The Physician's Pocket Lawyer

LANDES

V ad e me c u m

BIOSCIENCE

Table of contents 1. The Basics

11. Running a Laboratory

2. Medical Malpractice and Risk Management

12. Pharmacy, Prescribing, and Dispensing Medications

3. The Business Office

13. Medical Education and Licensing

4. Medical Ethics

LANDES BIOSCIENCE

V ad e me c u m The Physician’s Pocket Lawyer

14. Occupational Medicine

5. Hospital Staff 6. Pediatrics 7. Obstetrics and Gynecology 8. Emergency Room 9. Psychiatry 10. ICU and End of Life Decision Making

The Vademecum series includes subjects generally not covered in other handbook series, especially many technology-driven topics that reflect the increasing influence of technology in clinical medicine. The name chosen for this comprehensive medical handbook series is Vademecum, a Latin word that roughly means “to carry along”. In the Middle Ages, traveling clerics carried pocket-sized books, excerpts of the carefully transcribed canons, known as Vademecum. In the 19th century a medical publisher in Germany, Samuel Karger, called a series of portable medical books Vademecum. The Vademecum books are intended to be used both in the training of physicians and the care of patients, by medical students, medical house staff and practicing physicians. We hope you will find them a valuable resource.

All titles available at

I SBN 1- 57059- 689- 1

www.landesbioscience.com 9 781570 596896

Charles Ellington John Bradley

v a d e m e c u m

The Physician's Pocket Lawyer

Charles Ellington, M.D., J.D. Asst. Professor Family and Community Medicine Southern Illinois University School of Medicine Decatur, Illinois, U.S.A.

John Bradley, M.D., M.M.M. Professor Family and Community Medicine Southern Illinois University School of Medicine Decatur, Illinois, U.S.A.

LANDES BIOSCIENCE

GEORGETOWN, TEXAS U.S.A.

VADEMECUM The Physician's Pocket Lawyer LANDES BIOSCIENCE Georgetown, Texas U.S.A. Copyright ©2003 Landes Bioscience All rights reserved. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publisher. Printed in the U.S.A. Please address all inquiries to the Publisher: Landes Bioscience, 810 S. Church Street, Georgetown, Texas, U.S.A. 78626 Phone: 512/ 863 7762; FAX: 512/ 863 0081 ISBN: 1-57059-689-1

While the authors, editors, sponsor and publisher believe that drug selection and dosage and the specifications and usage of equipment and devices, as set forth in this book, are in accord with current recommendations and practice at the time of publication, they make no warranty, expressed or implied, with respect to material described in this book. In view of the ongoing research, equipment development, changes in governmental regulations and the rapid accumulation of information relating to the biomedical sciences, the reader is urged to carefully review and evaluate the information provided herein.

Dedication This book is dedicated to all physicians who are trying to do the right thing.

Contents Introduction...................................................................... 1 1. The Basics ......................................................................... 2 2. Medical Malpractice and Risk Management ................... 11 3. The Business Office ........................................................ 19 4. Medical Ethics ................................................................. 34 5. Hospital Staff .................................................................. 41 6. Pediatrics......................................................................... 45 7. Obstetrics and Gynecology ............................................. 49 8. Emergency Room ............................................................ 52 9. Psychiatry........................................................................ 55 10. ICU and End of Life Decision Making ........................... 58 11. Running a Laboratory ..................................................... 63 12. Pharmacy, Prescribing, and Dispensing Medications ...... 66 13. Medical Education and Licensing ................................... 69 14. Occupational Medicine ................................................... 73 Glossary .......................................................................... 77

Authors

Charles Ellington, M.D., J.D. Asst. Professor Family and Community Medicine Southern Illinois University School of Medicine

Decatur, Illinois, U.S.A.

John Bradley, M.D., M.M.M. Professor Family and Community Medicine Southern Illinois University School of Medicine

Decatur, Illinois, U.S.A.

Acknowledgments The authors wish to acknowledge Bethany Spielman, J.D. Ph.D.; Darrell Statzer, M.D.; Cesar Arguelles, M.D.; and Robert Wesley, M.A.; for their valuable assistance in reviewing this manuscript.

CHAPTER 1 INTRODUCTION

Introduction This book is meant for you. Whether you are a busy physician, surgeon, resident, fellow, or medical student, the need to answer legal questions arises all too often. Nearly all these questions seem important at the time. Where can we go for answers? Most of these questions need to be answered now, and you couldn’t get a lawyer to help in time even if you could afford one. What do you do in the middle of a busy clinic, on the floor, or worse, in the middle of the night? Well most of us wing it, because that is our only choice. We just hope it turns out right. For years it has seemed to us that we almost need a “lawyer in our pocket” to consult at these busy times. Since most lawyers probably wouldn’t fit, even in a first year resident’s pocket, we have written this book in hopes of having the next best thing. The Pocket Lawyer is designed to give quick helpful answers to those pesky legal problems that keep coming up at the most inconvenient times. While trying to be as accurate as possible, it is organized in a convenient, efficient way. It is also a size that will fit in your pocket, whether you have the paper or pda version. The idea is to provide a resource that can be used quickly and conveniently while “on the firing line.” We hope you find it helpful and (horrors) even enjoyable. This is not a book that most users will ever want to sit down and read through. It is meant to look things up. However, each chapter has a brief overview of the contents of that chapter. We did this so that if you are not sure where to look up information about your question, the chapter introduction might be a place to start. There is an index, table of contents, and glossary as well. This book is not, and can never be, a substitute for competent legal advice (although we have tried really hard, it’s always possible we made a mistake). Anyway, it is only meant as a basic guide for general questions. But, we hope that it will make your life a little easier.

The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

CHAPTER 1

The Basics This chapter provides an introduction to the American legal system including the following: the legal system physician/patient relationship (starting and ending) decision-making and informed consent confidentiality standards of proof.

The Legal System What is the purpose of the American legal system and how is it organized? The purpose of the American legal system is to prevent or resolve disputes in a nonviolent and fair way. Laws, also called statutes, are the code of conduct which guide this system. Statutes are passed by the Congress or state legislatures (the legislative branch). Statutes generally must be signed by and are enforced by the President or Governor (the executive branch). Where there is a dispute as to what a statute actually means in a particular circumstance, courts (the judicial branch) will tell us what it means (interpret the law). Courts also interpret general legal principles handed down from England. This body of legal decisions is called common law, and was developed by judges over many years. These decisions, as well as those interpreting specific statutes, serve as precedent or persuasive authority to other courts interpreting statutes or new cases. Congress or state legislatures may also delegate the authority to make rules and regulations to a specific agency, such as the Food and Drug Administration. The specific rules these agencies promulgate have the force of law. This type of law is called administrative law. Since the United States has both a federal government and state governments, it has both federal laws and state laws. Federal laws apply to the entire country and trump state laws. State laws apply only to the particular states that enacted them, and court decisions interpreting those laws are only binding in that state. However, the state may look to another state for guidance. Laws can generally be divided into two categories: criminal laws and civil laws. Criminal laws regulate the conduct of individuals in relation to society. Examples of crimes include murder, robbery, arson, rape, etc. Crimes must always be defined by a statute. If a person violates a criminal law, the dispute is between the government (sometimes called the people) and that person. A prosecutor makes the case against the person accused who is called the defendant. The defendant always has the right The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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to a lawyer and a jury. A jury, if one is requested, decides what the facts actually are in a particular case. The jury is instructed about the law in a particular case by the judge and the jury then applies the law to arrive at a particular conclusion. If the defendant is found guilty, the judge, except in death penalty cases, will decide what punishment to inflict. A jury must decide whether to impose the death penalty. If the crime is a misdemeanor, the punishment cannot exceed one year in jail. If it is a felony, the maximum punishment may (but does not have to) exceed one year in jail. In contrast, civil laws regulate the conduct between private individuals. If a person breaks one of these civil laws, a harm has been committed. This harm is also called a tort. A tort is simply a civil wrong, and a tortfeaser is the person who did the wrong. Examples of torts include medical malpractice, manufacturing defects, automobile accident injuries, and private property damage. The person who claims to have been wronged is called the plaintiff, and the person who supposedly did the wrong is called the defendant. Usually the tortfeasor and the defendant are the same. Again a judge decides what the law is; the jury decides what the facts are; and the jury applies the law to the facts. If the plaintiff wins the case, the jury decides the damages that the defendant will have to pay. This is almost always money. A few things have to be pointed out. First, whether in a civil or criminal case, persons accused of wrongdoing have the right to retain a lawyer. In a criminal case, if you cannot afford a lawyer, one will be provided for you. Second, they have a right to know that someone has a complaint against them, what the complaint is, and have a reasonable time to respond. Third, they have the right to present their case in court, including calling witnesses and offering physical evidence. Fourth, they have the right to have an impartial decisionmaker. In sports terms it’s like having a right to know what the rules of the game are, who the opposing team is, being allowed to actually play, and having a referee or umpire who isn’t on the take. In legal terms this is called due process of law. It’s the idea of being fair to everybody involved in a dispute. What recourse does a person have if they are dissatisfied with the result the court? Every person (with some exceptions) has the right to one appeal once a court has issued a final judgment. In federal court, the appeal would be to federal circuit court. In state court, the appeal is usually to a middle level appellate court. Most cases are not overturned on appeal. The reason is that appellate courts don’t rehear the entire case. They simply look at the record of the trial to see if any important mistakes were made. They look at issues of law, and most of the time they don’t second-guess the judge (or jury) who was actually present for the testimony and presentation of evidence. If persons are unhappy with what the appellate court decided, then they can petition for a hearing before the Supreme Court. This is called a writ of certiorari and does not have to be granted. While there is a right to petition the Supreme Court, the court is not obligated to hear your case.

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The Physician/Patient Relationship

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May a physician choose whom to treat and whom not to treat? Yes, with very few exceptions. Some of those exceptions would include refusing to treat someone based solely on their race, religion, national origin, HIV status, or refusing to screen and stabilize someone in the emergency room. When has a legal obligation to treat a patient been created? Another way to ask this question is when has the physician-patient relationship been created? The physician-patient relationship is a special kind of relationship that carries with it certain responsibilities and is necessary before a malpractice claim can be made. It is created when a person seeks out the medical or surgical services of a doctor, and the doctor agrees to treat the person as a patient. Both the patient and physician have to agree to the relationship. It doesn’t matter who is paying the bill or who initially solicited the relationship. Sometimes it is unclear whether such a relationship exists, but in close cases judges usually rule that it exists. Examples: What if a patient leaves the emergency room against medical advice and then suffers injury? In this case, a doctor-patient relationship has been created. But as long as the doctor has adequately warned the patient, he or she would not be liable. An adequate warning would include explaining to the patient the nature of the illness, why treatment is needed, and the potential consequences of leaving against medical advice. Does a duty to treat exist if the patient does not pay his or her bill? Yes. The physician-patient relationship creates a duty that is separate from whether a patient pays his or her bill. However, a physician may terminate a patient for nonpayment as long as the physician complies with the legal requirements of termination. Can a telephone conversation result in an agreement to treat? Yes. Although some physical contact is usually necessary, a telephone conversation can result in the creation of the physician-patient relationship if the doctor recommends treatment or hospital admission. However, a conversation in which the physician only recommends the patient go back to his or her initial physician or surgeon has not been considered enough to create the relationship. Can reading an x-ray result in a physician-patient relationship? Yes. Because the patient could reasonably rely on the radiologist’s interpretation, a duty to treat has been created. Can examining a pathology slide create a physician-patient relationship? Yes. By examining the slide, the physician assumes responsibility for this aspect of the patient’s care. In so doing, he or she is obligated to use appropriate professional judgment and meet the standard of care. Can answering a medical question for a friend result in an agreement to treat? Yes. If the friend or acquaintance might reasonably rely on the recommendations, then an agreement to treat could exist. However, if the physician says that his opinion is only cursory, that he would need to examine the patient and take a more thorough history before giving any specific advice, that might offer some protection. Further

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protection can be had if the physician tells a friend he/she should go back to their primary doctor. Does answering a “curb-side” consult create a physician-patient relationship? Maybe. It all depends on the level of interaction between the curbside consultant and the patient. If the physician answers general questions, never sees or examines the patient, and does not charge a fee, it is very unlikely that a physician-patient relationship has been created. If the level of interaction is greater, such as the consultant actually examines the patient or charges a fee, then a physician-patient relationship probably has been created. It is important to keep in mind that although a physician is not obligated to give free medical advice, the physician owes a duty to those who reasonably rely on such advice. Again, the level of interaction with the patient is determinative. Is the consultant functioning as a textbook, a teacher, or an actual consulting physician? Does giving a second opinion create a physician-patient relationship? Yes, if the physician rendering the second opinion actually treated the patient or affirmatively advised how treatment should proceed. Once a physician has agreed to treat a patient, what special obligations does he or she have? The physician has a professional obligation to provide medical services consistent with the standard of care. The physician has a duty to provide care which an ordinary competent physician would provide under the same or similar circumstances. In other words, the physician has an obligation to provide good care for the patient consistent with the standard of care. In addition, the physician has a duty to refer if he or she does not have the knowledge or skill to treat the patient. These duties continue until the relationship is properly terminated. In addition, if the physician promises a certain result that does not occur, even if the physician was not negligent, the patient can sue for breach of contract. Although this type of suit is unusual, it most often occurs when a physician promises a specific outcome to a patient. For example, a plastic surgeon can be sued for breach of contract if he or she promises a specific cosmetic result that does not happen. A physician can give therapeutic reassurance, but he or she should avoid promising a specific outcome. Can a physician fire a patient, and if so, how? Yes, a physician can generally unilaterally “fire” a patient. But the physicianpatient relationship must be terminated in an appropriate way. Although the specific requirements of termination depend on state law, some general guidelines are recommended. A certified letter should be sent to the patient explaining that the relationship is terminated, the patient’s medical illnesses or conditions, and what additional care is needed. In addition the patient must be given enough time to find another doctor. The terminating physician should still provide care in the mean time, especially in emergency situations.

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What is the penalty if a physician inappropriately terminates the physician-patient relationship? A physician may be guilty of breach of contract, malpractice, or abandonment.

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What is abandonment? Abandonment occurs when a physician fires a patient without giving the patient enough time to find another physician and where the physician’s care is still needed. It may also occur if a physician leaves town without coverage. In addition, a pregnant woman cannot be fired without risking abandonment. She may, of course, be transferred to a higher level of care for medical reasons. If the patient is injured as a result of the lack of medical care, he or she can sue the physician for breach of contract or negligence. Examples: Can a physician fire a patient who is noncompliant? Yes. A physician may unilaterally fire a patient for noncompliance or other reasons. A patient is responsible for cooperating with the reasonable diagnostic or treatment plan of the physician. If the patient fails to comply after being adequately warned, this failure to comply will limit the physician’s liability. Can a physician fire a patient in an emergency? No. In order for a physician to properly terminate the physician-patient relationship, he or she must give the patient adequate time to find another physician. The withdrawal of a physician from a patient’s care in an emergency is the clearest example of what the law of abandonment seeks to prevent. Can a psychiatrist fire a mentally ill patient? Yes. However, the physician-patient relationship should not be terminated if the patient is in the middle of a crisis or emergency. The termination should be done in writing to create a paper trail as psychiatric patients may misunderstand or misinterpret a verbal communication. Can a patient fire a physician? Yes. A patient can terminate the physician patient relationship at any time for any reason. The termination can be by words (“I’m firing you as my doctor”) or actions (such as leaving the hospital against medical advice). The physician still has an obligation to inform the patient of continuing risks if treatment is not sought. It is important for the physician to document the circumstances around the termination and have at least one or two witnesses to verify the facts in writing. Although controversial, you should probably send the patient a letter if he or she fires you. This mainly functions to create a paper trail of what happened and to provide protection to you if the patient later comes back and says they did not actually terminate the physician-patient relationship. This letter should also be sent by certified mail.

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Decision-Making and Informed Consent Who makes health care decisions for the patient? The patient. The doctor provides information, recommendations, and offers treatment, but the patient decides whether to accept and follow the treatment and recommendations. Is a physician required to get consent before treating a patient? Yes. A physician must get a general consent to engage in diagnosis and treatment. If consent is not granted, the physician could be liable for an unwanted touching or battery. Consent can be written or verbal, but written consent provides much stronger evidence of proof in court. In most doctor’s offices, the patient usually signs a general consent to treatment before being seen. This document memorializes the consent the patient provides. Also, a physician may be sued for battery in certain cases. A battery is an unwanted touching such as slapping someone. Battery cases against physicians usually result from a physician doing additional surgical procedures for which the patient did not consent. Examples: A gynecologist suspects a patient has a large ovarian cyst which is causing significant pain. Surgery is scheduled and the patient only consents to drainage of the cyst. Upon entering the abdomen the ovary is normal but the patient’s gall bladder is apparently full of stones. If the surgeon removes the gall bladder without the patient’s consent, the physician may be liable for a battery. Are there times when express consent is not required? Yes. Consent can be implied from the circumstances. If a patient acts in a specific way which clearly shows they are consenting to medical care, express consent is not required. For example, if a patient shows up at a doctor’s office or emergency room and requests to be seen, these circumstances imply consent. Examples: May a physician treat an unconscious person in an emergency? Yes. This is “presumed consent” where it is presumed that an unconscious person in an emergency would consent to medical treatment. May a physician treat a minor without the parent’s consent? Not generally. There are some important exceptions to this rule. Refer to the chapter on Pediatrics and the Law for a more in depth discussion. In an emergency, can a minor be treated without the parent’s consent? Yes. May an intoxicated person who lacks capacity to consent be treated? Yes. In an emergency situation, consent is presumed. However, in a non-emergency situation, consent would be required. What is informed consent? Informed consent is the legal doctrine that requires a patient be given enough information to make an informed, educated decision about a proposed test or treatment. It implies that the physician and patient make decisions together. It respects

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the right of the patient to self-determination and autonomy. It is not only legally but also ethically required. It arises out of a communication between the physician and patient.

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What information must be disclosed for informed consent? For there to be informed consent, a physician must do the following: 1. Explain the treatment, procedure, or disease; 2. Inform the patient of the benefits of the proposed treatment and the likelihood of success; 3. Discuss reasonable alternatives, including no treatment, and make sure the patient knows the likely outcome without the proposed treatment or non-treatment; 4. Disclose material risks of the treatment or procedure to the patient. This discussion is often times recorded by a signed consent form. It is important to note that a physician does not have to disclose every risk, only material risks. Material risks are important or significant risks. Minor or idiosyncratic risks are not considered material by most jurisdictions. Examples of what is and isn’t informed consent: Is having the nurse go into a patient’s room and getting the patient to sign a consent form informed consent? No. Informed consent is not a form that is signed. Although it may be memorialized by a form, it is the exchange of information by a patient and physician whereby a patient can make an informed choice about a proposed treatment or procedure. Is there informed consent if the doctor has the patient sign the consent form without any explanation? No. Again, informed consent requires that the physician disclose information to the patient so the patient can make an informed decision about treatment. Simply having someone sign a form does not meet that requirement. What is the penalty for not obtaining informed consent? The physician can be sued for negligence for not meeting the duty to disclose material information to the patient. The patient must prove that the physician knew or should have known the risk not disclosed was material and that the failure to disclose the risk resulted in the patient’s injury. In the U.S., jurisdictions are split on how to decide if the patient would have refused the treatment or procedure if informed of the risk. One way is called the subjective test and requires the finder of fact, usually the jury, to decide if the actual patient would have refused the test or treatment if informed of the risks. This can be problematic because most people with 20/20 hindsight would earnestly believe they would have refused the test or treatment. This places the physician in a very difficult position. Fortunately, most jurisdictions follow the objective test, which requires that the jury decide whether a reasonable person in the same situation as the patient would have consented to the treatment. This avoids placing the physician in danger of the patient’s anger and bitterness following an undesirable outcome. It also makes proving an informed consent case against a physician very difficult.

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What are the defenses for failing to obtain informed consent? Although these aren’t defenses in the legal sense, they are effective methods of protecting yourself. The best way to protect yourself against an informed consent lawsuit is to document that you counseled the patient about the procedure or treatment. The documentation does not have to be all-inclusive, but it should comment on the specific risks that were disclosed. Further, language such as “risks including, but not limited to” may be helpful show you informed the patient of other risks not specifically enumerated. A second defense would be emergency. Physicians are generally not required to obtain informed consent in emergency situations. A third defense is the “so what” defense. This defense argues the patient would have had the procedure or treatment anyway. Are there times when a physician is not required to obtain informed consent? Yes, but be careful. If the physician believes it would be harmful to disclose a risk of the procedure or treatment, he or she may avoid disclosing under the therapeutic privilege. Therapeutic privilege means the physician’s privilege not to disclose information to the patient that is likely, simply by its disclosure, to cause serious harm to the patient. However, the physician must prove that he or she was acting in the patient’s best interest and that disclosing the information would have had serious negative consequences on the patient’s well being. In practice, this is very rarely used and is risky.

Confidentiality May a physician disclose patient information to a third party without consent? No. Ethical and legal standards require that patient information be kept confidential. Confidentiality requires patient consent before records are released to a third party. However, records can generally be released to a medical consultant without consent, although it is probably the best practice to always obtain consent any way. In an emergency, information can be released without consent. Examples: A patient’s wife calls the office and wants to know the results of the patient’s blood tests. Can that information be given without the patient’s express consent? No. Family members generally may not access the medical record without the patient’s consent. The emergency room calls your office and one of your patients arrives and is unconscious. They want you to fax over the patient’s records immediately. No family members are present with the patient. Can you provide the information? Yes. In an emergency you can provide information from the medical record. Consent will be assumed.

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How should consent be obtained before records are released to a third party? Generally, when patients initially register with a physician, they sign a consent form that allows information to be released to insurance companies and others entities required for billing. If information needs to be sent to a third party for a referral, the patient must sign a release of records statement that is specific for that party. In addition, HIPAA (Health Insurance Portability and Accountability Act) sets specific federal standards for disclosure of medical information to third parties. Please see discussion under Business Records. What is the penalty for disclosing patient information without consent? Most states have enacted legislation that penalizes physicians who disclose confidential information. Penalties can be significant. In addition, state medical boards may impose sanctions for acting unethically.

Standards of Proof What is meant by standards of proof? A standard of proof is the degree of certainty that something must be demonstrated to win the case. There are three basic standards of proof in the United States: Preponderance of the evidence: This standard requires something be more likely true than not, or in other words at least more than 50 % likely. This is the lowest standard, and the one usually used in a civil trial. Clear and convincing evidence: This standard approaches the “beyond a reasonable doubt” standard. It is certainly more than the “preponderance of the evidence” standard. It is understood by some to mean more than 75% certain that the facts are true. This standard is usually applied in fraud and gender discrimination cases. Beyond a reasonable doubt: This standard requires proof that is entirely convincing and satisfying. It can leave no question as to guilt. It is the standard applied in criminal trials.

CHAPTER 1 CHAPTER 2

Medical Malpractice and Risk Management This chapter discusses the following: what is the standard of care what is medical malpractice (in legal thinking) what to do if you get sued (or think you’re going to get sued) what goes on before the trial (including everything from what to do if you think you may be getting sued to how to act in a deposition) what goes on during the trial (including how a trial is conducted, expert testimony, and defendant testimony) risk management alternative dispute resolution.

What is the Standard of Care? One of the most important things an expert testifies about is the standard of care. The standard of care is another way of saying the duty a physician owes to a patient. In almost all states the standard is the prudent physician. This doesn’t mean a physician has to be the best doctor or even an average doctor, just prudent. To determine if a physician acted prudently, an expert is almost always required. At the same time, the expert usually testifies whether the physician breached the standard of care. An expert also testifies about causation. Is there medical evidence that the physician’s breach of duty caused the defendant’s injury? Sometimes, this can be the hardest thing to prove and often is not entirely clear. For example, if a physician fails to diagnose lung cancer in a timely fashion and the patient dies from the disease, did the physician’s failure result in the patient’s death? What if the tumor was stage III at the time the patient went to the doctor and stage IV when it was finally diagnosed? These are hard questions even for an expert witness.

What is Medical Malpractice? Medical malpractice is a specific legal term that applies only when specific criteria are met. Those specific criteria or elements include the following: 1. duty to provide medical care consistent with the standard of care 2. failure to meet that duty (you didn’t follow the standard of care) 3. injury suffered by the patient (something bad happens to the patient) 4. causal connection between the breach of the physician’s duty and the patient’s injury (also called proximate cause). This means convincing the jury that the physician’s failure caused the bad thing to happen.

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What this means in general is that you treat your patient and there is a bad outcome. The patient then claims that your treatment caused the bad outcome because you didn’t follow the generally accepted practice in this case (i.e., you didn’t meet the standard of care). If the patient can prove all of the elements of a malpractice claim, then he or she has a right to collect money from the physician for the damages suffered. Prove means a jury is satisfied that the “preponderance of the evidence” standard has been met. What kind of things are not malpractice? Basically, anything that does not meet all four elements or requirements of the specific claim is not malpractice. Simply having a bad outcome is not malpractice. Making a mistake where the patient is not injured is not malpractice. Following the standard of care and having a bad outcome is not malpractice. Who can sue me? Literally, anyone can sue you for anything. The real question is: can they make it stick? In practical terms, a lawyer will rarely ever accept a case that is completely frivolous—to do so would require spending a large amount of time on an unwinable case. What should I do if I think I messed up and there’s no sign the patient or family will sue me? Most studies show that good patient communication can significantly improve doctor/patient relations. If you mess up, don’t avoid the patient or the family. Don’t be evasive or act like you’re hiding something. You need to be honest and open, and at the same time don’t give away the farm. In other words, be available for the patient and family, answer questions the best you can, and even admit that a bad outcome occurred. Don’t lie. You don’t have to admit any personal wrongdoing. After all, that would have to be decided by a jury anyway. What are some warning signs I might be getting sued? One of the first signs comes from the patient and his or her family if they state they want to look into their legal options. Studies show that patients with a strong family support structure are more likely to sue than those without such structures. Other signs include requests for medical records by attorneys, being named as a respondent in discovery, and actually being served with a summons. What if I am sued frivolously? Frivolous lawsuits are a burden on both the person being sued and the legal system. A lawsuit is frivolous if there is no factual or legal basis to make a claim. If you are sued frivolously, you may request the court dismiss your case, and as a punishment to the attorney bringing the lawsuit, request he or she be sanctioned. Sanctions may include monetary fines as well as disciplinary action by the state bar.

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What should I do if I think I’m going to get sued? The first thing you should do is contact your malpractice insurance carrier and consult an attorney. You probably should not talk about the case with anyone else with the exception of your spouse and very close and trusted friends. It is easy to isolate yourself at times like this, but you should fight the urge. Your malpractice carrier will generally provide you with a local attorney. Many physicians urge getting a second lawyer not hired by the insurance company. Their concern is that a lawyer hired by the insurance company may be representing the insurance company’s interest and not yours. If that is the case, the lawyer is violating his or her ethical obligation of loyalty to the client. There is no hard and fast rule about this and much depends on the particular circumstances and the individual attorney. One more piece of advice is DO NOT ALTER THE MEDICAL RECORD. In legal language, alter means to dishonestly change. If appropriate changes need to be made, do so in a way that shows how it was changed, what the original record was, the date, and who changed it. In other words, be honest. Anything that looks like you tried to alter evidence will be very damaging in court. What happens if I get sued? First, a legal document, called a complaint, is filed with the court by the person suing you. Next, you will be served with the complaint usually by the Sheriff. The complaint (a legal document) specifically spells out the persons involved, alleges the specific reason why you are being sued, and prays for (asks the court for) damages. It also says that the state where the lawsuit was filed has appropriate “jurisdiction.” The complaint usually demands a trial by jury. In many states, the complaint must be accompanied by an affidavit or sworn statement by the attorney stating the claim was reviewed by a physician and has merit. You must respond to this complaint within a specified amount of time or a judgment will be entered against you. You can respond in a number of ways: you can deny everything in the complaint, admit certain things and deny others, or admit everything. In addition you can counter sue if you have a potential claim against the patient, (there are specific rules for doing this that are beyond the scope of this book). Your response will be filed by your attorney. At that time you can make motions (request the court take certain actions). If the complaint filed against you does not assert enough facts to actually rise to a cause of action (e.g., a malpractice claim that says your red hair caused the patient to suffer from anxiety) you can move to dismiss the lawsuit. You can also ask the court to dismiss the lawsuit if it was filed in the wrong state (e.g., you and the patient live in Illinois, you treated the patient in Illinois, but the patient files the lawsuit in Hawaii). After your response has been filed, if the presiding judge allows the lawsuit to proceed on, both sides take part in what is called “discovery.” Can I settle out of court, and what happens if I do? You may settle out of court if you and the person suing you can reach a mutually acceptable settlement. In fact, your attorney may advise you to do so. You can also take the case to trial. But bear in mind, if you do settle, you will be reported to the

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National Health Care Practitioner Data Bank, it will raise your malpractice premiums, and you will probably have to disclose this information when you apply for privileges with hospitals and insurance companies. In spite of this fact, settling out of court may still be the best thing to do. It depends in large part on the circumstances of the case.

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What is the National Health Care Practitioner Data Bank? This is a data bank run by the federal government which serves as a repository for information on physicians who lose medical malpractice claims at trial or who settle out of court for more than $1. Reporting is mandatory and hospitals are supposed to check it before they give you privileges. If they do not, they can be liable if you mess up. What is discovery? Discovery is the general term for collecting the facts of the case by both sides. It is basically where you tip your hand to the other side before trial and vice versa. By each side showing the other the evidence they have, there is less likelihood of people being ambushed at trial. More importantly, discovery helps settle disputes out of court. Two main types of discovery are depositions and interrogatories. What is a deposition? A deposition is sworn testimony given in person outside of the courtroom before trial. A court reporter is present to record the testimony. Its purpose is to find out what a witnesses will say at trial and to impeach them (undermine their credibility) if they change their story later on. A lawyer can depose almost anyone even marginally associated with the case. This means you. The rules for a deposition are much less restrictive than for a trial, and the attorney can ask you a broad array of questions ranging from your education and training to questions about the case itself. Most of the time you’ll have to answer the question. Your attorney (who will be present) may object, but usually he or she will direct you to go ahead and answer the question. If a question is completely out of bounds or inappropriate, your attorney may direct the court reporter to certify the question. This means you should not answer the question and there will be a hearing before a judge to determine if it is appropriate. If you are ever deposed, here are ten rules to remember: 1. Know the record intimately. 2. Listen to each question carefully and respond only when you understand it completely. 3. Respond only to the question asked. Do not ramble on, tell stories, or volunteer information. 4. Refer to the medical record when necessary. 5. Ignore the theatrics and body language of the plaintiff ’s lawyer. 6. Be consistent. 7. After finishing one question, wait for the next question before answering. Sometimes an attorney will intentionally leave a long awkward pause to try to spur you on to say more. Resist the urge.

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8. Be very careful when you respond to leading questions. Lawyers are excellent at leading people down the prim rose path with statements like “Is it a fair statement…” or “Let me summarize…” or “I understand your testimony is….” 9. Be careful with conversation during breaks. Lawyers are good at causing you to let your guard down by engaging you in conversation. What you say could impact the case. Be polite but on guard. 10.Maintain a professional demeanor at all times. What is a respondent in discovery? A respondent in discovery is a person who is not actually being sued but may have information relevant to the lawsuit. A respondent in discovery may be deposed (have their depositions taken) and sometimes is required to answer interrogatories (see below). It’s important to understand that respondents in discovery are sometimes re-designated as defendants. So the plaintiff ’s lawyer may be fishing for more people to sue—like you. What are interrogatories? While depositions are taken “live” and can be asked of almost anyone, interrogatories are written questions which one side asks of the other. There are specific rules governing the way they can be asked. Again, the point is that you show the other side what evidence you have and vice versa. This is supposed to avoid trial by ambush and help facilitate settlement. You provide the answers to your attorney who drafts the written response. The answers must be given under oath. The lawyers drafting the responses to interrogatories are usually skillful enough to avoid giving away too much information. What kind of questions are asked in interrogatories? Almost anything can be asked so long as it is marginally relevant. How does a malpractice trial work? A malpractice trial works like any other civil trial, except that a malpractice trial almost always includes an expert witness. The various parts of a trial are as follows: Opening Arguments: Each side makes opening arguments where they summarize their case and tell the jury what they plan to prove. Plaintiff’s Case in Chief: The plaintiff presents the case in chief, i.e., calls witnesses and introduces evidence to prove his or her claim. The plaintiff must prove a prima facia case at this point or the case will be dismissed. That means he or she must put on enough evidence to assert the basic claim. In the case of a malpractice suit, evidence must be presented to prove each of the four elements of the claim. The plaintiff ’s witnesses are subject to cross-examination by the defendant’s attorney. Motion to Dismiss: If the defendant feels the plaintiff has not sufficiently made his or her case, he or she may move to dismiss the case. Judges usually do not dismiss cases at this point unless the plaintiff’s case is pretty bad. The Defendant’s Case in Chief: If the case is not dismissed, the defendant will present the case in chief. The defendant will call witnesses to rebutt the plaintiff ’s

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case and bolster his or her own case. Defense witnesses are subject to cross-examination by the plaintiff ’s attorney. More Motions: After the defendant’s case in chief, the plaintiff and defendant can both make motions asking the judge to rule in their favor. This is usually only done when the other side has obviously failed to provide any legitimate case. Rebuttal Testimony: Then each side may present testimony to rebut what the other side just showed. Rebuttal testimony can only be within the scope of previous testimony. Closing Arguments: Finally, after each side presents the case in chief and rebuttal testimony, each side makes closing arguments that summarize the case from their point of view. Jury Instructions: After closing arguments, the judge instructs the jury. Verdict: The jury goes off and deliberates and (hopefully) arrives at a verdict which is entered by the judge. If the verdict is patently out of bounds, the judge can issue a judgment not withstanding the verdict. In other words, the judge can completely over rule the jury. The case is then over. At that point, either side can file an appeal. What is an expert witness? An expert witness helps to explain medical facts to a jury so they understand them. Since most people haven’t gone to medical school, the jury may have trouble making sense of all the medical evidence that will be presented. The expert witness provides the medical expertise on a case to help the jury arrive at a verdict. Each side usually hires an expert witness (who happens to be very well paid) who will testify favorably to that side. Often, medical malpractice suits come down to which expert is more credible or believable. May a subspecialist testify as an expert witness against a primary care physician? Yes. The expert needs to be qualified to testify about the standard of care. If a family practice physician or general pediatrician is sued for failing to diagnose a lethal heart murmur, a subspecialist, such as a pediatric cardiologist, may testify to the standard of care because this is within his or her area of expertise. However, if a subspecialist is being sued, generally the primary care physician may not testify. For example, if an orthopedic surgeon improperly repairs a fractured hip, a family doctor usually will not be allowed to testify as an expert. I lost at trial. Can I appeal and what are my chances of winning if I do? You can appeal if you lose at trial, but your chances of winning are probably small. This is because appellate courts only review cases to see if any significant mistakes in applying the law were made at trial. They do not retry cases, call witnesses, or re-examine evidence. These things were all done at trial, and great deference will be given to the decisions made by judge and jury who were actually present at the trial. If you lose on appeal you can ask the supreme court to hear your case. This is called a petition for certiorari. However, supreme courts usually turn down most of

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these petitions. They only agree to hear important cases that have significance for the whole state.

Risk Management What can I do to keep from getting sued? Practice the best medicine you can and be good to your patients. Several studies have shown that good patient communication reduces your chances of being sued. If you do mess up, don’t run off and hide. Be accessible and as helpful as you can to the family and straight forward in answering their questions. Don’t ever lie. You don’t have to admit to malpractice or give away the farm. Be kind, considerate, and competent. Also, document what you do. This is especially important in the area of informed consent. These recommendations are good advice for everyone all the time. What is my relationship to the lawyer provided by my malpractice carrier? The lawyer provided by your malpractice insurance company is supposed to represent you. In fact, the lawyer has an ethical duty to represent your best interests. Since your malpractice carrier will likely be paying any settlements or judgments against you, it appears you both have the same interest. However, occasions may arise where it may be in your best interest to take the case to trial, but in your malpractice carrier’s best interest to settle. In that case, your lawyer still is supposed to represent your best interest, but he or she may harbor divided loyalties. Do I need another lawyer other than the one provided by my malpractice carrier? In light of the answer to the above question, some argue that a defendant in a malpractice action should always consult an attorney not hired by the malpractice carrier. May I be held liable for the misdeeds of other physicians? Generally not. Physicians are not required to attend their patients 24 hours a day. Usually they cannot be held responsible for what other physicians do. Examples: May I be held liable for a “negligent referrals”? A referring physician is usually not responsible for the actions of a specialist. However, if the specialist does not provide care, or provides negligent care, and the referring physician also has a duty to provide such care and does not (usually because he or she assumes the specialist will provide it), both physicians can be liable. May I be held liable if the guy covering my call messes up? Maybe. Again, physicians are generally not responsible for the actions of other physicians, but if you negligently select someone to cover your patients you may be held liable. Can Managed Care Organizations be sued for malpractice? Usually not. Any suit against an MCO, PPO, or HMO for negligently denying claims which result in a patient being injured is most likely barred by federal statute. Under federal law, namely ERISA, any of these insurance plans which are part of an

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employee compensation package are protected from negligence claims. This is a very complex issue, a full discussion of which is beyond the scope of this book. May I be sued for what a nurse or physician’s assistant does? Yes, under certain circumstances. If the nurse or physician’s assistant is your employee you can be sued under the doctrine of respondeat superior. This means the person for whom the nurse or PA works is responsible if they mess up. For example, in a doctor’s office, if a nurse puts in sutures the physician can be liable for the nurses negligence. Also, even if the nurse is not the physician’s employee, the physician can sometimes be held responsible for the nurse’s actions. Under the “captain of the ship” doctrine, physicians, in this case usually surgeons, were considered to have absolute control over their domain and were therefore responsible. This theory usually applied to the activities which occurred in the operating room. This theory has been supplanted by the more modern “borrowed servant theory” which holds physicians liable for the acts of those whom they directly supervise.

CHAPTER 1 CHAPTER 3

The Business Office This chapter discusses the following: • medical records • confidentiality of the record • employee relations including ADA, employment contracts, and sexual harassment • business organizations • insurance and billing fraud.

Medical Records What is the purpose of the medical record? The medical record has many purposes. First and foremost, it provides a valuable record of the patient’s history and assists the physician in providing quality patient care. It also provides effective communication among various treating physicians. Further, it provides a contemporaneous legal document which protects the rights of both the patient and the physician. In addition, it provides information for billing. Who owns the medical record? The tangible record, the actual paper and ink or computer recordings, is owned by the physician who is responsible for creating it. If several physicians are responsible for creating the record, then the facility, or the business entity for which the physician works, is the owner. The intangible data, the information contained in the chart, is owned by the patient, although the exact details of this ownership is spelled out by statutory, administrative, and common law. In any case, the patient is always able to access the medical record. This is reflected in the Uniform Health Care Information Act which has been adopted by more than 30 states. Examples: A group practice maintains paper charts on its patients. A patient wants to “pick up his chart.” Who owns the record, and what should the practice do? The practice itself owns the paper and ink. The patient owns the information contained in the chart. The patient has a right to access the chart, but not take it with him. The group may charge the patient a reasonable fee for copying the chart. A solo practitioner maintains an electronic medical records system on all her patients. Who owns the record of a particular patient?

The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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The physician owns the actual physical computer system, and the patient owns, or at least has access to the information that is stored. Copies of the chart should be provided to patients at a reasonable fee who request it .

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What general standards of record-keeping should a physician follow? Some states (such as Washington) have statutes and regulations of medical record keeping. Medicare and Medicaid also have specific standards of record keeping. In addition, the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) has promulgated guidelines that may apply to some physician practices which are closely affiliated with a hospital. Although it is in the physician’s best interest to review these standards, the sheer size of these recommendations makes this a formidable task. Some general recommendations include the following: • be contain complete patient information (see below) • be kept in a confidential manner • be legible • have an authentication mechanism including either written or electronic signatures • have institutional guidelines establishing quality assurance and chart reviews, completion requirements, and the period of time the records will be retained. What information should a patient’s chart contain? JCAHO and Medicaid require the following be on the chart: • identifying information such as name, address, and phone number; • record of consent to be treated and informed consent; • any known advance directives; • chief complaint; • history of present illness or subjective portion of a SOAP note; • past medical history including illnesses, surgeries, medications, and allergies; • social history; • family medical history; • relevant orders; • lab and x-ray reports; • consultant information; • any other reports from surgeries, procedures, and tests; • progress notes from each visit which detail your observations, how treatment is going, and any complications of the disease or treatment, and hospital discharge summaries including a final diagnosis; • documentation of patient refusal of treatment; • missed or cancelled appointments; • how you followed-up on lab or test results; • specific instructions you have given the patient (e.g., diet, exercise, etc.), and other correspondence with patients.

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Basically, it should be a single reporting of everything you have done for this patient. Should a medical record ever be altered? A person may make honest changes to the record at any time. However, you should not “change the facts.” Any alterations made should be clearly made, dated, and should not destroy or wipe out the original. The old record should not be destroyed or made illegible (beyond what it already may be). To amend the record, simply add the changes in chronological order. In addition, the physician should add a note in the margin noting a change was made. Tampering with the medical record is a serious act. If the physician is involved in legal proceedings, improper altering of the medical record can have disastrous consequences. It implies the physician’s case is weak and that the entire set of facts s/he has put forth “lack truth and merit.” How long should the medical record be kept? If possible, medical records should be kept indefinitely. However this is often impractical. If records cannot be kept indefinitely, they should be kept for at least 10 years or until the patient reaches majority (legal age of adulthood) plus the statute of limitations. In any case where there is pending litigation or the possibility of litigation the records should be maintained. In addition specific state and federal laws may add additional requirements.

Confidentiality How should medical records be safeguarded? Physicians should provide “reasonable” safeguards for patient records. There are few guidelines as to what this means, however JCAHO has certain criteria which may be helpful. In any case, the following minimum safeguards should be observed: a written policy on safeguarding medical records, background checks on individuals handling records, records should be locked in a fireproof room or cabinet, do not keep medical records in publicly accessible areas or on publicly accessible computer systems, change locks and passwords regularly, and maintain an off site backup system. Example: Are there special concerns about trash pick-up and protecting the medical record? Yes, individuals who pickup the trash should be instructed on their duty of confidentiality and should sign an agreement that they will not reveal any confidential material which they may encounter, and that they will dispose of the trash in a way that does not reveal patient information. Are electronic or computerized medical records a valid form of record keeping? Yes. Some practitioners favor this form of record-keeping as superior to paper records for several reasons. These records are legible, provide quality improvement mechanisms such as medication cross-checking and practice guidelines, track lab

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and x-ray orders, results and follow-up very effectively, and provide specific date and time of any changes made. Further, it may help confirm you are not over-charging or under-charging patients or their insurers. The law recognizes electronic business records and allows for their admission in court.

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What special security concerns are raised by electronic medical record? Confidentiality is the main legal and ethical concern raised by electronic medical records. Safeguards of confidentiality must be in place. Basically electronic records raise the same concerns as paper records with the additional concerns of preventing unauthorized access and maintaining the integrity of the record. The obvious advantage of electronic records is that they may be accessed when needed even in the middle of the night by an emergency room physician. However, unauthorized users must be restricted, and mechanisms to do so must be in place. This can be accomplished through the use of passwords, ID numbers, digital signatures, firewalls, and protocol wrappers. Most electronic systems have audit trails that record the time, date, and identity of all persons who access the record. This can be a great tool preventing unauthorized access. Examples Can electronic records be sent over the internet? Yes, but records which are sent over the internet or other public networks must be encrypted. Should I have virus protection on my system? Definitely. Your office should have strict rules for downloading unauthorized software. In addition, you should have antivirus software that is updated regularly in order to ensure the integrity of the record.

HIPAA What is HIPAA and how does it impact confidentiality? HIPAA stands for the Health Insurance Accountability and Portability Act. It is a federal law that sets in place strict privacy standards on the use and disclosure of health information for “covered entities.” It was designed to facilitate electronic transfer of information, but it applies to non-electronic communications as well. In addition, covered entities must have contracts with business associates to protect health information. What is a covered entity (does HIPAA apply to me)? A covered entity is any health provider, hospital, health plan, or health care clearinghouse that sends information electronically in connection with a standard transaction. An example of this would be electronic billing. If you have someone else submit claims for you or transmit health information electronically, you still have to comply.

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What is a business associate? A business associate is someone who uses individually identifiable health information in performing a service for a covered entity. This would include businesses that do billing, utilization review, accounting, consulting, practice management, etc. It would not include employees and the medical staff unless the hospital provides a service (such as billing) for the member of the medical staff. If I do not submit claims, do I still have to comply? No, as long as you do not transmit other health information electronically. Keep in mind that if you plan to bill electronically in the future, you will ned to comply at that point. If I am a covered entity, is only electronic information protected? No, all “individually identifiable” health information is protected. This means any information that is sufficient enough to identify a specific person is protected. What is the timetable for complying with HIPAA? Health care providers, most health plans, and health care clearinghouses must comply by April 14, 2003. Covered entities have until April 14, 2004 to comply with the business associate provisions. How may I use or disclose protected health information? The use and disclosure of health information is divided into four categories: 1. Required Disclosure: A provider is required to disclose health information if it is requested by the Secretary of the Department of Health and Human Services to investigate compliance with HIPAA, and if it is requested by the patient; 2. Patient Permission Not Required: A provider may use or disclose patient information if it is necessary to treat the patient, obtain payment, or carry out health care operations (such as quality assessment, credentialing, etc.). It also allows disclosure of information for public purposes such as reporting child abuse, rape, gun shot wounds, STDs, etc.; 3. Authorization Required: Any information where disclosure is not required or permitted is protected and requires prior written authorization for any use or disclosure. This would include, among other things, selling patient information, using it for marketing, and disclosing psychiatric information. Providers may not require consent before providing care. 4. Opportunity to Object Required: In two special cases, providers may use or disclose information after they give the patient an opportunity to object. First, providers may place the patient’s name, location, general condition, and religious affiliation in the facility directory and to anyone who asks. They also may disclose all information to clergy. Second, information may be disclosed to family members and other individuals who are involved in the patient’s care.

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What specific rights do patients have under HIPAA? Patients have the following rights: 1. The right to inspect and copy their own records; 2. The right to amend their records (this carries significant legal risk for you, so consult legal counsel if this issue arises); 3. Right to an accounting of certain types of disclosures within 6 years before the request, starting of course on April 14, 2003;

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4. Right to restrict use or disclosure of health information; 5. The right to receive information about their health in a confidential way; 6. The right to have a notice of privacy practices. This requires you draft a privacy notice carefully. What specific requirements does HIPAA place on my organization? 1. Implement an extensive set of policies and procedures to protect health information; 2. Designate or hire a privacy officer; 3. Designate a person to receive complaints; 4. Implement a program to train employees and sanction those who fail to comply; 5. Establish safeguards to prevent improper disclosure of health information; 6. Mitigate any potential harmful effects from improper disclosure; 7. Do not intimidate of retaliate against persons exercising their rights under HIPAA; 8. Keep documentation of policies, procedures, and written communications for 6 years. If state law is more stringent, does it override HIPAA? Yes. Although state law is usually subordinate to federal law, this is a special case where if the state law is more stringent than the federal law, the state law applies. What penalties exist under HIPAA for illegal disclosure of protected information? HIPAA provides for both civil and criminal penalties. Criminal penalties include three levels of severity: 1. Basic offenses include a maximum fine of $50,000 and up to 1 year in prison; 2. Offenses committed under false pretenses carry a maximum fine of $100,000 and up to 5 years in prison; 3. Offenses with the intent to use the information for commercial gain or for malicious purposes carry a maximum fine of $250,000 and up to 10 years in prison.

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Civil penalties include $100 per violation up to $25,000 per year for violations of the same level of severity. What should my organization or practice do to comply with HIPAA? The following steps can help you become HIPAA compliant: 1. Set up a HIPAA task force; 2. Designate or hire someone to serve as a HIPAA compliance officer; 3. Educate yourself and your employees; 4. Critically examine how your organizatoin uses and discolses health information; 5. Develop specific goals and a timeline to address the shortcomings found in the above examination; 6. Determine if state law applies a more stringent standard than HIPAA; 7. Draft policies and procedures; 8. Write a notice of privacy practices; 9. Incorporate HIPAA into your overall compliance program.

Employee Relations When interviewing potential employees, what are questions you can’t ask? Federal law forbids you from asking questions that are considered unfair or inappropriate. You may not ask a persons age, religion, marital status, sexual orientation, or whether he or she has children. However , if the potential employee brings it up in the interview, you may discuss it further and ask additional questions. May an employer discriminate against a disabled person? No. The Americans with Disabilities Act forbids an employer from discriminating against persons with disabilities whether they are applicants or employees. The law also applies to the issue of access to public buildings such as doctor’s offices. The law exempts employers with fewer than 15 employees. It requires employers use the same standards in hiring, firing, and promoting employees regardless of disability. It requires employers make reasonable accommodations for disabled employees. It should be noted that even a disabled employee must be able to perform job with reasonable accommodation. What qualifies as a disability under the ADA? Many different disabilities are covered including mental illness, mental retardation, ADHD, learning disability, HIV, cancer, blindness, deafness, and former drug and alcohol abuse. Current illegal drug abuse does not qualify, but current alcohol abuse does.

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What is a reasonable accommodation? A reasonable accommodation is “one that does not cause significant difficulty or expense in relation to the employer’s operations, financial resources or facilities.”

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What special access and services should a doctor’s office provide for patients? New buildings and alterations of existing buildings must follow specific ADA guidelines including and adequate number of handicap accessible and van accessible parking spots and wheel chair ramps. Also, common areas of existing buildings must be made accessible by removing architectural barriers if doing so is “easily accomplished and able to be done without much difficulty or expense.”

Business Organizations Medical practices can be organized in the forms of what business entities? The business structure of a medical practice can take the form of a sole proprietership, a partnership, a corporation, or a limited liability company. Each one has its own distinct advantages and disadvantages. What is a sole proprietorship? This is the type of business entity where the physician is the sole owner of the practice. The physician/owner has complete autonomy in the management of the company. The income from the practice is considered his or her personal income and is taxed only once. Also, the financial liability of the company is also the physician’s personal liability. In other words, the physician is personally responsible for the debts of the business. What is a partnership? A partnership is a business entity that is owned by two or more persons, or partners. The rules of the partnership are governed by statute and the partnership agreement, and the partnership is considered to be contractual in nature. Unless otherwise specified, each partner has equal say in how the business is run, each partner has equal share in the profits (or losses), and majority vote is controlling. Unless otherwise specified, the partnership continues indefinitely, but ends if one of the partners dissolves the partnership or dies. Advantages of a partnership include a way to pool capital, share expenses, and allocate responsibility. In addition, there is equal opportunity for decision-making and sharing profits. Further, profits are taxed only once as personal income of the partners. Disadvantages of a partnership lie in the fact that general partners are usually personally responsible for what other partners do. This includes responsibility for debts as well as the professional negligence or malpractice of the partners. Partners are also responsible for money the partnership loses. If your partner goes out and borrows money in the name of the partnership, you are stuck with the debt.

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What is a corporation? A corporation is a business entity that functions like a separate person. It is a legally created organization formed after certain documents, including articles of incorporation, have been filed with the secretary of state of the state of incorporation. Persons who provide capital (money) for the corporation become shareholders and have certain voting rights as defined by statute and by the rules of the corporation. Decisions are made by a majority vote (51%) of the shareholders. In the past, corporations were not allowed to practice medicine. However, most states now allow the creation of professional or service corporations for this purpose (and to practice other professions such as law or architecture). A corporation may be formed by one person or several persons. The main way a corporation differs from a partnership is that corporate shareholders are not personally liable for corporate losses or the acts of negligence by partners. In a partnership there is potentially unlimited liability for loses and act of negligence by partners. This protection from liability is the major advantage of a corporation. Another advantage is that the corporation continues when shareholders die. This translates into the practice being more valuable should it be sold. Another advantage is corporations have more access to some employee benefit plans. However, this advantage does not allow greater contributions to retirement plans. Originally corporations could place a greater percentage of salary into a retirement plan than could individuals, but this was changed by the Tax Reform Act of 1986. Disadvantages of a corporation relate to its complexity. Corporations tend to be more expensive to run because of attorneys’ fees and the need to keep special records such as minutes. Corporations are taxed at a higher rate. Corporate profits that are disbursed to an individual are taxed a second time as personal income tax. One way some practice avoid this pitfall is to plan for the corporation not to have any income by paying out any profits as employee salaries. This way, income is taxed only once as personal income. A special note about S Corporations is in order. Some corporations file their taxes under subchapter S of the tax code which allows certain corporations with fewer than 75 employees to be taxed as a partnership. This avoids the double taxation problem and provides an obvious tax advantage for physician practices. However there are specific legal requirements to file this way, so competent and experienced legal counsel should be sought prior to filing as an S Corporation. What is the difference between a for-profit corporation and a not-forprofit corporation? A for-profit corporation can have shareholders who receive dividends and other disbursement of profits. A not-for-profit corporation cannot have shareholders or distribute income to private individuals, and does not have to pay taxes. If it does distribute profits, it violates its special tax -exempt status and can get into serious trouble with the IRS. The line sometimes becomes blurred when hospitals try to recruit physicians and offer them special incentive packages.

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What is a limited liability company? A limited liability company (LLC) is a business entity that is a hybrid between a corporation and a partnership. LLCs are a recent phenomenon and only started in 1994. Almost every state now recognizes them, but not every state allows physician practices to be organized in this fashion. The advantage of an LLC is that income is taxed only once just as it is in a partnership. However, the individual owners are protected from liability just like a corporation. So with the best of both worlds, why doesn’t everyone organize as an LLC? There are also some disadvantages. For example, since LLCs are so new, the law is relatively undeveloped. So if legal problems arise, there may be very little precedent to guide you. In addition, they are more expensive to run, due to additional paper work, than even a corporation. Further, if the LLC wants to retain some of its profits for capital investment, the shareholders still are taxed. When thinking about the different business entities, remember that each one has advantages and disadvantages. If you are starting a practice or buying one, think about your particular needs and select the type of business entity which best serves those needs. You will need detailed legal advice beyond the scope of this book. May physicians also work as employees for a practice, hospital or other healthcare organization? Yes. This practice is becoming more common. The benefits of this type of practice are less personal risk for the physician and a more secure income. The main disadvantage is less control over the operation of the practice. Most physician employees work under a contract that specifies the responsibilities of the physician, compensation, and incentives.

Medicare/Medicaid Fraud and Abuse Is receiving a kickback for referring a Medicare or Medicaid patient illegal? Yes. Federal law makes it illegal for anyone to pay remuneration of any kind for referring an individual for supplies or services. Penalties can be as high as a $25,000 fine and 5 years in prison. Any doctor, therapist, pharmacist, etc., who receives a referral from someone who will gain from it, including himself or herself, is subject to prosecution. What are safe harbors? Specific exceptions that are not considered illegal kickbacks. These are very narrowly construed, and strict compliance with the letter of the law is required. Some safe harbors include investments in large publicly held corporations, certain real estate and equipment rentals, the sale of a medical practice which meets specific requirements, certain group purchasing plans, certain price reductions associated with a health plan, etc. Physicians who have specific questions in this area should consult experienced legal counsel.

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What kinds of bonuses and incentives can not-for-profit hospitals offer physicians? Not-for-profit hospitals must be careful the way they offer incentives to physicians. They cannot dispense profits to physicians, or anyone else. This is called private inurement and is illegal. They can offer incentive packages for recruiting and production, but these must be reasonable. For example, a $20,000 signing bonus might be reasonable, whereas a $100,000 signing bonus may not be.

Contracts What is a contract? A contract is a legally enforceable agreement. It is a promise that the law recognizes a duty to fulfill or for which a remedy will be provided if it is broken. Or in English, if you make a contract you must carry it out or you can be penalized. The purpose of having enforceable agreements is to allow predictability and consistency in business. For example, you contract to buy 2000 influenza vaccines at $10 each. Your supplier does not deliver the vaccines in time, forcing you to buy them from another supplier for $11 each. You had to pay $2000 more than the contract price. Under the law, you have a right to collect $2000 from the original supplier by bringing suit. What are the different types of contracts? In medicine, contracts may take many forms. Contracts may be for the sale of goods, may describe agreements between physicians and managed care companies, may take the form of a lease or a real estate contract, may be employment contracts where the physician is an employer or employee, and others. What are the basic parts of a legally enforceable contract? An enforceable contract has three basic parts or elements: offer, acceptance, and consideration. What is an offer? An offer is a communication by one party to another of his or her willingness to enter into a legally binding agreement. It must be specific and firm enough to allow courts to enforce it. An offer generally can be revoked anytime prior to acceptance, although firm offers (special offers involving the sale of goods) may be open for a specified period of time. An offer terminates if the person making it dies or if it is rejected. A counter-offer is a rejection and new offer. Examples Dr. Jones, a well respected physician in town, stands up at a medical staff meeting and states she is looking for a partner. Dr. Smith is a young physician finishing his residency and is looking for a practice opportunity after finishing his training. Did Dr. Jones offer Dr. Smith a partnership position? No. The communication would not be considered an offer. It is too vague in many respects. First, it does not state when the contract would begin or end, how much compensation would be given or how much it would cost to “buy in” to the

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practice, or even to whom exactly it was made. Further, it may not have been directed at Dr. Smith who was napping. In short, not enough details were provided to make it enforceable. Same example as before, only this time, Dr. Jones offers Dr. Smith a “partnership” in her practice for $110,000 a year. Is this an offer? No. Even though a salary has been named, other terms such as how long the contract would be, how many hours a week Dr. Smith would have to work, how call would be organized, etc. have not been named. Without these terms, there aren’t enough details to create an effectively enforceable contract. Therefore, Dr. Jones’ comments do not constitute and offer. Jones provides Smith with a 10 page written document describing in specific detail the following: that if Smith worked for Jones, Smith would be compensated $110,000 per year, that the term of the agreement would be for 2 years, he would have to work at least 36 hours a week in the office, take call one weekend in 3, and other specific responsibilities. Would this be an offer? Yes, the terms are specific enough to give meaning to a contract if it would form. It includes payment of salary, duration of the agreement, and specific duties to be performed. These terms are specific enough to allow a court to enforce the contract should it be agreed to by both parties. What is acceptance? Acceptance is a manifestation of a willingness to be bound by the terms of the contract. It must be made with knowledge of the offer and be a response to it. Any purported acceptance that changes the terms of the offer is a rejection and new offer. Acceptance may be in writing, but it may be verbal. Any clear indication is acceptance. Examples Dr. Elder offers Dr. Young an employment contract to come and work for him for $110,000 per year. Young writes Elder back and says “How about $120,000 a year?” Is this an acceptance? No. Any response that significantly changes the terms of the agreement is not an acceptance, it is a new offer. Two weeks later, Young’s other practice opportunities fall through. Young calls Elder up and says “I’d like to accept your offer to work for $110,000. Unfortunately, Elder has already hired someone else. Is Elder obligated to hire Young? No. An offer is only open until it is rejected or revoked. Young’s “acceptance” is really a new offer. Dr. Able offers to lease office space to Dr. Baker for $1000 per month and faxes to his current office a written lease agreement. Baker faxes Dr. Able back and says “I accept.” An hour later he gets a better offer and tries to back out. Did he accept? Yes. Any affirmative response, by voice, mail, electronic transmission, or facsimile machine is an acceptance. In this case, Dr. Baker is stuck with the lease agreement.

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What does a physician need to know before negotiating a contract? What are your goals, i.e., what do you hope to get out of the deal? What will happen when the contract is over? How do I get out of the contract if I want to? What do other physicians say about the organization I am contracting with? Read the Contract What are various clauses that are commonly used in physician employment and managed care contracts? Integration clause: says the written contract is the complete agreement between the parties and other agreements made in the negotiation process are not part of the agreement. These clauses are fairly common and protect the parties from oral statements being asserted as part of the contract. Severance clause: says that if one part of the contract is held invalid or illegal, the rest of the contract remains in effect. Arbitration clauses: clauses which require disputes between parties to be settled through an arbitration process instead of or before going to court. Arbitration is less formal and less expensive than a fully involved legal proceeding. As a result, these clauses tend to be good for both parties. Non-compete (restrictive covenant) clause: this clause says you will not compete with your employer (hospital, physician’s group, etc.) after you leave employment. It must specify a specific geographic location (usually a radius of a certain number of miles) and a time period before it expires. You may or may not be able to negotiate them out of the contract. Liquidated damages clause: often times goes along with a non-compete clause. These specify a certain dollar amount of damages you are responsible for if you break the contract. To be legal, these clauses cannot technically be a penalty, although they often are. Sometimes, this will in effect let you buy out of a contract. Are non-compete clauses enforceable? Usually yes, if they are “reasonable” as to the time and geographic area of the restriction. For example a 2 year, 20 mile radius might be reasonable, but a 5 year, 100 mile radius might not be. However, this varies from state to state.

Insurance What are the main types of health insurance? Health insurance falls into 2 categories: government sponsored and non-government sponsored. Government sponsored health insurance includes Medicare, Medicaid, SCHIP (sometimes called KidCare), and Champus (for veterans and their families). Private insurance is often times purchased by employers for employees, and consequently is governed by a federal law called ERISA. Private health insurance may also be purchased by private individuals directly from insurance companies, although this often is prohibitively expensive.

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What is Medicare? Medicare is government sponsored health insurance for the elderly. It is also available for people who are disabled, renal dialysis patients, and railroaders. It is funded and administered by the federal government. Part A covers hospitalization only, and Part B (which the patient must purchase) covers outpatient services and doctor’s bills. What is Medicaid? Medicaid is a federally funded, state administered health insurance for the poor.

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What is a “spend down?” A certain dollar amount that must be spent on health care services, supplies, treaments, etc., by the patient and from the patient’s own resources, before Medicaid benefits kick in. What is Medicare/Medicaid fraud? This is a felony. It occurs when someone “knowingly makes false statements” when billing under these programs. Because these programs are federally funded, it is a federal crime. While honest mistakes are not fraud, it is in your interest to be certain that billing is completely honest and you are careful about justifying your charges. What are ways physicians commit Medicare fraud? • Charging for services not performed • A repeated pattern of unnecessary procedures • Receiving kickbacks and bribes • Unbundling services that should be billed globally in order to get more money • Seeing your own patient in consultation • Upcoding service (using a higher billing code than what you actually did) Is it illegal to upcode private insurance patients? Yes, this is still considered fraud. If the telephone or U.S. Postal Service is also used in the process, it is a federal crime. Is down-coding considered fraud? Actually down-coding is considered fee shifting and is technically illegal. This is usually only prosecuted if it is done to increase Medicare reimbursements. This might occur when down-coding allows a physician to unbundle services and consequently charge a greater overall fee to Medicare. Down-coding also results in lost revenue for your practice. Can I be prosecuted for mistakenly upcoding patient charges? Yes, especially if it is a repeated pattern of using a higher code every time. Most of the cases prosecuted are egregious such as charging for services that were never provided.

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What can happen to me if I am convicted of Medicare or Medicaid fraud? You will be sentenced under federal sentencing guidelines, and the judge will have little discretion in determining your punishment. This could result in jail time. In addition, the medical board will likely take action against you and could suspend you from practice. What is indemnity insurance? This is traditional insurance that pays a certain percentage of medical expenses. A common type of insurance is 80/20 where the insurance company pays 80% of the medical expenses (over the deductible if there is one) and the patient pays the other 20%. What is a PPO? A PPO, or preferred provider organization, is a network of physicians, hospitals, labs, etc. where providers agree with insurance companies or other third party payers to provide services at a certain fee in exchange for being on the preferred physician list. Insurance companies utilize the PPO to keep costs down, but patients often complain it limits their choice of a physician. What is an HMO? An HMO, or health maintenance organization, is an arrangement between an insurance company and health care providers where the provider gets paid a certain amount of money every month or year to take care of a specific panel of patients. If the health care expenses for the provider in a given month are low, the provider gets to keep the extra money. If, however, expenses are greater than expected, the provider may have to eat part of the cost.

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CHAPTER 4

Medical Ethics This chapter discusses the following issues: • what is the difference between ethics and the law • ethical standards in the physician-patient relationship • enforcement mechanisms for those standards • penalties for noncompliance with ethical standards • medical research and the role of the institutional review board (IRB) • ethical implications of contemporary issues including pharmaceutical representatives, end of life decision-making, stem cells, and cloning. What is the difference between ethics and law? Ethics are moral rules that establish a certain level conduct, in this case the conduct of professionals. Laws are a general set of rules that govern conduct of everyone in a society. If you break a law you could go to jail or be fined. If you are a physician and you violate an ethical rule, you could be disciplined by a medical licensure board or even suspended from practice. What is the physician’s first ethical duty? “First do no harm” (Primum non nocere). This is the first and foremost rule a physician should follow. This principle is called nonmaleficence. What is the physician’s second ethical duty? Do good for your patients. This is the principle of beneficence and gives vitality and life to the medical profession. What ethical standards are required of physicians in the context of the doctor-patient relationship? A physician has four principle ethical responsibilities to the patient: • confidentiality • privacy • truthfulness • professionalism or fidelity

Confidentiality What is meant by confidentiality? Confidentiality means you don’t share patient information with anyone without the patient’s consent. The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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Why is confidentiality so important? Confidentiality is absolutely essential for the proper functioning of the physicianpatient relationship. If patients do not believe their physicians will hold their communications in confidence, they will be afraid to be open and honest. As a result, patients may withhold information from their physicians, and this could be injurious to their lives and health. Are there times when a doctor can reveal a patient confidence? Yes, even though confidentiality is very sacred, there are a few occasions when it can be broken. Obviously, if the patient consents, a physician can reveal patient information. There are also a few other exceptions to this rule. When may a doctor breach patient confidentiality? • If it is necessary to protect the patient or another person from serious bodily harm • To report communicable diseases as required by law • To report gunshot wounds and in knife wounds as required by law • To report child abuse and neglect • Otherwise as required by law or court order Examples: You have a patient who makes a credible threat to harm someone. Are you legally obligated to report this information to the police? Yes. Under the Tarasoff case, a physician is liable to third parties in this circumstance. For a more complete discussion, see Chapter 9: Psychiatry. If a patient makes a credible admission to you of involvement in child molestation, may you report the patient? Yes. All states have statutes that require physicians and psychologists to report suspected child abuse. These reports are even admissible in court proceedings. The physician is protected from any civil liability for reporting as long as he or she acts in good faith, i.e., honestly. Furthermore, good faith on the part of the physician is presumed. This means you are assumed to have acted honestly (in good faith) unless there is a really good reason to think otherwise. You are a physician contracted by an employer to perform a work physical on an employee. During your evaluation you have serious concerns about the patient’s mental state. Do you reveal this information to the employer? Yes. If the information serves a substantial and valid business interest of the employer, and if the physician is retained by the employer, the information may be disclosed. This is an interesting situation because in this case your obligation is more to the employer. See Occupational Medicine chapter.

Privacy/Autonomy What is meant by privacy? Privacy, which is similar to but distinct from confidentiality, means “a state or condition of limited access to a person.” This means a person has the right to be let alone. No one has the right to touch or intrude upon another person. In medicine,

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a physician should not force care upon a patient or perform procedures upon someone without his or her consent. Autonomy is a closely related concept. If the physician knows best, shouldn’t he or she decide what a patient should do? No. This paternalistic attitude does not respect the patient’s individuality. The physician can make recommendations to the patient based on his or her superior knowledge of medicine, but the physician does not appreciate all the different ways such a decision may impact a patient’s life. The patient has to live with the decision, and the patient gets to decide.

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What should a physician do to safeguard a patient’s autonomy? The main thing a physician should do is respect the patient’s wishes. Remember that the patient is the decision-maker and that informed consent must be obtained from the patient. Example You are evaluating a 72 -year-old female for chest pain. As part of the work-up, you think the patient should have an adenosine stress test. After explaining the risks and benefits of the procedure, you ask the patient what she wants to do. She says, “you’re the doctor, you tell me.” What do you do? Although paternalism is considered inappropriate, many patients, especially older ones, still expect a physician to tell them what to do. Respect for autonomy does not mean a physician cannot provide an opinion or make a recommendation. This case is rather straight-forward in that the physician can make a recommendation. However, there are still inherent risks in the procedure and you must still inform the patient. In cases that are less clear cut, often times the family or loved ones can help the patient decide.

Truthfulness Does a physician have an ethical obligation to tell patients the truth? Yes. A physician has an ethical duty to be truthful to his or her patients. This is an established rule of ethics and the responsibility of every physician. Patients have a right to know their medical condition and should not be misled by their physicians. Why should a physician be truthful to patients? For many of the same reasons that a physician should protect patient confidences and respect personal autonomy. If a physician is going to be effective and if the health care system is going to work, patients have to trust their physicians. If they believe their physician is lying to them, patients may not follow appropriate medical advice or be totally forthcoming with their medical history. In addition, being untruthful with patients degrades their individual dignity and diminishes their role as an informed decision-maker.

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Are there times when a physician may withhold information from a patient? Yes, but be careful. If disclosing information or risks of certain procedures to a patient would be seriously detrimental to the patient’s physical or psychological well being, it is ethically and legally acceptable not to disclose. However, these cases are rare. Examples As a physician, I made a mistake that resulted in a complication. If the patient asks what happened, what should I say? You should be honest about the facts of the case and explain them so the patient understands what has happened. It does not mean you must confess to malpractice or any wrongdoing, but you are ethically obligated to give full, honest disclosure of the facts. There is no legal obligation to provide this information, unless you are testifying under subpoena.

Professionalism/Fidelity What is meant by the terms “fidelity” and “professionalism?” Professionalism means putting the patient’s interest above your own (within reason). Fidelity says the physician should be faithful to the patient. It implies that a physician should work hard to do what is in the patient’s best interest and avoid conflicts of interest that would cause him or her to act otherwise. What are conflicts of interest and why should they be avoided? A conflict of interest is any situation that may cause a significant division of your loyalty. If your loyalty to the patient is paramount, then any situation that may cause you to act in any other way other than in the patient’s best interest is a conflict of interest. Some are obvious; some are subtle. For example, referring patients to a medical facility or home health agency that the physician owns, may place the physician’s financial interest above what is best for the patient. What might happen to a physician who violates these ethical standards? Any range of things from probation to suspension from practice. Certain activities such as breaching confidentiality or failure to obtain informed consent may also carry civil penalties. Performing a procedure on a patient without consent, e.g., take out the appendix when the patient only consented to a cholecystectomy, will get you sued and/or prosecuted for battery. Various entities may discipline a physician depending on who gets the complaint. A state licensing board could potentially suspend a physician from practice or place him or her on probation. A hospital staff could place a physician on probation or suspend privileges. Even insurance companies may withdraw their credentials for certain violations. What are hospital ethics committees? Ethics committees are hospital committees comprised of physicians, clergy, administrators, people from the community, etc., which provide consultation on hospital patients when ethical issues are raised. They provide guidance on complicated issues when an objective viewpoint is helpful.

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When should I ask for an ethics consult? Ethics consults are very helpful when you are faced with a tough ethical issue and you don’t know what to do. They also can provide validation and support when faced with a difficult family or the possibility of litigation. Who can request an ethics consult? Although this depends on the organization, most of the time almost anyone may request an ethics consult, including the physician, resident, or nurse.

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As a physician, am I bound by the decision of a hospital ethics committee? No. Although physicians are expected to give deference to hospital ethics committees, they are not bound to follow their recommendations. However, because of the interdisciplinary and objective nature of these committees, physicians are advised to give serious consideration to what they have to say. Examples Do physicians have an ethical requirement to report unethical or incompetent colleagues? Yes. Can I have sex with a patient? Absolutely not. A cardinal sin in the medical profession is when a physician has sexual relations with a patient. Such a physician takes advantage of the power he or she has over the patient and exploits a sacred trust. Such a physician can face severe penalties including suspension from practice by the licensing board. If I fall in love with a patient and want to have a romantic relationship with that individual, what can I do? In that situation you should explain how you feel to the patient and your ethical responsibilities. This means you cannot be the patient’s physician and that another physician should assume care. Even after another physician has assumed care, you may not exploit your prior role as a physician or any professional knowledge that may have been gained in any future relationship. Is accepting gifts from pharmaceutical companies a conflict of interest? It depends. Gifts that are not of substantial value and provide a benefit to the patient are probably ok. This would include note pads, pens, pen lights, reflex hammers, and even textbooks. Even free dinners are not unethical if they are educational and provide a benefit to the patient. However, free vacations, plane tickets, hotel rooms, and money for expenses to conferences is unethical. Scholarships for medical students and residents are ethical as long as the educational institution selects the recipients. The important thing to keep in mind is that you don’t accept gifts with strings attached. Also, when being educated by a person with business sponsorship, remember that potential bias may exist. Does teaching in a medical school or residency raise any ethical concerns? Yes, but most can be easily avoided. In a teaching hospital or clinic, the patient should be so informed. Patients must be aware they are in a teaching setting. This

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information could be conveyed by a sign saying a particular clinic was affiliated with the school of medicine. The patient must consent to be evaluated and treated by residents and students. All persons involved in the patient’s care must maintain confidentiality at all times and should sign documentation stating they understand this legal and ethical responsibility. Further, patient care should not be compromised for the sake of teaching. Interestingly, teaching hospitals have better outcomes than non-teaching hospitals. I’m a 1st year surgery resident working on the trauma service. Whenever a blunt trauma patient comes in and it appears he or she will not survive, the attending let’s us place a central line and a chest tube for practice. Is this ethical? Probably not. Often times an argument can be made for a last ditch effort to try to save the patient, and in a severe trauma, even efforts with little chance of success may be tried. This is not inappropriate. However, if procedures to better assess the patient or to save the patient’s life have already been done, superfluous procedures are not ethical. Furthermore, if the patient has already expired, proper respect must be shown. The family would have to consent to any further procedures (e.g., a post mortem exam). Does the family always have to consent to an autopsy? Unless the case is a coroner’s case, in which the coroner makes the final decision, the family must consent. A physician may try to persuade the family to request an autopsy in cases where the cause of death is unclear, but the family decides. What safeguards must be followed in human experimentation? Any research on human beings must have the Institutional Review Board (IRB) approve the research. The IRB also must state in writing that the research will comply with all HHS regulations. May children participate in clinical research? Yes, but there are special regulations for minors to participate. Some specific requirements include the following: the parents or legal representatives must provide informed consent, the research must be such that a competent adult would consent, and the type of research being done requires minors to participate. Is a therapeutic trial of a particular treatment ethical? Yes. Often times different treatments must be tried in order to find one that is effective. This is appropriate, as long as the patient provides informed consent and the treatment is not experimental. What is an Institutional Review Board (IRB) and what does it do? IRBs are committees comprised of various persons which assures all research involving human subjects is conducted in an ethical fashion. They must comply with federal regulations by ensuring the following standards are followed: • risk to the human subjects is minimized • risks to which the human subjects are subjected is reasonable compared to the anticipated value of the data to be obtained

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• human subjects are chosen in a fair way • informed consent is obtained • if possible, the data will be monitored to maintain the safety of the human subjects • confidentiality is reasonably maintained. Is stem cell research ethical or unethical? It depends on whom you ask.

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CHAPTER 1 CHAPTER 5

Hospital Staff This chapter discusses the following: • governance • credentialing and privileging • National Health Care Practitioner Data Bank • hospital committees and discoverability of their proceedings • potential antitrust pitfalls. Who governs the practice of medicine in a hospital? Generally, the medical staff. This means that the doctors who practice in a hospital govern its medical activity according to an agreed on set of rules and bylaws. In other words, the staff is to be self-governing, although most hospitals have some governing board (hospital board of directors) that provides further oversight. What does it mean to be credentialed by a hospital? It means to be appointed to the medical staff and permitted to practice medicine at a particular hospital. This is recommended (or not) by the existing staff, and approved (or not) by the hospital governing board. What does it mean to be granted privileges at a hospital? Privileges delineate the specific activities a physician may engage in at a hospital. For example, a family doctor may have privileges to do uncomplicated deliveries but not c-sections. What is proctoring? Proctoring is practice where a physician who is new or hasn’t practiced in a while is supervised by another physician for a specific period of time. The purpose is to make sure the physician is up to par on his or her skills. The physician should be informed of his or her progress. The final recommendations of the proctor are sent to the department chair and then to the credentialing committee. What are active medical staff privileges? A member of the active medical staff is considered to have full credentials to admit and be fully responsible for patients. These physicians often have to participate in hospital wide assurance audits, serve on hospital committees, and usually must accept patients who do not have a regular physician.

The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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What are courtesy privileges? Courtesy privileges are generally extended to physicians who admit a small number of patients a year to a particular hospital. These physicians are usually members of another hospital’s medical staff. Physicians with courtesy privileges generally have fewer administrative responsibilities than general staff physicians. Often times they do not have to accept patients admitted with no physician, do not have to serve on hospital committees, and do not have to vote on staff issues. What are house staff privileges? House staff privileges are given to interns and residents at their participating teaching hospital. They can practice medicine under the supervision of the teaching faculty.

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What is the purpose of credentialing committees? The purpose of hospital credentialing committees is to ensure that a physician has the proper training and/or experience to carry out the activities requested. This promotes good quality patient care and protects the hospital from liability. Also, accrediting bodies like the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires that any physician practicing in a joint commission accredited hospital be granted privileges before being allowed to practice. Can hospitals be held responsible for the mistakes of staff physician? Yes. Hospitals can be found liable for failing to investigate physicians in the credentialing process and for not aggressively policing those physicians already on staff. That is why most of them take the credentialing process so seriously. Hospitals can also be liable if they fail to check the National Practitioner Data Bank. What is the National Practitioner Data Bank? It is an information clearinghouse which provides information on physicians who have been disciplined, suspended from practice, had a malpractice judgment entered against them, settled a malpractice claim out of court, or had their privileges suspended or restricted by a hospital or health care entity for more than 30 days. Hospitals are supposed to check it before they give you credentials. If they don’t and you mess up, they can be held liable. Can a hospital or peer review committee be held liable for taking action against or failing to credential a physician? Usually not. The Health Care Quality Improvement Act of 1986, which also established the National Practitioner Data Bank, gives immunity to health care entities and credentialing committees as long as they provide the physician with due process. However, if a committee does not provide due process, then it can be liable. In the credentialing process, what is meant by “due process?” Due process means following a set of rules and treating physicians fairly and consistently. It also means treating everyone the same. Hospital procedures should be clearly written. In actions against staff physicians, due process requires at least fair

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notice of the complaint to the physician, an opportunity for the physician to present evidence in his or her favor, and an impartial decision maker. Generally, all of the procedural safeguards associated with an actual trial are not required. For example, the right to cross-examine witnesses and the right to an attorney are not guaranteed. What can credentialing committees do to ensure that due process is maintained? Hospitals need to have clearly written bylaws that govern the credentialing process. In addition, credentialing committees need to carefully follow these guidelines and apply them equally to all physicians. Model bylaws, promulgated by medical societies, are a good reference in writing or updating hospital bylaws to ensure they are fair and meet due process requirements. What can physicians expect if the credentialing committee seeks to suspend or revoke their privileges? This situation can be very difficult for the physician charged. There will likely be a hearing similar to a malpractice trial, except the physician’s peers are the judge and jury. The physician is usually not permitted to bring an attorney to the hearing room. Multiple charges of inadequate patient care may be leveled against the physician at one time, and the physician usually does not have a chance to see the evidence ahead of time. In addition, hearsay evidence is usually admitted which may be impossible to cross-examine. The physician is allowed to call witnesses and present evidence, but not necessarily cross-examine witnesses. In arriving at a decision, the committee attempts to act in an unbiased fashion. What are the consequences of having your privileges revoked? This can very negative for your career. First of all, you will not be able to take care of your patients in that particular hospital or access their records. This will significantly limit your ability to function effectively as a physician. Second, the revocation of privileges will be reported to the National Practitioner Data Bank, the state medical board, and other data banks affecting insurance and managed care credentialing. This could result in the state licensing authority taking action against you. It could also lead to losing your credentials with insurance companies and managed care organizations. Third, you bear the cost of the hearing and any subsequent economic loses resulting from the board’s decision. If you lose at the hearing, what recourse do you have? Very little. You can appeal the decision to hospital board, but this is rarely successful. Most states allow physicians to file a lawsuit against the hospital and the credentialing committee, but these too are rarely successful. Possible grounds include the hospital significantly failing to follow its own bylaws; due process not being followed in the hearing process; discrimination on the basis of race, gender, religion, or political association; and antitrust violations or anticompetitive conduct by the credentialing committee.

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Are members of credentialing committees immune from liability for their decisions? Generally yes, as long as they follow due process. But an aggrieved physician may charge the committee did not follow adequate due process. Further, committee members are not protected from antitrust liability if they act to illegally restrain trade, for example, running a competitor out of business for purely economic reasons. Are records of peer review proceedings confidential and protected from being used in a law suit? Yes, with a few exceptions. Generally these records may not be disclosed in a lawsuit. However, if a person sues a hospital for negligently giving a physician privileges, the credentialing records in that case are discoverable. Also, these records are discoverable in cases where the physician sues the hospital for denying or revoking privileges.

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CHAPTER 1 CHAPTER 6

Pediatrics This chapter covers the following topics: • consent to treat • emergency treatment • parental refusal to treat • emancipated and mature minors • family planning and sexually transmitted diseases • child abuse and neglect Who generally provides consent for treatment of the pediatric patient? The parents. A physician must obtain consent from the parents before providing non-emergency medical treatment. Under the law, the child is, in most cases, considered incompetent to make his or her own health care decisions. The parents are considered the most suitable persons to act on the child’s behalf (as a surrogate). Can a physician treat a child in an emergency situation without parental consent? Yes. This varies by state law but most jurisdictions recognize the need to treat children in emergency situations. Consent is presumed in this case, just like other emergencies. How serious an emergency is necessary before a physician can treat a minor without parental consent? The law may not specifically say, but it should be serious enough to threaten life or limb. Examples A young boy is involved in a motorbike accident and suffers a ruptured spleen. Without an emergency splenectomy and blood transfusion he will probably die. May a physician perform an emergency splenectomy and blood transfusion if the parents cannot be notified? Yes. This is a clear-cut case of a life threatening situation where waiting for parental consent would jeopardize the life of the child. The law will side with the physician in this case. Would it make any difference if the boy’s parents are Jehovah’s Witnesses and do not approve of blood transfusions on religious grounds? No. The need to save the life of the child will clearly outweigh any religious convictions the parents might subsequently have against emergency treatment. The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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A young girl fractures her femur in a soccer game. Without emergency surgery to correct neuro-vascular compromise, she will likely lose her leg. If the parents cannot be notified, can surgery be performed to save the leg? Yes. Although this is not life threatening, it is limb threatening. The girl will likely suffer serious harm if treatment is postponed while the physician searches for the parents. The law will almost certainly look favorably on the physician in this case. A ten-year-old boy is brought to your clinic by his adult aunt for a sore throat. The aunt says he has a fever, white patches on his throat, and was exposed to a friend who has strep throat. His symptoms started 2 days ago. May you treat this child without parental consent? No. Although strep throat does have significant sequelae, the child’s health probably will not be significantly compromised if you wait a day or two to get parental consent.

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What are some good faith steps a physician should take, if time permits, in treating a minor in an emergency? • Assess the situation to see if it is truly an emergency • Reassure and comfort the patient • Make a good faith attempt to contact the parents • Make the best clinical judgment under the circumstances as to how long treatment may be postponed before there are serious consequences. Are there times other than in emergency situations when parental consent is not required? Yes. In certain cases minors are considered to have capacity to make their own health care decisions. Four specific circumstances include the following: • the emancipated minor • family planning and to a certain extent abortion • treatment of sexually transmitted diseases • treatment for mental illness and drug and alcohol abuse What is an emancipated minor? A “minor” is a person who is legally considered a child and unable to make their own decisions. A court may “emancipate” some minors making them a legal adult. The minors usually must be at least 16-years-old, self-supporting, and possess the ability to make their own decisions. Emancipation means the minor no longer needs parental consent for making decisions, including medical decisions, and can enter into binding contracts. This means if an emancipated minor goes to the doctor, the doctor can treat without parental consent. It also means the minor is personally responsible for the bill. Pregnancy and military service are two other ways a minor may be emancipated.

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If a 14-year-old girl comes into my office to get birth control pills, do I need her parents consent? This varies by state law, but probably not. Most states have passed statutes that allow minors to obtain birth control without parental consent above a certain age. In many states, that age is twelve. Can I tell her parents? No. That would legally violate patient confidentiality. That does not mean you shouldn’t encourage the minor to discuss the issue with her parents. Is a girl required to notify her parents and/or get their consent prior to having an abortion? A qualified no. Although some state laws require parental notification or consent, these laws must provide “an alternative procedure whereby authorization for the abortion can be obtained.” This means that a court can approve the abortion, even if the parents do not. Can a minor be treated for a sexually transmitted disease without parental consent? Generally, yes. Most states have statutes which allow minors to be treated for STDs without parental consent. The age at which this can be done various depending on the state. The rationale is minors may avoid being treated if they have to tell their parents, and as a result the infected minor will spread the disease even more. Can minors obtain treatment for mental illness and drug and alcohol abuse without obtaining parental consent? In most states, yes. The rationale is that these individuals should be encouraged to seek help. Physicians should make every attempt to persuade the minor to notify his parents and involve them in his or her care. In the above two cases, who gets the bill? If the child is under the parent’s insurance, the parents would receive the bill. This could result in confidential information being disclosed the parents. The patient should be aware of this up front, and other means of payment should be arranged if this is unacceptable for the patient. Do the parents have a duty to provide medical care for their minor children? Yes, parents have the responsibility to provide for the basic needs of their children. One of these basic needs is medical care. If the parents refuse necessary medical treatment, may the State step in and require treatment? Yes. The legal doctrine is called parens patriae.

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May the State force necessary medical treatment on children even if that treatment violates the religious beliefs of the children? Yes, but it must be necessary to save life or limb, not just desirable. What is a mature minor? A mature minor is someone under 18 years of age who, by reason of his or her maturity, has the intelligence and judgment to make certain decisions. The law recognizes that sometimes health care decisions that personally affect a minor are best made by that person. Is a physician required to report suspected child abuse or neglect? Yes. Nearly all states have mandated reporter statutes which require physicians, teachers, social workers, and others to report suspected child abuse. The report is usually made to the state department of children’s services. Initial reports usually must be made within 24 to 48 hours of the time abuse or neglect is suspected. Most states have a 24 hour hot-line for reporting.

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Can a physician be penalized for reporting suspected child abuse or neglect? No. Almost all states provide immunity from prosecution or civil action for physicians who report suspected child abuse or neglect in good faith. Note that suspected abuse means you have some reason to think it might have happened, not that you know it happened. In addition, good faith is presumed. Again, this means the law believes you acted honestly unless there is a compelling reason to think otherwise. May a physician take protective custody of a child who is in danger of immediate harm from the parents through abuse or neglect? Yes. The law allows this and protects the physician from liability if he or she acts in good faith. This does not mean you have to take the child home. It usually means you admit the child to the hospital.

CHAPTER 1 CHAPTER 7

Obstetrics and Gynecology This chapter covers the following issues: • abortion • sexually transmitted diseases, partner notification, and reporting • medical malpractice and obstetrics • illicit drug use during pregnancy • domestic violence • sexual assault. When may a woman legally obtain an abortion? Under Roe v. Wade, a woman may have an abortion at anytime for any reason during the first trimester. During the second trimester, the individual state may impose certain restrictions designed to protect the woman’s health, but those restrictions are limited only to that concern. During the third trimester of pregnancy, the individual state may place the interest of the fetus above the woman and prohibit abortions except to save the life or health of the mother. Roe v. Wade has been modified by Planned Parenthood v. Casey. Under the new rule, the state may not unduly burden a woman’s right to have an abortion. Is a woman required to obtain her partner’s consent prior to having an abortion? No. If the state does not have the power to limit a woman’s choice to have an abortion, the state cannot bestow that power on the woman’s partner or husband. Is a minor required to obtain parental consent before she can have an abortion? No. A minor does not have to have parental consent prior to having an abortion. However, the law does permit a hearing before a judge who provides the go-ahead in this case. The court tries to determine what is in the best interest of the minor. Although parental consent is not required, the patient should be encouraged to share the information with her parents and to discuss the case with them. If a mother refuses treatment which is considered necessary for the life or health of the fetus, can the government intervene and force the mother to have this treatment? No. The government may not interfere with a woman’s choice of medical treatment for her unborn child.

The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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If a patient uses illegal drugs during a pregnancy, and the baby is born with these drugs in his or her system, should the state child welfare agency ( in Illinois the Department of Children and Family Services) be notified? Yes. Often this is required by state law. Is a physician required to report a diagnosis of an STD to the health department? Yes. This requirement is established by statute. The specific data including the patient’s name and address that are required vary from state to state. You should contact your local health department for specific reporting requirements. Is a physician required to notify the partner of a patient with an STD? A physician’s duty is to notify the health department or other relevant authorities. The health department should notify the partner. If a physician does not notify the health department, he or she can be liable for negligence if the partner becomes infected.

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How long after a delivery can a physician be sued? The statute of limitations for medical malpractice is 1 or 2 years depending on the state. However, in many states, that statute of limitations does not start running until the child reaches age 18. If the child is mentally disabled (e.g., from cerebral palsy) the statute of limitations never starts running. That means you can be sued forever in those cases. What is a physician’s legal obligation to report domestic violence? In cases of domestic violence and abuse, a physician should encourage the patient to seek help from the authorities. However, if she refuses, the physician has no legal obligation. What is rape (sexual assault)? Rape is traditionally defined as a crime of violence where a woman is forced to have sexual intercourse with a man. A more modern definition of sexual assault is nonconsensual sex, where one person forces another to engage in sexual activity either through physical force or chemical means. A man can assault another man. A man can assault his wife. A wife can assault her husband. A woman can assault another woman. Examples A girl is drugged at a party and a guy has sex with her while she is unconscious. Is that sexual assault? Yes. Use of a chemical agent to subdue the will is no different under the law than a gun or a knife. A man is forced to have anal intercourse with another man. Is that sexual assault? Yes. Under the modern definition, sexual assault does not have to be by a man against a woman. It simply has to be nonconsensual.

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If a patient comes to the ER and says she has been raped, what should be done? First, comfort and console the patient. Notify the police. A careful gloved examination must be done using a rape kit. The exact legal requirements vary by state. Remember that everything done is potentially admissible in court and must be done precisely and carefully. If a woman comes to your private office and has been raped, what should you do? The best thing to do is send her to the emergency room. It is doubtful that you will have a rape kit in your office and that your staff will be experienced in this area. The ER has more experience in this area as well as the appropriate resources to conduct the examination and collect samples. Why is it important to follow the guidelines of the rape kit so carefully? First of all, physical evidence will hopefully prove who the perpetrator is. Any semen, blood, or hair samples will be extremely useful in identifying this individual. Secondly, the samples have to be protected from adulteration, either intentional or unintentional. Extreme care must be used in collecting the samples, and chain of custody must be maintained. If there is any period of time between the collection of the sample and its introduction into court that cannot be accounted for, the evidence will probably be thrown out.

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CHAPTER 8

Emergency Room This chapter discusses the following: • consent to treat under emergency circumstances • treatment of minors • EMTALA, COBRA, and antidumping laws • combative patients. If a patient comes to the emergency room, does he or she ordinarily need to consent to treatment? Yes, people come to the ER for a variety of reasons that are not emergent. Like other patients, consent usually must be obtained by personally discussing it with the patient. The patient signs a consent form as a record that consent was given If a person comes to the ER and is unable to give consent, e.g., is unconscious, may the ER doctor treat that patient without consent? Yes. If someone is brought to the ER with an emergency condition and is unable to specifically give consent, consent is presumed. Emergency care can be started immediately. If an unconscious patient is brought to the ER, is treated, and then becomes conscious, may he or she refuse treatment at that point? Yes. Any patient capable of understanding his or her medical condition and potential treatments can refuse. The doctors, however, were correct to treat this person while he or she was unconscious. If a person under age 18 is brought to the ER with a true emergency, may he or she be treated without the parents’ consent? In an emergency situation, consent is presumed. Life or limb saving care should not be postponed in an effort to obtain parental consent. See Chapter 6: Pediatrics for a full discussion of this subject. If a combative patient presents to the ER, what should I do? The first thing that should be done is to attempt to calm the patient down. If this is unsuccessful, call security. If the patient poses an immediate danger to those in the area, he or she may be physically restrained. The restraints should be used only long enough to maintain the safety of those in the area. If the patient meets the criteria for an involuntary admission, this should be considered. In any case, professional judgment should always be exercised. The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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Example A patient presents to the ER intoxicated, belligerent, and loud. He has a laceration on his head which you are attempting to suture. After he threatens a nurse, security is called. He throws the laceration tray at the guard. What should you do? Physically restrain the patient and finish suturing if possible. Reassess the patient, and if no longer necessary, remove restraints. If the patient remains combative and appears to be a danger to himself or others, take steps for an involuntary admission. Can I hold a patient against his or her will? Yes. This is called an involuntary admission. If a patient is mentally ill and a danger to self or others, most states allow for involuntary admission. Certain state specific guidelines and procedures should be followed. If these procedures are not followed, a physician can be guilty of false imprisonment. Can a hospital turn patients away from its emergency room? No. Under a law called EMTALA, an emergency department cannot deny emergency screening and stabilization to a patient if it provides those services. It also is required to care for women in active labor. What is EMTALA? EMTALA is the Emergency Medical Treatment and Active Labor Act. It applies to hospitals that accept Medicare or other government programs. It significantly affects hospitals with emergency departments. It was designed to prevent dumping patients (typically those without insurance) who are in need of emergency treatment or who are in active labor from one hospital to another. Although EMTALA was written to avoid quality issues and state malpractice issues, one of the best ways to avoid EMTALA problems is to take care of your patients and not dump them on someone else. What is COBRA (Consolidated Omnibus Budget Reconciliation Act)? COBRA is a large piece of legislation that contains various provisions, one of which is EMTALA. Some people use these terms interchangeably. What if a patient with an emergency condition needs to be transferred to another facility? This can be done, but proper procedures must be observed, including, but not necessarily limited to the following: • The patient must be stabilized first; a woman in active labor must be delivered. • The physician should sign a certificate saying that the medical benefits of care provided by transferring the patient to another hospital outweighs the risks of transfer • The receiving hospital has room and qualified personnel • Copies of the medical records are sent • Transfer is effectuated by doctor to doctor contact (one doctor must speak to another)

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What are the potential penalties for illegally dumping patients? Hospitals and physicians can be fined up to $50,000 per violation. Example A patient presents with a renal vein thrombosis. The urologist on call refuses to see the patient. No other urologist is available. The ER physician attempts in vain to change the urologist’s mind. The patient must be transferred to another facility. Is the urologist guilty of an EMTALA violation? Yes. By accepting call at the hospital, a physician agrees to see emergency patients. Further, the community has a reasonable expectation of emergency care. Is a physician required to report physical violence such as gun shot wounds and stabbings to the police? Yes. Almost all states have enacted laws which require physicians to report violence such as gunshot wounds and stabbings. This does not violate the duty of confidentiality. See Chapter 4: Medical Ethics for more details.

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CHAPTER 1 CHAPTER 9

Psychiatry This chapter discusses the following: • commitment procedures • assessment/determination of competency/capacity • treatment of minors • refusal of treatment • duty to warn • special confidentiality issues. What type of individual may be committed? Almost all states have a mechanism to hospitalize individuals against their will. Although every state has slightly different criteria for who may be committed, almost all have 2 thing in common: • the patient must appear to have a mental illness and • the patient must pose some type of harm—typically to self or other. Some states (e.g., Hawaii and Delaware) include harm to property in this category. These elements must be proven by clear and convincing evidence (75% certainty). What procedures must be followed? Most states have two mechanisms for commitment: Emergency commitment and court ordered commitment. How does an emergency commitment work? Any person of legal age can sign a petition (promising to tell the truth) saying that the patient poses a danger to self. This must be followed by one and sometimes two certificates from a psychiatrist, physician, or sometimes a psychologist which says the patient poses a danger to self or others and needs immediate care. Without a certificate, the patient may usually be held for only 24 hours. If a certificate accompanies the petition, the patient may be held longer (for up to 1 to 6 weeks depending on the state). What is court ordered commitment? This type of commitment is ordered by a court after a hearing. The process is started when someone over 18 files a petition. An expert then files a certificate stating the person is a danger to self or others and needs psychiatric treatment. The court will commit the person if there is clear and convincing evidence (about 75% degree of certainty) that the requirements for commitment are met. The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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What rights do committed patients have? Patients who are involuntarily hospitalized have the right to treatment and basic necessities of life, a safe environment, freedom from unnecessary restraints, and basic education or training. With regards to commitment and treatment, a patient has the right to the “least restrictive alternative.” What is meant by the “least restrictive alternative”? In the commitment process, a patient should only be involuntarily hospitalized if there is no other option which is less restrictive. This also applies to patients which are in the hospital where physical or chemical restraints may be used. May a patient who is involuntarily hospitalized refuse medication? Generally yes, although the law is unclear. Simply because patients are committed to a psychiatric hospital does not mean they are incompetent to refuse medication. If a psychiatric patient is under 18, who consents to treatment? Most states allow older minors (usually over 12) to obtain mental health and psychiatric services without parental consent. However, the minors should be encouraged to discuss their illness and treatment with their parents.

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What is the physician’s duty to maintain confidentiality regarding the psychiatric patient? The physician has a very serious duty not to breach confidentiality. This duty is particularly important in the mental health milieu given the social stigma attached to mental illness. Many states impose stiff penalties for doctors that breach confidentiality. Special mental health codes establish greater penalties for breaching patient confidences beyond what already exists for physicians in general. Further, specific standards and safeguard must be maintained in record keeping to assure the information is protected from unauthorized use. Are there times when a physician must breach confidentiality? Yes. If there is a serious threat to someone’s life or health, the physician has a duty to warn third parties. This duty came to the forefront in the Tarasoff case. In this case a female college student was murdered by a mentally ill young man after he saw a psychologist. The psychologist thought the young man might try to harm the young girl, and campus police were alerted. The boy was detained by the police, and a supervising psychologist felt the boy posed no danger. However, Ms. Tarasoff was not told any of this. The boy was released 2 months later and killed Ms. Tarasoff. Tarasoff ’s parents sued the psychologist and the university, and the court decided that the psychologist had a duty to warn Ms. Tarasoff and had failed to do so. Although Tarasoff is not binding in other states, the duty to warn is nicely illustrated by this case. What uncertainties have resulted from Tarasoff? How specific does the threat need to be? How do you determine if someone is really in danger? What type of warning is sufficient?

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If the victim is not specific, what is the physician’s duty? What can a physician do, post-Tarasoff to meet this duty? In the midst of the uncertainty following Tarasoff, there are two principles that emerge: a potential harm and a potential victim. For example, if the threat is to the city of Los Angeles, there is no duty to warn. If the threat is to John Doe, there is a duty. However, in a post-9/11 world this may change. Is a person institutionalized in a mental hospital considered competent to make healthcare decisions? Yes. Simply because a patient has been committed to a psychiatric hospital does not mean he or she is incompetent to make health care decisions. Competency is a specific determination by a court. If a person is declared incompetent, who makes health care decisions for that person? A guardian is appointed by the court to make these decisions. If no one is available to become guardian, who makes health care decisions for the incompetent patient? In this case, the State will appoint a guardian to act on the patient’s behalf. Most states have a specific government agency to act as a guardian if no one else can be found to serve. Is specific consent required for every thing done in the psychiatric hospital, or only certain procedures/treatments? Day to day treatments do not require specific consent. However, invasive or unusual treatments do require specific consent. Examples A psychiatrist wants to increase the dose of a patient’s anti-psychotic medication. Is specific consent from the guardian required to do this? No. This is considered a routine matter and specific consent is not required. A psychiatrist wants to administer ECT (electroconvulsive therapy) to a depressed patient. Does the guardian need to specifically consent to this procedure? Yes. Due to the unusual and special nature of ECT, specific consent is usually required. There may also be specific procedural requirements in the law, and specific states may impose additional requirements.

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CHAPTER 10

ICU and End of Life Decision Making This chapter covers the following: • advance directives including living wills and durable powers of attorney for health care • surrogate decision making in the absence of an advance directive • capacity and competency • organ donation • futility of treatment • ethics committees. Who makes health care decisions for patients who are seriously ill? The patient makes his or her own health care decisions. This is the basic rule and is in place so patient autonomy will be respected, even when the patient is seriously ill. What if the patient is unable to make his or her own health care decisions? If the patient is not able to make health care decisions, then someone else must be chosen to make decisions for the patient. This other person is sometimes called a surrogate decision-maker. This decision-maker is not the patient’s physician. For approaches in selecting a surrogate, see below. How does a physician determine if a patient is unable to make health care decisions (lacks capacity)? The key question is does the patient understand the nature of the disease and potential treatments and can the patient express his or her wishes? This standard requires only a basic understanding of the disease and potential treatments, and does not require an in depth scientific knowledge. For example, if a patient understands she has heart failure and needs medicine to help the heart work better, this understanding would be sufficient. Patients have capacity if they can explain their healthcare situation in their own words in a way that demonstrates they can make their own decisions. If a patient is unable to make health care decision, does that mean he or she is incompetent? No. Incompetence is a determination by a court of law, not a doctor. But a doctor can provide insight as to whether a patient is able to make decisions affecting his or her health care. How is a surrogate decision-maker chosen? If the patient is able to decide, the patient is the decision-maker. The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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If the patient is unable to decide, the court appointed guardian is the decisionmaker. If the patient is unable to decide and has no guardian, then the advance directive would determine the decision-maker. If the patient is unable to decide, there is no guardian, and there is no advance directive, many states allow for the next of kin to decide. If a healthcare surrogate act exists, how the surrogate is chosen depends on state law. If the patient is unable to decide there is no guardian, no advance directive, and no next of kin, or close friends (allowed in some states), then a petition for guardianship should be initiated with the court so a decision-maker can be appointed. In the interim, it should be presumed that the patient would consent to care unless there is there is some clear expression to the contrary such as a living will. What is meant by the term “advance directive?” Advance directives are documents meant to express patients’ wishes about medical care, should they become unable to make their own decisions. These legal documents can be helpful to families and physicians when patients are critically ill and unable to express their own wishes. Two types of advance directives are the Living Will and the Durable Power of Attorney for Health Care. What is a living will? A living will is a type of advance directive that allows for the withholding of lifesustaining treatments in the case of a terminal illness where death is imminent. It does not apply to patients in a persistent vegetative state, and it does not authorize another person to make any other kind of health care decisions. It only applies in a very narrow set of circumstances. It does not contemplate any other special circumstances. What is a durable power of attorney for heath care (DPOA-HC)? A DPOA-HC is a type of advance directive that provides more flexibility than a living will. It is effective when the patient is unable to make his or her own health care decisions, and establishes a person to make decisions. Death does not have to be imminent and it can cover all types of medical care including feeding tubes, IV fluids, etc. In some states, the principle patient can limit the DPOA’s scope of authority. From the doctor’s point of view, for decision-making purposes, talking with the DPOA is like talking to the patient. How is the DPOA-HC supposed to make medical decisions for the patient? The surrogate in the DPOA-HC is supposed to decide what the patient would want in that particular circumstance, not what he or she would want. Sometimes this can be a difficult decision for the DPOA-HC, but the patient’s wishes, if they can be ascertained, must be followed.

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What is the difference between a power of attorney and a durable power of attorney for health care? Power of attorney gives another person the right to manage your business or financial affairs. It must be given when the patient has appropriate mental capacity and terminates when the patient loses capacity. It does not authorize a person to make health care decisions for you. A DPOA-HC is different. It authorizes someone to make health care decisions for you, but not business decisions. It also must be signed when the patient has appropriate mental capacity, but it becomes effective and remains effective when the patient loses mental capacity. Hence it is durable for the patient’s incapacity. Which one is better (a living will or DPOA-HC)? A durable power of attorney for health care is certainly more flexible than a living will and applies in many more situations. It allows for medical treatment to be withheld in cases where the patient clearly would refuse it, but yet is not terminal. Between a living will and a DPOA-HC, which one takes precedence? The DPOA-HC takes precedence. The reason is because a DPOA-HC expresses the patient’s wishes in that particular situation to the best of his or her ability. A living will is a one-time decision that applies in a narrow set of circumstances. In some states, a more recent living will might take precedence over a DPOA-HC.

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What is a guardian? A guardian is a person appointed by the court to make decisions for an individual when that individual is unable to do so. There are two types of guardians: guardians of the person and guardians of the estate. The guardian of the person makes health care decisions for the patient. The guardian of the estate manages the business affairs of an individual. When is a guardian necessary? Although there is no clear-cut standard to determine the need for a guardian, most states require the patient suffer from a mental defect of some kind as well as the inability to “care for oneself or one’s estate.” If there is a dispute between the guardian and the DPOA-HC, who wins? The guardian. Guardianship serves as a final safeguard against even potential abuses by the DPOA-HC. Example If the DPOA-HC wants to allow a patient to die against his clearly expressed wishes, and evidence suggests the DPOA-HC is acting just to inherit money, what can be done? A guardian can be appointed who would help in deciding what you, the doctor, should or should not do. The DPOA-HC is supposed to make decisions that best approximate what the patient would choose in that circumstance. Although no one can be sure what the patient would actually want, the DPOA-HC in this case is acting clearly for personal gain and against the wishes and best interest of the patient.

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Guardianship proceedings should be initiated to appoint someone who will act according to the patient’s wishes. In this case, the physician is best advised to obtain the advice of an ethics committee. A physician cannot be forced to do something he or she thinks is immoral. What if there is a dispute between family members? If there is no DPOA-HC or guardian, the next of kin usually decides. If the patient is married, this person will be the spouse. However, disputes usually arise when there is no living spouse, in which case the decision-makers are the adult children. Avoid becoming personally involved in family disputes as much as possible, as these can often back fire on the physician. Have the family go off and discuss the case among themselves, and come back and give a single decision. It is best to request the family appoint a single spokesperson for the family so there is clear communication. If the family members are still unable to decide, the physician should request an ethics consult. Is a physician required to provide care that he or she believes is futile? No. There is no legal or ethical duty to provide futile care. For example, if a healthy person comes to you requesting an appendectomy, you are not obligated to arrange this. However, in the ICU setting, denying care which the patient’s loved ones believe is life saving or life prolonging looks bad and can result in negative feelings on the part of the family. In this case, an ethics consult can help provide protection for the physician. Also, some states including Virginia and Texas have statutes which deal with futile care. Isn’t stopping life sustaining medical treatment euthanasia? It is ethical and legal to stop life sustaining medical care if the patient or his or her surrogate wishes to do so. Although this may be considered by some to be “passive euthanasia,” withholding care is not actively taking someone’s life like “active euthanasia.” What is the difference between active and passive euthanasia? Active euthanasia is where the doctor performs an act to take the life of the patient with the purpose of ending the patient’s suffering. Passive euthanasia is letting a patient die and end his or her suffering by withholding treatment. The difference is that in passive euthanasia the doctor is not the direct cause of the patient’s death. Examples A patient is dying from metastatic breast cancer and is requiring higher doses of morphine for pain control. Is it ethical to give enough morphine to control the pain, even though it carries with it the risk of respiratory suppression? Yes. Although there is a risk of respiratory suppression, this is not the purpose. The purpose is to control the patient’s pain; respiratory suppression is an unintended consequence. As long as this is the case, it is not unethical. The principle is known as the “double effect.” In this case, the two effects are pain control and hastening death.

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A 78-year-old widower is admitted to the ICU after suffering a severe stroke. He is in a coma and his prognosis is poor. His son wants to stop nutritional support and “let nature take its course, the daughter wants to continue to have everything done. As a physician, what do you do? Neither request is in itself unethical. The crux of the problem is actually arriving at a decision. After the doctor provides some guidance, it would be best to have the son and daughter go off and decide and come back with a consensus decision. If they cannot, the physician should seek and ethics consult and perhaps consider pursuing guardianship. When may patients organs be harvested? After they are dead. In some cases, living donations of kidneys and parts of the liver are made. For purposes of organ donation, how is death determined? In these cases, death usually means brain death. Brain death is usually defined by the following: • Unreceptive and unresponsive • No spontaneous movements or breathing • No reflexes • If there is any question that the patient is dead, brain death should be confirmed by 2 EEGs done 24 hours apart which show no brain wave activity above baseline.

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Who provides consent for organ donation? There are two ways consent is obtained. First, the patient can make his or her wishes known before death by an act such as signing an organ donation card. Second, if the deceased has not expressed his or her wishes, the next of kin may give consent. How can a person express his or her desire to be an organ donor? At least 44 states have passed legislation allowing people to sign the back of their driver’s licenses to say they want to be an organ donor. This signing usually must be witnessed by two persons. A person can also become an organ donor through a will, living will, or other writing. What if a patient clearly expressed his or her wishes to make an anatomical gift, but the family object? Under the law, the organs may still be harvested. However, as a practical matter, most if not all organ banks will decline such anatomical gifts. Can a family be paid for donating the organs of their deceased relative? No. This is illegal.

CHAPTER 1 CHAPTER 11

Running a Laboratory Discusses the following: • CLIA regulations • Blood-borne pathogen prevention. Are laboratories in physicians’ offices regulated by the government? Yes, office labs are governed by the Clinical Laboratory Improvement Amendments. What is the Clinical Laboratory Improvement Amendments (CLIA)? CLIA is a federal law passed in 1988 that requires doctors’ offices to get certification from the federal government before doing lab tests on humans. What types of certification are provided? All clinical laboratories must have one of 5 types of certificates: • Registration certificate • Certificate of waiver • Certificate of provider performed microscopy • Certificate of compliance • Certificate of accreditation What are waived lab tests? These are simple lab tests that are easy to perform by following the manufacturer’s instructions. Examples of such test include the following: • Fecal occult blood testing • Urine dipsticks • Urine pregnancy test • Blood glucose testing which is done on instruments approved by the FDA for home use • Hemoglobin testing on single-analyte instrument. What types of tests are considered provider performed microscopy? Provider performed microscopy must be done by a physician and applies to procedures that are moderately complex, performed by a bright field or phase contrast microscope, and involve minimal handling. Such tests include the following: • Wet mounts and KOH preps • Urine sediment • Semen analysis for the presence or absence of motile sperm The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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• Fecal leukocyte testing • Pinworm examination • Ferning. In my office, we perform only simple waived lab tests. Are we subject to all of the CLIA regulations? No. Laboratories that perform only waived tests are essentially exempt from CLIA regulations. They should, however, comply with the manufacturer’s instructions. However, all labs still must register with the government and be certified. In my office, I analyze urine samples under the microscope. Am I required to comply with CLIA? Provider performed microscopy requires a certificate. However, if your lab does waived test and provider performed microscopy (which must be done in conjunction with a physical exam of the patient) and waived tests, it is not subject to routine inspections. It is still subject to random inspections and compliance investigations.

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What specific standards are required of laboratories performing nonwaived tests? Every lab performing non-waived tests are subject to following requirements: • Personnel standards—written standards regarding employee responsibilities and requirements, as well as supervision • Patient test management—policies and procedures on the entire testing process • Quality control—internal checks to make sure the testing process is accurate • Quality assurance—a system to evaluate the quality of the whole process • Proficiency testing—specified testing to assure those performing the lab tests know what they are doing How long is a CLIA certificate good for? 2 years Where can I get more information about CLIA? Information about CLIA regulations can be obtained from the Department of Health and Human Services Center for Medicare and Medicaid Services website at www.cms.hhs.gov/clia/default.asp. How is the prevention of blood-borne pathogens regulated? OSHA promulgated the Blood-Borne Pathogen Standards in 1991 to prevent the transmission of blood-borne pathogens, in particular Hepatitis B and HIV. What should a physician’s office or hospital do to comply with these standards? Any employer that has at least 1 employee who can be exposed to a blood-borne pathogens is required to have on file an exposure control plan which is updated

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every year. This plan must be available to employees and any OSHA representative who requests it. What specific issues need to be addressed in the exposure control plan? • Universal precautions • Controls in the workplace • Protective equipment • Housekeeping policies • Policies for hazard communications • Hepatitis B program • Training program What are universal precautions? Procedures for avoiding contact with blood or infectious material in every case, not just when you think the patient is HIV positive or hepatitis B positive. What workplace controls need to be implemented? Engineering controls such as sharps boxes, biohazard bags, safety cabinets, etc., and safe practice controls such as hand washing, not keeping food next to blood or tissue samples, etc. What type of protective equipment is required and when should it be provided? Equipment necessary to minimize the exposure of an individual to blood or other infectious agent (lab coats, goggles, gloves, gowns, etc.) must be provided to the employee at no charge. What housekeeping policies need to be in place? Basically, policies which require the work area to be clean must be in place. What are the specific requirements for hazardous communications? Places which may contain infectious material should have proper warning signs or other indications (e.g., red bags) that the material is hazardous. What is the nature of the Hepatitis B program that must be implemented? First, the employer must make the hepatitis B vaccine available to all employees free of charge within 10 days of beginning employment. The employer also must have a program of testing and follow-up on those who may have been exposed to the virus. What kind of training program is the employer required to provide? The employer must provide employees with occupational exposure to bloodborne pathogens specific training on the exposure and how to avoid it. The employer also must keep record of the training for three years.

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CHAPTER 12

Pharmacy, Prescribing, and Dispensing Medications This chapter discusses the following: • drug labeling • off label prescribing • experimental medications • herbal remedies • cosmetic and food products • product liability. What does drug labeling mean in the legal sense? When a drug is labeled for a specific indication, this means the FDA has approved the drug for this particular use. For example, a particular NSAID may be approved for treating chronic pain but not acute pain. To receive a particular indication, the pharmaceutical company must show sufficient clinical data to support that indication. What may pharmaceutical representatives tell you about their drugs? Drug reps may tell you about their medication in the context of its indicated (FDA approved) use. They are not supposed to discuss uses which are not indicated or experimental uses. If you have specific questions in this vein, you may make a medical inquiry to the drug company. What is “off label” prescribing? Off label prescribing is prescribing a medication for a purpose for which it is not approved (indicated) by the FDA. May a physician prescribe a medication “off label”? Yes. Even though a particular drug is approved by the FDA for a particular use, it may be prescribed by a physician for any use. To be approved by the FDA, a drug must undergo extensive testing and scrutiny. Drugs may have many legitimate uses supported by the medical literature for which they are not approved. To await FDA approval might deny valuable treatments to patients. Consequently, a physician may prescribe a medication “off label.” Is there potential liability for “off label use” of a drug? As with any medication, misuse can result in liability. Using a medication for its indicated purpose provides significant support that it was used in accordance with The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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the standard of care. However, if a medication’s “off label” use is well supported by the medical literature, using it appropriately should not significantly increase a physician’s liability risk. What is a controlled substance? A controlled substance is chemical substance that has potential for abuse. The Drug Enforcement Administration (DEA) has established a rating system or schedule to describe the risk of abuse: • Schedule I: High potential for abuse. There are no legal uses for these substances which include heroin and marijuana. Some states have attempted to make marijuana a Schedule II drug, however, it is still a Schedule I drug by federal standards. • Schedule II: High potential for abuse and dependence. There are legal uses for these substances which include morphine, cocaine, and amphetamines. Some states require triplicate scripts. • Schedule III: Moderate potential for dependence. Includes Darvocet, Tylenol #3, etc. • Schedule IV: Limited potential for dependence. Includes benzodiazepines, etc. • Schedule V: minimal potential for abuse. Are there any restrictions on the way physicians can prescribe controlled substances? Yes. To prescribe a controlled substance, a physician needs both a state controlled substance license and a federal DEA certificate. Prescribing habits are monitored in various ways depending on the state. Except in emergencies, you should not prescribe controlled substances to yourself or your family. What is an experimental medication? An experimental medication is the same as an investigational drug. Such drugs are in the process of being approved by the FDA. Their safety and efficacy are being studied. Are there special requirements for prescribing experimental medications? Yes. Investigational drugs must be given as part of a research protocol. Specific informed consent for the experimental medication must be obtained. Is “off label” prescribing the same thing as using an experimental medication? No. Off label prescribing involves drugs which have already been approved for use. Investigational drugs have not yet been approved, but are in the process of being approved. Are herbal remedies and cosmetics regulated the same way as medications? No, they are regulated by the Center for Food Safety and Applied Nutrition. The Food, Drug, and Cosmetic Act governs the way they can be labeled and mar-

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keted. Quality control standards are rather loose and efficacy does not have to be proven. May a physician recommend an herbal remedy, cosmetic, or food product? Yes. Physicians do this all of the time when they recommend a well balanced diet. This is perfectly appropriate as long as it is done in accordance with good medical practice. May a physician be held liable for recommending an herbal remedy? Yes. Just like all other actions, if a physician breaches his or her duty to meet the standard of care, he or she may incur liability. In recommending and herbal remedy, keep in mind that their safety and efficacy have not been established and the amount of active ingredient may be highly variable. Can the pharmaceutical company be held responsible for manufacturing a drug which is later found to be harmful to patients? Yes. Pharmaceutical companies are held strictly liable for design and manufacturing defects of a medication. This means the manufacturer is always liable for injuries which result from product defects. This branch of law is called products liability. There are 2 types of product defects: design defects and manufacturing defects. Design defects is where when the drug or product, even when properly manufactured, is dangerous. Manufacturing defects result from errors in the manufacturing process. For example, Thalidomide caused birth defects by mere effect of the drug. This would be considered a design defect. A manufacturing defect would be the accidental addition of an adulterant to an otherwise safe medication.

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Where a physician properly prescribes a medication, and that medication carries a hidden danger of harm, can the physician be held responsible? Yes. Although most of the liability in this case would lie with the manufacturer, physicians may be liable in certain circumstances. Under the law, a physician is considered a learned intermediary. This means if you suspect or should suspect an FDA approved drug, such as phen phen, may cause harm to your patient you may be responsible for harm that results. Consequently, the physician is responsible to explain potential risks of a medication to the patient.

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Medical Education and Licensing This chapter discusses the following: • the legal process of becoming a doctor, from medical school to residency to licensure • affirmative action in admission to medical school • disciplinary actions against medical students and residents including probation and dismissal • the rights of the medical student and resident in the disciplinary process • the resident as student and employee. What are the educational requirements to become a doctor? To be a doctor (not necessarily licensed), a person must obtain a doctoral degree in medicine. This can be accomplished by completing a course of study at an allopathic school leading to an M.D. or an osteopathic school leading to a D.O. In the U.S., a person generally must complete a bachelor’s degree before starting medical school. What are the requirements to obtain a license to practice medicine? A person may obtain a license to practice medicine if he or she has a medical degree, has completed the minimum number of years of residency training as required by each state (ranging from one to three years), and meets other moral, ethical and educational requirements. Each state decides what their specific requirements are. Does a license determine what branch of medicine I practice? No. A license makes all medical practice legal from dermatology to neurosurgery. How is my practice limited to a certain area of medicine? On an outpatient basis the limits are personal, moral, and ethical, not legal. In other words, you can legally do anything you want on outpatients. However, you shouldn’t if you haven’t been trained. Many 3rd party payers won’t pay for procedures you are unqualified for and you could subject yourself to huge legal risks. Inpatient practice is limited by the credentialing process. Generally, a hospital medical staff will only grant privileges for what you are qualified to do. This is generally determined by your board certification.

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How is specialty certification regulated? This is done through the American Board of Medical Specialties (ABMS) which oversees the various specialty boards. Each specialty board sets requirements for its specific specialty. As a resident, when can I moonlight? To moonlight, you must have a license to practice medicine in the state in which you will moonlight. This is an absolute requirement. Also, you should have malpractice insurance coverage which is usually not provided by your training program. In addition, your program may require you to obtain their approval before you are allowed to moonlight and may limit your moonlighting. What special concerns do I need to keep in mind when moonlighting? Remember that each state’s requirements to get a license are different. Also, keep in mind that you will probably need to secure your own malpractice insurance. Make sure you see your malpractice coverage in writing before you take someone’s word that you are covered on their policy. What are the reasons that medical students and residents may be disciplined? Medical students, interns, and residents can be disciplined for a number of reasons. These reasons are usually either academic or non-academic. Academic reasons include poor exam scores, poor performance on oral or practical exams, mistakes in patient care, etc. Non-academic reasons include cheating, plagiarism, unethical conduct and the like. Non-academic problems are very difficult to correct because they are a result of the student or resident’s character. Consequently, they are usually considered much more serious than academic problems.

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What are the various ways medical students and residents may be disciplined? The first step in the disciplinary process is usually discussion and a warning. The second step is probation, especially for less serious concerns. Probation may either be academic or nonacademic. Medical schools and residency programs like to start here to make sure they provide the person being disciplined sufficient warning that there is a problem and adequate time to correct it. This also helps legally protect the school should the one being disciplined later decide to sue. If the person on probation does not take steps to correct the problem, the institution may start dismissal proceedings. What are your rights if your medical school wants to dismiss you? You have a right to due process, but not to the extent in the legal system. Generally, this means you have a right to know the charges against you, you have the right to a hearing by an impartial decision-maker, and you have a right to defend yourself by testifying on your own behalf and calling witnesses. If you lose at the hearing, you have the right to appeal the decision.

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If you go to a hearing, what can you expect? The hearing will be conducted like a trial, although the strict legal formalities will not necessarily be followed. The medical school will present evidence against you which will support their side. This evidence may make you look bad, and it may be difficult for you. You will be allowed to call witnesses and testify on your own behalf. You probably will not be allowed to bring an attorney in the room with you, but some schools allow you to bring one person with you as moral support. Is a resident considered a student or employee? In a strange way, the resident is both a student and an employee. Traditionally, residents were considered students. They weren’t given any compensation except for housing at the hospital—hence the term resident. However, residents began to get paid for the work they did, and they took on the role of an employee. Now, residents are usually employees of the hospital, yet still retain their role as students. Does this distinction matter in the disciplinary process? Not very much. Generally, courts will give significant weight to decisions made by residency programs in the educational process. That is because a judge feels the doctors who work with a particular student or resident every day are much better suited to decide about matters of medical education. One way the distinction matters is that under the employee definition a residency program may simply fire you at the discretion of the program director without giving you a hearing. This prerogative of the program director is usually spelled out in the employment contract. Further, the contract may not be renewed at the discretion of the program director. This usually only happens after several discussions with the resident, and after the resident has been placed on probation. However, no actual dismissal hearing is usually required. Can residents of a particular program form a union? Yes, but there can be difficulties. Several residency programs throughout the country have unions. Because it is unethical for physician to go on strike, the unions usually address resident concerns such as working hours, vacation, and number of days on call. The union may serve as an advocate for the resident who has been disciplined or dismissed. What recourse does the disciplined medical student or resident have? If you have been placed on probation, the first option you have is to shape up. Medical schools and residencies exist to train you and want to give you an opportunity to correct the deficiency. Take advantage of this. It is truly your best option. If you feel you have been wrongfully treated, you should be permitted to write a statement for your file stating your side of the story and why you feel you were disciplined inappropriately. If you have been dismissed from either medical school or residency, you have the right to appeal to the Dean and/or the hospital administrator. Don’t expect any miracles. It is very rare that a medical school dean or hospital CEO would reverse such a disciplinary decision.

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If you lose your appeal, you can sue to be reinstated. What you will have to prove is that your school or program acted capriciously, usually in violation of your right of due process. If you had been on probation and warned appropriately, it is unlikely you will have much of a case. However, if your civil rights were violated you may have an EEOC (Equal Employment Opportunity) claim or civil rights lawsuit. Just remember, judges don’t like to second-guess academic decisions made by physician teachers. Can licensed physicians be disciplined for inappropriate conduct? Yes. See the chapter on ethics for a complete discussion.

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CHAPTER 1 CHAPTER 14

Occupational Medicine This chapter discusses the following: • who do you work for • worker’s compensation • disability benefits What is worker’s compensation? Worker’s compensation is a state run program that pays workers for injuries or illnesses that occur in the workplace. The program exists in all 50 states. The key factor is that the injury must occur on the job (arise out of the course of employment). Injuries suffered at home chopping wood, playing ball, or any place other than on the job are not covered. It is financed by compulsory employer contributions. Does a worker’s compensation claim require a showing of fault? No, this is a no-fault system. It pays whether either party was at fault. Even if the employee was at fault, it still pays. What must the worker show in order to make a claim? The employee must prove he suffered some type of injury or illness which occurred at work. The injury generally must result in a disability or loss of earning potential. Some states allow recovery in cases even where no disability results, such as where a worker gets a scar. May an employee collect benefits for the aggravation of a pre-existing condition? Yes, as long as the exacerbating events occurred on the job. Is information shared with a physician in a worker’s compensation evaluation confidential? Yes. Although the patient usually presents with a release of information form authorizing the physician to release the medical records to the employer and insurance company, this does not authorize release of all records. Only records which are relevant to the claim should be submitted. In fact, there are cases where physicians have been sued for releasing a person’s HIV status to an employer. When providing records, be careful.

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What is the treating physician’s role in the workers’ compensation process? The main role of the treating physician is to make an objective, unbiased evaluation of the patient and his or her illness or injury. The physician should meticulously document the patient’s history and physical exam findings. Comments about the cause of the injury should be made with caution, since those comments may have to be defended in court or in a deposition. What is Social Security Disability? Social Security pays benefits under 2 programs to persons who are unable to work. The first program (usually just referred to as Social Security) pays money to people who have payed into the program. It also pays money to certain disabled dependents of persons in the program. The second program is called SSI, which stands for supplemental security income. SSI pays money to persons who are disabled (including those under 18) and who have a limited income. SSI benefits do not depend on whether the disabled person has paid in to the program. What does “disabled” mean? For social security purposes, “disability” means “the inability to engage in any substantial gainful activity by reason of any medically determinable physical impairment(s) which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months.” What does the term “medically determinable physical impairment” mean? This means a physical or psychiatric disorder that can be medically determined from history, physical examination, and diagnostic testing. It has to be verifiable medically, and not just what a patient tells you. How do I know if a disease or physical impairment is severe enough to qualify? The Social Security Administration has produced a listing of impairments which are considered to be adequate enough to qualify an individual for disability. There are separate listings for adults and children.

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What is the process a person must go through to get disability benefits? Most claims are processed through a local office or state agency. If a claim is denied, an appeal can be made to SSA. Claims that are still denied can be ajudicated before an administrative law judge. As a physician, what is my role in the disability process? The most common role for the doctor is as the treating physician. As a treating physician your job is to provide quality medical care for the patient. The treating physician is considered the best source of information in the disability determination process. You will not be required to determine if the patient is disabled, but you will be expected to determine whether you think the patient can work.

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Physicians also participate in the process by performing disability examinations, reviewing claims, and testifying as medical experts. Do I, the doctor, determine if someone is disabled? No. This is a determination made by the Social Security Administration. The physician’s role is simply to provide information, and offer an opinion if asked. The physician does not determine if someone is disabled. If a patient wants me to fill out or do a disability exam do I have to? No. This is up to the physician to decide if he or she wishes to participate in this fashion. Are there other disability programs other than social security? Yes, disability insurance is commonly purchased by employers/employees. It often pays more. There are 2 different types: one type pays only if the person cannot perform any meaningful work (much like social security), the other type pays if the person cannot perform his or her occupation. This distinction can be important for professionals. For example, if a retina surgeon who makes $800,000 per year is injured and cannot work as a retina surgeon, but can still make hamburgers at McDonald’s, this distinction is critical.

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CHAPTER 1 GLOSSARY

Abandonment Here the doctor ends the physician-patient relationship when the patient still needs medical attention, without the patient’s consent, and without giving the patient time to find another doctor. An example would be where a doctor goes on vacation and does not arrange for coverage of his critically ill patients in the hospital. Other less dramatic examples may also rise to the level of abandonment. Acceptance An affirmative manifestation that a person agrees to be bound by the terms of an offer and enter into a contract. It has to be a clear cut manifestation, such as saying “I accept” but may also be simply following the terms of the offer. Anyway, it requires doing something. Action Another name for a lawsuit. An action is sometimes called a civil action to distinguish it from criminal court proceedings. Americans with Disabilities Act (ADA) The Americans with Disabilities Act is a federal law which was enacted to eliminate discrimination against persons with disabilities. It requires access for the disabled to public facilities (including doctor’s offices) and protects employees and potential applicants from discrimination based upon the disability. It also requires employers to make reasonable accomodations for disabled persons in the work environment. Affidavit A written statement which is the same as sworn testimony. If a person lies in an affidavit, he or she may be guilty of perjury. Alternative Dispute Resolution A mechanism for resolving disputes without going to court. This has become a popular, less expensive alternative to long, costly legal battles. Examples include arbitration and mediation. Appeal Taking the outcome of a lower court to a higher court for review. In state and federal court, there are generally two levels of appeal: first to an intermediate appellate court, and second to the supreme court. American citizens usually have the right to appeal one time. There is no legal right to have your appeal heard by the supreme court. This usually occurs only with the court’s permission. Administrative law decisions can also be appealed. The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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Arbitration A form of alternative dispute resolution where the parties to a dispute take their concerns to an unbiased third party. A hearing is held, but strict procedural rules are generally not followed. Arbitration is usually less expensive and burdensome than going to court. It is a practice commonly used in labor disputes. Arbitration may or may not be binding, depending on the rules agreed to in advance. Autonomy The principle of self-determination that forms the ethical basis for the law of consent and informed consent. Autonomy holds that the best person to make decisions for you is you, and that no one should impose his or her will on you unless there is a very good reason. This principle will hopefully avoid reliving past atrocities where individuals were subjected to horrific medical treatments and experiments against their will. And it should keep doctors from doing things to or for patients that they do not want. Beneficence The ethical concept of doing or promoting good. Burden of Proof The responsibility of a plaintiff or defendant in a lawsuit to prove the facts necessary to support his or her claim (see proof ). Capacity The state of being legally qualified to make decisions. It requires that someone understand in a basic sense the consequences of their actions. In a medical context, this would include the nature of the illness, the nature of the intervention, the risks, and benefits. Capacity is assumed in persons over 18, unless there is some valid reason to conclude otherwise. For example, if someone has severe Alzheimer’s Disease and does not understand the nature of his or her illness or potential treatments for that or other diseases, that individual would lack capacity. If you are concerned that someone may lack capacity, you should explain the situation to them and see if they appear to understand by explaining it back to you in their own words. Capitation A system of paying health care providers where the provider gets a certain amount per month or year for managing the care of a panel of patients and therefore assumes financial risk. If few people in the panel require care, the provider expends few resources and the provider profits. However, if many people are ill and require expensive care, the provider will expend a large amount of resources, possibly far exceeding reimbursement through the health plan, and the provider loses money. Case Law Court opinions interpreting other court opinions or statutes as applied to specific situations or cases. These court opinions then serve as precedents in the future. This form of judge made law is sometimes called common law.

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Clinical Laboratories Improvement Amendments (CLIA) Clinical Laboratories Improvement Amendments is a federal law (42 U.S.C. sec 263a) which requires all laboratories, whether in the hospital or a doctor’s office to be certified. The goal is to provide federal quality assurance for lab tests. Consolidated Omnibus Budget Reconciliation Act (COBRA) A federal law which, among many other things, is supposed to prevent dumping patients by one hospital on another. The specific part of COBRA which forbids dumping patients is called EMTALA. Common Law The collected case law that forms the body of judge made law in the United States. Common law also refers to English case law prior to the revolution which was incorporated into American law. Competency A legal determination of a person’s mental capacity. In medicine, it is usually applied to a patient’s ability to make health care decisions. It is a determination made by a court, not a doctor. If a patient is incompetent, he or she cannot give informed consent. The court will generally appoint someone, a guardian, to make decisions on his or her behalf. Under the law, competency is presumed. However, certain factors may call competency into question, such as serious mental illness. Competency also may relate to a person’s ability to testify, stand trial, make contracts, or write a will. Complaint The first document which is filed to start a law suit. It is filed by the plaintiff or the person who is suing. There are specific rules on how complaints must be written and filed, but all complaints should contain at least 1) the court where the complaint is filed has jurisdiction, 2) the grounds for the law suit, and 3) what kind of compensation that is sought. The complaint and a summons must be formally given to or served on the defendant.

Glossary

Chain of Custody The record of custody or control of evidence from the time it is collected until it is offered in a legal proceeding. Chain of custody shows that the evidence in question has not been tampered with. Physicians encounter this situation where they have to collect evidence that may have legal consequences such as urine drug screens and hair and semen samples from rape victims. Class Action A special kind of lawsuit where many persons claiming to be injured by one defendant in a similar way; they sue collectively as a “class” to have more power. Class action law-suits are seen in cases involving defective products or medications.

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Confidentiality The ethical and legal doctrine that protects certain types of communications from disclosure to third parties. It applies specifically to professional communications between the attorney and client and between the doctor and patient. If an attorney or physician breaches confidentiality, he or she may face serious consequences. There are also new requirements under a federal law called HIPAA. Consent Where one person agrees to the proposition of another and accepts the consequences of that proposition. An example would be consent to medical treatment. Consent may be implied when a person’s actions show they agreed to the proposition, or express if the person specifically states verbally or in writing that he or she consents. Consideration Something of value given in exchange for something as part of a contract. Consideration is necessary for a contract to be enforceable. For example, if John tells Sally he will wash her car but forgets about it, he is under no legal obligation because Sally did not give him anything of value in exchange for the promise. However, if Sally gave John $20 in exchange for John’s promise to wash her car, there is consideration and technically there is an enforceable contract. Contract A legally enforceable agreement. To be legally binding a contract must include an offer, acceptance of that offer, and some kind of exchange called consideration. Contributory Negligence A legal principle that applies where a person, who is suing another for negligence, is in part responsible for his or her own injuries. It most jurisdictions it results in a reduction of the monetary award in proportion to the plaintiff’s contribution. Corporation A legally created entity, with the same legal status as a person, which is usually formed to conduct business. Corporations may also be created for charitable or notfor-profit purposes. It is run by a board of directors which is elected, in the case of for-profit corporations, by the shareholders. In not-for-profit corporations the directors may be appointed or elected by members of the community which are affiliated with the corporation. Credentialing The process of admitting physicians to the medical staff of a hospital or managed care health plan. Hospital credentialing usually occurs through committees comprised of physicians and administrators. Damages Money awarded by a court to compensate an individual for injuries he or she has suffered due to the negligence of another. Damages may compensate an individual

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Defendant The person being sued in a lawsuit. In a medical malpractice law suit, the physician would be the defendant. Deposition Oral testimony given under oath outside of court before trial. It is used by the opposing side to find out what evidence the other side has as well as to keep witnesses from changing their story at trial. DNR (Do Not Resuscitate) An order written by a doctor not to resuscitate a patient if he or she goes in to cardiac or respiratory arrest. This is done only in accordance with the clearly expressed wishes of the patient or appropriately designated surrogate decision-maker. It is usually done in the case of seriously ill or debilitated patients in which CPR would most likely be futile, such as terminal cancer. Double Effect An ethical principle that has specific application to medical ethics in modern society. It holds that certain actions are not wrong, even if they have serious negative consequences, if the intended effect is beneficial and the negative consequences are unintended. For example, if a cancer patient has severe, intractable pain, a doctor who titrates the patient’s morphine up to achieve adequate pain control is not wrong, even if it suppresses respiration and causes death. Due Process of Law The idea that everybody has a right to “their day in court.” It means a person shouldn’t have his or her property or rights taken away without certain guarantees to assure fairness. These guarantees include the right to know the charges or complaint against you, the right to respond, the right to have fair and appropriate procedural rules such as the right to call and question witnesses, and the right to an impartial decision-maker. Durable Power of Attorney for Health Care A legal instrument which designates someone to make health care decisions for you should you become unable to make them for yourself. It is “durable” because it remains in effect even if you become incompetent or lose decision-making capacity. It is called a “power of attorney” because someone else will be managing your affairs for you. It is for “health care” because it only applies to health care decisions. This advance directive is very useful because it provides guidance in a wide variety of circumstances.

Glossary

for lost wages, medical expenses, cost of repair or replacement, pain and suffering, etc. Punitive damages are somewhat different and are awarded in special cases and serve only to punish the tort-feasor. In this latter case, the conduct of the tort-feasor must be so egregious it merits punishment.

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Emancipated Minor A minor who is 16-years-old or older who is self-supporting and has been declared by a court to be emancipated. This minor is considered an adult for purposes of consenting to medical procedures and making contracts. Minors are also considered emancipated if they become pregnant or enter military service. Emergency Medical Treatment and Active Labor Act (EMTALA) This federal statute prohibits transferring (or dumping) patients to other hospitals until their medical problems are stabilized. It also prohibits dumping women in active labor. It also prohibits transferring patients to another hospital unless a physician at the receiving hospital formally accepts the transfer except to a higher level of care by prior agreement. The penalties for violators are severe. Evidence Material, including oral testimony, documents, medical records, affidavits, exhibits, charts, graphs, etc. which is admissible at trial. It is offered to prove a given fact. Expert Witness In a medical malpractice law suit, an expert witness is a physician who testifies about the standard of care and whether the physician’s failure to meet that standard led to the injury for which he or she is being sued. These people are paid for their service. Food and Drug Administration (FDA) The federal agency responsible for approving medications and medical devices to be sold in the U.S. Fiduciary A special relationship of trust between a professional and the person he or she is serving, such as between an attorney and client or a physician and patient. It carries with it the ethical legal duty to act with the utmost care for the good of the client or patient. Finder of Fact In a trial, this is usually the jury. The finder of fact determines which evidence and testimony is believable and from this decides what the actual facts of the case are. The finder of fact then applies the law to these facts and arrives at a verdict. Finder of Law In a trial, this is the judge. The judge makes legal determinations such as which evidence is allowed to be considered, what facts must be proved for the plaintiff to win, etc. The judge does not decide which evidence and testimony is believable. However, the judge instructs the jury on how to apply the law to the specific facts of the case.

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Fraud A deliberately misleading act or deception by one person on which another person relies on to their detriment. For example, Jones sells basement office space to Dr. Smith and says that it has never leaked. In reality, the basement gets 3 feet of water in it each time it rains and Jones knows this. If Dr. Smith gets flooded out, Jones is guilty of fraud. Good Samaritan Statutes Laws passed by state legislatures that give immunity to physicians and other medical personnel who stop to help someone in an emergency. The purpose of these laws is to encourage physicians and others to stop and help out in emergency situations. Guardian A guardian is a person who is appointed by a judge to make decisions for a person who is unable to do so. There are two types of guardians. A guardian of the person makes personal choices for the person such as health care decisions. The guardian of the estate directs the business affairs of the person. Health Care Surrogate Act A law passed by the state legislature that formalizes the ability of another person to make health care decisions for a patient should the patient become unable to do so. The surrogate is usually the closest family member. In the absence of a specific statute, the common law usually provides for a surrogate decision-maker. HEDIS Health Plan Employer Data and Information Set is a core set of health care quality and economic standards established by the National Committee for Quality Improvement which are used by utilization review organizations to evaluate quality, access, patient satisfaction, membership, utilization of health care resources, financial issues, and other measures. HIPAA Health Insurance Portability and Accountability Act is a federal law that sets standards regarding sharing and disclosing information, (including electronically) to third parties. It carries significant penalties for violation. HMO Health Maintenance Organization is a health care organization that provides health care for a specific, defined groups of patients at a capitated rate.

Glossary

Firm Offer In the law of contracts, a firm offer is an offer by someone to buy or sell goods or services at a certain price, and the offer will be held open for a specific period or reasonable time not to exceed 3 months.

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Incompetence A legal declaration by a court that an individual is unable to manage his or her own affairs and requires a guardian to do so. This is not a determination a doctor, family member, or anyone other than a court can make. Informed Consent Consent given by a patient to a physician to undergo a medical procedure or treatment after the patient has been informed of the nature of the treatment, the risks and benefits, alternatives, and anticipated outcome of the procedure. Institutional Review Boards (IRBs) Committees in teaching hospitals and medical schools that must approve any research project that involves human subjects to ensure it is conducted in conformity with federal regulations and ethical standards. Interrogatories Written questions submitted by one side of a lawsuit to the other prior to going to trial. The purpose of interrogatories is for each side to find out what evidence the other side has (in hopes that they will settle out of court and not clog up the legal system with frivolous lawsuits). Jurisdiction The legal term that means a particular court has the authority to preside over a lawsuit. If two physicians from Texas get in a dispute over who rightfully owns their office building in Dallas, a court in California would not have jurisdiction. Jury Instructions Specific written instructions given to the jury at the end of a trial to guide them in arriving at a verdict. Jury instructions are very important because they often provide a basis for the losing side to appeal. Living Will A living will is an advance directive that states a patient does not want life sustaining medical treatment in cases where death is imminent. Because of it’s narrow scope, it is of limited usefulness in most cases. LLC A Limited Liability Company is one way a business can be organized. It is a relatively new hybrid between a partnership and a corporation in an attempt to have the best of both worlds. Malpractice A specific legal term that describes a specific wrong committed by a professional such as a physician or attorney. Medical malpractice occurs when a physician has a specific duty to care for a patient according to the standard of care, fails to meet that duty, and as a result the patient suffers harm.

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Mediation A form of alternative dispute resolution. A hearing is conducted by a hearing officer called a mediator, and the rules are less stringent than in court. It is much less expensive. The purpose of mediation is to bring both sides to a mutually agreeable resolution. Unlike arbitration, the results are non-binding. Medicaid A government sponsored program to pay for health care for poor people. It is funded mostly by the federal government but administered by the state governments. Medicare A federally sponsored insurance program to help pay for health care for senior citizens. Medicare also provides benefits for certain other groups such as retired railroad workers and renal failure patients. It is funded and managed by the federal government. Part A Medicare pays for inpatient services, and Part B Medicare pays for outpatient services and doctors’ fees. Minor Any person under 18 years of age. Minors are generally not legally responsible for contracts they sign or in civil actions. Except in the case of a mature or emancipated minor, a minor may not consent to medical treatment Motion A request made to the court by one side in a lawsuit asking for something specific. Motions can be made before, during, or after the trial, and can relate to anything from exclusion of evidence, to requests for a new trial, request to have certain testimony stricken from the record, etc. National Practitioner Data Bank A national data bank which contains information about physicians who have lost a malpractice lawsuit, settled out of court, been suspended from practice, or had their hospital or managed care privileges revoked. Hospitals are supposed to check it before they credential a physician and can be held liable if they don’t.

Glossary

Mature Minor The term applied to someone younger than 18 who, because of being particularly mature, is able to understand his or her health status and make informed medical decisions. This concept applies by statute to young people seeking birth control services, treatment for STDs, and counseling and treatment for psychiatric disorders and drug and alcohol abuse. It also applies in certain Jehovah’s Witness cases where a well informed, and mature minor may be permitted to refuse a potentially lifesaving blood transfusion. Since pregnancy emancipates a minor, it does not fall into this category.

Glossary

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Negligence Failure to use reasonable care and diligence which causes someone else to become injured or suffer as a result. In medicine, if negligence results in a harm it is malpractice. Non-compete Clause A phrase in a contract, usually an employment contract, that says if you stop working for your employer you will not work within a certain distance of your employer (e.g., 20 miles) within a certain period of time (e.g., 2 years). Non-compete clauses are usually upheld if they are “reasonable” as to geographic distance and time. The exact geographic distance and time period varies depending on the jurisdiction. Nonmaleficence The ethical principle of not harming others. In medicine, this principle is codified in the maxim primum non nocere (first do no harm). Occupational Safety and Health Administration (OSHA) This is the federal agency charged with maintaining safety in the work place. Parens Patriae The legal concept that the state is the ultimate guardian of everyone and can act on behalf of minors and disabled persons. Paternalism The belief, often seen in medicine, that certain individuals know what is best for others. Physicians are sometimes accused of paternalism, when by way of their education, presume to know what is best for the patient, without taking in to account the patient’s own thoughts and feelings. Partnership A particular way of organizing a business, where control, profits, and liability are shared equally and fully among each and all partners. Peer Review A system of health care quality control where cases are reviewed by persons of similar training or education, usually physicians. Physician/Patient Relationship A special relationship between a physician and a patient which is created when the patient seeks the services of a physician, and the physician agrees to treat the patient. The relationship places certain requirements on the physician to act in accordance with the standard of care, not abandon the patient, etc. Plaintiff The person in a lawsuit who is suing another. The plaintiff bears the burden of proof.

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Priviliges The right of a physician or other health care provider to perform specific procedures or treatments in a hospital or health care organization. Prima Facie Providing evidence that on its face meets the legal criteria for a particular claim. For example, in a malpractice lawsuit against a physician, a prima facie case would demonstrate the physician had a duty, breached the standard of care, and as a result a patient was injured. However, a prima facie case can be refuted by evidence from the other side. If the prima facie case is not made, the plaintiff loses. Proctoring The practice of supervising physicians who are new or who have been out of practice for a while as part of the credentialing process. This is almost always for a specific period of time. Product Liability The legal liability of a manufacturer for making a defective product. Defects may be either in the design itself on the actual making of the product. Pharmaceuticals are a big source of product liability litigation because of the potential for new drugs to cause harm and because of the deep pockets of pharmaceutical companies. Proprietorship A type of business entity where one person completely owns the business and is the sole decision maker. The profits of the business are taxed as personal income and the owner has personal responsibility for liabilities of the company. Regulation Rules promulgated by administrative agencies which have the force of law. For example, the FDA has strict rules for the approval of new drugs. Drug companies which do not follow these rules can be penalized as law breakers. Res Ipsa Loquitor Literally, the thing speaks for itself. This legal doctrine describes negligence which is so obvious it does not require an expert witness. An example would be if a patient is to have his right foot amputated, and the surgeon mistakenly amputates the left foot. Respondeat Superior The legal principle that the employer is legally responsible for acts of the employee done while on the job. It does not apply to acts which are not within the scope of the employment.

Glossary

Preponderance of the Evidence The level of proof that says something is more likely than not to be true, or 51% likely to be true. This is the level of proof usually required in a civil case.

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S Corporations Special corporations which are taxed like a partnership. There are specific rules they must follow (i.e., they can only have a certain number of employees). This type of business entity is being supplanted by the LLC. Stare Decisis The legal doctrine of letting cases which have already been decided serve as precedent for new cases. It creates consistency and predictability in the law. Statute A law passed by a legislature. It usually must be signed by the President or the Governor. Statute of Limitations A specific time limit after which a lawsuit or criminal charges cannot be filed. In civil cases it is usually one to two years, but it can be longer in certain cases. Certain crimes, such as murder, do not carry a statute of limitations. Stipulation Agreeing to certain facts prior to a lawsuit. This saves time and energy trying to prove or disprove facts which are of little consequence, important to both sides, or almost certain to be proven true. Strict Liability The principle that a manufacturer is always liable for harm that results from product defects. Subpoena A court order requiring a person to testify in court or to produce documents or records. If a person fails to comply with a subpoena he or she can be punished. Therapeutic Privilege The privilege physicians have to withhold certain information from patients if that information will likely cause serious harm to the patient. It must be exercised with caution. Tort A private wrong or offence committed by one person against another. The person who was harmed is usually awarded money to compensate for the harm suffered. Tort-feasor One who commits a tort. Voir Dire Jury selection. Jurors are actually de-selected from a pool of potential jurors. Jurors can be excluded for cause (e.g., the juror is good friends with the defendant) or by means of a peremptory challenge (almost any reason).

CHAPTER 1 FOOTNOTES

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32.

Current Opinions of the American Medical Association Council on Ethical and Judicial Affairs, Opinion 9.12. Current Opinions of the American Medical Association Council on Ethical and Judicial Affairs, Opinion 9.131. Traveler’s Ins. Co. v. Bergeron, 25 F. 2d 680, 49 S.Ct. 33 (1928). Hoover v. Williamson, 236 Md. 258, 203 A. 2d 861 (1964). Brumbalow V. Fritz, 183 Ga. App. 231, 358 S.E. 2d 872 (1987). Viita v. Dolan, 155 N.W. 1077 (Minn. 1916). Hamel v. Bashline, 224 Pa. Super. 407, 305 A. 2d 57 (1973). St. John v. Pope, 901 S.W. 2d 420, 38 Tex. Supp.Ct.J. 723 (1995). Rule v. Cheeseman, 181 Kan. 957 317 P. 2d 472 (1957). Walters v. Rinker, 520 N.E. 2d 468 (Ind.Ct.App. 1988). Osborne v. Frazor, 425 S.W. 2d 768 (Tenn. 1968). Reynolds v. Decatur Memorial Hosp., 277 Ill. App. 3d 80, 660 N.E. 2d 235, 214 Ill. Dec. 44 (1996). Hickey v. Traveler’s Ins. Co., 158 A.D. 2d 112, 558 N.Y.S. 2d 554 (1990). Stohlman v. Davis, 220 N.W. 247 (Neb. 1928); Mucci v. Houghton, 57 N.W. 305 (Iowa 1894); Grace v. Myers, 29 S.E. 2d 553 (N.S. 1944). Chase v. Clinton County, 217 N.W. 565 (Mich. 1928). 17 A.L.R. 4th 132. 100 A.L.R. 3d 723. Millbaugh v. Gilmore, 30 Ohio St. 2d 319, 285 N.E. 2d 19 (1972). Current Opinions of the American Medical Association Council on Ethical and Judicial Affairs, Opinion 8.08. Cobbs v. Grant, 502 P. 2d 1 (Calif. 1972). Sandy v. Hardy, 379 A. 2d 1014 (M.D. 1977). Current Opinions of the American Medical Association Council on Ethical and Judicial Affairs, Current Opinion 5.05 (1997). Federal Rules of Civil Procedure 12 (b). Leaman T, Saxton J. Preventing Malpractice: The Co-Active Solution. New York: Plenum, 1993:68-70. 29 U.S.C.A. sec. 1001-1461. Parsley v. Associates in Internal Medicine, 484 N.Y.S. 2d 485 (1985). Joint Conference of Commissioners on Uniform State Laws, Uniform Health Care Information Act, 9 U.La.Ann. 478 (1988). Washington Administrative Code, Title 246: Department of Health sec. 246-318440, Records and Reports—Medical Record System. 2 Wigmore (3d ed. 1940) sec. 278 at 120. Uniform Health Care Information Act, sec. 7-101. Rule 34 Federal Rules of Civil Procedure; Rule 803(b) Federal Rules of Evidence; Bray v. Bi-State Development, 949 S.W.2d 93 (1997). Current Opinions of the American Medical Association Council on Ethical and Judicial Affairs, Current Opinion 5.07. 42 U.S.C. sec. 12101 et seq.

The Physician’s Pocket Lawyer, by Charles Ellington and John Bradley. ©2003 Landes Bioscience.

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The Physician’s Pocket Lawyer 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60.

61. 62. 63. 64. Notes

65. 66. 67.

Reviewing the Americans with Disabilities Act, Am. Prac. Adv. 43 (1995). The Americans with Disabilities Act of 1990, Am. Prac. Adv. 47 (1992). I.R.C. sec. 1361-1379. 42 USCS sec. 1320a-7b(b)(1)(A),(B). Beauchamp T, Childress J. Principles of Biomedical Ethics. 3d ed. Oxford UniversityPress, 1989. Current Opinions of the American Medical Association Council on Ethical and Judicial Affairs, Current Opinion 5.05. Current Opinion 2.02. People v. Stritzinger, 137 Ca. App. 3d 126, 186 Cal. Rptr. 750, 752 rev’d 34 Cal. 3d 505, 668 P. 2d 738, 194 Cal. Rptr. 431 (1983). Bratt v. Int’l Business Mach. Corp., 392 Mass. 508, 467 N.E.2d 126, 137 n.23. Ferdinand D. Shoeman, “Privacy: Philosophical Dimensions of the Literature,” in Shoeman, ed., Philosophical Dimensions of Privacy, p. 3. AMA Principles of Medical Ethics, Principle II, AMA Council of Ethical and Judicial Affairs, Code of Medical Ethics: Current Opinions with Annotations. Current Opinions of the American Medical Association on Ethical and Judicial Affairs, Current Opinion 8.08. Current Opinion 8.12. Current Opinion 8.032. Current Opinion 8.035. Current Opinion 9.11. Pons v. Ohio State Medical Bd., 66 Ohiio St. 3d 619, 623, 625, 614 N.E.2d 748, 752, 753 (1991). Current Opinions of the American Medical Association on Ethical and Judicial Affairs, Current Opinion 8.14. Current Opinion 8.061. Current Opinion 2.07. Darling v. Charleston Community Memorial Hospital, 211 N.E.2d 253 (1965). Belotti v. Baird, 443 U.S. 622 (1989). 410 U.S. 113 (1973). Danforth v. Planned Parenthood of Central Missouri, 428 U.S. 52 (1976). Id. Current Opinions of the American Medical Association on Ethical and Judicial Affairs, Current Opinion 8.17. Thompson v. Sun City Comm. Hosp. 141 Ariz. 597, 688 P.2d605 (1984). Wyatt v. Stickney, 35 F. Supp. 781 (M.D. Ala.), enforced 334 F. Supp. 1341 (M.D. Ala.), affd. In part, rev’d and remanded in part sub nom. Wyatt v. Aderholt 503 F.2d 1305 (5th Cir. 1974). Youngberg v. Romeo, 457 U.S. 307 (1982). Lake v. Cameron, 364 F.2d 657 (D.C. Circ. 1966). Tarasoff v. Regents of the University of California, 17 Cal.3d 425, 529 P.2d 334, 131 Cal.Rptr. 14, 551 P.2d 334 (1976). Sales B, Powell DM, VanDizend R. Disabled Persons and the Law: State Legislative Issues. New York: Plenum Press, 1982:469-474. Beecher A. A definition of irreversible coma: Report of the Ad Hoc Committee of the Harvard Medical School to examine the definitions of death. JAMA 1968; 205:337. Uniform Anatomic Gift Act of 1987, National Conference of Commissioners on Uniform State Law. 42 CFR sec. 493.5©(1)-(5), 493.45(a), 493.49.

Footnotes 68. 69. 70. 71.

91 42 CFR sec 493.19©(1)-(9). Current Opinions of the American Medical Association on Ethical and Judicial Affairs, Current Opinion 8.19. Social Security Administration Pub. No. 64-039, May 2002. Doe v. Roe, 190 A.D. 2d 463 (1993), Urbaniak v. Newton, 277 Cal. Rptr. 354 (Cal. App. 1 Dist. 1991).

Notes

LANDES

V ad e me c u m

BIOSCIENCE

Table of contents 1. The Basics

11. Running a Laboratory

2. Medical Malpractice and Risk Management

12. Pharmacy, Prescribing, and Dispensing Medications

3. The Business Office

13. Medical Education and Licensing

4. Medical Ethics

LANDES BIOSCIENCE

V ad e me c u m The Physician’s Pocket Lawyer

14. Occupational Medicine

5. Hospital Staff 6. Pediatrics 7. Obstetrics and Gynecology 8. Emergency Room 9. Psychiatry 10. ICU and End of Life Decision Making

The Vademecum series includes subjects generally not covered in other handbook series, especially many technology-driven topics that reflect the increasing influence of technology in clinical medicine. The name chosen for this comprehensive medical handbook series is Vademecum, a Latin word that roughly means “to carry along”. In the Middle Ages, traveling clerics carried pocket-sized books, excerpts of the carefully transcribed canons, known as Vademecum. In the 19th century a medical publisher in Germany, Samuel Karger, called a series of portable medical books Vademecum. The Vademecum books are intended to be used both in the training of physicians and the care of patients, by medical students, medical house staff and practicing physicians. We hope you will find them a valuable resource.

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Charles Ellington John Bradley