Hand Book Of Risk Management

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RISK MANAGEMENT HANDBOOK YALE-NEW HAVEN HOSPITAL YALE SCHOOL OF MEDICINE

Major Topics Introduction What Is Risk Management ? Risk Management at Yale-New Haven Hospital Insurance Program at Yale Medical Center Overview of the Legal System Medical Record Documentation Incident Reporting The Physician - Patient Relationship Informed Consent Infectious Disease Control Confidentiality Patients' Rights January, 1997. Copyright 1997, Yale-New Haven Hospital and Yale University. All rights reserved.

Detailed Table of Contents Introduction What Is Risk Management ? Risk Management at Yale-New Haven Hospital Insurance Program at Yale Medical Center Reporting Potential Claims/Lawsuits Overview of the Legal System The Civil Court System The Statute of Limitation The Summons and Complaint The Discovery Process Depositions and Interrogatories The Trial Federal and State Governmental Agencies Potential Legal Action Or Governmental Investigation Reporting professional Misconduct Medical Record Documentation Proper Documentation of the Medical Record What to Avoid in the Medical Record Docunmentation of Incidents and Unanticipated Patient Outcomes Frequently Asked Questions Regarding Medical Records Incident Reporting Quality Assurance Review and Analysis of Incident Reports The Physician - Patient Relationship Recommendations for a Healthy Physician - Patient Relationship Frequently Asked Questions Regarding The Physician - Patient Relationship YNHH Risk Management Handbook-Contents

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Informed Consent What Is Informed Consent? What Information Should Be Discussed With The Patient During The Informed Consent Process? How Should The Informed Consent Process Be Documented In The Medical Record? The Consent Form Entries In The Medical Record When Is Informed Consent Not Required? Patient Advanced Directive Policies Do Not Resuscitate Orders Frequently Asked Questions Regarding Informed Consent Infectious Disease Control What goes in Red Bags ? What goes in Clear Bags ? What goes in a Sharps Container? Confidentiality Patients' Rights The Patient Representative

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Introduction Yale-New Haven Hospital and Yale School of Medicine comprise one of the preeminent medical centers in the nation. The institutions undertake to train medical professionals, advance medical science and improve the delivery of health care. In addition, the hospital is committed to providing the best quality of care possible, as well as the continuous assessment and improvement of the quality of care and services rendered to our patients. The risk management program at the hospital plays a crucial role in fulfilling these commitments. The goals of the overall risk management program are to identify areas of actual or potential risk, prevent, as much as possible, injuries to patients, visitors and employees, and to prevent or limit financial loss to the hospital and its staff. Financial loss can occur in a number of ways. From a risk management perspective, the primary concerns are those financial losses associated with the inherent risks that exist in providing health care services, which can result in a patient instituting a medical malpractice claim or lawsuit against the hospital and/or a health care provider. The key element in the success of the risk management program in preventing and reducing these particular claims and associated financial losses, is the participation of physicians, nurses, other health care providers and hospital employees in implementing effective risk management strategies. Each individual must be committed to reducing risks. The purpose of this handbook is two-fold: 1) to provide information that addresses a number of the medical-legal and risk management issues encountered by physicians and other health care providers; and 2) to serve as an easily referenced resource for such information, supplementing additional information also contained in some of the hospital's administrative policy and procedure manuals. The intent in highlighting these issues is to make all health care providers more aware of important opportunities they have to reduce the risks of injury to patients and others, reduce the risks of financial loss to the hospital and staff, and improve the quality of care. Since these issues and related procedures may change over time, the hospital intends to periodically update this handbook. YNHH Risk Management Handbook-Contents

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What is Risk Management ? Risk management is a planned and systematic process to reduce and/or eliminate the probability that losses will occur in a specific setting. It consists of three distinct, yet interrelated areas: 1) risk identification and loss prevention; 2) loss reduction; and 3) risk financing. To be most effective in the hospital setting, risk management involves a multidisciplinary and proactive approach. The first component involves those activities related to risk identification and loss prevention. Generally, these activities include the identification and correction of situations or problems which may give rise to events or incidents of potential liability for the hospital, its employees, physicians and other health care providers. These activities are vital to successful risk management since in most cases, the cost of preventing a liability claim is far less than the cost of resolving the claim after it occurs. Loss prevention activities also consist of the planning and presentation of regular educational programs to clinical and administrative departments which includes: 1. orientation of new employees including medical staff, residents and nurses; 2. continuing education in the form of in-service programs regarding medical-legal and risk management related subjects; and 3. special seminars or conferences for target audiences in response to particular risk management problems. The second component involves loss reduction activities. Loss reduction includes those steps which are taken after an event or incident occurs that are aimed at minimizing the adverse impact, financial or otherwise, of such an event or incident on the patient, the hospital and its staff. These loss reduction activities are multifaceted and, depending on the facts and circumstances of the particular occurrence, include involvement and input from a number of the medical and administrative staff throughout the hospital. The foundation of an effective loss reduction program includes procedures that identify and respond as soon as reasonably possible to incidents which occur. In this way any adverse impact potentially resulting from the incident can be best minimized. These activities include the hospital's management of professional and general liability claims reported under its insurance program. The third component is risk financing, which involves the mechanisms utilized to ensure that there are adequate financial resources available to cover any potential liability situations, and includes the procurement of adequate liability insurance coverage at reasonable premiums to cover such losses. To respond to this need, the medical center has developed a professional and general liability insurance program which provides coverage for "medical malpractice" and other types of negligence claims. Risk financing also involves the effective negotiation and use of indemnity provisions in hospital contracts to transfer liability risks to other parties whenever possible. The hospital's risk management program primarily is administered by the Office of Legal Affairs in the areas of loss reduction and loss prevention. However, risk management at the hospital is a coordinated effort integrating many administrative and clinical departments throughout the hospital. In particular, the hospital's Patient Relations and its Quality Assurance Departments work closely with the Office of Legal Affairs in the hospital's overall risk management effort.

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Risk Management at Yale-New Haven Hospital The risk management program at all Yale-New Haven Hospital ("YNHH") facilities is coordinated through the Office of Legal Affairs and Risk Management, which is located in the Clinic Building, Room 230, Ext. 5-2291. The Director of Legal Affairs is responsible for the activities the department and the YNHH risk management program. The department has a staff of three attorneys who handle a wide range of issues on behalf of YNHH including answering questions about patient consents, DNR orders, withdrawal of treatment issues, business transactions, contract negotiations, leases and regulatory matters. The attorneys are available to speak at inservices, at Grand Rounds and other educational programs on topics of interest to departments. The Office of Legal Affairs is responsible for managing and investigating the professional and general liability claims that are made against the medical center facilities, its employees and insured physicians. Members of the office staff are available for individual consultation on risk management and liability issues. The Office of Legal Affairs is also responsible for managing certain insurance policies that have been secured by YNHH and its insured physicians. Staff members assist physicians and others with questions concerning insurance coverage, premium payments and proof of insurance. The attorneys in the department are available via telephone to answer hospital/patient related legal questions Monday through Friday, 8:30 a.m. to 5:00 p.m. An attorney from the department is always on-call after hours and on weekends and can be reached by beeper through the YNHH page operator, at 5-3111.

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Insurance Program at Yale Medical Center In 1978, several other major teaching hospitals formed an insurance company (the "Company") chartered in Bermuda to underwrite medical professional liability insurance, commonly referred to as medical malpractice insurance, and general liability insurance for the participating hospitals and schools of medicine, physicians and dentists closely affiliated with each hospital, and the physician and non-physician employees of each hospital. Yale-New Haven Hospital and Yale School of Medicine joined the Company in 1979. The hospitals and their affiliated universities who participate in the insurance program (and who are the principal Named Insureds) are: 1. 2. 3. 4. 5. 6. 7. 8.

The Presbyterian Hospital in the City of New York The Society of The New York Hospital Cornell University The University of Rochester (Strong Memorial Hospital) The Johns Hopkins Hospital The Johns Hopkins University Yale-New Haven Hospital Yale University

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In addition to the primary coverage provided through the program, the participating institutions purchase excess insurance from some of the largest and most reputable insurance companies issuing policies covering health care related risks in the United States. The policy is written on a claims made basis, which means it covers claims or adverse medical incidents actually reported to the insurer during the policy year resulting from services rendered during the policy year or after inception of an insured's coverage under this program (the retroactive date), whichever is earlier. Claims related to services rendered prior to an insured physician's or dentist's coverage under this program should be covered by the insurance carried by that insured at the time the service was rendered. The scope of the malpractice coverage provided by the insurance program's policy generally parallels that customarily included in medical professional liability policies. This generally includes coverage for such allegations as negligence, breach of patient confidentiality and lack of informed consent, for example. Coverage is extended for professional service of a medical nature performed anywhere in the world, provided suit is brought in the USA, its territories or Canada. Interns, residents and fellows are insured solely for activities performed within the scope of their formal program and approved affiliations. This does not exclude coverage for "good samaritan" activities, but does exclude coverage for "moonlighting". Non-physician employees, including nurses, therapists, social workers, and psychologists are automatically covered under the policy but only while acting within the scope of their employment. The general liability insurance provided under the program is limited to acts and conditions arising out of activities on behalf of the hospital (or Named Insured) and does not provide coverage in homes or private offices, except where such offices are located in a facility owned or controlled by a participating institution. Physicians and other insureds who terminate their insurance voluntarily, or who retire or leave a participating institution will continue to be covered for claims made subsequent to their departure but arising out of professional services rendered during the period of their participation in the program. This insurance coverage will be provided as part of the institution's policy in future years. The program will provide departing insureds this so-called "tail-coverage" for future unreported claims at no additional premium charge, as long as the insured's sponsoring institution remains a participant in the program. In the event an institution no longer participates in the program, it will be the possible for that institution to buy "tail coverage" for itself as well as current and prior staff. No coverage is provided for any claim arising out of services rendered after an individual terminates participation in the program. To be covered under the insurance program, physicians and dentists must participate under the sponsorship of a Named Insured institution, meet the eligibility criteria of the Company and be subject to and comply with the hospital's credentialing and reappointment process and requirements. Coverage may be withheld or terminated if a physician or dentist does not meet the required eligibility or underwriting standards of the Company. Insured physicians, dentists and other health care providers are required to participate in regularly scheduled risk management and quality assurance education programs either conducted or sponsored by the institution. Since the policy is written with a common aggregate limit of liability, each participating institution is listed as a "Named Insured" on the policy. Individual physicians and dentists are additional insureds and do not have an "individual" policy. Premiums are determined each year in the aggregate at a level deemed sufficient to cover anticipated claims and necessary reserves, plus certain costs such as reinsurance premium and administrative expenses. The institutions who comprise the Company have established procedures for the management and resolution of claims brought against the hospital, the School of Medicine or its insured physicians or employees. The participating institutions have engaged a company with expertise in the management of medical professional liability claims to assure adherence to these agreed upon claims management procedures. All insured physicians, dentists and other health care providers are have a duty under the policy to cooperate with the hospital's representatives, the Company and its agents, and to assist in the investigation, defense and resolution of claims. Insured physicians and dentists can obtain further information regarding the insurance program by contacting the Office of Legal Affairs. YNHH Risk Management Handbook-Contents

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Reporting Potential Claims/Lawsuits The policy requires that, in order to minimize costs and to insure the efficient handling of claims, physicians and other insureds promptly report the following circumstances: 1. Any medical incident which could result in a claim; 2. A request for information or medical records by a patient's attorney, unless the request is clearly related to worker's compensation or other non-professional liability related litigation; 3. A threat of legal action or demand for compensation by the patient or his or her representative; or 4. The service of formal suit papers. All such reports should be made to the Office of Legal Affairs, which administers the claims management program at the hospital and School of Medicine. Written communications to the Legal Office should be so addressed and marked privileged and confidential. Copies of this correspondence should not be directed to others outside the Legal Office.

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Overview of the Legal System In the current health care environment, an increasing number of patients who believe they have sustained physical or psychological harm (a "bodily injury") as a result of the hospital's or a health care provider's negligence bring claims or lawsuits to recover damages. A number of factors are felt to contribute to patients' decision to sue, such as the experiencing of an unexpected or less than perfect result, or a feeling that they have been treated in an uncaring, rude, unsympathetic and/or less than professional manner. Many believe the most important factor that causes a patient to resort to litigation is a breakdown in the patient-physician relationship. Although some patients have legitimate reasons to bring a claim or lawsuit, much of the increase in litigation is attributable to our living in a society which commonly uses litigation to address any perceived injustice. Generally, hospitals and health care providers need to be concerned about two types of negligence claims, professional liability (commonly referred to as "medical malpractice") and general liability. Professional liability, or medical malpractice claims, generally concern allegations of negligence regarding the rendering of professional services which result in bodily injury to the patient. Negligence, in the professional liability setting, is defined as a departure, either by the acts or omissions of a health care provider, from the accepted standards of care. General liability, or general "negligence" claims, usually concern allegations of negligence regarding the maintenance of the hospital's or a health care provider's buildings and/or property resulting in bodily injury or property damage to a visitor, or less commonly, to a patient. Negligence, in the general liability setting, is defined as the failure to exercise a reasonable degree of care which the law requires to protect others from a foreseeable or unreasonable risk of harm. In a physician's office or the common areas of the hospital (rather than a specific patient room), a number of factors may give rise to a claim for general liability. Most often, general liability claims involve "slips and falls". However, a number of other occurrences can give rise to these types of claims.

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The Civil Court System Medical malpractice and negligence lawsuits are brought in the civil court system, usually under state, but occasionally under federal law. This body of law, the statutory part of which is periodically amended by legislative bodies and all of which is subject to interpretation by the courts, is ever subject to change, expansion and reinterpretation. In these lawsuits, the person bringing the claim (the plaintiff) must establish the following four elements: 1. 2. 3. 4.

A legal duty was owed to the plaintiff. The standard required to meet that duty was breached. A causal relationship existed between that breach and the injury claimed. Damages were sustained by the plaintiff directly as a result of that breach and the injury caused by it.

A legal duty is established when a hospital or health care provider undertakes the care and treatment of a patient, whether it be to treat only a certain ailment or injury, at a certain place and for a specified time, or for ongoing care and treatment. The breach of the standard must be established by expert testimony. The relevant standard is the one in effect at the time of the incident, not when the claim is made. Causation is the connection between the failure to meet a duty owed and the event (the injury) which occurred. This is often times referred to as "proximate cause." The damages are the injuries and as a practical matter are defined as the estimated monetary equivalent to compensate the injured person for the loss or injury sustained. In order to become familiar with issues and chronological events of a medical malpractice or negligence lawsuit, the following specific areas will be discussed: 1. 2. 3. 4.

The Statute of Limitation The Summons and Complaint The Discovery Process Depositions and Interrogatories

The Statute of Limitation The statute of limitation defines the time within which a plaintiff must commence a lawsuit by complying with certain prescribed procedures. The statutes of limitation for civil actions, which differ depending upon the type of action, are usually state laws. These time periods allow a plaintiff or his or her authorized representative a reasonable time to discover and investigate whether he or she was injured as a result of a defendant's negligence. In Connecticut, personal injury lawsuits, which include medical malpractice and non-medical malpractice actions (general liability), must be commenced by the patient (the plaintiff) against the hospital or a health care provider (the defendant) within two (2) years from either the date or discovery of the act or omission from which the injury is alleged to have been caused, but in no event more than three (3) years from the date of the act or omission complained of. In Connecticut, there is no extension of this statute even if the injury occurred to a minor. Due to a recent statute change, a plaintiff may get an automatic three month extension to the two year statute if application is made to the court prior to the two year period; therefore, some suits may be brought two years and three months after the incident.

The Summons and Complaint While a letter of representation from an attorney may be the initial indication of a claim or potential lawsuit, it is the filing and service of specific legal pleadings known as the Summons and Complaint, which initiate the formal litigation process. A Summons, which notes the plaintiff(s), defendant(s) and jurisdiction of the lawsuit, generally gives little indication of the specific allegations which form the basis of the lawsuit. The Complaint describes, with more or less specificity, the dates and allegations of negligence against each YNHH Risk Management Handbook-Contents

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defendant, and the injury and damages allegedly sustained by the plaintiff. These materials must be served on the defendant(s) and filed in court. Service may be in person, in which case the Summons and Complaint should immediately be sent to the Legal Office; service may also be accepted in the Legal Office, if coverage is confirmed and the defendant has not moved out of the area. The Complaint allegations will be answered later in the litigation.

The Discovery Process This second aspect of the litigation process involves the investigative phase of the lawsuit. Both the plaintiff(s) and defendant(s) seek to discover information by obtaining witness testimony, medical records, expert opinions, documents, etc. The period of time for discovery varies depending upon the complexity of the case and the number of parties involved but, in general, it will encompass a minimum of 2 years, and can extend for as long as 5-7 years.

Depositions and Interrogatories Depositions and interrogatories are often the most important part of the discovery process, especially for an individual defendant. A deposition is a formal legal process whereby oral testimony is taken, under oath, in the presence of a court reporter. Depositions may take place in an attorney's office or in an appropriate room in the medical center, with the attorneys representing all parties involved in the litigation present. Generally, all of the parties in the lawsuit will be deposed, and on occasion, the deposition of non-party fact witnesses and experts will be taken. Any physician, nurse, other health care provider and medical center current or former employee scheduled to be deposed will meet with defense attorneys prior to testifying. At this meeting, your attorney will discuss the case, the medical records, and the procedural rules of the deposition. Remember, a deposition is an adversarial procedure that is in the area of expertise of lawyers, not health care professionals. Attorneys who specialize in the medical malpractice field have an excellent working knowledge of medicine, with some having extensive expertise in certain specialties. Therefore, although some questions posed may appear to be innocuous, they may be phrased ambiguously or duplicitously to elicit extremely damaging admissions. Always remember that the goal of the plaintiff's attorney is to gain admissions and/or inconsistencies in the testimony to support allegations that an accepted standard of care was breached. Your attorney will prepare you for the type of questions that may be asked and the best way to answer such questions. Some guidelines to remember when testifying include: 1. Do not volunteer information or attempt to answer questions outside your area of expertise and/or knowledge. The purpose of your testimony is not to educate the plaintiff's attorney. 2. If you do not know the answer to the questioned asked, do not guess. State you do not recall or do not know. 3. If you do not understand the question, say so. Ask if the attorney can rephrase the question or define a term in a manner you can understand. 4. Do not hesitate to ask to refer to the medical records during your testimony. 5. Always remain calm and composed. Never become argumentative with adversarial counsel. Take your time in answering the question. 6. If you become tired or confused, ask if you can take a brief recess. 7. During a deposition you must answer audibly; a shake of the head or an umm will elicit a reminder from the court reporter. Following your deposition, the court reporter will send a written record of your testimony, called a transcript, to your attorney. It is unusual for a court reporter to record the testimony of a witness without some errors or YNHH Risk Management Handbook-Contents

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omissions. Your attorney will provide you with a copy and ask you to review it in order to note any errors or inaccuracies which should be corrected. It is important that you carefully review the transcript since once you verify that it is an accurate version of your testimony, it functions as your sworn testimony. The testimony of a witness at a deposition can be introduced as evidence at the time of trial, and, if the testimony of a witness during trial differs from that given at deposition, the opposing party will use such discrepancies to impeach the credibility of the witness. Interrogatories are a series of written questions propounded by one party upon another to obtain factual information. Answers to the interrogatories are prepared, in writing, and when sworn to, the written responses may be used as evidence at trial. Counsel representing the plaintiff(s) and defendant(s) will consult with the client and prepare the answers to the interrogatories. Interrogatories are commonly used in Connecticut and can be a valuable tool in fact gathering during the discovery process.

The Trial If the defendant(s) decides not to settle the case and the plaintiff decides not to voluntarily withdraw the lawsuit, the case will be scheduled for a trial. When the case is tried, the plaintiff is required to present his or her case first followed by the defendant(s). The trial proceeds in the following chronological order: 1. Selection of the jury. 2. Opening statements (the plaintiff first followed by the defendant[s]). 3. The plaintiff's case (testimony of the plaintiff, testimony of any subpoenaed defendants, testimony of fact witnesses and the testimony of any expert witnesses for the plaintiff). 4. The defendant's case (testimony of the defendant[s], testimony of fact witnesses and the testimony of any expert witnesses for the defendant[s]). 5. Closing statements (the plaintiff first followed by the defendant, with the plaintiff allowed a final rebuttal). 6. The judge's instructions to the jury. 7. Jury deliberations. 8. The jury's verdict. The role of the judge is not to decide whether a defendant is negligent, but to see that the trial is conducted in a fair and impartial manner and to rule on matters of law. It is the responsibility of the jury, after considering the evidence, which consists of the witness testimony, medical records and any other exhibits allowed into evidence by the judge, to render a verdict either in favor of the defendant(s) or plaintiff. The civil jury in Connecticut State Court is comprised of six jurors and usually two alternates. During opening statements, the attorneys representing the plaintiff and defendant(s) will provide the jury with an overview of the case and the facts they intend to prove or disprove during the trial. The plaintiff, by law, has the burden of proving that a defendant departed from accepted standards of care and that this departure was the proximate cause of an injury. The plaintiff will present his or her proof first, usually by the testimony of witnesses and experts, as well as the introduction of records and documents into evidence. Following the direct examination of a witness by an attorney, opposing counsel is entitled to cross-examine the witness. During closing statements, the attorneys representing the parties have the opportunity to summarize to the jury the evidence they have offered to prove their case or rebut that offered by the opposing side. Like the opening statements, the plaintiff is the first to present arguments to the jury, followed by the defendant(s), with the plaintiff having a final rebuttal opportunity. During the closing arguments, it is common for the attorneys to comment on the credibility of the fact and expert witness testimony the jury has heard, and to suggest to the jury which witnesses they should find to be the most credible and convincing. Following closing statements, the judge will instruct the jury on the law and how they should apply it to the evidence they have heard and seen. This is commonly referred to as "charging" the jury. Following being charged by the judge, the jury will be sent out to deliberate. Often, a number of questions will be presented to YNHH Risk Management Handbook-Contents

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the jury on a written verdict sheet, and they will be asked to render a verdict on each question. All six jurors must agree in order for a verdict to be reached. If a jury renders a verdict in favor of the plaintiff, they will also be instructed to award monetary damages, and when there are multiple defendants, apportion the damages among them. Should the jury find in favor of the defendant(s), unless the plaintiff appeals, the lawsuit has ended. The judge may overturn a plaintiff's verdict or reduce the amount awarded. A defendant has the right to appeal when a verdict in favor of the plaintiff is rendered.

Federal and State Governmental Agencies The conduct of hospitals, physicians and other health care providers, has come under increasing scrutiny by federal and state regulatory agencies. Some agencies are responsible for collecting and maintaining data regarding medical malpractice settlements and disciplinary actions taken against licensed health care professionals, while others are charged with the responsibility for investigating patient complaints regarding medical treatment. The activities described above usually occur outside the civil legal system, but are closely related to it. The establishment of the National Practitioner Data Bank ("NPDB") was mandated by the Health Care Quality Improvement Act of 1986 ("HCQIA") and responsibility for its implementation and management resides with the U.S. Department of Health and Human Services. The act was passed by Congress to encourage good faith professional review activities and restrict the ability of incompetent physicians and licensed health professionals to avoid discovery of prior substandard or unprofessional conduct by mandating the reporting of specific information. The HCQIA requires: 1) health care entities and State Boards of Medical Examiners to report certain information to the NPDB, and 2) hospitals and health care entities to request information from the data bank in various situations. Some of the information which must be reported to the NPDB includes: 1. The payment of a medical malpractice claim settlement made on behalf of a licensed heath care professional. 2. Sanctions taken by licensure boards against health care professionals. These include license revocation, suspension and restriction, as well as any suspension, censure, reprimand or probation due to professional incompetence. 3. Actions taken by health care facilities against physicians and dentists that adversely affect that provider's clinical privileges for more than 30 days and which are based on professional conduct or competence. Some of the information which must be requested from the NPDB includes: 1. Hospitals are required to request information on every physician and other licensed health care professional who applies for a position on its medical staff (courtesy or otherwise). In addition, the hospital must request information for physicians and other licensed health care professionals on its medical staff or having clinical privileges every two years. The Connecticut Department of Public Health and Addiction Services is responsible for investigating complaints by patients and others regarding medical treatment rendered by both health care entities and individual physicians, nurses and other licensed health care professionals. Any individual receiving a notice from the state indicating it is investigating a complaint should treat it with the utmost seriousness, since an investigation with adverse findings could affect the status of a practitioner's license. Should you receive such a notice, you may wish to consult with the Office of Legal Affairs for advice on how to handle the matter.

Potential Legal Action or Governmental Investigation If any health care provider or hospital employee learns of an incident or complaint that may lead to legal action YNHH Risk Management Handbook-Contents

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against the hospital or a staff member, that person should immediately notify the Office of Legal Affairs. The person reporting the potential action may be subsequently contacted by a representative from the Office of Legal Affairs regarding the matter. Hospital personnel should not speak with attorneys or investigators who are not affiliated with the hospital regarding any matter involving the hospital unless specifically authorized by the Office of Legal Affairs. Questions as to whether a person is a hospital representative or for other guidance should be directed to Office of Legal Affairs.

Reporting Professional Misconduct The hospital is required by law to report to the Department of Public Health the termination or restriction of staff privileges of any licensed physician. In addition, physicians and hospitals are required by law to report to the Board of Medical Examiners any information which appears to show that a physician is or may be unable to practice medicine with reasonable skill and safety. The Board will then make its own investigation. While this reporting may be prescribed by law, it should also be considered by such practitioners as a moral and ethical obligation. Should you become aware of information regarding the professional misconduct of a physician, contact the Office of Legal Affairs.

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Medical Record Documentation The medical record serves many purposes but its primary function is to plan for patient care and provide for continuity in information about the patient's medical treatment. As a permanent record, the patient's medical record informs other health care providers both inside and outside the hospital about the medical history of the patient. In addition, the medical record: 1. provides information which serves as the basis for financial reimbursement to hospitals, health care providers and patients; 2. serves as a legal document for use by an injured patient against other parties or for use in other legal proceedings; 3. is used by hospital quality assurance and peer review committees, State licensing agencies, State regulatory agencies, and other entities in accessing the quality of patient care by hospitals and health care providers; 4. is a key portion of accreditation processes such as that of the JCAHO. From the risk management perspective, the medical record is a crucial element in preventing and minimizing the potential adverse consequences of malpractice litigation. Ultimately, it serves as the basis for the defense of malpractice claims and lawsuits. Medical records which are poorly maintained, incomplete, inaccurate, illegible or altered, create questions of fact regarding the treatment given to a patient. Patient's attorneys often institute malpractice lawsuits when they believe the questions of fact created by incomplete and poorly documented medical records will cause a jury to find liability against a hospital and/or health care provider. Proper documentation in the medical record creates a legal document which accurately and completely reflects the care provided to a patient and, in a courtroom setting, it may be likened to a witness whose memory is never lost. It serves to correlate, for all involved, important patient information regarding the treatment rendered and the patient's treatment plan, and is the means by which a level of communication is achieved YNHH Risk Management Handbook-Contents

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among all health care providers involved in the patient's care.

Proper Documentation of the Medical Record Each and every page of a patient record should be clearly labeled with the patient's complete name and medical record number. Individuals making entries in a patient's chart should do so only through a password electronic system, or on hospital approved medical record forms and then only with pen rather than pencil, which might fade and become illegible, or felt tips which might bleed through the page. Include the complete date of the entry with the month, day, year and time of day. Use only hospital accepted medical abbreviations and terminology. Associated records and tests such as EKG's, EEG's, fetal monitoring tracings, etc., should all be properly labeled with patient's name and medical record number, and when appropriate, the date and time performed. All entries in the medical record should be dated, include an indication of the time the note was written and be signed by the person making the entries. Attending physicians may be required to review and countersign progress notes by interns and residents. Progress notes by junior residents should include reference to the fact that a specific aspect of the patient's condition or treatment plan was discussed with a senior resident or attending physician. All examinations of the patient should be documented in the record. Progress notes should indicate that the patient was kept informed of his or her condition, as well as the treatment plan. Document all instances of patient non-compliance or refusal of recommended treatment and that the patient was informed of potential consequences. Patient records should never be altered. One should not erase, obliterate or attempt to edit notes previously written. All corrections, late entries, entries made out of time sequence, and addenda should be clearly marked as such in the record, and should be dated and timed on the day they are written and signed. Draw a single line through any erroneous chart entry and write "error" with the date and time, as well as your initials. The following diagram is representative of the manner in which charting errors should be corrected: Health care providers should only document factual and objective information from their own treatment and/or observation of the patient. When documenting information derived from other sources, for example, other health care providers, other medical records, or entries in the same medical record, be sure to reference the source of that information. Subjective documentation is far less clinically useful than objective information. Examples of objective/subjective charting include: OBJECTIVE STATEMENTS SUBJECTIVE 1. Half of breakfast eaten 1. Diet taken fairly 2. No complaints of pain 2. Had a good day 3. Surgical incision healing - no sign of infection 3. Wound okay 4. Thrashing in bed 4. Appears restless 5. IV site clear and infusing at 40 drops per minute 5. IV running well A means by which health care providers can document factual and relevant information is by specifically charting information based upon what is: 1. Seen - charting observations regarding bleeding, deformities, drainage, color of urine, patient posture and/or attitude; 2. Heard - the patient's complaints/statements, moaning, breathing abnormalities, bowel sounds; 3. Smelled - malodorous drainage, alcohol or acetone on breath, fecal or vomitus odor; YNHH Risk Management Handbook-Contents

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4. Felt - areas of induration, hot, cold, dry or moist skin, motion at a fracture site. When a patient is discharged, it is good medical practice to write a final note commenting on the stability of the patient by noting the patient's vital signs, the status of recovery from the condition on admission, or for an elective admission, the status of recovery from the elective treatment/surgery. The note should completely document the discharge instructions given to the patient and/or the patient's family members. Following a patient's discharge, health care providers should promptly complete the medical record in accordance with hospital requirements to enable the medical record department to secure the patient record expeditiously and safely.

WHat to Avoid in the Medical Record Avoid the use of words that subjectively categorize a patient's treatment or condition, such as unintentionally, inadvertently, unexplainably, accidentally and unfortunately. Do not leave loose ends in the chart. Follow-up on diagnostic tests ordered with results not yet received, and/or abnormal test results. The medical record should never be used as a forum for remarks to "cover" yourself. Never make statements in the record which criticize or cast blame upon others, or are intended to serve as gratuitous remarks. Do not engage in battles in the chart over treatment decisions. When disagreements regarding a patient's treatment plan occur, a case conference should be called to resolve them. This advice, however, is not intended to preclude using the medical record to list differential diagnoses and the process of excluding potential diagnoses.

Documentation of Incidents and Unanticipated Patient Outcomes Incidents and unanticipated patient outcomes should be promptly, clearly and objectively documented in the medical record. Because these occurrences may form a basis for litigation even when there has been no negligence, the best defense is a record which contains timely, accurate and properly charted information. Assign a member of the treatment team with first-hand knowledge of the event to record the event. Entries regarding an incident should include the date and time of the incident, a brief factual and objective description of what was seen and heard, using exact quotes when possible of the patient's description of the event, along with the findings of any physical examination and follow-up care. When there is no apparent injury as a result of the incident, this should be clearly documented in the record. Avoid writing information unrelated to the medical care of the patient. The record should not make reference to the preparation of an incident report and/or notification of the hospital's Office of Legal Affairs. When unanticipated patient outcomes occur, documentation of the complication(s) should also be accurately recorded. Entries should include information regarding the complication in an objective fashion without judgment as to whether the complication is acceptable, unacceptable or anyone is to blame. The entry should indicate that the patient was informed of the complication and its consequences, as well as any change in his or her treatment plan, should it be necessary.

Frequently Asked Questions About Medical Records Question: How should a physician respond to a letter from a patient's attorney requesting medical information? Answer: Be sure the request contains an original dated written authorization from the patient, or the parent or guardian of a child, or when the patient is deceased, the appropriate legal representative of the patient's estate. If the release is more than one year old, it is prudent to request a more recent one. Forward a complete copy of the YNHH Risk Management Handbook-Contents

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patient's record, or only specifically requested items if they have been detailed. You may request a reasonable fee for photocopies and processing the request; by statute in Connecticut a hospital may charge 65cents per page plus 1st class postage; a physician's office may charge 45cents plus postage. You should not prepare a written summary of the patient's care and treatment. Because specific laws and regulations impose liability and monetary penalties for the unauthorized disclosure of patient information regarding HIV status, alcohol or drug treatment and psychiatric treatment, without specific written authorization from the patient, a release form for this information must explicitly authorize its release. It is strongly recommended that you notify the Office of Legal Affairs of any record request by an attorney or dissatisfied patient so that individual consultation and advice regarding the request can be provided. Question: What do I do if I disagree with a note that someone wrote in the chart? Answer: It is not uncommon for members of the health care team to disagree occasionally among themselves or with a consultant's recommendations. Usually, these disagreements can be resolved by discussing them at case conferences and do not need to be documented in the record. However, when a health care provider believes the patient's care is affected, the disagreement should be discreetly, factually and objectively documented, always expressing a tone of concern for the patient's well-being, rather than hostility among the members of the team. Example: Dr. Doe's recommendation that the patient be started on Streptomycin is noted. Due to the patient's prior history of being sensitive to this medication, the patient will be continued on his current antibiotic regimen and will be followed with daily blood cultures. Question: How long must I retain a medical record on a patient whom I have not seen in sometime? Answer: In Connecticut, a hospital must retain a patient record for at least 25 years. Licensed health care providers must retain office records for 7 years from the date of last treatment or 3 years from the death of the patient. Question: Who owns the medical record? Answer: The health care provider or facility that created the records owns the original. A patient is entitled to a copy of the record but not the original. Question: What do I do if a patient demands to see his or her record while he or she is hospitalized, before it is complete, or in the office? Answer: YNHH Risk Management Handbook-Contents

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Generally the patient has the right to a copy of the hospital record after the patient is discharged and after it is completed (e.g., operative notes and discharge summary dictated and signed). However, there may be times when, to defuse a situation, you may decide to let the patient read the original. When this occurs, a staff member must be present to maintain the integrity of the record, prevent the patient from adding comments or crossing out notes, and possibly to answer questions about the notes.

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Incident Reporting The hospital's risk management program employs a number of systems to identify and provide notification of incidents or events that have occurred involving patients, visitors, staff, equipment, facilities or grounds which are likely to give rise to potential liability, affect the quality of patient care or affect safety in the hospital. The early identification of such occurrences allows the hospital to immediately investigate the circumstances of the incident, and if necessary, institute corrective action to prevent similar occurrences in the future. One of the systems used to identify and report patient and visitor related occurrences is the hospital's incident report system. Health care providers and other hospital employees are required to report and complete a Report of Incident form (F-877) regarding any patient or visitor who, while within hospital jurisdiction and/or while on hospital premises, is involved in an occurrence which has caused or has the potential to cause injury or loss or damage to their personal property. This includes incidents where the possibility of injury existed although no injury was actually incurred and those incidents which are inconsistent with the routine care of a particular patient or routine operation of the hospital. The following are some examples of reportable incidents: 1. Error in the care of patients (e.g., errors in the administration of medications, treatments, mismatched transfusions, retained foreign bodies following surgery, etc.). 2. Development of conditions seemingly unrelated to the disease for which the patient was admitted (e.g., pressure sores, pediculosis, diarrhea or impetigo in the Newborn Nursery, etc.). 3. Adverse or suspected adverse reactions to a manipulative procedure, medication or transfusion. All health care providers should be familiar with the complete hospital incident reporting procedures which can be found in the Yale New Haven Hospital Administrative Policy and Procedure Manual, I-3. The following is a brief discussion of the procedures involved in incident reporting. For incidents involving patients, the person completing the Report of Incident form should be the individual who witnessed, first discovered, or is most familiar with the incident. Each section of the form must be completed according to the directions on the form. The report must then be immediately presented to the reporter's supervisor who must then investigate and recommend corrective action. The description of the incident should be a brief narrative which should consist of an objective description of the facts. It should not include the writer's judgment as to the cause of the event. Quotes should be used where applicable with unwitnessed incidents, e.g., "Patient states..." The name of any witnesses should be included on this report. The name of the employee directly involved in the incident can be recorded in the witness space as well, if the employee is not the reporter. The patient must be examined by an appropriate physician, who should complete the appropriate section on the form regarding his or her findings. The Report of Incident form should be completed no later than the end of the shift during which the incident occurred or was discovered to have YNHH Risk Management Handbook-Contents

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occurred and must be forwarded to the Central Nursing Office within 24 hours and the Office of Legal Affairs within 48 hours. All incidents involving visitors must be reported to the supervisor in the area where the incident occurred. A visitor who has sustained an injury while in the hospital should be escorted by a staff member to the Emergency Service for medical attention. If the injured person refuses medical attention, this must be noted on the Report of Incident form. The Report of Incident form is an administrative document, not part of the medical record. The fact that an Report of Incident form has been completed should not be reflected in the medical record, nor should the report be placed in the medical record. In addition, no copies of the Report of Incident form may be made. An objective description of the incident should be recorded in the medical record by both the medical and nursing staff along with any follow-up observations, diagnostic studies and results, and/or related treatment. Whenever a patient or visitor incident is of an unusual or serious nature, the Office of Legal Affairs must be called immediately. If a medical device is involved (caused or contributed to death of, serious injury to, or serious illness of a patient): 1. 2. 3. 4. 5. 6. 7. 8.

report the incident to Nurse Manager/designee; notify the Office of Legal Affairs fill out a device incident report form; record the manufacturer, model number, serial number, and control number of the equipment on the incident report; save the original packing if possible; when equipment is involved, impound the equipment, the disposable product used with the equipment, and the packaging materials from the disposable product; tag the equipment with a sign that states "EQUIPMENT BROKEN - DO NOT USE"; notify Medical Engineering that you have a piece of equipment that has been involved in an incident and requires evaluation.

Quality Assurance Review and Analysis of Incident Reports Report of Incident forms and other significant incidents are reviewed on an ongoing basis by a number of departments and committees in the hospital. This review process allows for: 1. Identification and documentation of trends within service(s) and those that cross over services that might affect policies or procedures. This review provides another method to aid in assuring quality patient care through promoting development of accident prevention and loss control programs. 2. Recognition and identification of hospital-wide programs to correct identified problems. 3. Assessment of conformance to required standards of practice and care. Each service reviews and analyzes all reported incidents on an ongoing basis and reports trends and corrective actions taken as part of the periodic QA/QI reports.

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The Physician - Patient Relationship YNHH Risk Management Handbook-Contents

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Physicians who carefully listen to patients and comfortably share medical information with them have discovered the cornerstone of the art of medicine. A healthy physician-patient relationship can make a difficult diagnosis more bearable for the patient. It can help a resistant patient understand the need for a procedure or medication, and allow the physician to develop a realistic plan for continuing care. When a physician's relationship with a patient is marked by mutual trust and open communication, he or she has taken a major step towards the assurance of patient satisfaction. Evidence shows that a clear, two-way conversation is a key element in the prevention of patient dissatisfaction and malpractice claims. In fact, many episodes of patient dissatisfaction triggered by an iatrogenic injury or other "adverse outcome" can be defused by a reasonable explanation from the physician who has established a good basis for communication. On the other hand, inadequate communication and misunderstanding are often the inciting agent that transform a poor medical outcome into a legal action against a physician, even when quality care was delivered. Most studies show that a significant percentage of malpractice lawsuits are ultimately resolved without any payment to the patient. Many risk managers believe that a large number of these malpractice cases could be avoided if physicians listened more attentively to patients who experienced less than optimal or unexpected treatment outcomes. Techniques for increasing patient satisfaction through improved communication are now widely recommended for malpractice claims prevention.

Recommendations for a Healthy Physician - Patient Relationship Risk management begins the moment a professional relationship is established with a patient. The understanding by, compliance by and satisfaction of any patient ultimately depend on oral and written communication. The following general points will be helpful as you build each physician-patient relationship. The result should be a mutually rewarding experience for both the physician and patient. 1. Introduce yourself to every new patient and describe your relationship with other health care providers, such as students, nurses, physician assistants, residents, fellows, consultants, and the relevant attending, referring and primary care physicians. 2. Address your patients appropriately and modify your greeting as your relationship progresses. It is best to begin with formal titles; then, if both sides are comfortable with doing so, shift to something less formal. If possible, use a translator to help communicate with patients who speak a foreign language with which you are unfamiliar. 3. Sit down close to the bedside, if possible, and make frequent eye contact. Be attentive to the patient's non-verbal communication. Offer your own encouraging feedback through gestures and words. 4. Begin with open-ended questions to allow patients to talk of their symptoms, previous care, impressions of their prognosis, and the role of family members in decision making. Focus questioning to obtain specific information. 5. Ask for the patient's expectations of your care. Involve the patient and family (if the patient so desires) directly in the care as much as possible. 6. Limit the use of medical jargon. Relate information at an appropriate level of understanding for the patient. Use pictures and models to help explain complicated concepts. 7. Provide emotional support to grieving, anxious, frightened, or depressed patients. Reassure your patients that you will be helping them throughout the course of their medical problems and will be available to answer questions as they arise. 8. Be punctual for meetings with patients and families. 9. Avoid criticizing another physician's management of your patient with words or gestures. The other physician may have had different data and resources available at the time of initial decision making. Medical problems usually appear more clearly when viewed retrospectively. Malpractice cases have often been precipitated by criticism of this kind and you may find yourself an expert witness based on your comments. 10. Never guarantee the outcome of a treatment, orally or in writing. Prepare patients for any pain, discomfort, and disability that they can reasonably expect from diagnostic and therapeutic YNHH Risk Management Handbook-Contents

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11. 12.

13.

14. 15.

interventions. Make clear the necessity and effectiveness of intervention if disability is the expected result. Document these discussions. arise. Send a written summary of your findings and the medical plan to your patient's primary physician following a hospital stay or major office visit. When multiple clinicians are involved, clearly delineate roles among the parties and convey this to the patient in a manner that will facilitate coordination of patient care. When it is necessary to discuss fees, be open and frank concerning the cost of care. Where appropriate, help educate patients concerning today's often confusing health care system. You might consider providing an estimate of the cost of an anticipated course of therapy or operation. However, be careful not to make representations of the prospective cost of hospitalization or other services not within your control. Be aware of the state and federal laws regarding health care law for your patient population. Information on childhood vaccinations, prenatal nutrition programs, Medicare benefits, and other topics are vital for proper care of your patient. Be sure your office staff and answering service treats the patient with courtesy and consideration.

Frequently Asked Questions About The Physician - Patient Relationship Question: When a patient is difficult, non-compliant or otherwise incompatible, and a physician believes that he or she cannot continue to provide care within these constraints, what is the best way to go about terminating the physician-patient relationship? Answer: The instances of the patient's non-compliance and difficult or disruptive behavior should have been noted contemporaneously with their occurrence in the patient's medical record. Once a physician has made the decision that the relationship will be terminated, the reasons for the decision should also be noted in the medical recor\. Always attempt to meet with or speak with the patient (and family members, if appropriate) to inform them of your decision, explain the reasons for it, and to answer any questions the patient may have. It is recommended that you notify the patient in writing, both by certified and regular mail, of your decision and the specific professional reasons for terminating the relationship. This should be done even if you have met with the patient. The following should be included in the letter: 1. Offer to continue treatment for at least 30 days (or for a period of time appropriate for the status of the patient's medical condition), until the patient retains another physician. 2. Offer to provide information to assist the patient in selecting a new physician to assume their care. You may also offer to or actually provide the names of several physicians or clinics to help the patient in selecting a new physician. 3. Advise the patient of a specific date when you will consider the relationship terminated. 4. Offer to provide the new physician with copies of the patient's medical records upon the request of the patient. 5. If one of the issues with the patient involves the failure to follow directions or advice, it is useful to describe the medical problem, the recommendations and the degree of urgency involved. Since the circumstances involved with each patient are unique, you may wish to contact the Office of Legal Affairs for specific advice. Question: If the patient has not paid my bill for professional services, may I terminate the relationship? YNHH Risk Management Handbook-Contents

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Answer: Yes. Use the principles noted above for notifying the patient. However, the law does not permit the refusal to forward medical records even though a bill has not been paid.

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Informed Consent Many physicians feel that informed consent is merely a formality necessary to obtain the patient's signature on a form in order to allow a specific procedure or treatment to be performed on the patient. Rather, informed consent should be thought of as a communication process through which a patient, with the advice and support of his or her physician, makes decisions concerning the treatment he or she will receive. The process assists in developing the critical element of trust between the physician and patient, and is often the most important discussion a physician will have with his or her patient. Patients may bring a claim or lawsuit against the hospital and/or a physician predicated solely on the allegation that they did not give their consent; this is called a battery. A second more common claim is that the consent given was not based upon proper and adequate information; this is known as a claim for "lack of informed consent." This type of claim is usually found as part of the typical malpractice or negligence action. Because of this type of potential claim, from a risk management perspective, the informed consent process plays a crucial role in minimizing the exposure of both the hospital and physicians to medical malpractice claims and lawsuits.

What Is Informed Consent? Informed consent is a three part process in which there is an exchange of information between the physician and patient. The first part is the disclosure and explanation to the patient, in language that the patient can understand, of the nature of a proposed procedure or treatment, its potential risks and benefits, and reasonable alternatives which may be available. The second part of the process involves: 1) ensuring that the patient understands what has been explained to him or her (to the best of the patient's intellectual capacity); 2) the patient accepting the risks; and 3) the patient giving his or her consent to undergo the procedure or treatment. Finally, the process must be documented. In the process noted above, in many instances, the patient will be asked to sign a form acknowledging that he or she has received sufficient information upon which informed consent can be given for the procedure or treatment, and has given his or her voluntary permission to undergo it. Also, the physician who had the discussion with the patient must document the details of the discussion in the patient's medical record. Physicians are responsible for obtaining informed consent. The physician who will perform the proposed procedure or treatment should engage in this process with the patient. It is acceptable for a physician to delegate the task of obtaining the patient's signature on the necessary consent form to another member of the health care team. However, this should occur only after the discussions necessary for a patient to give his or her informed consent have occurred.

What Information Should Be Discussed With The Patient During The Informed Consent Process? Where possible, it is desirable for the informed consent discussion to occur a sufficient period of time before YNHH Risk Management Handbook-Contents

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the proposed procedure or treatment in order to allow the patient time to consider the information and ask questions. During the discussion, it is recommended that the physician use language the patient can understand and avoid the use of "medical jargon." The informed consent discussion may take place in the physician's office prior the patient's hospital admission, in the patient's hospital room, and in emergent situations, in the emergency room or other procedure/treatment areas of the hospital. A patient must have capacity in order to give informed consent. This requires that the patient understand the proposed procedure or treatment and be able to voluntarily give or withhold his or her consent after making an informed decision. Informed consent may be given by adult patients with capacity, the parent or legal guardian of a minor, emancipated minors under specific circumstances or a court or patient designated surrogate of a patient without capacity. In some instances, a family surrogate may give consent. The following information should be discussed with the patient and documented in the medical record: 1. The nature of the patient's illness, the diagnosis, the proposed treatment plan and the prognosis. 2. A description of the recommended procedure or treatment, and its purpose. 3. The probable outcome particularly if it is difficult to predict, and the patient's expected post-procedure/treatment course. 4. The most likely risks and side-effects, the potential benefits, as well as the potential complications of the procedure or treatment. (see below) 5. Reasonable alternative methods of treatment or non-treatment including the risks, benefits, complications, and prognosis associated with each alternative or with non-treatment. As a general rule, a physician is required to disclose information to a patient that a reasonably prudent person under similar circumstances would want to know. A physician need not disclose all of the risks or complications which may occur, but should discuss: 1) those commonly associated with the procedure or treatment and having a reasonable chance of occurring; and 2) those which have a small chance of occurring, but which have grave consequences. Less common or remote risks/complications should be discussed with the patient if they are significant to that patient.

How Should The Informed Consent Process Be Documented In The Medical Record? The informed consent process is documented in two separate ways in the medical record. The first way is by obtaining the patient's signature on an appropriate consent form following the necessary disclosure of information upon which a patient can give his or her informed consent. The second way is by documenting the informed consent process in the patient's medical record. This can be an entry in the office records maintained by a physician or by a progress note in the hospital record.

The Consent Form State law and hospital policies and procedures require that written informed consent must be given by all patients before any non-emergency operation, invasive procedure or treatment, regardless of whether that procedure takes place in the operating room, a treatment room or office. The hospital has developed a consent form for surgical operations and diagnostic or other therapeutic procedures, which must be signed by all patients and the responsible physician. These consent forms can be found on all patient units. When questions arise regarding the need for or use of these forms, the Office of Legal Affairs should be consulted.

Entries In The Medical Record The contemporaneous documentation of the informed consent process serves as the foundation for the defense of any subsequent claim by a patient for lack of informed consent. The signature of the patient on a consent form alone is not legally determinative evidence that the patient has given informed consent. Poor or absent documentation will force a physician to testify from recollection about an event which occurred several years YNHH Risk Management Handbook-Contents

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previously, which will undermine his or her credibility. In addition, poor or absent documentation may be a significant factor in a patient's attorney's decision to institute a legal action. To reiterate, the physician who had the discussion with the patient must document the details of the discussion in the patient's medical record. The entry in the medical record regarding the informed consent process should describe the information disclosed to the patient. Avoid the use of summary statements such as "The patient was advised of the potential risks/complications of the operation and alternatives" and instead, note at least some of the actual risks, complications and alternatives discussed with the patient. For example, the entry could state that "information regarding the risks, complications and alternatives were discussed with the patient and/or family, including but not limited to ...", followed by the specific information discussed. Note whether the patient was given any booklets or written material regarding the procedure or treatment. It is also important to document any questions asked by the patient and the answers given.

When Is Informed Consent Not Required? In certain situations, the patient's informed consent is not required before a physician may proceed with the delivery of medical care. In each of these situations, the hospital has developed specific policies and procedures to follow with which all physicians and other health care providers should be familiar. The Office of Legal Affairs should be contacted to answer questions regarding these procedures or provide advice on how to deal with specific situations. These situations include: 1) Emergency treatment - Often a physician will determine that a patient is in immediate need of medical treatment but is unable to give consent because of a physical or mental impairment. Medical treatment can be instituted under these circumstances once it is determined that: a) a delay in treatment would be life threatening or cause the patient serious harm; b) no close family member or surrogate is available to give consent on behalf of the patient; and c) the physician has no evidence that would suggest that the patient would oppose the treatment. The physician should document in the medical record the emergency circumstances under which the medical treatment without consent was rendered. This emergency exception should be narrowly construed. 2) Therapeutic privilege - This is the term used to describe the withholding of certain information from the patient by the physician based upon his or her judgment that disclosure of the information would have a harmful effect on the patient. When a physician invokes such a privilege, it is imperative that the objective justification for it be documented in the patient's medical record. This should include the reason why information was withheld, and both the information that was disclosed and not disclosed. It is not acceptable to use this privilege because the patient would be "anxious" or "upset" by the information, or the family does not want the patient told. The use of therapeutic privilege should be carefully considered and used infrequently. 3) Lack of Capacity - This is a situation in which a person lacks the legal capacity to make certain decisions regarding his or her care. Often, it may be possible to obtain family or surrogate consent; in other cases it may be necessary to have a court make such a determination in a special proceeding. When questions regarding the capacity of a patient arise, you may wish to consult with the Office of Legal Affairs for advice.

Patient Advanced Directives Policies The Federal Patient Self-Determination Act requires hospitals to develop policies and procedures that recognize a patient's right to accept or refuse medical treatment and to formulate advance directives in accordance with state law. The regulations require that adult patients be given written information at the time of admission regarding state law concerning advance planning for their medical treatment. In addition, a summary of the hospital's policy regarding these rights must be supplied; and the verbal and written information given to the patient must be documented in the medical record. All physicians and other health care providers should be familiar with this information and the hospital's policy and procedures regarding these subjects. Every physician has an important responsibility for ensuring that patients understand their right to plan in advance for their medical treatment. YNHH Risk Management Handbook-Contents

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It is important to note that both written (e.g., living wills and health care proxies) and oral advance directives (e.g., statements made orally to a physician, witnessed by a third party and documented in the chart) are recognized under state law.

Do Not Resuscitate Orders Unless there is a Do Not Resuscitate (DNR) order in the medical record, all patients suffering cardiac or respiratory arrest will receive appropriate cardiopulmonary resuscitation (CPR). Physicians and other health care providers should be familiar with the hospital's Limiting Life Support Treatment policy. The responsible attending physician must discuss the DNR order with patient, family members and/or surrogate, and this physician must write the DNR order. No specific medical pre-condition is required for the entry of a DNR order consented to by a competent adult patient, and this written or oral consent must be obtained prior to writing the order, unless it is determined that the patient would suffer immediate and severe injury from a discussion of such an order. A DNR order may be written for an incompetent patient if the patient had, prior to losing capacity, consented to a DNR order. Before giving consent to a DNR order, a patient or the patient's surrogate, must be advised by the responsible attending physician of the patient's diagnosis and prognosis, the reasonable foreseeable risks and benefits of CPR, and the consequences of a DNR order. The patient's attending physician must document the medical record regarding discussions about DNR orders and the decisions made by the patient or the patient's surrogate.

FREQUENTLY ASKED QUESTIONS REGARDING INFORMED CONSENT Question: May a patient revoke his or her consent for a procedure or treatment once it is given? Answer: Yes. A patient has the right to revoke his or her consent either verbally or in writing at any time. When this situation occurs, the patient's physician should be notified immediately. A patient has the right to revoke his or her consent during a procedure or treatment. If this occurs, the procedure or treatment should be terminated at the earliest (and safest) time possible. The patient's revocation of consent must be documented in the medical record. Question: Is it acceptable to obtain consent over the telephone by a parent, legal guardian, or surrogate, when they are unable to come to the hospital? Answer: Yes, but consent should only be obtained in this manner in emergency situations or when it is determined by a physician that the delay in treating the patient, while waiting for the arrival of the parent, legal guardian, or surrogate, would cause greater harm to the patient. The physician should disclose the same information as under normal circumstances. The substance of the telephone conversation and the name and telephone number of the person giving the consent must be documented in the medical record. Also, the telephone conversation should be witnessed by another professional staff member who should countersign the note in the medical record. Question: YNHH Risk Management Handbook-Contents

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Consent forms are often signed in the office prior to admission for surgery. How long is the form to be considered valid? Answer: At Yale-New Haven Hospital, a surgical consent form is valid for up to 30 days, unless the surgeon has evidence that the patient has revoked consent. Question: Are faxed consent forms valid? Answer: Usually the health care facility is required to maintain original evidence of consent in its record. Faxed consent forms may be considered acceptable in unusual circumstances, but must be followed by the original form (brought from the office) immediately. Question: My patient has been premedicated but has not signed the consent form. May surgery proceed? Answer: It is much preferable to obtain documentation of the consent prior to premedication. However, presuming that the physician has discussed the surgery with the patient prior to premedication, documentation by the responsible physician of that discussion in the medical record may be acceptable under hospital policy. If the patient signs a form after premedication, the physician must document that fact and that the patient was awake, alert and aware of the circumstances. Question: My patient did not sign a consent form prior to surgery. Now that the surgery has taken place, should I get the form signed? Answer: No, this should never be done. Either no consent was necessary (because the surgery was an emergency), or consent was documented by the surgeon prior to surgery in a progress note. "Retrospective" consent is ineffective.

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Infectious Disease Control The ability of the hospital to control infectious disease is an important element of its overall risk management efforts. All health care providers must comply with federal, state and municipal rules and regulations, in addition to the hospital's policies and procedures regarding the control of infectious disease. Some of the aspects of infectious disease control which you should familiarize yourself with include: YNHH Risk Management Handbook-Contents

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1. 2. 3. 4.

Preventing and reporting communicable diseases Universal blood and body fluid precautions Needlestick precautions Proper medical waste disposal

States and often, cities, require all physicians and hospitals to report cases, carriers or persons infected with specified communicable diseases. Several of the more common diseases include botulism, chicken pox, dysentery, encephalitis, rubella, gonorrhea, Hepatitis (A, B, Non-A, Non-B), Lyme disease, meningitis, rabies, Streptococcal sore throat, syphilis, tuberculosis, and whooping cough. Reporting procedures will vary somewhat as between the states. Patients need not consent to this reporting and in fact, may not refuse. There are penalties for the failure to report. Questions about assistance with infectious disease reporting may be directed to the hospital Department of Epidemiology and Infection Control. Since a medical history, examination or laboratory testing cannot reliably identify all patients infected with HIV, Hepatitis B or other blood borne pathogens, health care providers must utilize universal blood and body fluid precautions in caring for all patients. These precautions include, but are not limited to: 1) Hands must be washed before and after contact with patients, even when gloves have been used. If hands, or other parts of the body, come in contact with blood, body fluids or human tissue, they should be immediately washed with soap and water. 2) Gloves must be worn when contact with blood, body fluids or contaminated surfaces is anticipated. 3) Gowns or plastic aprons are indicated if blood splattering is likely. Masks and protective goggles must be worn if aerosolization or splattering is likely to occur, such as in certain dental and surgical procedures, wound irrigations, post mortem examinations and bronchoscopy. 4) To minimize the need for emergency mouth to mouth resuscitation, mouth pieces, resuscitation bags or other ventilation devices must be available for use in areas where the need for resuscitation is predictable. 5) Sharp objects, such as needles and glass, must be handled in a manner to prevent accidental cuts or punctures. Used needles should not be bent, broken, reinserted into their original sheaths, recapped, or unnecessarily handled. Immediately after use, they must be discarded intact in puncture resistant needle disposal containers. All needle stick accidents, mucosal splashes or contamination of open wounds must be reported immediately to Personnel Health Services. 6) Blood spills should be cleaned up promptly with a disinfectant solution such as 1:10 dilution of bleach. 7) All patient specimens should be considered bio-hazardous and bagged for transport to laboratories. These precautions may minimize transmission of disease from patient to health care provider and decrease the likelihood that other more easily transmitted organisms are transmitted to other patients. Occupational exposure to, and the transmission of, Hepatitis B (HBV) and human immunodeficiency virus (HIV) are of the utmost importance from a risk management standpoint because of the need to protect health care workers, patients and visitors from these viruses. Needlestick injuries are the largest source from which occupational exposures to these agents arise in the hospital workplace. Since all hospital workers are at risk of needlestick injury, adherence to the following practices is useful in preventing needlesticks: 1) Avoid rushing when handling needles. 2) Avoid pulling hard when encountering resistance in withdrawing needles from patients. 3) Seek assistance when using a needle in caring for an uncooperative patient. YNHH Risk Management Handbook-Contents

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4) Avoid recapping under all circumstances, but never recap a needle that has been used on a patient. 5) Dispose of needles properly in puncture resistant containers. Never leave needles on beds, stretchers, or bedside tables since they may injure staff, patients, or visitors. Do not throw them into regular garbage containers where they may injure housekeeping staff. 6) Never put needles in your pocket. 7) Never try to remove anything from a needle container or force needles into a full container. 8) Pick up improperly discarded needles with care and dispose of them in a puncture-resistant container. In the event a needlestick does occur, promptly wash the area with soap and water, record the patient's name and hospital number, prepare an incident form and report the event to Personnel Health. Attempts to "milk" the wound to express contaminants are ineffective and only damage tissues further. Personnel Health will provide you with information about or appropriate testing for hepatitis and HIV along with any recommended prophylaxis. The improper disposal of medical waste not only has the potential to cause injury to health care workers, patients and visitors, but can have widespread public health effects. A number of federal, state and local regulatory agencies, in addition to hospitals, have promulgated regulations and policies governing medical waste disposal with which all health care workers should familiarize themselves. Improper disposal of medical waste could expose the hospital to significant penalties, including fines and the suspension of services. The following guidelines will be of assistance in complying with the rules and regulations governing the disposal of medical waste.

What goes in Red Bags ? 1. Blood bags, IV bags and all tubing. 2. Items dripping and/or saturated with blood, or caked with dried blood. 3. Containerized body fluids greater the 20cc.

What goes in Clear Bags ? 1. Everything that is not contaminated by blood or body fluids.

What goes in a Sharps Container? 1. Anything that has a potential to cut, puncture, or pierce. For example, used and unused hypodermic needles; syringes (with or without needles attached); pipettes; scalpel blades; blood vials; slides and cover dishes; and culture dishes.

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Confidentiality Patients have the right to expect that all communications and records pertaining to their care will be treated as YNHH Risk Management Handbook-Contents

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confidential, and that their rights to privacy will be protected. Therefore, all health care providers must treat patient related information in a confidential manner, and guard against the indiscriminant and/or unauthorized release of such information. Although such an act may occur unintentionally, the hospital, physicians and other health care providers may be found liable for the unauthorized or improper disclosure of medical information. Discussion of patient related information should be conducted only in locations where confidentiality can be maintained. Health care providers should refrain from such discussions in elevators, hallways, dining areas and other public areas. Health care providers should use discretion when discussing medical information concerning a patient in front of visitors or family members, and should first determine whether the patient wishes to have this information discussed in the presence of such persons. In addition, the patient's permission should be obtained prior to leaving a message containing confidential medical information on a telephone answering machine, or with family and/or household members. Health care providers should not disclose patient related information when asked by unidentified or unknown persons, or in response to telephone inquiries, other than providing hospital approved condition reports, e.g., critical, stable, etc. In such situations, the requesting party should be referred to the patient's attending physician for further information. Patients' medical records should be guarded at all times in areas where entries to the record are made to prevent unauthorized access. Medical records should be stored and protected according to hospital policy, preventing passers-by from viewing the record. Access to patient information via electronic systems should also be protected according to hospital policy, with access code and password security maintained. In order to maintain the peer review privilege and patient confidentiality, staff meetings to discuss patients and M & M reviews should be conducted in appropriate locations. Materials distributed should be collected and not left for members of the general public to find.

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Patient's Rights The hospital is committed to ensuring that the individual rights of all patients are respected during their hospital stay. Most importantly, all patients have the right to expect to be treated with dignity and respect. It is important for all health care providers to be familiar with patients' rights under state law and hospital policy and observe them at all times. Patients afforded these basic considerations are usually more satisfied with their hospital experience, and from a risk management perspective, it makes them less likely to make a complaint, which could ultimately result in a claim or lawsuit. The hospital is obligated to provide appropriate assistance, including the use of an interpreter, to ensure that patients understand their rights. All individuals are entitled to receive emergency care and/or treatment without discrimination due to race, color, religion, sex, national origin, disability, sexual orientation, or source of payment. Patients are entitled to be informed of the identity and role of all physicians and support staff involved in their care, and have the right to refuse treatment or examination by them. Patients have the right to privacy while in the hospital and to expect all information and records regarding their care will be kept confidential. Patients must be given all the information they need to give informed consent regarding treatment and refusal of treatment. Under most circumstances patients are entitled to review, and should they so desire, obtain a copy of their medical records (after discharge if the record is a hospital record). A patient may refuse to take part in research and should be able, without fear of reprisals, to complain about the care and services they have received. YNHH Risk Management Handbook-Contents

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Patients, or appropriate family members, should be informed about unexpected and/or negative outcomes promptly. This should include the nature and cause of the event, if known, as well as the manner in which the event will affect the patient's prognosis and treatment plan. Failing to disclose, or disclosing only partial information regarding such occurrences, is perhaps the most common cause of patient dissatisfaction. Often, this dissatisfaction results in malpractice claims and lawsuits. Regardless of how difficult it may be for patients, it is legally unwise to speculate on the cause of an untoward event. Patients should also be made aware that in order for the health care team to render good care, patients have certain responsibilities. The most important of these is to provide, to the best of their knowledge, accurate and complete information about their present complaints, past illnesses, hospitalizations, medications and other matters relating to their health. Patients are responsible both for following the treatment plan recommended by the members of the health care team, and for the consequences should they refuse treatment or not follow recommended instructions. While trying to treat all patients with dignity and respect, occasionally, the use of physical restraints must be employed to protect and avoid harm to the patient or those surrounding the patient. In almost all circumstances, prior to the use of restraints, the written order of a physician who has examined the patient must be obtained. In emergency situations, a registered nurse may order restraints but the physician must be contacted immediately. It is imperative that the patient's medical record be documented regarding the need for, use of, and termination of restraints. Hospital policies are in compliance with the JCAHO policies on restraints and will generally provide a sound procedural approach. Competent adult patients have the right to refuse treatment. Since this refusal may be subsequently disputed or denied by the patient, it is important that all health care providers document these occurrences in the patient's medical record. When a patient refuses treatment, it is important that his or her physician disclose the risks and consequences associated with the decision. The treatment being proposed and refused by the patient should be documented in the medical record, as well as the fact that the potential adverse consequences have been discussed with the patient (and when appropriate, family members). Similarly, adult patients may not be detained in the hospital should they wish to leave against medical advice, except under extreme circumstances prescribed by law. Again, the patient's medical record should be documented regarding his or her voluntary decision to be prematurely discharged, noting the potential adverse consequences that have been discussed and that the patient understands them. The record should also note that further care has been recommended, as well as where and when the patient intends to obtain this care. In addition, most hospitals require that the patient be asked to sign a form indicating he or she is being discharged against medical advice. The patient's refusal to sign this form, which often occurs, should be documented in the record.

The Patient Representative The hospital has a patient representative to serve as a liaison between the patient and his or her family, and the medical and administrative staff of the hospital. The patient representative acts as advocate, ombudsman and agent for the patient and enhances patient care by assuring the identification, investigation and amicable resolution of patient complaints and problems. In addition to resolving patient complaints, the patient representative can explain hospital policy and procedures for the patient and/or family and handle lost property claims. From a risk management perspective, the patient representative plays a critical role in preventing patient complaints which, without their early intervention, could evolve into malpractice claims and lawsuits against the hospital and/or health care providers. All health care providers are encouraged to contact the patient representative for assistance. Footnotes: A medical device is an instrument, apparatus, contrivance, implant, in vitro reagent, or other similar or related YNHH Risk Management Handbook-Contents

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article, including any component, part or accessory (e.g., catheters, infusion pumps, suture materials, syringes, defibrillators, pacemakers, hospital beds, patient restraints, wheelchairs, tampons, in vitro diagnostics, etc.). Permanent impairment of a body function or permanent damage to a body structure. Necessitates immediate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Note, however, that the physician-patient relationship generally cannot be terminated during a medical emergency, labor or any other acute event.

Handbook Contents Page | Risk Managment Home Page January, 1997. Copyright 1997, Yale-New Haven Hospital and Yale University. All rights reserved.

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