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

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

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

4 Malpractice Professional misconduct encompassing an unreasonable lack of skill or unfaithfulness in professional or fiduciary duties. 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. Has grown much faster than overall health care inflation. Most Common Targets: Most Common Targets: Obstetrics Obstetrics Neurology Neurology Emergency room care Emergency room care Konig, Health Care News, January 2006 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. 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” 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.” 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. 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. Torts cover intentional acts and accidents.

9 Medical Claims Only 1.53% of those injured by medical negligence file a claim. Only 1.53% of those injured by medical negligence file a claim. Estimate: 98,000 deaths/year Estimate: 98,000 deaths/year 57-70% of claims result in no payment to the patient. 57-70% of claims result in no payment to the patient. Cost to defend a claim on average: $24,669 Cost to defend a claim on average: $24,669 Jury trials: average $4.7 million Jury trials: average $4.7 million http://aspe.hhs.gov http://aspe.hhs.gov http://aspe.hhs.gov Student Doctory Network Student Doctory Network

10 Liability ED Liability ED A 15-year Emergency review A 15-year Emergency review Causes/missed diagnoses: appendicitis, myocardial infarction, fracture, infection, aneurysm, and cerebrovascular disease. Ann Emerg Med 2007;49[2]:196. 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 % Failure to order indicated tests: 58 % Incorrect interpretation of tests: 37 % Incorrect interpretation of tests: 37 % Most of the missing tests were imaging, such as ultrasound, radiographs, or CT 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 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 Excessive workload - 23 percent of cases Handoffs - 24 percent of cases with error and bad outcome. Handoffs - 24 percent of cases with error and bad outcome. Lack of supervision Lack of supervision Fatigue Fatigue Patient-related factors Patient-related factors In one of six missed diagnoses, test results did not reach the correct clinicians. 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 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 Lack of Duty – to provide care Deviation from the Standard of Care Deviation from the Standard of Care Damages - foreseeable harm Damages - foreseeable harm Direct correlation - damages must occur from the breach of the alleged standard of medical care. Direct correlation - damages must occur from the breach of the alleged standard of medical care.

13 A liability of malpractice Physician-patient relationship Physician-patient relationship Breach of Standard of Care Breach of Standard of Care Most often contested Most often contested Negligent Act must have caused injury Negligent Act must have caused injury Patient must have sustained an 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 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 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. Average – typical, usual, a representative type, mediocre, run-of-the-mill, so-so, midway between the extremes, lack of distinction.

15 Insurance for the Sonographer SDMS 1M/6M SDMS 1M/6M $20 Student $20 Student $98 Full Time Employed $98 Full Time Employed $190 Part-time Employed $190 Part-time Employed $293 Self-employed $293 Self-employed ASE – no current offering 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)

16 Apology Law Allows health care providers to apologize and offer expressions of grief without their words being used against them in court. Allows health care providers to apologize and offer expressions of grief without their words being used against them in court. Goal: encourage communication Goal: encourage communication Disadvantage: court system Disadvantage: court system Virginia has an apology law. Virginia has an apology law. http:www.sorryworks.net/lawdoc.phtml 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. 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]. 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 Battery – injury by assault or inadequate care Negligence – below standard of care Negligence – below standard of care Wrongful Death Wrongful Death Loss of a Chance of Recovery or Survival Loss of a Chance of Recovery or Survival Res ipsa loquitur (the thing speaks for itself) Res ipsa loquitur (the thing speaks for itself) Lack of Informed Consent (considered battery) Lack of Informed Consent (considered battery)

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

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

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

23 Defensive Medicine A 2012 survey of 905 physicians: A 2012 survey of 905 physicians: 88% have been sued (National Ave: 25%) 88% have been sued (National Ave: 25%) 92 % have ordered tests, performed diagnostic procedures or referred to specialist for the sake of assurance 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. 33% reported using imaging technology in clinically unnecessary circumstances. http://www.healthblog.org/2008 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 Abnormal finding. In 40% of the cases, an abnormality was found at delivery Sonography report inaccurate- 67% Sonography report inaccurate- 67% Image quality problems – 30% Image quality problems – 30% Not following ACR guidelines – 10% Not following ACR guidelines – 10% Incorrect patient demographic – 5% Incorrect patient demographic – 5% Radiologists held liable - 60% Radiologists held liable - 60% Brennan, AJR, 1998 Brennan, AJR, 1998

25 Examples of When a Sonographer is Liable Physically molesting a patient. Physically molesting a patient. Letting a patient fall, causing injury. Letting a patient fall, causing injury. Giving the patient or accompanying doctor a wrong diagnosis 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. 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 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 Shortage of physicians and personnel ~6% imaging personnel ~6% imaging personnel Shorter exam time expectations Shorter exam time expectations Residents are specializing in higher reimbursement areas Residents are specializing in higher reimbursement areas Demand for primary care physicians Demand for primary care physicians Retiring physicians creating need Retiring physicians creating need

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

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

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

31 Decisions on Image, not on Interpretation Increased reliance on the Ultrasound Image Increased reliance on the Ultrasound Image Digitized world Digitized world Interventions based on Ultrasound image Interventions based on Ultrasound image Ultrasound more frequently used in guidance or interventional procedures Ultrasound more frequently used in guidance or interventional procedures No “fail-safe” 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. 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. 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 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. 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; 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: The preliminary report is equivalent to a worksheet. Limitations: Cannot have recommendations/ impression. Cannot have recommendations/ impression. Labeled "Preliminary Report." 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. 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. 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 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 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. 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 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 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. 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. 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 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. 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. Health insurance expenses are fastest growing cost for employers. Increased health costs correlate to drop in health insurance. Increased health costs correlate to drop in health insurance. 25% of housing problems attributed 25% of housing problems attributed 1.5 million foreclosures on homes /year 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. 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. 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. Workers contribution average: $3,400. 12% more than 2007. 12% more than 2007. The Henry J. Kaiser Family Foundation. Employee Health Benefits: 2008 Annual Survey. September 2008 The Henry J. Kaiser Family Foundation. Employee Health Benefits: 2008 Annual Survey. September 2008

46 The Self-insured Approximately 17 million Americans. Approximately 17 million Americans. Individual policy applications rose 18% in fourth quarter 2008 with ehealthinsurance (compared to 2007). Individual policy applications rose 18% in fourth quarter 2008 with ehealthinsurance (compared to 2007). Individual insurance companies are increasing rates nationwide 8%-56%. Individual insurance companies are increasing rates nationwide 8%-56%. Julie Appleby, USA Today Friday February 20, 2009 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. 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. 68 % had health insurance. 50 % of all bankruptcy filings were partly due to medical expenses. 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. 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: Most expensive conditions/percentage of national bill: Coronary artery disease (5.6%) Coronary artery disease (5.6%) 1.2 million stays, $53 Billion 1.2 million stays, $53 Billion Acute Myocardial infarction (3.7%) Acute Myocardial infarction (3.7%) Congestive heart failure (3.5%) Congestive heart failure (3.5%) Pregnancy and delivery (5.1%) Pregnancy and delivery (5.1%) Newborn infants (4.0%) Newborn infants (4.0%) http://www.hcup-us.ahrq.gov/reports/statbriefs/sb59.jsp http://www.hcup-us.ahrq.gov/reports/statbriefs/sb59.jsp

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

50 Institute for Energy and Environmental Research (IEER) Recommending New Guidelines 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 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. A female infant has about a seven times greater chance, according to Arjun Makhijani, Ph.D. AuntMinnie.com January 13, 2009 AuntMinnie.com January 13, 2009

51 Radiation Exposure Natural Radiation – such as radon Average person in the US receives 3 mSv of Natural Radiation Average person in the US receives 3 mSv of Natural Radiation Chest X-Ray 0.1 mSv or 10 days of natural Chest X-Ray 0.1 mSv or 10 days of natural Mammogram 0.7 mSv or 3 months Mammogram 0.7 mSv or 3 months Cardiac CT for calcium scoring 2 mSv or 8 months Cardiac CT for calcium scoring 2 mSv or 8 months An abdominal/spine CT is 10 mSv or 3 years An abdominal/spine CT is 10 mSv or 3 years 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. 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) (http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray)http://www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray

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

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

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

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

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

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

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

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

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

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


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