etiology of malpractice Objective 2

19. Etiology of Malpractice • 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)

20. Etiology of Malpractice • 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

21. Etiology of Malpractice • Negligent Referral • False Imprisonment (Restraints) • Defamation • Failure to Warn or Control (Safety) • Negligent Infliction of Emotional Distress

22. Etiology of Malpractice • Failure to Report • Infection control • Battered children • Elder abuse • Fraud and Misrepresentation • Loss of consortium

23. Defensive Medicine • A 2012 survey of 905 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

24. 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

25. Examples of When a Sonographer is Liable • 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

26. Recognize areas of risk Specific to Ultrasound Objective 3

27. Shortage • 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

28. Demands on Physicians/Providers • 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 • Matrix for standard of care

29. 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.

30. As professional image increases: • Reduction in supervision/requirements • Revision from direct to general supervision (Medicare) • Focus and attention increases • Expectation increases • ↓ supervision, ↑ risk

31. Decisions on Image, not on Interpretation • Increased reliance on the Ultrasound Image • Digitized world • Interventions based on Ultrasound image • Ultrasound more frequently used in guidance or interventional procedures • No “fail-safe”

32. Preliminary Reports Remember, we are not supposed to diagnosis, but…

33. A Preliminary Report • 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

34. 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.

35. Prelim: OB-GYN • Preliminary reports for fetal biometry, biophysical profiles, and viability can be given by a sonographer who is ARDMS-registered in that specialty, if the results are normal and the final report is complete within 2 hours;

36. AIUM on OB-GYN Prelims. • The preliminary report is equivalent to a worksheet. Limitations: • Cannot have recommendations/ impression. • Labeled "Preliminary Report."

37. 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.

38. 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

39. 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

40. 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

41. Identify statistics from the government and research articles Objective 4

42. The Uninsured • 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.

43. Expensive • 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.

44. Employers Expense • 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

45. Cost to Employees • 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

46. The Self-insured • 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

47. Medical Expense and Bankruptcy • 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.

48. Implication – Hospitalizations 2006 • Most expensive conditions/percentage of national bill: • 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%) • http://www.hcup-us.ahrq.gov/reports/statbriefs/sb59.jsp

49. Radiation Exposure Concerns • Informed Consent • Risk not mentioned – Expert knows best • unheard (by the patient) and unspoken (by the doctor) • Radiation risk understated • Equivalent of 500 chest X-Rays (64-slice Cardiac CT) • Full Disclosure • Comparison to background radiation for year

50. Institute for Energy and Environmental Research (IEER) Recommending New Guidelines • 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