MedicalLegal Issues in Sonography Introduction to Sonography Harry

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Medical-Legal Issues in Sonography Introduction to Sonography Harry H. Holdorf

Medical-Legal Issues in Sonography Introduction to Sonography Harry H. Holdorf

Quotes “There are no facts, only interpretations” - Nietzsche “Not everything can be counted,

Quotes “There are no facts, only interpretations” - Nietzsche “Not everything can be counted, counts, and not everything that counts can be counted. ” - Albert Einstein

Objectives Define liability, negligence and malpractice. n Review the etiology of malpractice n Identify

Objectives Define liability, negligence and malpractice. n Review the etiology of malpractice n Identify statistics from the government and research articles n Recognize areas of risk for ultrasound n Suggest improvements in day-to-day flow n

Malpractice n Professional misconduct encompassing an unreasonable lack of skill or unfaithfulness in professional

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

Malpractice Liability Has grown much faster than overall health care inflation. n Most Common

Malpractice Liability Has grown much faster than overall health care inflation. n Most Common Targets: n Obstetrics n Neurology n Emergency room care n

Medical Negligence n Medical negligence is a breach of duty to behave reasonably and

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

Errors in Medicine n Definition “…the failure of a planned action to be completed

Errors in Medicine n Definition “…the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim”

Malpractice Insurance n Tort law is the name given to a body of law

Malpractice Insurance n 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. ” n 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. n

Medical Claims Only 1. 53% of those injured by medical negligence file a claim.

Medical Claims Only 1. 53% of those injured by medical negligence file a claim. n Estimate: 98, 000 deaths/year n 57 -70% of claims result in no payment to the patient. n Cost to defend a claim on average: $24, 669 n Jury trials: average $4. 7 million n

Liability ED n n Causes/missed diagnoses: appendicitis, myocardial infarction, fracture, infection, aneurysm, and cerebrovascular

Liability ED n n Causes/missed diagnoses: appendicitis, myocardial infarction, fracture, infection, aneurysm, and cerebrovascular disease. Failure to order indicated tests: 58 % Incorrect interpretation of tests: 37 % Most of the missing tests were imaging, such as ultrasound, radiographs, or CT

Contributing Factors n n n Excessive workload - 23 percent of cases Handoffs -

Contributing Factors n n n 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.

Liable for Medical Negligence Lack of Duty – to provide care n Deviation from

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

A liability of malpractice n Physician-patient relationship n Breach of Standard of Care n

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

Standard of Care /Three Words n n n Reasonable – not extreme, not excessive,

Standard of Care /Three Words n n n 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 SDMS 1 M/6 M n $20 Student n $98 Full

Insurance for the Sonographer SDMS 1 M/6 M n $20 Student n $98 Full Time Employed n $190 Part-time Employed n $293 Self-employed n n ASE – no current offering n SVU 1 M/3 M n $29. 50 Student n $90. 00 Full-Time Employed (W-2) n $90. 00 Part-time Employed (W-2) n $176 Self. Employed (1099)

Review the etiology of malpractice Objective 2

Review the etiology of malpractice Objective 2

Etiology of Malpractice Battery – injury by assault or inadequate care n Negligence –

Etiology of Malpractice Battery – injury by assault or inadequate care n Negligence – below standard of care n Wrongful Death n Loss of a Chance of Recovery or Survival n Res ipsa loquitur (the thing speaks for itself) n Lack of Informed Consent (considered battery) n

Etiology of Malpractice Abandonment n Breach of Privacy and Confidentiality n Breach of Contract

Etiology of Malpractice Abandonment n Breach of Privacy and Confidentiality n Breach of Contract or Warranty to Cure n Products or Strict Liability for Drugs and Medical Devices n Actions of Health Care Providers n

Etiology of Malpractice Negligent Referral n False Imprisonment (Restraints) n Defamation n Failure to

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

Etiology of Malpractice n Failure to Report Infection control n Battered children n Elder

Etiology of Malpractice n Failure to Report Infection control n Battered children n Elder abuse n Fraud and Misrepresentation n Loss of consortium** n

Loss of Consortium n A claim for damages suffered by the spouse or family

Loss of Consortium n A claim for damages suffered by the spouse or family member of a person who has been injured or killed as a result of the defendant’s neglect or intentional or otherwise wrongful acts.

Defensive Medicine n A 2015 survey of 905 physicians: n 88% have been sued

Defensive Medicine n A 2015 survey of 905 physicians: n 88% have been sued (National Ave: 25%) n 92 % have ordered tests, performed diagnostic procedures or referred to specialist for the sake of assurance n 33% reported using imaging technology in clinically unnecessary circumstances.

Specific to Sonography Average pay-out $300, 000 (2015) n Abnormal finding. In 40% of

Specific to Sonography Average pay-out $300, 000 (2015) n Abnormal finding. In 40% of the cases, an abnormality was found at delivery n Sonography report inaccurate- 67% n Image quality problems – 30% n Not following ACR guidelines – 10% n Incorrect patient demographic – 5% n Radiologists held liable - 60%

Examples of When a Sonographer is Liable n n Physically molesting a patient. Letting

Examples of When a Sonographer is Liable n n 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.

Recognize areas of risk Specific to Ultrasound Objective 3

Recognize areas of risk Specific to Ultrasound Objective 3

Shortage of physicians and personnel n ~6% imaging personnel n Shorter exam time expectations

Shortage of physicians and personnel n ~6% imaging personnel n Shorter exam time expectations n Medical Residents are specializing in higher reimbursement areas n Demand for primary care physicians n Retiring physicians creating need n

Demands on Physicians/Providers Less time per patient n Driven by reimbursement basis fee per

Demands on Physicians/Providers Less time per patient n Driven by reimbursement basis fee per service (office and outpatient) n Learning new computer systems n Computer Order Entry Systems n Electronic Medical Records n PACS n

Traditionally n As a delegated, supervised agent, sonographers malpractice risk was lower: n Not

Traditionally n As a delegated, supervised agent, sonographers malpractice risk was lower: n Not considered an independent provider Such as…PA, MD, PT n “Supervised” by licensed person insulates risk n Implication is the employer is responsible if employer is named.

As professional image increases: n Reduction in supervision/requirements n Focus and attention increases n

As professional image increases: n Reduction in supervision/requirements n Focus and attention increases n Expectation increases n ↓ supervision ↑ risk

Decisions on Image, not on Interpretation Increased reliance on the n Ultrasound Image n

Decisions on Image, not on Interpretation Increased reliance on the n Ultrasound Image n n n Digitized world n Interventions based on Ultrasound image Ultrasound more frequently used in guidance or interventional procedures

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

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

A Preliminary Report n n Is not considered legally hazardous as long as the

A Preliminary Report n n 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.

Areas of Risk – Preliminary Reports AIUM on OB-GYN n A preliminary report is

Areas of Risk – Preliminary Reports AIUM on OB-GYN n 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 n Preliminary reports for fetal biometry, biophysical profiles, and viability can be

Prelim: OB-GYN n 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;

AIUM on OB-GYN Prelims. n The preliminary report is equivalent to a worksheet. Limitations:

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

AIUM on OB-GYN Prelims. n A written policy for communicating the differences and changes

AIUM on OB-GYN Prelims. n A written policy for communicating the differences and changes that arise between the preliminary and final report must be in place. n Verified final reports must be available within 24 hours of completion of the exam.

Preliminary Reports – ICAEL n The ICAEL strongly discourages the use of sonographer prepared

Preliminary Reports – ICAEL n 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. n ICAEL: Intersocietal Commission for the Accreditation of Echocardiography Laboratories

Preliminary Reports – Vascular n Vascular technologists frequently report critically important data that they

Preliminary Reports – Vascular n 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. n Society of Vascular Technologist and Society of Vascular Surgery

Proposed Description of Vascular Technologist Occupation Conducts tests, using judgments formed from a review

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

Identify statistics from the government and research articles Objective 4

Identify statistics from the government and research articles Objective 4

Employers Expense Health insurance expenses are fastest growing cost for employers. n Increased health

Employers Expense Health insurance expenses are fastest growing cost for employers. n Increased health costs correlate to drop in health insurance. n 25% of housing problems attributed n 1. 5 million foreclosures on homes /year n

Cost to Employees Workers pay $1, 600 more in premiums annually for family coverage

Cost to Employees Workers pay $1, 600 more in premiums annually for family coverage than they did ever before. n The annual premium a health insurer charges an employer for a health plan covering a family of four averaged $12, 700. n Workers contribution average: $3, 400. n n 12% more than 2015.

Medical Expense and Bankruptcy n A recent study by Harvard University researchers found that

Medical Expense and Bankruptcy n A recent study by Harvard University researchers found that the average out-ofpocket medical debt for those who filed for bankruptcy was $12, 000. n 68 % had health insurance. n 50 % of all bankruptcy filings were partly due to medical expenses.

Implication – Hospitalizations n Most expensive conditions/percentage of national bill: n Coronary artery disease

Implication – Hospitalizations n Most expensive conditions/percentage of national bill: n Coronary artery disease (5. 6%) n 1. 2 million stays, $53 Billion Acute Myocardial infarction (3. 7%) n Congestive heart failure (3. 5%) n Pregnancy and delivery (5. 1%) n Newborn infants (4. 0%) n

Radiation Exposure Concerns Informed Consent n Risk not mentioned – Expert knows best n

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

Institute for Energy and Environmental Research (IEER) Recommending New Guidelines n Women are 52%

Institute for Energy and Environmental Research (IEER) Recommending New Guidelines n Women are 52% more likely to get cancer from the same amount of radiation dose compared to men

Radiation Exposure Natural Radiation – such as radon n Average person in the US

Radiation Exposure Natural Radiation – such as radon n Average person in the US receives 3 m. Sv of Natural Radiation n Chest X-Ray 0. 1 m. Sv or 10 days of natural n Mammogram 0. 7 m. Sv or 3 months n Cardiac CT for calcium scoring 2 m. Sv or 8 months n An abdominal/spine CT is 10 m. Sv or 3 years n 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.

Non-Clinical Criteria Influencing Hospital Choice Keeping patients informed about treatment both during and after

Non-Clinical Criteria Influencing Hospital Choice Keeping patients informed about treatment both during and after visit (77%) n Conducting scheduled appointments on time(75%) n Room appearance (66%) n Ease of scheduling appointments (64%) n Food and entertainment options in room (63%) n Value for the money (62%) n

Suggest improvements in day-to-day flow Ultrasound is a great place to be! Objective 5

Suggest improvements in day-to-day flow Ultrasound is a great place to be! Objective 5

Forbes. com n In Pictures: “Jobs That Can Earn More Than $100, 000 Without

Forbes. com n In Pictures: “Jobs That Can Earn More Than $100, 000 Without College” n Author: Klaus Kneale Ultrasound Technologist n 90 th Percentile Income: $110, 000 n 75 th Percentile Income: $82, 500

Ultrasound reduces costs Limitation to unreimbursed care will encourage growth, shying away from $$$

Ultrasound reduces costs Limitation to unreimbursed care will encourage growth, shying away from $$$ procedures. n Needle guidance procedures n Biopsy guidance n Central Line Placement/complications n Reducing amount of anesthesia for nerve blocks n Foreign body visualization n Frees more expensive imaging equipment n

Quality vs. Cost n Instant decision on patient care n “Modern day stethoscope” n

Quality vs. Cost n Instant decision on patient care n “Modern day stethoscope” n Expensive test overuse, abuse n Consumer awareness of radiation exposure/use n Lawsuits over radiation exposure (peds)

Best protection n Imaging equipment performance should be evaluated regularly to ensure good image

Best protection n Imaging equipment performance should be evaluated regularly to ensure good image quality. n Image phantom checks as suggested. n Safety check all cords. n Follow manufacture recommendations for transducer

Best Practices n Document!! n For reimbursement consideration: all exams require: n Documentation n

Best Practices n Document!! n For reimbursement consideration: all exams require: n Documentation n Completeness n Medical necessity

Documentation n Edits/Additions appropriately for your institution n Single line to cross out n

Documentation n Edits/Additions appropriately for your institution n Single line to cross out n Add/edit n Why n Date n Initial

Best Protection n Follow your hospital/departmental protocol for the procedure/exam you are doing. n

Best Protection n Follow your hospital/departmental protocol for the procedure/exam you are doing. n Perform in the manner in which you have been trained.

The golden rules Come to work Fit n Come to work educated n Do

The golden rules Come to work Fit n Come to work educated n Do not misrepresent yourself!! n

n If you have not been trained…. n Don’t do the exam!!! n The

n If you have not been trained…. n Don’t do the exam!!! n The END