1 2 Chapter 9 Corporate Structure and Legal Issues See text case – Denton RMC v. LaCroix – pp.186 & 228 – LaCroix suffered irreversible brain damage from cardiac arrest and loss of oxygen during a c-section. Anesthesiologists settled with the LaCroixes for $1.25m. Was the hospital also liable for $8.8m. in damages medical negligence under a theory of corporate liability? Consider anesthesia department policies and procedures. I. Express Corporate Authority - the power granted by state statute, p.187 A. Implied Corporate Authority - authority not expressed by written words. B. Ultra Vires Act- acting beyond scope of authority. II. Corporate Committee Structure, p.190 A. Executive Committee - liaison between management and full board B. Bylaws Committee - reviews & recommended bylaw changes to the governing body C. Finance Committee - oversees financial affairs of the organization. D. Joint Conference Committee - representatives from medical executive committees of governing body and medical staff, including representation from administration and nursing to discuss matters of policy and practice pertaining to patient care. E. Nominating Committee - develop and recommend criteria for governing body membership. F. Planning Committee – recommends the use & development of organizational resources consistent with the mission & vision of the organization. G. Patient Care Committee - review, evaluate and implement plans for improving organizational performance. H. Audit and Regulatory Compliance Committee - develop corporate auditing policies & procedures & review reliability & integrity of financial & operating information I. III. Safety Committee Responsibilities - responsible for overseeing organization’s safety management program. Corporate Ethics, p.192 A. Developing a code of ethics – guidelines to carry out mission, vision, & values B. Corporate conduct under scrutiny – monitored for conduct like false advertising, kickbacks, & fraudulent acts C. Sarbanes-Oxley Act, p.193 3 1. Was signed into law by President Bush on July 30, 2002, in response to the Enron debacle & high-profile cases of corporate mismanagement 2. The Act contains 11 titles, or sections, ranging from additional corporate board responsibilities to criminal penalties, and requires Securities & Exchange Commission to implement rulings on requirements to comply with SOX. 3. Several Major Provisions of SOX a. Certification of financial reports b. Criminal and civil penalties for securities violations c. Significantly longer jail sentences and larger fines of corporate executives, who knowingly misstate financial statements. d. Codes of ethics and standards of conduct for executive officers and board members (most companies have expanded code of ethics to include all employees) D. Build & restore trust – lack of trust is pervasive in the health care system (malpractice, IOM report on mistakes, etc.) & requires strategies by organizations to establish ethical cultures that build consumer trust E. Elements of a Corporate Compliance Program, p. 194 1. Federal government initiative to investigate and prosecute health care organizations for criminal wrongdoing 2. Establishment of policies and procedures 3. Appointment of a corporate compliance officer 4. Communication of program to employees 5. Implementation of program 6. Consistent enforcement IV. Corporate Negligence, p.194 A. Doctrine under which hospital is liable if it fails to uphold proper standard of care owed the patient. B. Theory of liability creates a non-delegable duty which the health care corporation owes the patients. C. Darling v. Charleston Community Memorial Hospital – A Benchmark Case, p.196 4 1. 18 years old Football player injured. 2. Fracture of tibia and fibula 3. Leg casted by general practitioner in emergency department 4. Patient complains of pain. 5. No specialist called for consultation. 6. Two weeks later – patient transferred. 7. Eventually leg amputated. 8. No expert testimony presented. 9. Documentary evidence included medical records, hospital’s bylaws, Illinois hospital Licensing Act, & JCAHO standards 10. Hospital, as a corporate entity, liable for both the negligent act of nurses, & physicians V. Doctrine of Respondeat Superior, p.197 A. Respondeat Superior – “let the master answer.” 1. Legal doctrine holding employers liable for the wrongful acts of their employees. 2. Also referred to as vicarious liability, whereby an employer is answerable for the torts committed by employees. 3. To impute liability to the employer a. Master- servant relationship between employer and employee must exist. b. Wrongful act of employee must occur within scope of employment. B. Hoffman v. Moore Regional Hospital case, p.198 – Hospital not liable for negligence of radiologist under a theory of respondeat superior (member of a contract radiology group, not employee, no control, did not affect the patient treatment decision) C. Independent Contractors 1. Responsible for their own negligent acts 2. Principal must not have right to control agent’s work D. Corporate Officer/Director 5 1. An officer or a director of a corporation is not personally liable for the torts of corporate employees. 2. To incur liability, the officer or the director must be shown to have in some way authorized, directed, or participated in tortious act. VI. Governing Body Responsibilities, p.198 A. Appoint CEO and Medical Staff Appointments and Privileging Johnson v. Misericordia Community Hospital, p.203 – Failure to screen an applicant’s application can result in liability for patient injuries (prospective review, inputs, false applications) Elam v. College Park Hospital – Hospital is liable to a patient under the doctrine of corporate liability for negligence by independent physicians who are neither employees nor agents of the hospital. Candler General Hospital v. Persaud, p.205 – Hospital has a direct and independent duty to patients to reasonably assure that physicians using the hospital are qualified for the privileges granted (grant of temporary privileges, laparoscopic laser cholecystectomy procedure, and wrongful death claim) B. Comply with the law. C. Comply with standards of accrediting organizations. D. Provide timely treatment. E. Avoid self-dealing & conflict of interest. F. Provide adequate staff – deficient nursing care, timely response to patient calls, postoperative care, nursing facility staffing, deficient care given G. Provide adequate insurance. H. Be financially scrupulous. I. Require competitive bidding. J. Provide a safe environment – unsafe conditions, construction hazards, fire hazards, chemical hazards K. Medical equipment – failure to educate staff, failure to properly maintain equipment, contracted preventive maintenance. L. Duty to prevent falls – parking lot safety, hospital lot safety, stretcher safety, safe use of restraints, window safety, slippery floors, loading dock safety M. Duty to safeguard patient valuables. 6 VII. CEO/ Administrator Role and Responsibility, p.201 A. Tort liability of the CEO – wrongful injury in performance of duties B. CEO’s liability for the acts of others – not generally liable C. Regulatory agencies – correction of deficiencies VIII. Medical Staff, p.203 - Governing board has ultimate responsibility for approving: medical staff bylaws, application requirements for privileges, requirements for medical staff consultations, process for granting emergency staff privileges, peer-review process, process for auditing medical records, process for addressing disruptive physicians, & process for disciplinary action IX. Corporate Reorganization, p.222 A. Hospitals, because of fewer revenues from traditional sources (3rd party payers), have restructured to set-up related business enterprises in order to increase revenues to support patient care operations (diversification to expand book of business) B. Legal pressures present substantial impediments. C. Regulatory pressures 1. Taxation – for profits are non- exempt. 2. Third-party reimbursement – payers carve out unrelated costs. 3. Certificate of Need – (CON) 4. Financing – capital financing (caveat – physicians & fraud & abuse laws) 5. Corporate restructuring alternatives – not for profit examples a. Parent holding company model. b. Controlled foundation c. Independent foundation 6. General considerations – purpose is alternative sources of revenue. 7. Medical staff and restructuring – joint ventures 8. Fund raising - donors. 9. Competition and Restructuring a. Restructuring is an undertaking that requires careful planning and legal and accounting advice. 7 b. Restructuring should be undertaken not because it is “fashionable” but rather because it will provide the hospital with opportunities not available under its current structure. c. HCA v. FTC, p.227 – a proprietary hospital chain violated Section 7 of the Clayton Act as its acquisitions were likely to foster collusive practices harmful to consumers. 10. Safe Harbor Regulations - describe how health care providers should structure financial arrangements to be exempt from prosecution by the DOJ & FTC 11. Antitrust Safety Zone a. DOJ and FTC issued policy statements that address antitrust safety zones concerning mergers, joint ventures, etc. b. Statements give health care providers guidance which describe circumstances under which agencies will not challenge conduct as though they were violations of antitrust law 8 Chapter 10 Medical Staff Organization & Malpractice See text case, Bombagetti v. Amine, pp.233&271 - Surgeon mistakenly removed disk at L3-L4 rather than herniated disk at L4-L5. The patient’s condition worsened & the defendant’s negligence caused the plaintiff’s pain & suffering. I. Principles of Medical Ethics – See p. 270 and XXX. Below. II. Medical Staff Organization, p.233 A. Executive Committee – Peer review is the dominant responsibility. B. Bylaws Committee - Organization of the medical staff is described in its bylaws, rules and regulations. C. Blood Transfusion Committee - Develops blood usage policies and procedures & their oversight. D. Credentials Committee - Oversees application process for medical staff applicants, requests for clinical privileges, and reappointments to the medical staff. E. Infection Control Committee - Generally responsible for the development of policies and procedures for investigating, controlling and preventing infections. F. Medical Record Committee - Develops policies, and procedures, including completeness, legibility, & timely completion & clinical pertinence G. Pharmacy and Therapeutics Committee- Oversees tracking of medication errors, adverse drug reactions & use of medications through monitoring and evaluation H. Quality Improvement Council - Functions as patient care assessment & improvement committee I. Tissue Committee - Surgical case reviews, including justification & indications for surgical procedures. J. Utilization Review Committee - Monitors and evaluates utilization issues such as medical necessity and appropriateness of admission and continued stay as well as appropriate level of care. III. Medical Director, p.234 -Serves as a liaison between medical staff & organization’s governing body and management. 9 IV. Medical Staff Privileges A. Credentialing and Privileging Process 1. Medical staff application should provide pertinent personal & professional information. 2. National Practitioner Data Bank (NPDB)- Created by Congress as a national repository of information with primary purpose of facilitating a comprehensive review of physician’s and other health care practitioner’s professional credentials. 3. Delineation of Clinical Privileges - Process by which medical staff determines precisely what procedure a physician is authorized to perform. 4. Governing Body Responsibility – Has ultimate responsibility for the selection of the organization’s professional staff and ensuring that applicants to the organization’s medical staff are qualified to perform the clinical privileges requested. 5. Reappointments- Credentials and department evaluations should be reviewed at a minimum of every two years. 6. Screening for Competency – Hospital is responsible for ensuring that physicians are qualified for the privileges granted. B. Misrepresentation of Credentials – Can permanently revoke a physician’s license. C. Limitations on Required Privileges – Can limit if bylaws & due process are followed. V. Physician Supervision and Monitoring - Responsibility to recognize incompetence & suspend and terminate privileges (Darling case revisited) VI. Disruptive Physicians - Physician’s inability to work with other members of organizations staff can be sufficient grounds to deny staff privileges VII. Practicing Outside Field of Competency, p.237 - Carrasco v. Bankoff A. Surgeon not board certified in plastic surgery or trained in the management of burn cases. B. Standard of care required in a malpractice case will be that of the specialty in which a physician is treating, whether or not he or she has been credentialed in that specialty. VIII. Inadequate Patient Assessments, History and Physical Examinations 1. Moheet v. State Bd. of Regis. For Healing Arts, p.238&240 – The Hearing Commission had cause to discipline the physician by subjecting him and his medical license to public reprimand for failure to meet the standard of care and gross negligence. 10 2. Foley v. Bishop Clarkson Memorial hospital, p.240 - Hospital held that failure to obtain an adequate family history and perform an adequate physical examination violates the standard of care owed to the patient. 3. Gibson v. Moskovitz, p.241 – Physician held responsible in the wrongful death of a correctional facility inmate with a behavioral health condition. There was an incorrect diagnosis and treatment plan that ultimately resulted in the patient’s death from dehydration. IX. Misdiagnosing Unconscious Accident Victim was Malpractice, p.242 – Ramburg v. Morgan A. The police department physician examined an unconscious man who had been struck by an automobile. The physician concluded that the patient’s insensibility was a result of alcohol intoxication, not the accident, & ordered the police to remove him to jail instead of the hospital. The man, to the physician’s knowledge, remained semiconscious for several days and finally was taken to the hospital at the insistence of his family. The patient subsequently died. An autopsy revealed massive skull fractures. B. Although the physician does not ensure the correctness of the diagnosis or treatment, a patient is entitled to such a thorough & careful examination as his or her condition and attending circumstances permit, with such diligence and methods of diagnosis as usually are approved and practiced by medical people of ordinary or average learning, judgment, and skill in the community or similar localities. X. Failure to Obtain 2nd Opinion - Goodwich v. Sinai Hospital held that physicians must seek 2nd opinions when required A. Record was replete with documentation of questionable patient management & continual failure to comply with 2nd opinion agreements. B. Case demonstrates reasonable use of peer review process. XI. Aggravation of a Preexisting Condition, p.243 - Nguyen v. County of Los Angeles A. Hip study of eight-month-old female patient resulted in cardiac arrest and brain damage. B. Aggravation of a preexisting condition through negligence may cause a physician to be liable for malpractice. C. If the original injury is aggravated, liability will be imposed only for the aggravation, rather than for both the original injury & its aggravation. XII. Failure to Promptly Review Test Results, p. 245 - Smith v. U.S. Department of Veterans Affairs held that a physician’s failure to promptly review test results can be the proximate cause of a patient’s injuries XIII. Timely Diagnosis, p.247 – Powell v. Margileth 11 A. Physician treated patient for cat scratch disease later diagnosed as stage IV cancer (likely Hodgkins Disease), & patient died three years later. B. Physician can be liable for reducing a patient’s chances for survival. C. Timely diagnosis of a patients’ condition is as important as the need to accurately diagnose the patient’s injury or disease. D. Failure to timely diagnose can constitute malpractice if a patient suffers injury as a result of such failure. XIV. Misdiagnosis, p.251 - Corley v. State Department of Health Hospitals A. Failure to form a differential diagnosis can result in liability. B. Physician’s failed to consider other diagnoses – back pain was due to a malignant chest mass. XV. XVI. Pathologist Misdiagnosis of Breast Cancer - Anne Arundel Med. Ctr. Inc. v. Condon, p.252 held that pathologist’s failure to interpret invasive carcinoma was a departure from standard of care required and was proximate cause of patient’s injuries Delaying Treatment, p.255 – Blackmon v. Langley A. Patient not informed by physician that an x-ray showed a lung lesion later diagnosed as cancer. B. Physician may be liable for failing to respond promptly if it can be established that such inaction caused a patient’s death. XVII. Respond to Emergency Call, p.257 - Dillon v. Silver A. Physicians on call in emergency department are expected to respond to request for emergency assistance when such is considered necessary. B. Failure to respond is grounds for negligence should a patient suffer injury as a result of physician’s failure to respond. XVIII. Medication Errors – more frequent categories include wrong dosage, abuse in prescribing medications, medications aggravate preexisting condition. XIX. Surgery A. Examples of potential surgical negligence include, phantom surgeon, wrong surgical procedure, correct surgery- wrong site, wrong site- surgery and fraud. B. Foreign Objects Left in Patient, p.261 - Williams v. Kilgore 1. Needle fragment left in patient’s lower back, following a biopsy in 1964. 12 2. Back pain eventually resulted in removal of the fragment in 1985. 3. Suit was not time barred by statute of limitations based on when patient had reasonable knowledge of the injury. C. Wick v. Henderson, p.262– Improper positioning of arm resulted on ulnar nerve injury following gallbladder surgery (res ipsa loquitor was applied) D. Lacomb v. Dr. Walter Olin Moss Regional Hospital – Sciatic nerve injury resulted following a bladder suspension surgery (re ipsa loquitor was applied) XX. Failure to Maintain Adequate Airway - Ward v. Epting, p.262 A. Anesthesiologist failed to conform to the standard of care. B. Deviation from the standard was the proximate cause of the patient’s death. XXI. Failure to Refer, p.263 - Doan v. Griffith A. Patient had multiple facial fractures. B. A physician has a duty to refer patient whom he or she knows or should know needs referral to a physician familiar with and clinically capable of treating the patient’s ailments. C. To recover damages, plaintiff must show that the physician deviated from the standard of care and that the failure to refer resulted in injury. XXII. Improper Performance of a Procedure - Improper performance of a procedure can result in injury to the patient & liability for the physician XXIII. Failure to Follow Up, p.264 – Truan v. Smith A. Case of outrageous neglect by a physician of a breast cancer case B. Failure to provide follow-up care can result in a lawsuit if such failure results in injury to patient XXIV. Loss of Chance to Survive A. A loss of chance to survive can result in malpractice. B. See text cases: Boudoin v. Nicholson, Baehr, Calhoun and Lanasa, pp.253-254 Downey V. University Internists of St. Louis, Inc., p.264 XXV. Lack of Documentation – If it is not written down, it did not happen. 13 XXVI. Premature Discharge – Decisions to discharge patients should be based on medical reasons. XXVII. Abandonment, p.265 - Elements necessary to recover damages for abandonment are the following: Medical care unreasonably discontinued; discontinue against patient’s will; failure to assure follow up care for patient; foresight- failure could result in patient injury; & actual harm was suffered by patient. XXVIII. Infections, p.265 A. Nosocomial (hospital acquired) infections should be critically managed for individual patients. B. Infection rates should be studied to assure that they are within the range of the norm. XXIX. Psychiatry, p.266 A. Commitment – major risk areas of psychiatry are found on pp.266-269. B. Duty to Warn, p.269 1. Tarasoff v. Regents of the University of California held a duty to warn a patient’s foreseeable victims 2. Exceptions to duty to warn include confidentiality & statutes making the duty discretionary with mental health providers (Texas) XXX. Principles of Medical Ethics, p.270 A. Code of Medical Ethics includes principles of competence, compassion, Professionalism, & respect at several levels of interaction B. My Hopes for Help Crumble, p.271 – frustrated patient’s letter to her physician 14 Chapter 11 Nursing and the Law See text case, Ard v. East Jefferson General Hospital, pp. 276&307– Nursing staff breached the standard of care for failing to respond to a patient in distress who subsequently died. The patient’s wife unsuccessfully sought call bell help for 1 ¼ hours. The medical record further supported her testimony. I. Expanded Scope of Practice & Nursing Milestones, p.277 A. Refers to the permissible boundaries of practice for health care professionals, defined in state statues, which defines the actions, duties and limits of nurses in their particular roles B. Role of nurse continues to expand due to shortage of primary care physicians, everincreasing specialization, improved technology, public demand, & expectations within the professions itself C. 1952- All states, including the District of Columbia and U.S. territories, had enacted nurse practice acts D. 1990- The American Nurses Association (ANA) again amended its model definition for nursing practice to include the advanced nurse practitioner (NP) and the registered nurse (RN) II. Nursing Diagnosis Allowed in Cignetti v. Camel, p.278 A. Defendant physician ignored nurse’s assessment of patient’s diagnosis which contributed to delay in treatment and injury to the patient. Nurse testified that she told the physician that patient’s signs and symptoms were not those associated with indigestion. Defendant physician objected to this testimony, indicating that such a statement constituted a medical diagnosis by a nurse. The trial court permitted the testimony to be entered into evidence. B. Missouri Court of Appeals affirmed lower court’s ruling, holding that evidence of negligence presented by the hospital employee, for which an obstetrician was not responsible, was admissible to show events that occurred during patient’s hospital stay. III. Nurse Licensure A. Professional training is required for nurse licensure in all states. B. Out – of – state nurses are licensed by reciprocity, endorsement, waiver & examination. C. Suspension and Revocation of License - Violations may include procurement of license by fraud; unprofessional, dishonorable, and immoral or illegal conduct; performance of specific actions prohibited by statute; & malpractice 15 D. Practicing without a License 1. Health care organizations are required to verify that each nurses’ license is current. 2. Mere fact that an unlicensed practitioner is hired will not generally in and off itself impose additional liability unless a patient suffered harm because of an unlicensed nurse’s negligence. IV. American Nurses Association & the National League of Nursing – ANA is the national professional association for graduate nurses who are licensed, & the NLN is a membership organization for diverse stakeholders seeking to improve nursing services & education V. Nursing Negligence – National Practitioner Data Bank & the more common area of litigation, including anesthesia, diagnosis, & monitoring VI. Nurse Manager, p.280 A. Chief nursing officer has responsibility for maintaining standards of practice, maintaining current policy and procedure manuals, recommending staffing levels, coordinating and integrating nursing services with other patient care services, selecting nursing staff, & developing orientation and training programs B. Failure to supervise can lead to disciplinary action. VII. Certified Nursing Assistant A. An aid who has been certified and trained to assist patients with activities of daily living under the direction and supervision of an RN or LPN B. Nursing assistant help in positioning, turning, lifting, and performing a variety of tests and treatments C. Examples of patient injuries by nursing assistants for failure to follow policy and safe practices include patient burns (scalded), falls & transfer (lift) VIII. Float Nurse, p.282 A. Nurse who rotates from unit to unit based on staffing needs. B. “Floaters” can benefit an understaffed unit, but they also may present a liability as well if they are assigned to work in an area outside their expertise. C. If a patient is injured because of a floater’s negligence, the standard of care required of the floater will be that required of a nurse on the assigned patient care unit IX. Agency Staff, p.283 - Organizations are at risk for negligent conduct of agency staff & must assure that agency workers have the necessary skills and competencies to carry out duties and responsibilities assigned by the organization. 16 X. Special Duty Nurse A. A health care professional employed by a patient or patient’s family to perform nursing care for the patient. B. If a master- servant relationship exists between an organization and special duty nurse, doctrine of respondeat superior may be applied to impose liability on the organization for nurse’s negligent acts. XI. Student Nurses – Are entrusted with responsibility of providing nursing care to patients; personally liable for their own negligent acts, and the facility is liable for their acts on the basis of respondeat superior; & held to the standard of a competent professional nurse when performing nursing duties XII. Nurse Practitioner, p. 284 A. RNs that have completed education sufficient to engage in primary health care decision making. B. Trained in delivery of primary health care and assessment of psychological and physical health problems such as the performance of routine examinations and ordering of routine diagnostic tests. C. Adams V. Krueger, p.285 – NP’s negligence imputed to physician for incorrect diagnosis & treatment plan & for failure to review NP’s plan XIII. Clinical Nurse Specialist, p. 284 – Professional RN with an advanced academic degree, experience, and expertise in a clinical specialty (e.g., obstetrics, psychiatry, pediatrics, etc.). XIV. Nurse Anesthetist A. Administration of anesthesia by a nurse anesthetist requires special training and certification. B. Nurse-administered anesthesia was the first expanded role of nurses requiring certification. C. Oversight and availability of an anesthesiologist are required by most organizations. D. Major risks of nurse anesthetist include: 1. Improper placement of an airway 2. Failure to recognize significant changes in a patient’s condition 3. Improper use of anesthetics 17 E. Denton Regional Medical Centre V. La Croix, note case and not in text 1. Hospital held liable for negligence for failing to have an anesthesiologist present or available in surgery. 2. CRNA was present. 3. Patient suffered irreversible brain damage. 4. Multimillion dollar award to plaintiff XV. Certified Nurse Midwife, p.285 A. Nurse midwives provide comprehensive prenatal care including delivery for patients who are at low risk for complications. B. They often manage normal prenatal, intrapartum, and post-partum care. C. Provided that there are no complications, normal newborns are also cared for a nurse midwife. D. Nurse midwives often provide primary care for women’s issues from puberty to post menopause. E. Morris v. Department of Professional Regulation, p.286 - Practicing without a license resulted in suspension, probation & a fine. F. Ali v. Community Health Care Plan, Inc., p.286 – Standard of care required of a nurse midwife is that applicable to nurse midwife rather than an ob/gyn professional. XVI. Dilemma of two Standards of Care, p.288 - Edwards v. Brandywine Hospital A. Patient allegedly suffered staph infection from failure to change placement of catheter within 48 hrs. (AHA recommendation) B. Hospital had 72 hrs. rule C. When faced with dilemma of two standards for rendering patient care, an organization may find it more attractive to adopt the one least restrictive or labor intensive. D. Could prove to be costly decision for both patient and organization by increasing the risk of patient injury & organization’s exposure to corporate liability for any injury suffered from following the less restrictive standard XVII. Patient Misidentification, p.289 A. Surgical staples removed from wrong patient. 18 B. Chart was not checked. C. Wrist band was not checked. D. Wrist band was not checked against chart. (Meena v. Wilburn) E. Inadvertent or negligent switching of infants can lead to liability for damages. F. Damages in the amount of $ 110,000 were awarded for the inadvertent switching of two babies born at the same time. G. Follow organization’s policy and procedure in patient identification process. (De Leon Lopez v. Corporacion Insular de Seguros, p.290) XVIII. Patient Monitoring and Observation A. Eyoma v. Falco, p.290 1. Nurses have responsibility to observe the condition of patients under their care and report any pertinent findings to the attending physician. 2. Failure to note changes in a patient’s condition can lead to liability on the part of the nurse and organization a. Nurse assigned to monitor a post- surgical patient, left the patient and failed to recognize that the patient had stopped breathing. b. Nurse had been assigned to monitor the patient in the recovery room. c. She delegated duty to another nurse and failed to verify that the nurse accepted. the responsibility B. McCann v. ABC Insurance Company, p.290 1. Evidence presented indicated that the standard care would require that fetal heartbeats be monitored every ten minutes following removal of the fetal monitor. 2. Evidence presented indicated that this did not occur. C. Brandon HMA, Inc. v. Bradshaw, p.291 1. Failure to properly monitor patient admitted for bacterial pneumonia 2. Failure to report vital information to patient’s physician 3. Allowed condition to deteriorate to critical stage, before implementing urgent care or implementing life support 19 4. Plaintiff awarded $9 million for resulting brain damage & physical disability D. Porter v. Lima Memorial Hospital, p.292 1. Infant suffered paralysis from waist down following an automobile accident 2. Physician held responsible for not diagnosing spinal cord injury & initiating immobilization, care & work up 3. Nurse’s conduct not held to be a proximate cause of the paralysis (failure to repeat vital signs) E. Odom V. State Department of Health and Hospitals, p.293 –court held monitor should have been on, but was disconnected by the staff and led to patient’s death. F. Failure to report defective equipment can cause a nurse to be held liable for negligence if the failure to report is the proximate cause of a patient’s injuries (The defect must be known and not hidden from sight.), p.203 XIX. Delay in Reporting Patient’s Condition, p.293 A. An organization’s policies and procedures should prescribe guidelines for staff members to follow when confronted with a physician or other health care professional or other health care professional whose action or inaction jeopardizes the well-being of a patient. (Goff v. Doctors General Hospital, p.294) B. Physician inserted a catheter into the wrong artery in the patient’s right leg compromising the blood flow to the leg & causing loss of pulse and sensation C. This error was compounded when hospital nurses on the patient’s floor were unable to reach the physician for six hours and never attempted to reach a back- up physician to alert them of patient’s deteriorating condition (Cuervo v. Mercy Hospital, Inc.) D. Court held that there was sufficient evidence to authorize the jury to find that the nurse was negligent in failing to timely notify the physician that delivery of plaintiff’s child was imminent. E. This delay resulted in an unattended childbirth with consequent injuries. F. Plaintiff was awarded $15,000. (Hiatt v. Grace, p.294) G. Hospital’s nurse was negligent in failing to inform the physician of all the patient’s symptoms, to conduct a proper examination of the plaintiff, & to follow the directions of the physician. (Citizen’s Hospital Association v. Schoulin, p.294) 20 H. Failure to follow infection control procedures can result in cross contamination between patient’s, staff and visitor I. This failure to notify physician found to be a factor in the death of nursing home resident with decubitus ulcers; $2 million in punitive damages allowed. (Montgomery Health Care v. Ballard, p.295) XX. Delay in Treatment, p.295 – Howerton v. Mary Immaculate Hospital Inc. A. Minutes count! B. Nurses delay contacting obstetrician. 1. Patient suffers worsening pain (uterus had ruptured in three places during labor; baby had extensive neurological damage) 2. At trial, expert witness stated that labor and delivery room nurses should have immediately gone to the patient when they were notified of worsening pain, evaluate her condition, and notify her physician. XXI. Failure to Follow Orders, p.296 - Redel v. Capital Regional Medical Center A. Nurses caused permanent drop foot to the patient. B. They failed to follow the doctor’s oral orders to watch the patient closely and to place him in one continuous passive motion machine at a time during physical therapy. XXII. Leaving Patient Unattended, p.297 – Vanhoy v. U.S. A. Coronary bypass surgery patient left unattended for several hours by ICU nurses. B. Patient suffered anoxic brain injury & was permanently disabled. C. Awarded lump-sum payment of $3.5m. XXIII. Failure to Record Patient’s Care – Pellerin v. Humedicenters, Inc. A. Nurse admitted she failed to record site and mode of injection in ED records. B. Experts testified that failing to record this information is below standard care for nursing. C. Although these omissions could not have affected administration of the injection, they tend to indicate that the nurse did not follow accepted procedure while performing her job. D. Failure to discontinue a drug. E. Failure to identify the correct patient. 21 F. Failure to note an order change. XXIV. Medication Errors, p.297 A. Failure to administer drug. B. Failure to document drug wastage C. Administering a drug not prescribed D. Administration of wrong drug E. Failure to clarify orders. F. Ambiguous orders G. Administering the wrong dosage – Harder v. Clinton, p. 299 1. On appeal, plaintiff’s res ipsa loquitor pattern of proof was allowed 2. Case based on an overdose of a wrong prescription to a nursing home patient resulting in a leg amputation H. Negligent drug overdose I. Administering drug by wrong route J. Failure to discontinue a drug. k. Failure to identify the correct patient. L. Failure to note an order change. XXV. Failure to follow infection-Control Procedures, p.301 A. The patient brought a medical malpractice action against the hospital, seeking damages arising out of an operation performed with unsterile instruments. B. Nurse in charge of the autoclave used to sterilize instruments was alleged not to have properly monitored the sterilization process. (Howard v. Alexandria Hospital) XXVI. Negligent Procedures A. Monk v. Doctors Hospital 1. Negligent use of a Bovie plate led to liability in which nurse was instructed by the physician to set up a Bovie machine. 22 2. Nurse negligently placed contact plate of Bovie machine under the patient’s right calf causing burns. 3. Patient introduced instruction manuals, issued by the manufacturer, to support a claim that the plate was placed improperly. 4. Manuals had been available to the hospital B. Morris v. Children’s Hospital Medical Centre, p.302 1. Morris alleged from personal observation that the laceration to her daughter’s arm was caused by the jagged edges of a plastic cup that had been split and placed on her arm to guard an IV site 2. A nurse, qualified as an expert, expressed her opinion that the practice of placing a split plastic cup over an IV site as a guard constituted a breach of the standard of nursing care C. Bernardi v. Community Hospital Association -Nurse negligently injected the tetracycline into or adjacent to the sciatic nerve, causing the patient to permanently lose the normal usage of the right foot D. Ahmed v. Children’s Hospital of Buffalo 1. A nurse employed by the defendant amputated nearly one third of a one-month old infant’s index finger while cutting an IV tube 2. Damage awards of $87,000 for past pain and suffering & $50,000 for future damages 3. Defendant moved to set aside the verdict and sought a new trial 4. The appellate court found that the jury’s award of damages did not deviate materially from what would be reasonable compensation. E. Romero v. Bellina, p.303 1. Sponge and instrument miscounts 2. Both nurses and surgeons are responsible a. Surgeon’s duty is independent and nondelegable. b. Nurses have an independent duty that is a remedial measure. F. Always verify infant’s identification badge with mother’s XXVII. Patient Falls, p.303 - Among elders, falls represent the fifth leading cause of death and the mortality rate from falls increases significantly with age 23 A. Proper Use of Restraints – Estate of Hendickson v. Genesis Health Venture Inc., p.303 – failure to follow restraint policies was the proximate cause of death B. Failure to Raise Bed Rails – Polonsky v. Union Hospital, p.304 – nurse failed to exercise due care when she failed to raise rails after administering a sleeping medication C. Patient Fall: Safe Procedures Followed – Stoker v. Torenteno – nurse did not improperly leave a wheelchair resident alone in bathroom (no written or verbal order) D. Fall from Examination Table – Petry v. Nassau Hospital – damages recovered for fall from narrow exam table in emergency room (patient left unattended by nurse in charge) XXVIII. Failure to Question Discharge, p. 304 A. Koeniguer v. Eckrich - A nurse has a duty to question the premature discharge of a patient if he or she has reason to believe that such a discharge could be injurious to the health of the patient B. NKC Hospitals, Inc. v. Anthony, p.305 1. Hospital’s negligence is based on acts of omission by failing to have the patient examined by a physician and by discharging her in pain. 2. Evidence presented a woman conscious of her last days on the earth, swollen beyond recognition, tubes exiting almost every orifice of her body, in severe pain, and who deteriorated to the point where she could not verbally communicate with loved ones. 3. Negligence of hospital not superseded by that of the primary care physician. 4. Pain & suffering award of over $ 2 million was upheld. XXIX. Failure to Report Physician Negligence – Goff v. Doctors General Hospital, p.305 A. Patient bleeding seriously after childbirth due to physician’s failure to suture properly B. Note changes in patient’s condition C. Report changes in patient’s condition 1. Prompt notification required. 2. Physician failure to respond. 3. Report “all” patient symptoms 24 Chapter 12 Hospital Departments and Allied Professionals See text case Ronnie Green, pp. 311&353 – Failure to responsibly triage emergency patients can result in lawsuit (9-1-1 call outside hospital ER because the ER failed to treat a 3YOF who died three days later) I. First Responders, p.311 A. Many states have legislation that provides civil immunity to paramedics who render emergency lifesaving services. B. Riffe v. Vereb Ambulance Service, Inc., p.314 – wrongful death action resulting from (EMS) administering lidocaine at 44 times the normal dosage C. Application for Paramedic License Denied 1. Multiple felony convictions 2. Remanded to board based on pardon for convictions II. Emergency Department, p.314 A. Emergency Medical Treatment & EMTALA, p.315 1. In 1986, Congress passed the Emergency Medical Treatment and Active Labor Act (EMTALA) that forbids Medicare- participating hospitals from “dumping” patients out of emergency departments (EMTALA provision summarized) 2. An emergency medical condition is “a manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in (i) placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, (ii) serious impairment of bodily functions, (iii) serious dysfunction of any bodily organ or part….” 3. EMTALA Text Cases, pp.316-318 – Includes claims concerning patient screening, patient stabilization, alleged delay in patient transfer, appropriate screening and discharge, & transfer prior to stabilizing patient B. Wrong Record Fatal Mistake, p.318 -Trahan v. McManus 1. Terry was taken to the hospital after being injured in an automobile accident. 25 2. Upon ordering discharge, the ED physician had not realized that he had made the fatal mistake of looking at the wrong chart in determining Terry’s status. 3. Terry died at home in his father’s arms as his head slumped forward. 4. The Emergency Department physician, by his own admission stated that he acted negligently when he discharged Terry and that his actions led to Terry’s death. C. Duty to Contact On-Call Physician 1. Hospitals are expected to notify specialty on-call physicians when their particular skills are required in the emergency department. 2. A physician who is on call and fails to respond to a request to attend a patient can be liable for injuries suffered by the patients. 3. Claims include failure to respond to call, lack of timely response, & providing reasonable notice of inability to respond to call. D. Objectives of Emergency Care, p.320 1. Treatment must begin as rapidly as possible. 2. Function is to be maintained or restored. 3. Scarring and deformity are to be minimized. 4. Treatment regardless of ability to pay. 5. Frightening slackers (intoxicated alcoholic) is not acceptable. E. Patient Leaves Emergency Department Without Notice – Griffith v. University Hospital of Cleveland, p.320 1. In a wrongful death medical malpractice action alleging negligence, the trial court properly granted summary judgment 2. Under Ohio law, an emergency room nurse has no duty to interfere with an individual who leaves the ED without telling anyone and refuses treatment F. Failure to Admit – Roy v. Gupta, p.321 1. Physicians were found negligent in failing to hospitalize the patient or failing to inform her of the serious nature of her illness. 2. Trial court found that had the patient been hospitalized on her first visit, her chances of survival would have been increased. G. Documentation Sparse and Contradictory, p.321 - Fenney V. New England Medical Centre 26 1. ED physician failed to evaluate the patient and to initiate care within first few minutes of patient’s entry into the emergency facility. 2. Emergency physician had an obligation to determine who was waiting for physician care and how critical the need was for that care. H. Telephone Medicine can be Costly - Futch v. Attwood, p.321 1. Lauren was taken to the hospital emergency department. a. Hospital personnel contacted physician by phone. b. He returned the call and prescribed a Phenergan injection. c. Physician did not go to the hospital and had not been given Lauren’s vital signs when he suggested such an injection, and further failed to order any blood or urine tests. d. Hospital records revealed that Lauren’s glucose level was 507 at the time of admission. e. Lauren went into respiratory failure and eventually died. 2. The trial court allocated $98,000 for the conscious pain and suffering of Lauren. a. Defendant complained that the award of $98,000 was excessive. b. Appellate court could not find that the trial court had erred in concluding what sum was fair to both the parties. I. Improving Emergency Department Patient Care, p.322 1. Develop and implement policies and procedures. 2. Communicate with the patient and the patient’s family to ensure that a complete and accurate picture of the patient’s symptoms and complaints are obtained. 3. Communicate among healthcare professionals. 4. Provide continuing education programs for all staff members. 5. Institute a preventive maintenance program for emergency equipment. 6. Provide timely triage. 7. Do not take lightly any patient’s complaints - may be the most serious mistake in the emergency department. 8. Professionals who cannot accept the concept that all patients, regardless of ailment, must be treated should search for placement outside emergency department. 27 9. Hospitals need to determine what types of patients and levels of care they can safely address & communicate with other hospitals, including emergency medical service personnel in addressing transport and care issues. J. Emergency Room Vital to Public Safety, p.323 1. The hospital itself has come to be perceived as the provider of medical services. 2. Patients come to the hospital to be cured. 3. 4. Doctors who practice there are the hospital’s agents regardless of the nature of the private arrangements between the hospital and the physician. This is the reality of public perception and attendant public policy. K. State Regulations, p.324 1. Legislation in many states imposes a duty on hospitals to provide emergency care. 2. The statutes implicitly, and sometimes explicitly, require hospitals to provide some degree of emergency service. III. Laboratory, p.324 A. An organization’s lab provides data that are vital to a patient’s treatment. 1. Monitors therapeutic ranges, measures blood levels for toxicity, places and monitors instrumentation on patient units. 2. Provides education for the nursing staff (such as glucose monitoring). 3. Provides valuable data utilized in research studies. 4. Provides data on the most effective and economical antibiotic for treating patients. 5. Serves in a consultation role. 6. Provides valuable data as to the nutritional needs of patients. B. Claims include failure to follow transfusion protocol, mismatched blood & refusal to work with certain specimens; Dodson v. Community Blood Center, p.328 - Damage award appropriate for transfusing the patient with the wrong blood resulting in Hepatitis C C. Sander v. Geib, Elston, Frost Professional Association, p.330 1. Pap Smears suspicious of cancer were read as normal for several years 28 2. Eventual diagnosis was terminal & metastatic cancer 3. Court determined evidence relating to negligence claims pertaining to Pap tests taken more than two years before filing the action were admissible because the patient had a continuing relationship with the clinical laboratory as a result of her physician submitting her Pap tests to the laboratory over a period of time. IV. V. Medical Assistant, p.331 - An unlicensed person who provides administrative, clerical, and/or technical support to a licensed practitioner Nutritional Services, p.333 A. Need to provide nutrition. B. Failure to do so can result into a lawsuit. C. Lambert v. Beverly Enterprise – Nursing facility patients are highly vulnerable (patient suffered malnutrition, and motion to dismiss was denied). VI. Pharmacy, p.334 A. Immense variety and complexity of medications B. Impossible for nurses or doctors to keep up with the information required for safe medication use. C. The pharmacist has become an essential resource in modern hospital practice. D. Common types of medication errors: 1. Prescription errors a. Wrong patient b. Wrong drug c. Inappropriate drug ordered due to known drug allergies, drug-drug and fooddrug interactions. d. Wrong dose e. Wrong route f. Wrong frequency g. Transcription errors (due to illegible handwriting and improper use of abbreviation) h. Inadequate review of medication for appropriateness 29 2. Dispensing errors a. Improper preparation of medication b. Failure to properly formulate medications. c. Dispensing expired medications d. Mislabeling containers e. Wrong patient f. Wrong dose g. Wrong route h. Misinterpretation of physician order 3. Documentation Errors a. Transcription errors (often due to illegible handwriting and improper use of abbreviations) b. Inaccurate transcriptions to medication administration record (MAR) c. Charted but not administered. d. Administered but not documented on the MAR. e. Discontinued order not noted on the MAR. f. Medication wasted and not recorded. A. Government Control of Drugs, p.334 1. Federal Controls a. Controlled Substance Act (CSA) of 1970, signed into law on October 27, 1970, replaced virtually all preexisting federal laws dealing with narcotics, depressants and stimulants. b. Federal, Food, Drug and Cosmetic Act (FDCA) applies to drugs and devices carried in interstate commerce and to goods produced and distributed in federal territory. 2. State Regulations – Regulate Pharmacists & Pharmacies 3. Distribution (movement), Dispensing (processing), and Administration (single dose given to patient) of Drugs 30 4. Storage of Drugs – In original containers & labeled properly. 5. Drug Substitution – Dispensing a different drug or brand in place of the drug or brand ordered. a. Prohibited in some states. b. Formularies allow for generic substitution. 6. Decreasing Medication Misadventure a. Be sure handwriting is legible & print if necessary. b. For clarity, do not use felt – tip pens. c. Abbreviations should be used according to hospital policy. d. Do not write ambiguous orders. e. Always add a zero prior to a decimal. f. Hold orders should be accompanied by a time frame. g. Know about the medication you are prescribing. h. Be sure medications are properly diluted before prescribing. i. Be sure that medications are being administered by the proper route. 7. Expanding role of the pharmacist a. Duty to monitor patient’s medications (computer systems monitor for drugdrug interaction & drug- food interaction) b. Warning patients- potential for overdose c. Refusal to honor questionable prescriptions. d. Limited duty to warn (Pharmacists cannot possibly warn caregivers and patients of every potential danger of a drug) VII. Physical Therapy, p.340 A. The art and science of preventing and treating neuromuscular or musculoskeletal disabilities through the evaluation of an individual’s disability and rehabilitation potential. B. Pontiff v. Pecot & Associates, p.341 1. Physical Therapist - incorrectly interpreted physician’s orders 31 2. Plaintiff alleged that defendant failed to exercise degree of care and skill ordinarily exercised by physical therapists, failed to heed his protests that he could not perform the physical therapy treatments she was supervising, and failed to stop performing treatment after he began to complain he was in pain. 3. Plaintiff’s expert testified defendant deviated from standard of care by introducing a type of exercise not prescribed by the physician. 4. The appeals court found that the trial court was correct in its determination that the plaintiff presented sufficient evidence to show that therapist’s care fell below the standard of other physical therapists. C. Armintor v. Community Hospital of Brazosport, p.342 1. Oral contract to furnish services was terminated. 2. Hospital claimed that its attempt to establish a hospital – based physical therapy program would have been disrupted if the independent therapist had been permitted to continue treating patients. 3. Exclusion of a therapist is an administrative matter within the board’s discretion. D. Zucker v. Axelrod 1. Physical therapist charged with resident neglect for refusing to allow an 82-year-old nursing facility resident to go to the bathroom before starting his therapy treatment session. 2. PT assumed resident had gone to bathroom before therapy. 3. Court held resident neglect was supported by the evidence. E. Girgis v. Board of Physical Therapy 1. License was found to have been properly revoked 2. Physical therapist’s license had been properly revoked in eight other states VIII. Physician’s Assistant, p.342 A. Work as physician extenders B. Scope of practice is defined by each state. C. Physician Assistants responsible for own negligent acts IX. Radiology and Related Lawsuits, p.343 A. Negligence in medical imaging tests and therapies often involve a failure to protect patients from falls and the negligent handling of equipment. 32 B. Schopp v. Our Lady of the Lake Hospital, p.344 1. Patient fell at home, striking head and was eventually taken to hospital. 2. Patient’s death caused by the negligence of hospital staff by dropping an x-ray cassette on her head while undergoing a skull x-ray. X. Respiratory Therapist, p.345 A. Therapy is the allied health profession responsible for the treatment, management, diagnostic testing and control of patients with cardiopulmonary deficits B. Claims include failure to remove endotracheal tube which caused patient injury & was negligence; multiple use of same syringe violated state policy of quality patient care; failure to restock the code cart resulted in a substantial evidence finding of proximate cause of patient’s injuries (brain death) XI. Chiropractor, p.347 A. A chiropractor is required to exercise the same degree of care, judgment, and skill exercised by other reasonable chiropractors under like or similar circumstances B. Poor v. State (not in text) 1. Conspiracy to manufacture and distribute misbranded substance. 2. Introduced misbranded and adulterated drugs into interstate commerce with intent to defraud. 3. District and appellate courts found chiropractor’s conduct immoral. 4. Chiropractor’s denial, after taking advantage of a plea bargain, that he committed any of the acts he admitted to in the U.S. district court is disturbing and not consistent with the integrity expected of persons engaged in a professional occupation. XII. Dentistry, p.348 A. Dental malpractice cases are generally related to patients who suffer from complications of dental procedures. B. Examples of dental malpractice claims 1. Drill Bit Left in Tooth 2. Failure to Refer 3. Lack of Consent - Removal of tooth without consent 4. Lack of Consent – Removal of tooth without consent 33 C. Failure to Prescribe Antibiotics - Risk of not prescribing antibiotics is that bacteria can flow through the bloodstream to the heart. D. Failure to Prescribe Antibiotics - Risk of not prescribing antibiotics is that bacteria can flow through the bloodstream to the heart. E. Failure to Wear Protective Gloves F. Practicing Outside Scope of Practice – Brown v. Belinfante, p.350 - Dentist preformed several elective cosmetic procedures including a face lift, eyelid revision, and facial laser resurfacing. G. Dental Hygienist Administers Nitrous Oxide H. Failure to Supervise Dental Assistant XIII. Podiatrist, p.351 A. The legal concerns of podiatrist are similar to those of surgeons, including misdiagnosis and negligent surgery. B. Strauss v. Biggs 1. Podiatrist was found to have failed to meet the standard of care required of a podiatrist and that failure resulted in injury of the patient. 2. Podiatrist, by own admission, stated that his initial incision in the patient’s foot had been misplaced (He could not find the incision?) 3. Podiatrist acted improperly by failing to refer the patient, stop the procedure after the first incision, inform the patient of possible nerve injury, and provide proper postoperative treatment. XIV. Security, p.351 A. Hospitals have a duty to implement and maintain reasonable measures to protect patients from the criminal acts of third parties. B. If an attack or injury to a patient is not foreseeable, the hospital’s actions cannot be the proximate cause of patient’s injuries. C. Lane V. St. Josephs’ Regional Medical Center 1. Patient was sitting in emergency department waiting room, when a teenage boy, D.G., arrived with his mother. 2. After a short time, D.G. walked up to Lane and began to hit her on her right arm and shoulder. 34 3. Patient Lane’s son-in-law, who had accompanied her to the emergency room, jumped to her aid and struck D.G., knocking him to the floor. 4. The attack stopped and nothing further happened. 5. Lane suffered some injuries as a result of the attack. 6. The hospital was not held liable for Lane’s injuries. a. The attack upon Lane by D.G. was unexpected and no other evidence was designated to the trial court from which it could have concluded that the specific action of D.G. on the day in question was foreseeable b. The attack and the injury were not foreseeable, the actions were not the proximate cause of Lane’s injury, and that the center is entitled to judgment as a matter of law D. Hanewinckel v. St. Paul’s Property & Liability, p.351 1. Hospital female employee was attacked by a man in the hospital parking lot 2. Court held hospital breached its duty to employee by failing to patrol the lot 3. Employee was awarded $733,000. XV. Licensure and Certification of HealthCare Professionals, p.352 A. Recognition by a governmental or professional association that an individuals’ expertise meets the standards of that group. B. Some professional groups establish their own minimum standards for certification in those professions that are not licensed by a particular state. C. Certification by an association or group is a self regulation credentialing process. XVI. Licensing Healthcare Professionals A. Process by which a competent authority grants permission to a qualified individual to perform certain specified activities that would be illegal without a license. B. Licensure refers to the process by which licensing boards, agencies, or departments of the several states, grant to individuals who meet certain predetermined standards, legal right to practice in a health care profession and to use a specified health care practitioner’s title. C. Commonly stated objectives of licensing laws are to limit and control admission to the different health care occupations and to protect the public from unqualified practitioners by promulgating and enforcing standards of practice within the professions. 35 XVII. Suspension and Revocation of License, p.352 A. Licensing boards have authority to suspend or revoke the license of a health care professional found to have violated specified norms of conduct. B. Violations includes procurement of license by fraud, unprofessional, dishonorable, immoral, or illegal conduct, performance of specific actions prohibited by statute; and malpractice. XVIII. Multidisciplinary Approach to Patient Care A. Pain management programs often provide excellent examples of a multidisciplinary approach to patient care. B. Health care professionals should consider & discuss the patient perspective & put themselves in the role of a patient receiving treatment. XIX. Helpful Advice for Caregivers - Abide by the ethical code of one’s profession & practice quality care (character and competence). 36 Chapter 13 Information Management and Patient Records See text case, Proenza Sanfiel v. Department of Health case, pp.359&384 – A five-year suspension of Sanfiel’s nursing license upheld for disclosing confidential patient information to media. I. Information Management and Communication, p.359 A. Documentation of a patient’s illness, symptoms, diagnosis, & treatment B. Planning tool for patient care C. Document communication (such as, progress notes) D. Protect legal interests of patient, organization, & practitioner E. Provide database for use in statistical reporting. F. Continuing education G. Research H. Provide information necessary for third-party billing. II. Medical Record Contents A. Personal, medical, financial B. Admission record- age, address, reason for admission (social security number/personal health identifier), marital status, religion, health insurance, and advance directives III. IV. Documentation of Care, p.360 - Documentation includes record entries accuracy, regular nurse’s charting, for reimbursement, consistent recording of qualitative observations (vs. charting by exception), and adequate maintenance and timely completion of records. Privacy Act of 1974, p.362 - enacted to safeguard individual privacy from misuse of federal records, to give individual access to records concerning themselves that are maintained by federal agencies, and to establish a Privacy Protection Safety Commission. 37 V. Health Insurance Portability and Accountability Act (HIPAA), p.363 A. Privacy Provisions 1. Patients able to access their records and request correction of errors. 2. Patients must be informed of how personal information will be used. 3. Patient consent for release of information for marketing purposes required. 4. Patients can ask insurers and providers to take reasonable steps to ensure their communications are confidential. 5. Patients can file privacy related complaints. 6. Health insurers or providers document their privacy procedures. 7. Health insurers or providers designate a privacy officer and train their employees. 8. Providers may use patient information without patient consent for purposes of providing treatment, obtaining payment for services, and performing non –treatment operational tasks of the provider’s business B. Note Security Provisions Concerning Administrative, Physical and Technical Safeguards, pp.363-365 VI. Ownership and Release of Medical Records, p.365 A. Ownership resides with organization or professional rendering treatment B. Right to privacy C. Request by patients D. Failure to release records (can lead to legal action) E. Requests by third parties (insurance carriers processing claims, physicians, medical researchers, educators, government, agencies) F. Privacy exception (psychiatric records, criminal investigation, Medicaid fraud, substance abuse records) 38 G. Health Insurance Portability & Accountability Act (1996) provides protections for the privacy, confidentiality & security of patient information. VII. Retention of Information, p.368 A. Length of time medical records must be retained varies state to state. B. See Rodgers v. St. Mary’s Hospital of Decatur, p.369 - Illinois Supreme Court held that a private cause of action existed under the X-ray Retention Act, & that the plaintiff stated a claim under the act. The Act provides that hospitals must retain X-rays and other such photographs or films as part of their regularly maintained records for a period of five years. VIII. Electronic Medical Records (Advantages), p.369 A. Retrieve demographic information and consultants reports as well as lab, radiology, and other test results. B. Improve productivity and quality. C. Reduce costs. D. Support clinical research. E. Play a continuous role in education. F. Allow for interactive computer assisted diagnosis and treatment. IX. Electronic Medical Records (Disadvantages), p.370 A. Increased risk of loss of confidentiality and unauthorized disclosure of information B. Rapid growth of Internet has led to an explosion of high technology crime and related illegal activities. C. Increase in cybercrime has led to a need for high end technology products and services to combat these problems. D. Billions of dollars spent annually to protect networks and critical infrastructures from cyber-based threats. X. Medical Record Cases, pp.372-365 A. Moskovitz v. Mount Sinai Medical Center, pp.372-373 - Physician’s alteration of patient’s record supported punitive damages; shows malice on physician’s part (falsification of records) 39 B. Humana Hospital Corp. v. Spears Petersen, p.380- accreditation reports are privileged (JCAHO reports privileged from discovery) C. Search warrant, p.381 - peer review documents, are not subject to disclosure in Michigan (Liberman case) D. Staff privileging documents, pp.382-383 - discoverable in Illinois (May case), but not discoverable in South Carolina (McGee case) XI. Charting Advice, p.384 A. Complete and pertinent information B. Timely entries C. Legible entries D. Clear and meaningful information E. Complete documentation 40 Chapter 14 Patient Consent, Rights, and Responsibilities See text case, Matter of Hughes, pp.389&405 – Trial judge’s decision to appoint a temporary medical guardian for Mrs. Hughes was legally supportable; doubt existed as to whether she made a fully informed decision to refuse blood if this meant death; concerns a Jehovah’s Witness patient. I. Consent, p.389 A. Voluntary agreement by a person who possess sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on himself or herself. B. Express consent can take the form of verbal agreement or a written document authorizing medical care. C. Implied Consent is determined by some act or silence, which raises a presumption consent has been authorized (e.g., patient in accident and in comatose state). II. Informed Consent, p.390 – Canterbury v. Spence and the “reasonable man” standard A. Legal doctrine where the patient has right to know potential risks, benefits and alternatives of a proposed procedure. B. Patient has absolute right to know about and select from available treatment options. C. Informed consent is based on the duty of the physician to disclose sufficient information to enable the patient to evaluate proposed medical or surgical procedures before submitting to them. III. Issues A. Adequacy of consent-Consider what is ordinarily provided by other physicians. B. Verbal consent to surgery is sufficient. C. Written consents – See battery consent form elements on pp.391. D. Special forms of consent 1. Consent for specific procedures- surgery and diagnostic test 41 2. Temporary consent- summer camp 3. Implied consent- car accident, patient unconscious IV. Statutory Consent, p.392 - Consent is generally assumed for ambulance care (Good Samaritan statutes) & emergency departments (when the patient is clinically unable to give consent) V. Physicians, Hospitals and Nurses and Informed Consent, pp.392-397 A. A nurse generally has no duty to advise a patient as to a surgical procedure to be employed (may confirm with patient that the physician has explained the procedure). B. Advise patient as to the risks, benefits, and alternatives to a recommended procedure (this is the physician’s responsibility). C. Obtain a patient’s informed consent (nurse may witness that the risks, benefits and alternatives have been explained). D. Mathias v. St. Catherine’s Hospital Incorporation, pp.394-395 - Duty to inform rests with the physician and not the hospital (tubal ligation following a C-section without a signed consent form). E. Matthies V. Mastomonaco, pp.393-394 - An elderly woman living alone fell and fractured her hip and was hospitalized. The orthopedic surgeon decided on a conservative course of treatment for her hip, bed rest, rather than surgery. Court held that it is necessary to advise a patient when considering alternative courses of treatment. F. Riser v. American Medical Intern, Inc., pp.395-396 The radiologist performed a procedure not ordered by patient’s physician. The patient died 11 days later and the plaintiffs claimed that the patient was a poor risk. The district court awarded damages in the amount of 50,000 for the patient’s pain and suffering and $ 100,000 to each child. The court of appeals held that the radiologist breached the standard of care by subjecting the patient to a procedure that would have no practical benefit and failed to obtain the patient’s informed consent. G. Stamford Hosp. v. Vega, pp.396-397 – Trial court Improperly issued an injunction that permitted the hospital to administer blood transfusions following childbirth to Vega, a Jehovah’s Witness. 42 VI. Validity of Consent, p.397 A. Physician should provide as much information about the treatment as necessary for the patient to understand the risks and consequences of treatment. B. Courts generally utilize an “objective” or “subjective” test to determine informed consent. C. An objective test must show that a “reasonable person” would not have undergone a procedure if properly informed. D. A subjective test must determine if the “individual patient” would have chosen the procedure if fully informed. E. Ashe v. Radiation Oncology Association, p. 399 - An objective test is preferred in determining consent. Causation is better resolved on an objective basis (breast cancer patient became paraplegic after a radiation injury to her spinal cord). VII. Who May Consent, p.400 A. Competent patients B. Guardianship C. Consent for minors D. Incompetent patients E. Spousal consent & Greynolds v. Kurman, pp.403-404 - Patient was not capable of giving consent and physician should have sought consent from the next of kin (wife). VIII. Right to Refuse Treatment, p.402 - Religious beliefs- Jehovah’s Witnesses have generally refused the administration of blood or blood products. IX. Release Form A. Patient’s refusal to consent to treatment, for any reason, religion or otherwise, should be noted in the medical record, and a release form should be executed. B. Completed release provides documented evidence of a patient’s refusal to consent to a recommended treatment. 43 X. Exculpatory Agreements, pp.402-404 A. An agreement that relieves an individual from liability when he or she has acted in good faith. B. Exculpatory agreements generally invalid in health care setting XI. Proving Lack of Consent, p.404 A. Reasonably prudent person in the patient’s position would not have undergone the treatment if fully informed. B. Lack of informed consent is the proximate cause of the injury for which recovery is sought. XII. Informed Consent Claims and Defenses, p.405 A. Consent on behalf of the patient was not reasonably possible. B. Practitioner reasonably believed that further disclosure of risks could be expected to adversely and substantially affect the patient’s condition. XIII. Informed Consent & Disclosure of Risk A. Requires physicians to disclose the risks, benefits & alternatives of procedures. B. Informed consent is based on notions of liberty & individual autonomy. C. Consent should result from dialogue between the patient & physician. 44 Chapter 15 Patient Rights and Responsibilities I. Patient Rights, p.409 A. Right to Refuse or Discontinue Treatment (I.), pp.414-415 -In Harrell v. St. Mary’s Hosp. a competent person has a right to refuse treatment. A health care provider’s role is to honor patient’s wishes and not act for the state to assert state interests (pregnant Jehovah’s Witness; blood transfusion; court order). B. Right to Refuse or Discontinue Treatment (II,), p. 415 – In Matter of Dubreuil a pregnant patient refused blood during delivery by C- section for religious reasons. Her estranged husband gave consent and the trial court concurred. The Florida Supreme Court held a competent person has a right to refuse treatment if there is a surviving parent to care for minor children. C. Right to Designate a Decision Maker, p.417 D. Right to Execute Advance Directives, p.418 E. Discharge, p.422 – In Greer v. Bryant hospital staff was found negligent for not reporting fetal distress to Bryant, the patient’s physician (failure to override a physician’s decision) F. Right to Access Medical Records, p.423 G. Know Hospital’s Adverse Events, pp.423-424 H. Need to Participate in all Care Decisions to Help Prevent Medical Errors – a leading cause of death, pp.409-424 (inclusive of Patient Rights section). II. Patient Responsibilities, p.424 A. Provide caregivers with information relevant to medical complaints, symptoms, past illness treatments, surgical procedure, hospitalization, medication & information provided must be accurate, timely and complete. B. Oxford v. Upson County Hospital Inc., pp.446-427 - Court of appeals upheld trial court judge’s instructions to jury regarding causation, ordinary care and comparative negligence (patient injured by fall after fainting, but had failed to notify hospital staff that she felt dizzy). C. Tips to Help Prevent Medical Errors, pp. 429-430. 45 Chapter 16 Healthcare Ethics I. Ethics, p.433 - Branch of philosophy that deals with values relating to human conduct with respect to rightness and wrongness of actions and goodness and badness of motives and ends. A. Moral philosophy – right and wrong, including values or principles B. Micro ethics – an individual’s life experiences C. Macro ethics – a global view of right and wrong D. Ethics is used to signify: 1. Philosophical ethics – inquiry about conduct 2. Way of life – Judaeo Christian ethics 3. Rules of conduct or moral code – professional ethics E. Healthcare ethics encompasses many issues like the right to refuse treatment and making right decisions in difficult circumstances II. Morality, P.434 – A Code of Conduct A. Morality Legislated 1. Laws created to set boundaries for societal behavior 2. Laws are enforced to ensure expected behavior happens B. “Moral dilemmas” occur when moral ideas of right and wrong conflict III. Ethical Theories, pp.434-437 A. Normative Ethics – primarily concerned with establishing standards or norms for conduct B. Consequences and Teleologic Ethics – seek the greatest good for the greatest number (consequences, outcome) C. Situational Ethics – the ends can justify the means D. Utilitarian Ethics – a form of consequential ethics E. Deontological Ethics – duty-based ethics (Immanuel Kant, moral codes & rules) F. Nonconsequential Ethics – moral decisions on a case-by-case basis 46 G. Ethical Relativism – relative to the norms of one’s culture IV. Principles of Healthcare Ethics, pp.437-440 – caregivers often find that difficult decisions involve choices between conflicting ethical principles A. Beneficence – doing good, showing compassion, helping others, etc. B. Nonmaleficence – avoid causing harm to patients (“First, do no harm.”) C. Justice – fairness in the distribution of benefits & risks (Distributive justice requires treating all persons equally & fairly.) D. Autonomy 1. Right of a person to make one’s own decisions 2. Patient has right to accept or refuse care even if it is beneficial to save his or her life 3. Autonomy may be inapplicable in certain cases - affected by one’s disabilities, mental status, maturity, or incapacity to make decisions V. Virtue Ethics and Values, p.440 A. Virtue is normally defined as some sort of moral excellence or beneficial quality. B. Moral value is the relative worth placed on some virtuous behavior. 1. What has value to one person may not have value to another. 2. A value is a standard of conduct. 3. Values are used for judging goodness or badness of some action C. Pillars of Moral strength (Fig. 16-1, p.441) – courage, wisdom, commitment, compassion, fairness, honesty, integrity, and respect are examples of the pillars that have value when addressing difficult healthcare dilemmas. VI. Religious Ethics and Spirituality, pp.447-450 A. Judaism – monotheistic religion based on the Hebrew Bible B. Hinduism – polytheistic religion that includes reincarnation C. Buddhism – “do good, avoid evil, purify the mind” D. Taoism – the interaction of all things E. Zen – evolved from Buddhism 47 F. Christianity – monotheistic religion based on the Old and New Testaments G. Islam – monotheistic religion based on the Qur’an VII. Secular Ethics, p.450– based on codes developed by societies (Code of Hammurabi) VIII. Professional Ethics – standards or codes of conduct established by the members of a Profession IX. Ethics Committee, pp.451-456 A. Hospital Committee - offering objective counsel when there are difficult health care issues and decisions to be made- resource to patients, families and staff. B. Committee structured to include wide range of community leaders. C. Ethics committees analyze ethical dilemmas, advise and educate health care providers, patients, and families. D. Its goal is to assist patient and family, as appropriate, in coming to consensus with options that best meet patient’s goal for care. E. Encouraged by Quinlan case. X. Organizational Ethics A. Purpose: promote responsible behavior in the decision – making process B. Recent interest 1. healthcare organizations 2. Result of government regulations like Sarbanes Oxley Act & EMTALA 3. Accrediting agencies like the Joint Commission – improve the quality of care 4. Reasoning and Decision Making, pp.456-457 – ethical decision making involves a process of deciding the right thing to do when faced with a moral dilemma. 48 Chapter 17 Procreation and Ethical Dilemmas See text case, pp.463&482 – Whole Women’s Health v. Hellerstedt (2016) – SCOTUS determined that Texas’s law requiring abortion clinics to meet ambulatory surgery center standards and employ only physicians with admitting privileges at a local hospital are unreasonable regulations; they are an undue burden on women. I. Abortion, p.463 A. Premature termination of a pregnancy 1. Can be classified as spontaneous or induced. 2. May occur as an incidental result of a medical procedure or it may be an elective decision on the part of the patient 3. U. S. ranks number one in abortion rates in the developed world B. Right to Abortion, p.464 - Roe v. Wade (1973) gave strength to a woman’s right to privacy in matters relating to her own body, including how a pregnancy would end. During first trimester of pregnancy, the decision to undergo an abortion procedure is between the woman and her physician. During second trimester a state may regulate the medical condition under which the procedure is performed. During third Trimester a state may prohibit all abortions except those deemed necessary to protect maternal life or health. C. Abortion Review Committee Too Restrictive, p.464-465 - Doe v. Bolton (1973) - Court struck down four pre-abortion procedural requirements commonly imposed by state statutes. The requirements are residency, performance of a abortion in a hospital accredited by Joint Commission, approval by an appropriate committee of the medical staff, & consultations. D. Funding, pp.465-466 1. Not Required for Elective Abortions a. Beal v. Doe (1977) - The court ruled that it is not inconsistent with the Medicaid portion of the Social Security Act to refuse to fund unnecessary (although perhaps desirable) medical services. b. Maher v. Roe (1977)- States may refuse to spend public funds to provide non therapeutic abortions for women. 2. Not required for Therapeutic Abortions - Different states not compelled to fund Medicaid recipients’ medically necessary abortions for which federal reimbursement is unavailable, but may choose to do so (see Hyde amendment and Harris v. McRae, 1980). 49 3. Funding Discrimination Prohibited in Arizona – state may not refuse to fund medically necessary abortion procedures for pregnant women with serious illness while funding them for victims of rape or incest or to save the woman’s life (Simat Corp. v. Arizona Health Cost Containment System, 2002) E. States May Protect Viable Fetus, p.466 - In Colautti v. Franklin (1979) the USSC held that the state may seek to protect a fetus that a physician has determined could survive outside the womb. Determination of whether a fetus is viable is a matter for judgment for the physician. F. Consent, pp.467-469 1. Danforth v. Planned Parenthood (1976) - It is unconstitutional to require parental consent for minors under age 18. The statute failed to provide any definitive guidelines( lacks a reasonable exception). 2. Notice Requirement for Immature Minors Constitutional - In H.L. Matheson (1982) the court upheld a Utah Statute that required a physician to notify, “if possible”, the parents or guardian of a minor on whom an abortion was to be performed. However, a state may not constitutionally legislate a blanket unreviewable power of parents to veto their daughter’s abortion. 3. In re Anonymous (1987) - Consent not required for an emancipated minor (trial court decision). 4. Parental Notification not Required - Planned Parenthood v. Owens (2000) - The Colorado Parental Notification Act of 1998, which required physician to notify parents of a minor prior to performing an abortion upon her, violates minor’s rights protected by the U.S. Constitution. a. The act generally prohibited physicians from performing abortions on an unemancipated minor until at least 48 hours after written notice has been delivered to minor’s parent, guardian, or foster parent. b. The notice requirement lacks an exception. G. Abortion Counseling, p.469 1. City of Akron v. Akron Center for Reproductive Health (1983) - States cannot mandate what information physicians give abortion patients, or require that abortions for women more than three months pregnant be performed in a hospital. Justice O’Connor advocated the “no undue burden” standard in the dissent. 2. Rust v. Sullivan (1991) - Federal regulations that prohibit counseling and referral by family planning clinics that receive funds under Title X of the Public Health Service Act were found not to violate the constitutional rights of pregnant women. 50 H. Restricting Right to Abortion Affirmed, p.469-470 1. Planned Parenthood v. Casey (1992)- court reaffirmed a women’s right to have an abortion, state’s power to restrict abortions after fatal viability, and the state has legitimate interest in protecting the women and the fetus. 2. An undue burden to require spousal notification. 3. Not undue burden to require. a. A woman be informed of nature of abortion procedure and risks involved. b. A woman be offered information on the fetus and on alternatives of abortion. c. A woman to give her informed consent before abortion procedure. d. Parental consent be given for a minor seeking an abortion, providing for a judicial bypass option if the minor does not wish or cannot obtain parental consent. e. There be a 24-hour waiting period before any abortion can be performed. I. Viability Test Required, p.470 - Webster v. Reproductive Health (1989) - The statute was upheld providing that no public facilities or employees should be used to perform abortions. Physicians should conduct viability tests before performing abortions. J. Partial Birth Abortion, pp.470-471 1. In Stenberg v. Carhart (2002) the USSC declared unconstitutional a Nebraska ban on partial birth abortions using D& E and suction- curettage procedures because the law lacked an exception to protect the women’s health. 2. Partial- Birth Abortion Ban 2003 a. President Bush signs federal restrictions banning late term abortions b. 2005 – Bush asked USSC to review appellate court’s decision holding the act unconstitutional. c. 2006 – Oral arguments before USSC d. 2007 – USSC upheld Act (5-4) - It lacks an exception to protect the woman’s health & bars a procedure Congress found “brutal” and “inhumane” (D&E). K. Picketing Physicians, p.472-473: Privacy Issue - Murray v. Lawson (1994); Picketing physicians’ residencies (Murray – residential privacy is a sufficient public policy interest to justify injunctive restrictions; speech v. residential privacy; NJSC); Trespass, obstructing access to abortion clinics (USDC for DC- presence on the property constituted a trespass) 51 L. Continuing Controversy, p.473 1. Right-to-life advocates v. Pro-choice advocates 2. Employee refusal to participate in abortions, including pharmacy & birth control (pharmacists – unsettled area, conscience clause issue) 3. Use of force against demonstrators – lack of excessive force is key (Forrester v. City of San Diego, 1994). Everything has Changed Dobbs v. Jackson Women’s Health Organization case – Is the Mississippi law banning almost all abortions after 15 weeks gestation unconstitutional? No. There is no constitutional right to an abortion. Roe v. Wade & Planned Parenthood v. Casey are overruled. Abortion is not mentioned in the Constitution. The right is not embedded in our history as a country or essential to liberty. The precedent is overruled (SCOTUS, 2022). Allowing individual states to determine the legality of abortion potentially creates an array of hurdles for those seeking medical care and for physicians providing care. State trigger laws formally outlaw abortion immediately after the repeal of Roe or 30 days after SCOTUS transmits its judgment (7/26/22). The Texas trigger law makes performing an abortion a first-degree felony, including life sentences and a civil penalty of $100,000 per violation. Texas already passed a strict abortion law in 2021 banning the procedure beyond six weeks of pregnancy and providing no exceptions for rape or incest. II. Sterilization, pp.474-476 A. Elective Sterilization – upheld. B. Regulation of Sterilization for Convenience- hospitals must have consistent policies, including conscience clauses. C. Therapeutic Sterilization – upheld. D. Involuntary / Eugenic Sterilization acceptable with procedural safeguards (Buck v. Bell, USSC, 1927). III. Wrongful Birth, Life and Conception, pp.476-481 A. Wrongful Birth (Smith v. Coté, NH, 1986- rubella case) B. Wrongful Life (What is the value of being denied non-life?) C. Wrongful Conception/ Wrongful Pregnancy (negligent sterilization) 52 IV. Artificial Insemination, p.481 A. Injection of seminal fluid into a woman to induce pregnancy B. Includes insemination outside the woman’s body – “test-tube” babies C. Consent and confidentiality are significant considerations V. Surrogacy, pp.481-482 – reproduction whereby a woman agrees to give birth to a child she will not raise but surrender to a contracted party A. Surrogate may be the child’s genetic mother or a gestational carrier (embryo implant) B. Surrogacy contracts are prohibited in some states (invalid contracts) 53 Chapter 18 End-of-Life Issues I. Noteworthy Historical Events A. 1932- 1972 – Tuskegee study of Syphilis B. 1946 – Military Tribunal for War Crimes C. 1949 – Nuremberg Trials and International Code of Medical Ethics D. 1972 – Informed Consent – Canterbury v. Spence - reasonable patient standard E. 1976 – Substituted Judgment – In the Matter of Karen Ann Quinlan, p.488 E. 1990 – Patient Self-Determination Act and Nancy Cruzan, pp.490-491 F. 1994 – Oregon’s Death with Dignity Act G. 1996 – HIPAA – Protect patient privacy, confidentiality and security of patient information H. 1999 – Kervorkian convicted of 2nd degree murder I. 2002 – U.S. District Court upholds Oregon’s Death with Dignity Act J. 2004 – U.S. Court of Appeals upholds Oregon’s DDA K. 2006 – Supreme Court blocks Bush administration’s attempt to punish doctors who help terminally ill patients die(protects Oregon’s one-of-a-kind assisted suicide law) II. III. Patient Autonomy, pp.487-490 A. In re Storer – right of self-determination, p.493 B. In re Quinlan – right to refuse treatment C. Saikewicz, pp.488-489 – court approval to withhold treatment of an incompetent Constitutional Right to Refuse Care & Legislative Response – Patient Self-Determination Act of 1990, pp.491-492 A. Protection of a patient’s right to make decisions B. Organizations - required to observe, protect, and promote patient rights C. Cruzan v. Director, Missouri Department of Health (1990) 54 IV. Defining Death, pp.492-493 A. Irreversible cessation of brain function constitutes death. B. People v. Eulo – determination of brain death is death, p.493. C. O’Connor – clear and convincing evidence of a patient’s wishes is required terminate life support. V. Do-Not-Resuscitate Orders, p.493-494 – a type of advance directive not to use resuscitative measures to revive the patient & consented to by patient or his/her agent. VI. Withdrawal of Treatment, pp.494-497 A. Decision not to initiate treatment or medical interventions. B. Conroy, pp.495-496 – specific guidelines C. Jobes, p.496– artificial nutrition & hydration may be removed. D. Bouvia case, p.496 – competent patient may refuse life sustaining treatment. E. Barber, p.496 – physicians withdrew treatment honoring request of patient’s family, criminal. charges of murder and conspiracy were dropped. VII. Euthanasia, pp.497-500 A. Euthanatos (Gk.) – “good death” or “easy death” B. Active Euthanasia – intentional commission of an act (suicide) C. Passive Euthanasia – life-saving treatment is withdrawn or withheld. D. Voluntary Euthanasia – patient decision to die (Lane v. Candura, p.499-500) C. Involuntary Euthanasia – a third party makes the decision to terminate the life of an incurable person. VIII. Physician Assisted Suicide, pp.475-478 A. Physician Assisted Suicide – Jack Kevorkian (1990), p.501 B. Kevorkian Convicted of Second-Degree Murder (1999) C. Oregon’s Death with Dignity Act (1994), pp.501-502 1. Statute and Request 55 2. Gonzales v. Oregon – states can allow physicians to assist in the suicide of their terminally ill patients (2006), pp.502-504. D. Prohibition of Assisted Suicide Ruled Constitutional, p.502- U. S. Supreme Court, in two unanimous and separate decisions, ruled in 1997 that laws in New York and Washington prohibiting assisted suicide are constitutional, but states can allow physicians to assist in the suicide of their terminally ill patients. 1. Quill v. Vacco – not protected by Constitution’s equal protection clause 2. Washington v. Glucksberg – not protected by Constitution’s due process clause IX. Advance Directives, pp.504-511 - patient is obligated to make medical preferences known to the treating physician A. Living Will, pp.505-506 – guidance about patient’s wishes B. Healthcare Proxy, pp.509-509 – appoint a healthcare agent to make treatment decisions in the event of your incapacity. C. Durable Power of Attorney, p.509 – give another authority to act on your behalf in the event you become incompetent. D. Substituted Judgment – attempt to make the decision the patient would have made if competent. E. Guardianship, p.511 l. Court declares a person incompetent and appoints a guardian 2. Bush v. Schiavo, p.511 – Terri’s Law ruled unconstitutional (attempt to usurp the authority of the judiciary and legal guardians to make decisions) F. In re Martin, p.512 – Spouse’s Guardianship Rights Questioned – Martin’s spouse provided clear and convincing evidence that he would decline life support given his medical condition and prognosis; evidence was sufficient to show that the patient’s spouse was a suitable guardian (Mich. Ct. App. 1994). X. Autopsy, pp.511-515 – conducted to determine cause of death, and may resolve legal issues XI. Organ Donations, pp.515-517 A. Transplantation is done to treat patients with end stage organ disease who face organ failure. B. Uniform Anatomical Gift Act – statute enacted in all 50 states, and allows organ donation at the time of death, p.516. 1. Hospitals must have & implement written protocols regarding organ procurement. 2. Regulations cover duties of informing families of potential donors. 56 3. Discretion & sensitivity are necessary in dealing with families 4. Educate hospital staff about donation issues to facilitate timely donation & transplantation XII. Research, Experimentation, and Clinical Trials, pp.517-521 A. Institutional Review Board – way to approve and oversee the use of investigational protocols, pp.518-519. 1. Nuremberg Code & Declaration of Helsinki concern guidelines protecting human subjects. 2. Follow informed consent guidelines – disclose risks, competent consent, treatment alternatives, get written consent. B. Food and Drug Administration – terminally ill patients and access to experimental drugs not fully approved by the FDA (developing area of the law). XIII. Human Genetics, pp.521-523 A. Genetic Information Nondiscrimination Act of 2008 – prohibits discrimination based on genetic information with respect to health insurance and employment, p.522. B. Stem Cell Research, pp.522-523 – remains a highly controversial issue. 57 Chapter 19 Legal Reporting Requirements See text case, Michaels v. Gordon, pp.529&540 - Immunity for reporting suspected child abuse extended to a psychologist- no finding of bad faith. I. Child Abuse, pp.529-532 A. An abused child is one who has suffered intentional serious mental, emotional, sexual, and /or physical injury inflicted by a family or other person responsible for the child’s care. Some states extend the child’s care. Some states extend the definition to include a child suffering from starvation. B. Reporting requirements- All states have laws to protect abused children. C. Detecting abuse D. Good faith reporting E. Failure to report child abuse – psychologists, nurses, & physicians are typically mandatory reporters. II. Elder (Senior) Abuse, pp.532-534 - any form of mistreatment that results in harm or loss to an older person. A. Less likely to be reported than child abuse. B. National Center on Elder Abuse is directed by the U.S. Admin. on Aging C. Most states have statutes mandating the reporting of elder abuse. III. Communicable Diseases, pp.534-535 A. Reported to protect citizens from infectious diseases. B. Reporting required by statutes - Most states have mandatory reporting statutes. C. Acquired immunodeficiency syndrome (AIDS) – a reportable communicable disease in every state; required reporting is noted on p.534; mandatory testing of firefighters and paramedics for HIV does not violate Fourth Amendment or constitutional privacy rights, p.535 IV. Hospital Acquired Infections A. Medical errors and infections cause up to 98,000 deaths and hundreds of thousands of injuries annually in U.S. hospitals. 58 B. Sepsis and pneumonia cause nearly 50,000 deaths and cost more than eight billion to treat. C. Affordable Care Act requires participating hospitals to report hospital acquired infections or face Medicare reimbursement reductions. D. Hospitals showing improvement will receive more money. V. Births & Deaths, p.535 A. Reportable by statute B. Necessary to maintain census records VI. Suspicious Deaths A. Unnatural deaths must be referred to medical examiner (violent deaths, criminal activity). B. The medical examiner determines cause of death & aids with criminal investigation. VII. VIII. IX. Adverse Drug Reactions, p.535 – ADRs are unwanted or harmful reactions from the administration of a drug or drugs thought to be related to the use of the drug(s); pharmacies must maintain and report ADRs to the FDA. Physician Competency, pp.536-537 – The Healthcare Quality Improvement Act of 1986 authorizes the National Practitioner Data Bank to collect and release information on the professional competence and conduct of health care practitioners. National Practitioner Data Bank A. Reporting requirements - adverse licensure or professional review actions (30 days or longer) B. Required queries of data bank information C. Who should report? D. Data bank queries can be made by state licensing board, hospitals other than health care entities. E. Data bank fee F. Penalties for failing to report. 59 G. Confidentiality of data bank information X. Incident Reporting, pp.537-539 A. Hospital incident reports are discoverable. B. State reportable incidents include events that resulted in a patient’s serious injury or death. C. Reports should be directed to legal counsel for advice & not placed in the medical record. XI. Sentinel Events, pp.539-540 A. Reportable “sentinel events” include events that result in an unanticipated death or major permanent loss of function. B. Event is one of the following: suicide, unanticipated death of a full-term infant, infant abduction, rape, hemolytic transfusion reaction, or surgery on the wrong patient or wrong body part. C. Self- reporting is encouraged by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and events are subject to JCAHO review. XII. Root Cause Analysis A. A process for identifying the basic or causal factors that underlie the variation in performance, including the occurrence or possible occurrence of a sentinel event. B. Critical management and root cause analysis are equivalent to quality improvement systems and processes. C. JCAHO expects organizations to do root cause analysis. D. Provide for disciplinary action. 60 Chapter 20 Human Resources See text case, NLRB v. Shelby, pp.545&589- Employer’s interrogation of nursing facility employees about union meeting was an unfair labor practice and unlawful interrogation. J. Human Resources Roles and Responsibilities, pp.545-548 K. A. Job Description – describes the duties and responsibilities of the employee in a particular job. L. B. Recruitment and Hiring – involves a job application that gathers information about education, job history, references, etc. M. C. Employee References, p.547 – must be adequately scrutinized by employers to avoid potential liability for negligent hiring. N. D. Application Process, p.548 – involves verifying the applicant’s qualifications based on the documentation provided. O. E. Performance Appraisals – are usually performed annually to assess the employee’s performance. II. Employment at Will, pp.549-550 A. Employment at Will doctrine provides employment is at will of employer or employee. B. Employment may be terminated by either at any time. 1. For any or no reason 2. Unless a contract in place specifying terms and duration of employment C. Historically termination of employees for any reason is widely accepted. III. Public Policy Issues & Termination, pp.550-551 A. Public Policy 1. Public policy exception to employment at will doctrine provides employees may not be terminated for reasons contrary to public policy. 2. Public policy originates with legislative enactments. 3. Employment contract 4. Covenant of good faith and fair dealing 61 B. Public Policy Issues 1. Age 2. Race 3. Color 4. Religion 5. Sex 6. National origin 7. Pregnancy 8. Filing safety violation complaint 9. Union membership 10. Whistle blowing - reveals wrongdoing to a public entity. 11. Reporting- patient abuse a. Elder IV. Termination, pp.552-556 A. Unemployment Compensation, pp.556&557- denial for resignation and termination for cause (general rule) B. Employment Disclaimers – at-will status noted in employee handbook. C. Job Description – not a contract D. Termination for Cause – employment contract E. Violation of Non – Smoking Policy – for cause termination F. Termination and Financial Necessity – not a breach of an employment contract G. Hostile Attitude – good cause termination H. Improper Billing Practice – good cause termination I. Poor Work Performance – good cause termination J. Alcoholism – termination not discriminatory 62 IV. Wrongful Discharge, pp.557-558 A. Tort- wrongful discharge B. Contract - wrongful discharge C. Punitive Damages- tort law only (clear and convincing evidence) V. Retaliatory Discharge, pp.558-560 – In Dalby v. Sisters of Providence on p.559, a pharmacy technician stated a cause of action for wrongful discharge and intentional infliction of emotional distress. The technician made a good faith report of hospital’s noncompliance with the drug inventory and documentation requirements. VI. Fairness: The Ultimate Test, pp.562 - Bad faith and inexplicable terminations are subject to court scrutiny. VII. Effective Hiring Practices, pp.562-563 – Communicate clearly. VIII. Employee Rights, pp.562-567 A. Equal Pay Act (EPA) of 1963 – passed to address wage disparities based on gender. B. Refuse to Participate in Care – conscience clauses upheld. 1. Abortions 2. Pharmacists’ Refusal to Fill Prescriptions – See pp.563-564. C. Suggest Changing Physicians, p.565 – Deerman v. Beverley Cal. Corp. – North Carolina court of appeals held the nurse stated a claim for wrongful discharge in violation of public policy (LTC nurse advised family to consider changing physicians) D. Kirk v. Mercy Hospital Tri-County, p.566 - Nursing Practice Act (NPA) of Missouri provides a public policy mandate that nurses have a duty to provide the best possible patient care (hospital charge nurse was terminated for reporting a potential wrongful death to the patient’s family) E. Freedom from Sexual Harassment, p.565 – quid pro quo and hostile environment F. Whistleblowing, pp.565-567 – reveals wrongdoing (illegal, fraudulent activities) in the organization to a public entity. VIII. I. Employee Responsibilities, pp.567-571 – Examples are to maintain confidentiality, adhere to safe practices, adhere to professional standards, and report patient abuse. Labor Relations, p.571 A. Relationships between employees and employers are regulated by state & federal laws. 63 B. Federal laws generally take precedence over state laws when there is conflict between state and federal laws. C. State laws generally applicable when more rigid than federal laws II. Department of Labor - Functions are to promote welfare of wage earners, improve working conditions, and advance opportunities for profitable employment. III. Unions & Healthcare Organizations, p.572 IV. National Labor Relations Act A. Enacted 1935 to govern labor-management relations of business firms engaged in interstate commerce. B. Act defines certain conduct of employers & employees as unfair labor practices- provides for hearings on complaints that such practices have occurred. C. Act modified by Taft – Hartley amendments in 1947 and Landrum – Griffin amendments in 1959. V. National Labor Relations Board A. NLRB enforces and administers the NLRA. 1. Has jurisdiction over matters involving proprietary & not for profit health care organizations 2. Agency independent of Department of Labor which is responsible for preventing & remedying unfair labor practices by employers and large organizations B. Elections, p.573 - NLRA sets out procedures by which employees may select a union as their collective bargaining representative to negotiate employment and contract matters. C. Unfair labor practices, pp.573-574 1. No discrimination for being a union member. 2. Must bargain in good faith. D. Limitations on number of bargaining units 1. NLRB rule allowing hospital workers to form up to eight bargaining units 2. Upheld by U.S. Supreme Court VI. Norris-Laguardia Act, pp.574-575 A. Aimed at reducing number of injunctions to restrain strikes and picketing. 64 B. Sets procedures for handling labor disputes. C. Creates board of inquiry if a dispute threatens to interrupt health care. D. Board’s findings provide framework for arbitrator’s decisions. VII. Fair Labor Standards Act, p.575 - Establishes minimum wages, maximum hours of employment, overtime pay provisions, exempt employee’s provision, work week options. Civil Rights Act of 1964, pp.575-576 - Prohibits employers and state & local governments from discrimination in employment in any business on basis of race, color, religion, sex, or national origin. IX. Occupational Safety and Health Act, pp.520-523 A. Sets and enforces safety standards. B. Provides training, outreach, and education. C. Establishes partnership between employers and employees. D. Encourages continual improvement in workplace safety and health. E. An employer can be liable for damages suffered by employees from exposure to dangerous conditions that violate OSHA standards. X. Rehabilitation Act of 1973, pp.578-579 A. Protection for handicapped employees B. Applied to public and private organizations. C. Requirement to perform self-evaluation of compliance. D. Jobs must not be designed to eliminate hiring of disabled persons. XI. Family and Medical Leave Act (FMLA) A. Enacted to provide employees temporary medical leave if particular situations occur. B. Covered employers must grant eligible employees up to 12 weeks of unpaid leave during any 12-month period. C. Leave granted for certain circumstances. 1. Birth and care of employee’s child 2. Placement of adopted or foster child with employee 65 3. Care of immediate family member (spouse, child, or parent) with serious health conditions 4. Inability to work because of serious health condition. D. It’s illegal to terminate health insurance coverage for an employee on FMLA leave. E. Following FMLA leave, an employee’s job or equivalent must be restored. XII. State Labor Laws, pp.579-580 A. Union Security Contracts 1. Closed shop contract – particular union 2. Union shop contract – union membership 3. Some state statutes forbid such contracts and have right to work laws which protect everyone’s right to work. 4. Wage and hour laws- higher rate applies (state or federal) B. Child Labor Acts 1. Working papers required 2. Forbids employment of minors at night 3. Prohibits minors from operating certain machinery. XIII. Worker’s Compensation, pp.580-581 - based on employer-employee relationship and not negligence XIV. Labor Rights of Employees A. Organize and bargain collectively. B. Solicit and distribute union information. C. Picket D. Strike E. Concomitant responsibility to perform work duties properly. XV. Management Rights, pp.581-583 A. Receive a strike notice. B. Hire replacement workers. 66 C. Restrict union activity. D. Prohibit union activity during working hours. E. Prohibit supervisors from participating. XVI. Patient Rights During Labor Disputes A. Patient rights take precedence over labor management rights. B. Patients have right to privacy and well-being XVII. Administering Collective Bargaining Agreement, pp.528-529 A. Administered in good faith. B. Arbitration – binding decision XVIII. Affirmative Action Plan, pp.583-584 A. Prohibits discrimination on basis of age, race, color, religion, sex, national origin. B. Affirmative action program includes: 1. Collection and analysis of data on the race and sex of all applicants for employment 2. Non-discrimination clause in manuals 3. Use of data to show compliance with the law XIX. Discrimination in the Workplace, pp.584-589 A. Age: Discrimination in Employment Act of 1967, p.584 1. Promotes employment 2. Prohibits discrimination based on age, hiring, discharge, pay, term, conditions and privileges of employment B. Disability: Americans with Disabilities Act of 1990, pp.584-585 1. Review and revise job descriptions for compliance 2. Bring physical environment into compliance 3. Post notice describing purpose of ADA 4. Reasonable accommodation required C. Other 67 1. National Origin –See pp.585-586 & the Woodbine Health Center settlement. 2. Pay Discrimination – Equal Pay Act (1963), p.586. 3. Pregnancy Discrimination – Pregnancy Discrimination Act (amendment to Civil Rights Act of 1964) 4. Race Discrimination (CRA of 1964), pp.587-588 5. Religious Discrimination – reasonable accommodation 6. Sex Discrimination – CRA of 1964 and sexual harassment- hostile environment and quid pro quo 68 Chapter 21 Managed Care and National health Insurance See text case, Shea v. Esensten, pp.595&609 - Financial incentives that affect a physician’s decision to refer patients to specialists are material and require disclosure (patient died from a heart attack; had cardiac symptoms and family history of cardiac problems; PCP didn’t refer to cardiologist). I. Managed Care & Models of Managed Care Organizations (MCOs), pp.595-596 – Managed care is a shift from FFS and has existed for decades. MCOs limit provider choice and require prior authorization for services. A. Health Maintenance Organization – financing and delivery of prepaid services B. Preferred Provider Organizations - discounts for volume C. Exclusive Provider Organizations - like HMOs but under insurance law D. Point of Service Plans – go outside network by paying more. E. Experience Rated HMOs – employer pays based on its utilization. F. Specialty HMOs- like dental and mental health G. Independent Practice Associations – negotiate for physicians with third party payers. H. Group Practice – specialty specific or primary care and specialists I. Group Practice Without Walls – share administration and management J. Physician Hospital Organizations – joint venture K. Medical Foundations – negotiate for physicians with third party payers. L. Management Services Organizations – administration and management services for physicians M. Vertically Integrated Delivery System – provides physician and hospital services to patients. II. Important Aspects of Managed Care Arrangements, pp.597-599 A. Horizontal Consolidations – same business and level (community hospitals) B. State Laws – National Association of Insurance Commissioners Model HMO Act C. Case Management Firms – catastrophic cases D. Third Party Administrators – link between employer and insurer 69 E. Utilization Review 1. Prospective Review – precertification 2. Concurrent Review – processes of care 3. Retrospective Review – patterns of care 4. Utilization Management Firms – like TPAs 5. Negligent Utilization Review Decisions – Wickline v. State of California, p.598 – MCOs could be liable for utilization review process failures that cause patient Injury. F. Liability for Nonparticipating Hospitals – corporate negligence theory III. Employee Retirement Income Security Act of 1974, pp.599 – regulates employee welfare and benefit plans (See Rush case, pp. 578-579 – USSC upheld Illinois HMO act allowing insured patients to enforce rights via independent physician review; not preempted by ERISA) IV. Managed Care and Legal Actions, pp.600-602 A. Open Enrollment – annual & open for a minimum of 30 days B. Emergency Care – covered if an emergency. C. Benefits Denials – See Katskee case, pp.601-602 - Breast – Ovarian cancer syndrome held to be covered as an illness under the terms of the insurance contract. V. Antitrust, pp.581-583 A. Price Fixing - see Maricopa case, p.603- Price fixing by competitors is a per se violation (physicians had no financial stake in the venture) B. Market Power – raises antitrust implications. 1. Product Market – MCO continuum (managed FFS to HMO) 2. Geographic Market – service area C. Provider exclusion could be a boycott as in the Weis, Wilk, or Federation of Dentists cases (not in the text). D. Antitrust and Market Share- see Healthcare, Inc. v. Health Source Inc. case, pp.603-604 - competition between HMOs; Health Source’s exclusive agreements with physicians didn’t violate the Sherman Act; a vertical arrangement of exclusivity and not a boycott; involved in only 25%of PCP’s; had an opt out clause (lower capitation). 70 VI. National Health Insurance, pp.604-608 A. Patient Protection and Affordable Care Act (ACA) – See major reforms and provisions at pp.604-607. B. Court Challenges and Rulings, pp.607-608 1. NFIB v. Sebelius – The individual mandate is upheld as within Congress’s enumerated power to “lay and collect taxes.” 2. DHHS v. Florida, et al. – The “Federal Government may not compel the States to enact or administer a federal regulatory program” as in the Medicaid expansion of the ACA. 3. King v. Burwell – Enrollees receiving insurance coverage via the Federal Exchange may qualify for subsidies under the ACA (not limited to enrollment through a State exchange). C. Act Titles – See major provisions at pp.584-586. VII. Veterans Care, p.608 – The Veterans Health Administration provides healthcare benefits for over 8.76 million veterans at more than 1,700 sites. 71 Chapter 22 Professional Liability Insurance See text case, LaMure, pp.613&620- The malpractice insurer was not required to indemnify a physician for liability resulting from the sexual assault of a minor (constituted a criminal act and a policy exclusion) I. Insurance Policies, pp.613-614 A. Insurance is a contract that creates legal obligations on the part of both the insured and insurer. B. Insurer agrees to assume certain risks of the insured for consideration or payment of a premium C. Under terms of an insurance policy, insurer promises to pay specific amount of money if specified event takes place. II. Insurance Policy Provisions, p.614 A. Identification of the risk covered. B. Specific amount payable C. Specific occurrence III. Insurance: Risk Categories A. Risk of property loss or damage (home and contents, for example) B. Risk of personal injury or loss of life (AD &D, disability or life insurance are examples) C. Legal liability (being sued) IV. Insurance Policy Provisions, p.614 A. Occurrence- incidents arising during a policy year (reporting time doesn’t matter) B. Claims made- only claims made or reported during the policy year (instituted during year) C. Tail coverage- uninterrupted extension of an insurance policy period D. Umbrella- cover awards over the amount provided in the basic policy coverage. V. Insurance Policy Provisions Continued A. Insurance Agreement- will pay on behalf of insured. B. Defense and Settlement- will defend. 72 C. Policy Period- stated in the insurance contract. D. Amount Payable- up to the maximum limits stated in the policy. E. Conditions of the Policy- notice of occurrence, notice of claim, etc. VI. Conditions of Insurance Policies, pp.615-616 A. Assignment B. Subrogation C. Note other conditions. VII. Liability Insurance A. Purpose of liability insurance is to spread risk of economic loss among members of a group who share common risks B. As risk increases, premiums increase to cover associated risks. C. Premiums are placed in a shared risk pool, and funds are drawn to cover costs of lawsuits VIII. Liability of the Professional, pp.616-617 A. Insurance coverage especially important if caregiver is working B. Examples 1. As a volunteer at a clinic or health fair not sponsored by his or her employer 2. As an independent contractor providing a service in a patient’s home 3. For an independent agency or registry 4. For an organization that is covered by an insurance policy that has an exclusionary provision by which that insurance company disclaims liability for a professional’s malpractice actions brought against insured organization IX. Medical Liability Insurance, pp.618-619 A. Covered Claims – Insuring clause provides payment on behalf of insured if an injury arises from malpractice, error or mistake; and acts or omissions on part of the insured during policy period. B. Common Risk Covered – varies according to policy, but typically including torts like negligence, assault and battery as a result of failing to obtain consent, libel and slander, and invasion of privacy for betrayal of professional confidence. 73 X. Protecting the Organization, pp.619-620 A. Self-insurance and reinsurance concept, p.619 B. Trustee coverage- directors and officers liability insurance, p.619 C. Mandated medical staff insurance coverage and managed care organizations applications requiring set minimum liability limits, pp.619-620. D. Investigation and settlement of claims like use of a claims adjuster to settle and avoid legal action, p.620. 74