Hand Book of Risk Management

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Handbook Contents Page | Risk Managment Home Page

RISK MANAGEMENT HANDBOOK

YALE-NEW HAVEN HOSPITALYALE 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


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Informed Consent What Is Informed Consent?

What Information Should Be Discussed With The Patient During The InformedConsent Process? How Should The Informed Consent Process Be Documented In The MedicalRecord?

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


Introduction

Yale-New Haven Hospital and Yale School of Medicine comprise one of the preeminent medical centers in thenation. The institutions undertake to train medical professionals, advance medical science and improve thedelivery of health care. In addition, the hospital is committed to providing the best quality of care possible, aswell as the continuous assessment and improvement of the quality of care and services rendered to ourpatients. 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, asmuch as possible, injuries to patients, visitors and employees, and to prevent or limit financial loss to thehospital and its staff. Financial loss can occur in a number of ways. From a risk management perspective, theprimary concerns are those financial losses associated with the inherent risks that exist in providing health careservices, which can result in a patient instituting a medical malpractice claim or lawsuit against the hospitaland/or a health care provider. The key element in the success of the risk management program in preventingand 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. Eachindividual must be committed to reducing risks.

The purpose of this handbook is two-fold: 1) to provide information that addresses a number of themedical-legal and risk management issues encountered by physicians and other health care providers; and 2) toserve as an easily referenced resource for such information, supplementing additional information alsocontained in some of the hospital's administrative policy and procedure manuals. The intent in highlightingthese issues is to make all health care providers more aware of important opportunities they have to reduce therisks of injury to patients and others, reduce the risks of financial loss to the hospital and staff, and improvethe quality of care. Since these issues and related procedures may change over time, the hospital intends toperiodically update this handbook.


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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 willoccur in a specific setting. It consists of three distinct, yet interrelated areas: 1) risk identification and lossprevention; 2) loss reduction; and 3) risk financing. To be most effective in the hospital setting, riskmanagement involves a multidisciplinary and proactive approach.

The first component involves those activities related to risk identification and loss prevention. Generally, theseactivities include the identification and correction of situations or problems which may give rise to events orincidents of potential liability for the hospital, its employees, physicians and other health care providers. Theseactivities are vital to successful risk management since in most cases, the cost of preventing a liability claim isfar less than the cost of resolving the claim after it occurs. Loss prevention activities also consist of theplanning and presentation of regular educational programs to clinical and administrative departments whichincludes:

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 takenafter an event or incident occurs that are aimed at minimizing the adverse impact, financial or otherwise, ofsuch an event or incident on the patient, the hospital and its staff. These loss reduction activities aremultifaceted and, depending on the facts and circumstances of the particular occurrence, include involvementand input from a number of the medical and administrative staff throughout the hospital. The foundation of aneffective loss reduction program includes procedures that identify and respond as soon as reasonably possibleto incidents which occur. In this way any adverse impact potentially resulting from the incident can be bestminimized. These activities include the hospital's management of professional and general liability claimsreported under its insurance program.

The third component is risk financing, which involves the mechanisms utilized to ensure that there are adequatefinancial resources available to cover any potential liability situations, and includes the procurement of adequateliability insurance coverage at reasonable premiums to cover such losses. To respond to this need, the medicalcenter 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 effectivenegotiation and use of indemnity provisions in hospital contracts to transfer liability risks to other partieswhenever possible.

The hospital's risk management program primarily is administered by the Office of Legal Affairs in the areas ofloss reduction and loss prevention. However, risk management at the hospital is a coordinated effortintegrating many administrative and clinical departments throughout the hospital. In particular, the hospital'sPatient Relations and its Quality Assurance Departments work closely with the Office of Legal Affairs in thehospital'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 theOffice 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 managementprogram. The department has a staff of three attorneys who handle a wide range of issues on behalf of YNHHincluding answering questions about patient consents, DNR orders, withdrawal of treatment issues, businesstransactions, contract negotiations, leases and regulatory matters. The attorneys are available to speak atinservices, 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 liabilityclaims that are made against the medical center facilities, its employees and insured physicians. Members of theoffice 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 securedby YNHH and its insured physicians. Staff members assist physicians and others with questions concerninginsurance coverage, premium payments and proof of insurance.

The attorneys in the department are available via telephone to answer hospital/patient related legal questionsMonday through Friday, 8:30 a.m. to 5:00 p.m. An attorney from the department is always on-call after hoursand on weekends and can be reached by beeper through the YNHH page operator, at 5-3111.


Insurance Program at Yale Medical Center

In 1978, several other major teaching hospitals formed an insurance company (the "Company") chartered inBermuda to underwrite medical professional liability insurance, commonly referred to as medical malpracticeinsurance, and general liability insurance for the participating hospitals and schools of medicine, physiciansand dentists closely affiliated with each hospital, and the physician and non-physician employees of eachhospital. 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 theprincipal Named Insureds) are:

1. The Presbyterian Hospital in the City of New York 2. The Society of The New York Hospital 3. Cornell University 4. The University of Rochester (Strong Memorial Hospital) 5. The Johns Hopkins Hospital 6. The Johns Hopkins University 7. Yale-New Haven Hospital 8. Yale University


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In addition to the primary coverage provided through the program, the participating institutions purchaseexcess insurance from some of the largest and most reputable insurance companies issuing policies coveringhealth care related risks in the United States.

The policy is written on a claims made basis, which means it covers claims or adverse medical incidentsactually reported to the insurer during the policy year resulting from services rendered during the policy year orafter inception of an insured's coverage under this program (the retroactive date), whichever is earlier. Claimsrelated to services rendered prior to an insured physician's or dentist's coverage under this program should becovered 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 thatcustomarily included in medical professional liability policies. This generally includes coverage for suchallegations 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, providedsuit is brought in the USA, its territories or Canada. Interns, residents and fellows are insured solely foractivities performed within the scope of their formal program and approved affiliations. This does not excludecoverage for "good samaritan" activities, but does exclude coverage for "moonlighting". Non-physicianemployees, including nurses, therapists, social workers, and psychologists are automatically covered under thepolicy 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 ofactivities on behalf of the hospital (or Named Insured) and does not provide coverage in homes or privateoffices, 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 participatinginstitution will continue to be covered for claims made subsequent to their departure but arising out ofprofessional services rendered during the period of their participation in the program. This insurance coveragewill be provided as part of the institution's policy in future years. The program will provide departing insuredsthis so-called "tail-coverage" for future unreported claims at no additional premium charge, as long as theinsured's sponsoring institution remains a participant in the program. In the event an institution no longerparticipates in the program, it will be the possible for that institution to buy "tail coverage" for itself as well ascurrent and prior staff. No coverage is provided for any claim arising out of services rendered after anindividual terminates participation in the program.

To be covered under the insurance program, physicians and dentists must participate under the sponsorship ofa Named Insured institution, meet the eligibility criteria of the Company and be subject to and comply with thehospital's credentialing and reappointment process and requirements. Coverage may be withheld or terminatedif 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 scheduledrisk 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 coveranticipated claims and necessary reserves, plus certain costs such as reinsurance premium and administrativeexpenses.

The institutions who comprise the Company have established procedures for the management and resolution ofclaims brought against the hospital, the School of Medicine or its insured physicians or employees. Theparticipating institutions have engaged a company with expertise in the management of medical professionalliability claims to assure adherence to these agreed upon claims management procedures. All insuredphysicians, dentists and other health care providers are have a duty under the policy to cooperate with thehospital's representatives, the Company and its agents, and to assist in the investigation, defense andresolution of claims. Insured physicians and dentists can obtain further information regarding the insuranceprogram by contacting the Office of Legal Affairs.


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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, physiciansand 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 managementprogram at the hospital and School of Medicine. Written communications to the Legal Office should be soaddressed and marked privileged and confidential. Copies of this correspondence should not be directed toothers outside the Legal Office.


Overview of the Legal System

In the current health care environment, an increasing number of patients who believe they have sustainedphysical or psychological harm (a "bodily injury") as a result of the hospital's or a health care provider'snegligence 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 havebeen treated in an uncaring, rude, unsympathetic and/or less than professional manner. Many believe the mostimportant 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 isattributable 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 therendering of professional services which result in bodily injury to the patient. Negligence, in the professionalliability setting, is defined as a departure, either by the acts or omissions of a health care provider, from theaccepted standards of care.

General liability, or general "negligence" claims, usually concern allegations of negligence regarding themaintenance of the hospital's or a health care provider's buildings and/or property resulting in bodily injury orproperty damage to a visitor, or less commonly, to a patient. Negligence, in the general liability setting, isdefined as the failure to exercise a reasonable degree of care which the law requires to protect others from aforeseeable or unreasonable risk of harm. In a physician's office or the common areas of the hospital (ratherthan 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 thesetypes 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, butoccasionally under federal law. This body of law, the statutory part of which is periodically amended bylegislative 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. A legal duty was owed to the plaintiff. 2. The standard required to meet that duty was breached. 3. A causal relationship existed between that breach and the injury claimed. 4. 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 apatient, whether it be to treat only a certain ailment or injury, at a certain place and for a specified time, or forongoing care and treatment. The breach of the standard must be established by expert testimony. The relevantstandard is the one in effect at the time of the incident, not when the claim is made. Causation is the connectionbetween the failure to meet a duty owed and the event (the injury) which occurred. This is often times referredto as "proximate cause." The damages are the injuries and as a practical matter are defined as the estimatedmonetary 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 negligencelawsuit, the following specific areas will be discussed:

1. The Statute of Limitation 2. The Summons and Complaint 3. The Discovery Process 4. Depositions and Interrogatories

The Statute of Limitation

The statute of limitation defines the time within which a plaintiff must commence a lawsuit by complying withcertain prescribed procedures. The statutes of limitation for civil actions, which differ depending upon the typeof action, are usually state laws. These time periods allow a plaintiff or his or her authorized representative areasonable time to discover and investigate whether he or she was injured as a result of a defendant'snegligence. In Connecticut, personal injury lawsuits, which include medical malpractice and non-medicalmalpractice actions (general liability), must be commenced by the patient (the plaintiff) against the hospital or ahealth care provider (the defendant) within two (2) years from either the date or discovery of the act oromission from which the injury is alleged to have been caused, but in no event more than three (3) years fromthe date of the act or omission complained of. In Connecticut, there is no extension of this statute even if theinjury occurred to a minor. Due to a recent statute change, a plaintiff may get an automatic three monthextension to the two year statute if application is made to the court prior to the two year period; therefore, somesuits 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 isthe filing and service of specific legal pleadings known as the Summons and Complaint, which initiate theformal litigation process. A Summons, which notes the plaintiff(s), defendant(s) and jurisdiction of thelawsuit, generally gives little indication of the specific allegations which form the basis of the lawsuit. TheComplaint describes, with more or less specificity, the dates and allegations of negligence against each


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defendant, and the injury and damages allegedly sustained by the plaintiff. These materials must be served onthe defendant(s) and filed in court. Service may be in person, in which case the Summons and Complaintshould immediately be sent to the Legal Office; service may also be accepted in the Legal Office, if coverage isconfirmed and the defendant has not moved out of the area. The Complaint allegations will be answered later inthe 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, expertopinions, documents, etc. The period of time for discovery varies depending upon the complexity of the caseand the number of parties involved but, in general, it will encompass a minimum of 2 years, and can extend foras long as 5-7 years.

Depositions and Interrogatories

Depositions and interrogatories are often the most important part of the discovery process, especially for anindividual defendant. A deposition is a formal legal process whereby oral testimony is taken, under oath, in thepresence of a court reporter. Depositions may take place in an attorney's office or in an appropriate room in themedical center, with the attorneys representing all parties involved in the litigation present. Generally, all of theparties in the lawsuit will be deposed, and on occasion, the deposition of non-party fact witnesses and expertswill be taken.

Any physician, nurse, other health care provider and medical center current or former employee scheduled tobe deposed will meet with defense attorneys prior to testifying. At this meeting, your attorney will discuss thecase, 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 careprofessionals. Attorneys who specialize in the medical malpractice field have an excellent working knowledgeof medicine, with some having extensive expertise in certain specialties. Therefore, although some questionsposed may appear to be innocuous, they may be phrased ambiguously or duplicitously to elicit extremelydamaging admissions. Always remember that the goal of the plaintiff's attorney is to gain admissions and/orinconsistencies in the testimony to support allegations that an accepted standard of care was breached. Yourattorney will prepare you for the type of questions that may be asked and the best way to answer suchquestions.

Some guidelines to remember when testifying include:

1. Do not volunteer information or attempt to answer questions outside your area of expertise and/orknowledge. 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 notknow.

3. If you do not understand the question, say so. Ask if the attorney can rephrase the question or define aterm 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


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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 orinaccuracies which should be corrected. It is important that you carefully review the transcript since once youverify that it is an accurate version of your testimony, it functions as your sworn testimony. The testimony of awitness at a deposition can be introduced as evidence at the time of trial, and, if the testimony of a witnessduring trial differs from that given at deposition, the opposing party will use such discrepancies to impeach thecredibility of the witness.

Interrogatories are a series of written questions propounded by one party upon another to obtain factualinformation. Answers to the interrogatories are prepared, in writing, and when sworn to, the written responsesmay be used as evidence at trial. Counsel representing the plaintiff(s) and defendant(s) will consult with theclient and prepare the answers to the interrogatories. Interrogatories are commonly used in Connecticut and canbe 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 thelawsuit, the case will be scheduled for a trial. When the case is tried, the plaintiff is required to present his orher 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 afair and impartial manner and to rule on matters of law. It is the responsibility of the jury, after considering theevidence, which consists of the witness testimony, medical records and any other exhibits allowed intoevidence by the judge, to render a verdict either in favor of the defendant(s) or plaintiff. The civil jury inConnecticut 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 withan 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 wasthe proximate cause of an injury. The plaintiff will present his or her proof first, usually by the testimony ofwitnesses and experts, as well as the introduction of records and documents into evidence. Following thedirect 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 jurythe evidence they have offered to prove their case or rebut that offered by the opposing side. Like the openingstatements, the plaintiff is the first to present arguments to the jury, followed by the defendant(s), with theplaintiff having a final rebuttal opportunity. During the closing arguments, it is common for the attorneys tocomment on the credibility of the fact and expert witness testimony the jury has heard, and to suggest to thejury 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 theevidence they have heard and seen. This is commonly referred to as "charging" the jury. Following beingcharged by the judge, the jury will be sent out to deliberate. Often, a number of questions will be presented to


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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 jurorsmust agree in order for a verdict to be reached. If a jury renders a verdict in favor of the plaintiff, they will alsobe instructed to award monetary damages, and when there are multiple defendants, apportion the damagesamong them. Should the jury find in favor of the defendant(s), unless the plaintiff appeals, the lawsuit hasended. The judge may overturn a plaintiff's verdict or reduce the amount awarded. A defendant has the right toappeal 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 byfederal and state regulatory agencies. Some agencies are responsible for collecting and maintaining dataregarding medical malpractice settlements and disciplinary actions taken against licensed health careprofessionals, while others are charged with the responsibility for investigating patient complaints regardingmedical treatment. The activities described above usually occur outside the civil legal system, but are closelyrelated to it.

The establishment of the National Practitioner Data Bank ("NPDB") was mandated by the Health Care QualityImprovement Act of 1986 ("HCQIA") and responsibility for its implementation and management resides withthe U.S. Department of Health and Human Services. The act was passed by Congress to encourage good faithprofessional review activities and restrict the ability of incompetent physicians and licensed healthprofessionals to avoid discovery of prior substandard or unprofessional conduct by mandating the reporting ofspecific information. The HCQIA requires: 1) health care entities and State Boards of Medical Examiners toreport certain information to the NPDB, and 2) hospitals and health care entities to request information fromthe 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 careprofessional.

2. Sanctions taken by licensure boards against health care professionals. These include licenserevocation, suspension and restriction, as well as any suspension, censure, reprimand or probationdue to professional incompetence.

3. Actions taken by health care facilities against physicians and dentists that adversely affect thatprovider's clinical privileges for more than 30 days and which are based on professional conduct orcompetence.

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 careprofessional who applies for a position on its medical staff (courtesy or otherwise). In addition, thehospital must request information for physicians and other licensed health care professionals on itsmedical staff or having clinical privileges every two years.

The Connecticut Department of Public Health and Addiction Services is responsible for investigatingcomplaints by patients and others regarding medical treatment rendered by both health care entities andindividual physicians, nurses and other licensed health care professionals. Any individual receiving a noticefrom the state indicating it is investigating a complaint should treat it with the utmost seriousness, since aninvestigation with adverse findings could affect the status of a practitioner's license. Should you receive such anotice, 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


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against the hospital or a staff member, that person should immediately notify the Office of Legal Affairs. Theperson reporting the potential action may be subsequently contacted by a representative from the Office ofLegal Affairs regarding the matter.

Hospital personnel should not speak with attorneys or investigators who are not affiliated with the hospitalregarding 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 Officeof Legal Affairs.

Reporting Professional Misconduct

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


Medical Record Documentation

The medical record serves many purposes but its primary function is to plan for patient care and provide forcontinuity in information about the patient's medical treatment. As a permanent record, the patient's medicalrecord informs other health care providers both inside and outside the hospital about the medical history of thepatient. In addition, the medical record:

1. provides information which serves as the basis for financial reimbursement to hospitals, health careproviders and patients;

2. serves as a legal document for use by an injured patient against other parties or for use in other legalproceedings;

3. is used by hospital quality assurance and peer review committees, State licensing agencies, Stateregulatory agencies, and other entities in accessing the quality of patient care by hospitals and healthcare 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 minimizingthe potential adverse consequences of malpractice litigation. Ultimately, it serves as the basis for the defense ofmalpractice claims and lawsuits. Medical records which are poorly maintained, incomplete, inaccurate, illegibleor altered, create questions of fact regarding the treatment given to a patient. Patient's attorneys often institutemalpractice lawsuits when they believe the questions of fact created by incomplete and poorly documentedmedical 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 reflectsthe care provided to a patient and, in a courtroom setting, it may be likened to a witness whose memory isnever lost. It serves to correlate, for all involved, important patient information regarding the treatmentrendered and the patient's treatment plan, and is the means by which a level of communication is achieved


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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 medicalrecord number. Individuals making entries in a patient's chart should do so only through a password electronicsystem, or on hospital approved medical record forms and then only with pen rather than pencil, which mightfade and become illegible, or felt tips which might bleed through the page. Include the complete date of theentry with the month, day, year and time of day. Use only hospital accepted medical abbreviations andterminology. Associated records and tests such as EKG's, EEG's, fetal monitoring tracings, etc., should all beproperly labeled with patient's name and medical record number, and when appropriate, the date and timeperformed.

All entries in the medical record should be dated, include an indication of the time the note was written and besigned by the person making the entries. Attending physicians may be required to review and countersignprogress notes by interns and residents. Progress notes by junior residents should include reference to the factthat a specific aspect of the patient's condition or treatment plan was discussed with a senior resident orattending physician.

All examinations of the patient should be documented in the record. Progress notes should indicate that thepatient was kept informed of his or her condition, as well as the treatment plan. Document all instances ofpatient non-compliance or refusal of recommended treatment and that the patient was informed of potentialconsequences.

Patient records should never be altered. One should not erase, obliterate or attempt to edit notes previouslywritten. All corrections, late entries, entries made out of time sequence, and addenda should be clearly markedas such in the record, and should be dated and timed on the day they are written and signed. Draw a single linethrough any erroneous chart entry and write "error" with the date and time, as well as your initials. Thefollowing 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/orobservation of the patient. When documenting information derived from other sources, for example, otherhealth care providers, other medical records, or entries in the same medical record, be sure to reference thesource 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 specificallycharting information based upon what is:

1. Seen - charting observations regarding bleeding, deformities, drainage, color of urine, patient postureand/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;


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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 thepatient by noting the patient's vital signs, the status of recovery from the condition on admission, or for anelective admission, the status of recovery from the elective treatment/surgery. The note should completelydocument 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 inaccordance with hospital requirements to enable the medical record department to secure the patient recordexpeditiously 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-upon 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 statementsin the record which criticize or cast blame upon others, or are intended to serve as gratuitous remarks. Do notengage in battles in the chart over treatment decisions. When disagreements regarding a patient's treatment planoccur, a case conference should be called to resolve them. This advice, however, is not intended to precludeusing 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 themedical record. Because these occurrences may form a basis for litigation even when there has been nonegligence, 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. Entriesregarding an incident should include the date and time of the incident, a brief factual and objective descriptionof what was seen and heard, using exact quotes when possible of the patient's description of the event, alongwith the findings of any physical examination and follow-up care. When there is no apparent injury as a resultof the incident, this should be clearly documented in the record. Avoid writing information unrelated to themedical care of the patient. The record should not make reference to the preparation of an incident report and/ornotification of the hospital's Office of Legal Affairs.

When unanticipated patient outcomes occur, documentation of the complication(s) should also be accuratelyrecorded. Entries should include information regarding the complication in an objective fashion withoutjudgment as to whether the complication is acceptable, unacceptable or anyone is to blame. The entry shouldindicate that the patient was informed of the complication and its consequences, as well as any change in his orher 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 guardianof a child, or when the patient is deceased, the appropriate legal representative of the patient's estate. If therelease is more than one year old, it is prudent to request a more recent one. Forward a complete copy of the


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patient's record, or only specifically requested items if they have been detailed. You may request a reasonablefee for photocopies and processing the request; by statute in Connecticut a hospital may charge 65cents perpage plus 1st class postage; a physician's office may charge 45cents plus postage. You should not prepare awritten summary of the patient's care and treatment.

Because specific laws and regulations impose liability and monetary penalties for the unauthorized disclosureof patient information regarding HIV status, alcohol or drug treatment and psychiatric treatment, withoutspecific written authorization from the patient, a release form for this information must explicitly authorize itsrelease.

It is strongly recommended that you notify the Office of Legal Affairs of any record request by an attorney ordissatisfied 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 aconsultant's recommendations. Usually, these disagreements can be resolved by discussing them at caseconferences and do not need to be documented in the record. However, when a health care provider believesthe 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 ofthe team.

Example:

Dr. Doe's recommendation that the patient be started on Streptomycin is noted. Due to the patient's priorhistory of being sensitive to this medication, the patient will be continued on his current antibiotic regimen andwill 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 mustretain 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 ofthe 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:


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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 iscompleted (e.g., operative notes and discharge summary dictated and signed). However, there may be timeswhen, to defuse a situation, you may decide to let the patient read the original. When this occurs, a staffmember must be present to maintain the integrity of the record, prevent the patient from adding comments orcrossing out notes, and possibly to answer questions about the notes.


Incident Reporting

The hospital's risk management program employs a number of systems to identify and provide notification ofincidents or events that have occurred involving patients, visitors, staff, equipment, facilities or grounds whichare likely to give rise to potential liability, affect the quality of patient care or affect safety in the hospital. Theearly identification of such occurrences allows the hospital to immediately investigate the circumstances of theincident, and if necessary, institute corrective action to prevent similar occurrences in the future. One of thesystems used to identify and report patient and visitor related occurrences is the hospital's incident reportsystem.

Health care providers and other hospital employees are required to report and complete a Report of Incidentform (F-877) regarding any patient or visitor who, while within hospital jurisdiction and/or while on hospitalpremises, is involved in an occurrence which has caused or has the potential to cause injury or loss or damageto their personal property. This includes incidents where the possibility of injury existed although no injurywas actually incurred and those incidents which are inconsistent with the routine care of a particular patient orroutine 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, mismatchedtransfusions, 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 canbe found in the Yale New Haven Hospital Administrative Policy and Procedure Manual, I-3. The following isa brief discussion of the procedures involved in incident reporting.

For incidents involving patients, the person completing the Report of Incident form should be the individualwho witnessed, first discovered, or is most familiar with the incident. Each section of the form must becompleted according to the directions on the form. The report must then be immediately presented to thereporter's supervisor who must then investigate and recommend corrective action. The description of theincident should be a brief narrative which should consist of an objective description of the facts. It should notinclude the writer's judgment as to the cause of the event. Quotes should be used where applicable withunwitnessed 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 theemployee is not the reporter. The patient must be examined by an appropriate physician, who should completethe appropriate section on the form regarding his or her findings. The Report of Incident form should becompleted no later than the end of the shift during which the incident occurred or was discovered to have


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occurred and must be forwarded to the Central Nursing Office within 24 hours and the Office of Legal Affairswithin 48 hours.

All incidents involving visitors must be reported to the supervisor in the area where the incident occurred. Avisitor who has sustained an injury while in the hospital should be escorted by a staff member to theEmergency Service for medical attention. If the injured person refuses medical attention, this must be noted onthe Report of Incident form.

The Report of Incident form is an administrative document, not part of the medical record. The fact that anReport of Incident form has been completed should not be reflected in the medical record, nor should the reportbe placed in the medical record. In addition, no copies of the Report of Incident form may be made. Anobjective description of the incident should be recorded in the medical record by both the medical and nursingstaff 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 becalled immediately.

If a medical device is involved (caused or contributed to death of, serious injury to, or serious illness of apatient):

1. report the incident to Nurse Manager/designee; 2. notify the Office of Legal Affairs 3. fill out a device incident report form; 4. record the manufacturer, model number, serial number, and control number of the equipment on the

incident report; 5. save the original packing if possible; 6. when equipment is involved, impound the equipment, the disposable product used with the

equipment, and the packaging materials from the disposable product; 7. tag the equipment with a sign that states "EQUIPMENT BROKEN - DO NOT USE"; 8. 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 ofdepartments 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 thatmight affect policies or procedures. This review provides another method to aid in assuring qualitypatient 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 correctiveactions taken as part of the periodic QA/QI reports.


The Physician - Patient Relationship


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Physicians who carefully listen to patients and comfortably share medical information with them havediscovered the cornerstone of the art of medicine. A healthy physician-patient relationship can make a difficultdiagnosis more bearable for the patient. It can help a resistant patient understand the need for a procedure ormedication, and allow the physician to develop a realistic plan for continuing care. When a physician'srelationship with a patient is marked by mutual trust and open communication, he or she has taken a major steptowards the assurance of patient satisfaction.

Evidence shows that a clear, two-way conversation is a key element in the prevention of patient dissatisfactionand malpractice claims. In fact, many episodes of patient dissatisfaction triggered by an iatrogenic injury orother "adverse outcome" can be defused by a reasonable explanation from the physician who has established agood basis for communication.

On the other hand, inadequate communication and misunderstanding are often the inciting agent that transforma poor medical outcome into a legal action against a physician, even when quality care was delivered. Moststudies show that a significant percentage of malpractice lawsuits are ultimately resolved without any paymentto the patient. Many risk managers believe that a large number of these malpractice cases could be avoided ifphysicians listened more attentively to patients who experienced less than optimal or unexpected treatmentoutcomes. Techniques for increasing patient satisfaction through improved communication are now widelyrecommended for malpractice claims prevention.

Recommendations for a Healthy Physician - Patient Relationship

Risk management begins the moment a professional relationship is established with a patient. Theunderstanding by, compliance by and satisfaction of any patient ultimately depend on oral and writtencommunication. 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 careproviders, such as students, nurses, physician assistants, residents, fellows, consultants, and therelevant attending, referring and primary care physicians.

2. Address your patients appropriately and modify your greeting as your relationship progresses. It isbest to begin with formal titles; then, if both sides are comfortable with doing so, shift to somethingless formal. If possible, use a translator to help communicate with patients who speak a foreignlanguage with which you are unfamiliar.

3. Sit down close to the bedside, if possible, and make frequent eye contact. Be attentive to the patient'snon-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 questioningto 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 thepatient. Use pictures and models to help explain complicated concepts.

7. Provide emotional support to grieving, anxious, frightened, or depressed patients. Reassure yourpatients that you will be helping them throughout the course of their medical problems and will beavailable 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 haveoften been precipitated by criticism of this kind and you may find yourself an expert witness based onyour 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


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interventions. Make clear the necessity and effectiveness of intervention if disability is the expectedresult. Document these discussions.

11. arise. 12. 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 delineateroles among the parties and convey this to the patient in a manner that will facilitate coordination ofpatient care.

13. When it is necessary to discuss fees, be open and frank concerning the cost of care. Whereappropriate, help educate patients concerning today's often confusing health care system. You mightconsider 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 notwithin your control.

14. 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 othertopics are vital for proper care of your patient.

15. 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 shecannot continue to provide care within these constraints, what is the best way to go about terminating thephysician-patient relationship?

Answer:

The instances of the patient's non-compliance and difficult or disruptive behavior should have been notedcontemporaneously with their occurrence in the patient's medical record. Once a physician has made thedecision that the relationship will be terminated, the reasons for the decision should also be noted in themedical recor\. Always attempt to meet with or speak with the patient (and family members, if appropriate) toinform 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 decisionand the specific professional reasons for terminating the relationship. This should be done even if you havemet 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 thepatient'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. Youmay also offer to or actually provide the names of several physicians or clinics to help the patient inselecting 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 LegalAffairs for specific advice.

Question:

If the patient has not paid my bill for professional services, may I terminate the relationship?


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Answer:

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


Informed Consent

Many physicians feel that informed consent is merely a formality necessary to obtain the patient's signature ona form in order to allow a specific procedure or treatment to be performed on the patient. Rather, informedconsent should be thought of as a communication process through which a patient, with the advice and supportof his or her physician, makes decisions concerning the treatment he or she will receive. The process assists indeveloping the critical element of trust between the physician and patient, and is often the most importantdiscussion 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 allegationthat they did not give their consent; this is called a battery. A second more common claim is that the consentgiven was not based upon proper and adequate information; this is known as a claim for "lack of informedconsent." This type of claim is usually found as part of the typical malpractice or negligence action. Because ofthis type of potential claim, from a risk management perspective, the informed consent process plays a crucialrole 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 physicianand patient. The first part is the disclosure and explanation to the patient, in language that the patient canunderstand, of the nature of a proposed procedure or treatment, its potential risks and benefits, and reasonablealternatives which may be available. The second part of the process involves: 1) ensuring that the patientunderstands what has been explained to him or her (to the best of the patient's intellectual capacity); 2) thepatient 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 heor she has received sufficient information upon which informed consent can be given for the procedure ortreatment, and has given his or her voluntary permission to undergo it. Also, the physician who had thediscussion 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 proposedprocedure or treatment should engage in this process with the patient. It is acceptable for a physician todelegate the task of obtaining the patient's signature on the necessary consent form to another member of thehealth care team. However, this should occur only after the discussions necessary for a patient to give his orher informed consent have occurred.

What Information Should Be Discussed With The Patient During TheInformed Consent Process?

Where possible, it is desirable for the informed consent discussion to occur a sufficient period of time before


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the proposed procedure or treatment in order to allow the patient time to consider the information and askquestions. During the discussion, it is recommended that the physician use language the patient can understandand avoid the use of "medical jargon." The informed consent discussion may take place in the physician'soffice prior the patient's hospital admission, in the patient's hospital room, and in emergent situations, in theemergency 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 theproposed procedure or treatment and be able to voluntarily give or withhold his or her consent after making aninformed decision. Informed consent may be given by adult patients with capacity, the parent or legal guardianof a minor, emancipated minors under specific circumstances or a court or patient designated surrogate of apatient 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 personunder similar circumstances would want to know. A physician need not disclose all of the risks orcomplications which may occur, but should discuss: 1) those commonly associated with the procedure ortreatment 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 thepatient if they are significant to that patient.

How Should The Informed Consent Process Be Documented In The MedicalRecord?

The informed consent process is documented in two separate ways in the medical record. The first way is byobtaining the patient's signature on an appropriate consent form following the necessary disclosure ofinformation upon which a patient can give his or her informed consent. The second way is by documenting theinformed consent process in the patient's medical record. This can be an entry in the office records maintainedby 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 allpatients before any non-emergency operation, invasive procedure or treatment, regardless of whether thatprocedure takes place in the operating room, a treatment room or office. The hospital has developed a consentform for surgical operations and diagnostic or other therapeutic procedures, which must be signed by allpatients and the responsible physician. These consent forms can be found on all patient units. When questionsarise 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 defenseof any subsequent claim by a patient for lack of informed consent. The signature of the patient on a consentform alone is not legally determinative evidence that the patient has given informed consent. Poor or absentdocumentation will force a physician to testify from recollection about an event which occurred several years


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previously, which will undermine his or her credibility. In addition, poor or absent documentation may be asignificant 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 discussionin the patient's medical record. The entry in the medical record regarding the informed consent process shoulddescribe the information disclosed to the patient. Avoid the use of summary statements such as "The patientwas advised of the potential risks/complications of the operation and alternatives" and instead, note at leastsome of the actual risks, complications and alternatives discussed with the patient. For example, the entrycould state that "information regarding the risks, complications and alternatives were discussed with the patientand/or family, including but not limited to ...", followed by the specific information discussed. Note whetherthe patient was given any booklets or written material regarding the procedure or treatment. It is also importantto 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 thedelivery of medical care. In each of these situations, the hospital has developed specific policies andprocedures to follow with which all physicians and other health care providers should be familiar. The Officeof Legal Affairs should be contacted to answer questions regarding these procedures or provide advice on howto deal with specific situations. These situations include:

1) Emergency treatment - Often a physician will determine that a patient is in immediate need of medicaltreatment but is unable to give consent because of a physical or mental impairment. Medical treatment can beinstituted under these circumstances once it is determined that: a) a delay in treatment would be life threateningor cause the patient serious harm; b) no close family member or surrogate is available to give consent on behalfof the patient; and c) the physician has no evidence that would suggest that the patient would oppose thetreatment. The physician should document in the medical record the emergency circumstances under which themedical 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 thepatient by the physician based upon his or her judgment that disclosure of the information would have aharmful effect on the patient. When a physician invokes such a privilege, it is imperative that the objectivejustification for it be documented in the patient's medical record. This should include the reason whyinformation was withheld, and both the information that was disclosed and not disclosed. It is not acceptable touse this privilege because the patient would be "anxious" or "upset" by the information, or the family does notwant 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 decisionsregarding his or her care. Often, it may be possible to obtain family or surrogate consent; in other cases it maybe necessary to have a court make such a determination in a special proceeding. When questions regarding thecapacity 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 recognizea patient's right to accept or refuse medical treatment and to formulate advance directives in accordance withstate law.

The regulations require that adult patients be given written information at the time of admission regarding statelaw concerning advance planning for their medical treatment. In addition, a summary of the hospital's policyregarding these rights must be supplied; and the verbal and written information given to the patient must bedocumented in the medical record. All physicians and other health care providers should be familiar with thisinformation and the hospital's policy and procedures regarding these subjects. Every physician has animportant responsibility for ensuring that patients understand their right to plan in advance for their medicaltreatment.


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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) arerecognized under state law.

Do Not Resuscitate Orders

Unless there is a Do Not Resuscitate (DNR) order in the medical record, all patients suffering cardiac orrespiratory arrest will receive appropriate cardiopulmonary resuscitation (CPR). Physicians and other healthcare providers should be familiar with the hospital's Limiting Life Support Treatment policy. The responsibleattending physician must discuss the DNR order with patient, family members and/or surrogate, and thisphysician must write the DNR order. No specific medical pre-condition is required for the entry of a DNRorder consented to by a competent adult patient, and this written or oral consent must be obtained prior towriting the order, unless it is determined that the patient would suffer immediate and severe injury from adiscussion of such an order. A DNR order may be written for an incompetent patient if the patient had, prior tolosing 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 responsibleattending physician of the patient's diagnosis and prognosis, the reasonable foreseeable risks and benefits ofCPR, and the consequences of a DNR order.

The patient's attending physician must document the medical record regarding discussions about DNR ordersand 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 thissituation occurs, the patient's physician should be notified immediately. A patient has the right to revoke his orher consent during a procedure or treatment. If this occurs, the procedure or treatment should be terminated atthe earliest (and safest) time possible. The patient's revocation of consent must be documented in the medicalrecord.

Question:

Is it acceptable to obtain consent over the telephone by a parent, legal guardian, or surrogate, when they areunable 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 aphysician that the delay in treating the patient, while waiting for the arrival of the parent, legal guardian, orsurrogate, would cause greater harm to the patient. The physician should disclose the same information asunder normal circumstances. The substance of the telephone conversation and the name and telephone numberof the person giving the consent must be documented in the medical record. Also, the telephone conversationshould be witnessed by another professional staff member who should countersign the note in the medicalrecord.

Question:


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Consent forms are often signed in the office prior to admission for surgery. How long is the form to beconsidered valid?

Answer:

At Yale-New Haven Hospital, a surgical consent form is valid for up to 30 days, unless the surgeon hasevidence 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 consentforms 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 thatthe physician has discussed the surgery with the patient prior to premedication, documentation by theresponsible physician of that discussion in the medical record may be acceptable under hospital policy. If thepatient 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 theform signed?

Answer:

No, this should never be done. Either no consent was necessary (because the surgery was an emergency), orconsent was documented by the surgeon prior to surgery in a progress note. "Retrospective" consent isineffective.


Infectious Disease Control

The ability of the hospital to control infectious disease is an important element of its overall risk managementefforts. All health care providers must comply with federal, state and municipal rules and regulations, inaddition to the hospital's policies and procedures regarding the control of infectious disease. Some of theaspects of infectious disease control which you should familiarize yourself with include:


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1. Preventing and reporting communicable diseases 2. Universal blood and body fluid precautions 3. Needlestick precautions 4. Proper medical waste disposal

States and often, cities, require all physicians and hospitals to report cases, carriers or persons infected withspecified 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 varysomewhat as between the states. Patients need not consent to this reporting and in fact, may not refuse. Thereare penalties for the failure to report. Questions about assistance with infectious disease reporting may bedirected to the hospital Department of Epidemiology and Infection Control.

Since a medical history, examination or laboratory testing cannot reliably identify all patients infected withHIV, Hepatitis B or other blood borne pathogens, health care providers must utilize universal blood and bodyfluid 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 beimmediately 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 beworn if aerosolization or splattering is likely to occur, such as in certain dental and surgical procedures, woundirrigations, post mortem examinations and bronchoscopy.

4) To minimize the need for emergency mouth to mouth resuscitation, mouth pieces, resuscitation bags orother 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 orpunctures. Used needles should not be bent, broken, reinserted into their original sheaths, recapped, orunnecessarily handled. Immediately after use, they must be discarded intact in puncture resistant needledisposal containers. All needle stick accidents, mucosal splashes or contamination of open wounds must bereported 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 thelikelihood 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 healthcare workers, patients and visitors from these viruses. Needlestick injuries are the largest source from whichoccupational exposures to these agents arise in the hospital workplace. Since all hospital workers are at risk ofneedlestick 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.


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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, orbedside tables since they may injure staff, patients, or visitors. Do not throw them into regular garbagecontainers 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 nameand hospital number, prepare an incident form and report the event to Personnel Health. Attempts to "milk" thewound to express contaminants are ineffective and only damage tissues further. Personnel Health will provideyou with information about or appropriate testing for hepatitis and HIV along with any recommendedprophylaxis.

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 localregulatory agencies, in addition to hospitals, have promulgated regulations and policies governing medicalwaste disposal with which all health care workers should familiarize themselves. Improper disposal of medicalwaste 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 thedisposal 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 hypodermicneedles; syringes (with or without needles attached); pipettes; scalpel blades; blood vials; slides andcover dishes; and culture dishes.


Confidentiality

Patients have the right to expect that all communications and records pertaining to their care will be treated as


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confidential, and that their rights to privacy will be protected. Therefore, all health care providers must treatpatient related information in a confidential manner, and guard against the indiscriminant and/or unauthorizedrelease of such information. Although such an act may occur unintentionally, the hospital, physicians and otherhealth 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 bemaintained. Health care providers should refrain from such discussions in elevators, hallways, dining areasand other public areas. Health care providers should use discretion when discussing medical informationconcerning a patient in front of visitors or family members, and should first determine whether the patientwishes to have this information discussed in the presence of such persons. In addition, the patient'spermission should be obtained prior to leaving a message containing confidential medical information on atelephone answering machine, or with family and/or household members. Health care providers should notdisclose patient related information when asked by unidentified or unknown persons, or in response totelephone inquiries, other than providing hospital approved condition reports, e.g., critical, stable, etc. In suchsituations, 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 preventunauthorized access. Medical records should be stored and protected according to hospital policy, preventingpassers-by from viewing the record. Access to patient information via electronic systems should also beprotected 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 andM & M reviews should be conducted in appropriate locations. Materials distributed should be collected and notleft for members of the general public to find.


Patient's Rights

The hospital is committed to ensuring that the individual rights of all patients are respected during their hospitalstay. Most importantly, all patients have the right to expect to be treated with dignity and respect. It isimportant for all health care providers to be familiar with patients' rights under state law and hospital policyand observe them at all times. Patients afforded these basic considerations are usually more satisfied with theirhospital 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 thatpatients understand their rights. All individuals are entitled to receive emergency care and/or treatment withoutdiscrimination due to race, color, religion, sex, national origin, disability, sexual orientation, or source ofpayment. Patients are entitled to be informed of the identity and role of all physicians and support staffinvolved in their care, and have the right to refuse treatment or examination by them. Patients have the right toprivacy while in the hospital and to expect all information and records regarding their care will be keptconfidential.

Patients must be given all the information they need to give informed consent regarding treatment and refusalof treatment. Under most circumstances patients are entitled to review, and should they so desire, obtain acopy of their medical records (after discharge if the record is a hospital record). A patient may refuse to takepart in research and should be able, without fear of reprisals, to complain about the care and services they havereceived.


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Patients, or appropriate family members, should be informed about unexpected and/or negative outcomespromptly. This should include the nature and cause of the event, if known, as well as the manner in which theevent will affect the patient's prognosis and treatment plan. Failing to disclose, or disclosing only partialinformation 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 forpatients, 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 havecertain responsibilities. The most important of these is to provide, to the best of their knowledge, accurate andcomplete information about their present complaints, past illnesses, hospitalizations, medications and othermatters relating to their health. Patients are responsible both for following the treatment plan recommended bythe members of the health care team, and for the consequences should they refuse treatment or not followrecommended instructions.

While trying to treat all patients with dignity and respect, occasionally, the use of physical restraints must beemployed 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 contactedimmediately. 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 andwill generally provide a sound procedural approach.

Competent adult patients have the right to refuse treatment. Since this refusal may be subsequently disputed ordenied by the patient, it is important that all health care providers document these occurrences in the patient'smedical record. When a patient refuses treatment, it is important that his or her physician disclose the risks andconsequences associated with the decision. The treatment being proposed and refused by the patient should bedocumented in the medical record, as well as the fact that the potential adverse consequences have beendiscussed 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 bedocumented regarding his or her voluntary decision to be prematurely discharged, noting the potential adverseconsequences that have been discussed and that the patient understands them. The record should also note thatfurther care has been recommended, as well as where and when the patient intends to obtain this care. Inaddition, most hospitals require that the patient be asked to sign a form indicating he or she is being dischargedagainst medical advice. The patient's refusal to sign this form, which often occurs, should be documented inthe record.

The Patient Representative

The hospital has a patient representative to serve as a liaison between the patient and his or her family, and themedical and administrative staff of the hospital. The patient representative acts as advocate, ombudsman andagent for the patient and enhances patient care by assuring the identification, investigation and amicableresolution of patient complaints and problems. In addition to resolving patient complaints, the patientrepresentative can explain hospital policy and procedures for the patient and/or family and handle lost propertyclaims.

From a risk management perspective, the patient representative plays a critical role in preventing patientcomplaints which, without their early intervention, could evolve into malpractice claims and lawsuits againstthe hospital and/or health care providers. All health care providers are encouraged to contact the patientrepresentative for assistance.

Footnotes:

A medical device is an instrument, apparatus, contrivance, implant, in vitro reagent, or other similar or related


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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 vitrodiagnostics, 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 functionor permanent damage to a body structure.

Note, however, that the physician-patient relationship generally cannot be terminated during a medicalemergency, labor or any other acute event.


January, 1997.Copyright 1997, Yale-New Haven Hospital and Yale University. All rights reserved.

Documents

Hand Book of Risk Management