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Physician, nursing, facility implications of informed consent
FEBRUARY 1993, VOL 51,NO 2
AORN JOURNAL
Ethics Physician, nursing, facility implications of informed consent
F
orty years ago, patients relied on their physicians to make decisions about the best treatment alternatives for them. In 1957, as public expectations changed, a court in California enacted the doctrine of informed consent.' It was then that physician negligence rather than the charge of the intentional tort (ie, battery) became the basis for court action. This article explores the doctrine of informed consent and its impact on physicians, health care facilities, and perioperative nurses. Additional discussion includes recommendations for hospital and surgical consents.
the patient has an abject dependence upon and trust in the physician for the information that is relied upon during the decision-making process. Assumptions for this doctrine are that the patient is competent and not under the influence of any drugs. In the absence of an emergency, and with the exception of minors and incompetent adults, patients must consent for t h e m ~ e l v e s In . ~ the case of a minor or an incompetent adult, a legal guardian must consent unless he or she is unavailable and an
Informed Consent
I
nformed consent is given when the physician reveals to the patient the nature of his or her ailment and the proposed treatment and the probability and risks of consequences associated with such treatment. The patient has the right to ask questions and refuse care.2 The premise for informed consent is summarized in Cobbs v Grant (502 P2d 1, 9 [Cal 19721). This case states that 0 patients generally are unlearned in the medical sciences; therefore, except in rare cases, courts safely may assume that the knowledge of the patient and physician are not in parity, 0 a competent adult has the right to exercise control over what medical treatments are personally rendered, to be effective, a patient's consent to treatment must be an informed consent, and
Robin P. Newhouse, RN, MGA, CNOR, is the assistant director of surgical services, Greater Laurel (Md)Beltsville Hospital. At the time this article was written, she was the perioperative supervisor, Anne Arundel Medical Center, Annapolis, Md. She earned her AD in nursing f r o m Anne Arundel Community C o l l e g e , Arnold, Md, her BS degree in nursing from the University of Maryland, Baltimore, and her MGA degree in health care from the University of Maryland at College Park. 505
AORN JOURNAL
emergency exists.4 Competency is the physician’s judgment of the nonsedated patient’s ability to comprehend treatment information, deliberate the choices based on his or her individual needs, and communicate his or her decision.s A patient’s request for voluntary sterilization presents a special responsibility for informed consent. The patient must understand that the procedure will render him or her permanently unable to father or bear children, and the physician must be certain that the patient does not consent to sterilization under “duress, coercion, or deception.”6 This is particularly true when the procedure is paid with federal funds. In these cases, facilities must follow specific rules. The patient, in his or her right to self-determination, may refuse sterilization. This right is based on the common-law right to freedom from nonconsensual invasion of bodily integrity, reflected in the informed consent doctrine and the law of battery; the constitutional right of privacy; and the constitutional right to freedom of religion.’ This may include the right to die as disputed in current medical, ethical, and legal circles. The patient also has the right to make the “wrong” medical decision,* and he or she may withdraw consent while rational and able. The competent patient’s right to refuse care must be honored, even if the patient later becomes incompetent. The potential overriding considerations are the state’s interest in preserving life, preventing suicide, protecting innocent third parties, and maintaining the ethical standards of the health care profes~ion.~ The patient’s right to self-determination, however, outweighs “the interest of society in preserving life.”l0
Physician, Patient Considerations
T
he physician performing the procedure is responsible for obtaining the informed consent. It is the physician’s duty to explain the procedure to the patient and warn him or her of 506
FEBRUARY 1993, VOL 51, NO 2
appropriate risks and dangers and the probability of their occurring so the patient can make an “informed choice.”” The physician also must disclose other diagnosis methods and treatment alternatives, including low-risk and complicated alternatives.’? Court cases involving informed consent can be divided into three categories: 1) the physician misrepresents the nature or character of the procedure, 2) the physician fails to disclose “inevitable” risk, and 3) the physician fails to disclose “collateral” risk. l 3 The physician cannot be held liable for malpractice if alternatives omitted are not appropriate or if the plaintiff cannot establish that he or she would have chosen another method.14 American Jurisprudence lists disclosure as unnecessary if 0 risk is not foreseeable or inherent in the procedure, 0 withholding information is therapeutic with consideration for the patient’s psychological or physical well being, 0 the patient requests that the physician not disclose information, there is improper performance of the procedure, 0 the procedure is an emergency, the information has no relationship to the patient’s decision, 0 the patient would have proceeded with the alternative anyway, 0 the risk is known or obvious, or 0 the physician does not know or should not be aware of the risk.15 Additional liability occurs if the physician performs treatments beyond the consent boundaries. Consent for an operation or treatment arises from the contract between a physician and patient and is given only in connection with what the patient understands is to be done.16As part of informed consent, the patient should understand that the physician may need to modify or extend the procedure to accommodate unforeseen circumstances.17 Potential liability exists when the patient refuses care. The patient’s right to self-determination is foremost in the patient’s treatment
FEBRUARY 1993, VOL 57, NO 2
AORN JOURNAL
Informed consent is not only a legal duty but also a risk management tool for physicians. plan. When the competent patient does not accept the plan of treatment and his or her decision to do so could result in death, the physician’s duty to render care can be considered ended. This eliminates any possible criminal liability.ls This request may not appear rational, but the patient’s decision must be honored with few exceptions, and current law regarding living wills should be considered by the physician. There are two primary schools of thought concerning breach of duty arguments about informed consent. They are the traditional and the lay standard theories. The traditional or professional approach is measured by professional medical standards of customary disclosure practices of other physicians and consideration for reasonable physician disclosure under the same or similar circumstances. This theory postulates that the physician can make a judgment of how much information to disclose based on his or her evaluation of the individual patient’s needs. It applies to general procedures but not to complicated surgeries with a risk of death or bodily injury. The physician’s opinion is not subject to lay rules.19 The lay standard protects the patient’s right to self-determination. The physician’s duty to disclose information is based on the patient’s informational needs (ie, the information a patient needs to make a decision).20It protects the patient against a “conspiracy of silence.” If the patient is to suffer the consequences and expenses of the decision, the patient must know the alternatives and all risks.*’ Other schools of thought include the hybrid standard, which incorporates both the professional and lay theories, and the subjective patient standard, which requires full disclosure of all material facts.** The American College of Surgeons (ACS)
suggests that informed consent is not only a legal duty but also a risk management tool for physician^.^^ The use of consent forms should strengthen the physician/patient relationship via increased cornm~nication.~~ Patients usually expect perfect results from medical care, and informed consent helps establish a risk-assumption mindset in the patient.25According to the ACS, a reasonable approach to informed consent should answer the following patient questions. What do you plan to do to me? Why do you propose that procedure or treatment? Is there any alternative to this plan? Are there things I should worry about? and 0 What are the greatest risks, and what is the worst that could happen?26 Informed consent should include, at minimum, full disclosure of the nature of the diagnosed condition, all significant facts concerning the condition, and an explanation of the more probable consequences and difficulties inherent in the situation.27One researcher breaks this information into five elements: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the material risks; the alternatives and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risk associated with no treatment.28Another researcher suggests a similar list with the addition of information about the primary diagn~sis.*~ To secure a claim of lack of informed consent, the patient must prove that he or she was not informed of a specific risk that developed in the case, that the failure to inform him or her of that risk was negligent or a breach of the physician’s duty to the patient, and that a rea507
FEBRUARY 1993, VOL 51, NO 2
AORN JOURNAL
Witnessing a consent does not imply that the patient actually has given informed consent.
sonable person in the pretreatment position of the patient would have refused the treatment if informed of the risk.?”
Nui-sing Iniplicatioi?s
T
he perioperative nurse’s responsibilities include verifying that an informed consent has been obtained voluntarily from the patient or guardian and addressing any questions or concerns the patient has before surgery. The patient’s informed consent must be included on his or her chart when he or she arrives in the operating room.?’ The consent form should be signed several days before the elective procedure to allow time for the patient to ask questions and voice concerns.“ The consent can be witnessed by any individual specified in health care facility bylaws and regulations. Witnessing a consent verifies that the signature is the patient’s, but it does not imply that the patient actually has given informed consent. The nurse should verify the consent under the assumption that the patient understands the procedure. The physician cannot delegate the responsibility for obtaining informed consent or for the verification of the patient’s understanding of informed consent.” The information on the operative consent must be checked for accuracy preoperatively.3-‘ The perioperative nurse can check the permit for accuracy by comparing the proposed procedure and surgeon listed on the patient’s operative consent to the physician’s order for the procedure. These data should match the information posted on the OR schedule. If the patient consent does not match the physician order and the OR schedule. the nurse must resolve any discrepancies before the patient is sedated to ensure the patient’s understanding and to ensure that the proper instrumentation,
time allocation, and surgical team care plan are present. Additionally, if a patient signs a consent that contains abbreviations, he or she could misunderstand the intended meaning. In such a case, the patient’s misunderstanding could invalidate the consent. The nurse, therefore, should clarify all abbreviations, and the patient and witness should initial the changes on the form. The nurse also should ensure that the consent form contains the procedure to be performed, the operative side if applicable, and the physician’s name. In addition, the nurse ensures that the consent is signed by the patient or legal guardian and a witness and that the dates and times of the signatures are present.
Facility Implications
T
he Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that “the informed consent of the patient or, if applicable, the patient’s representative is obtained before anesthesia is administered and/or surgery is performed.”3s This consent must be present on the medical record. T h e American Hospital Association’s Statement on A Patient’s Bill of Rights discusses informed consent.3hIt includes the patient’s right to obtain current information in understandable terms regarding his or her treating physician, diagnosis, treatment, and prognosis. If, in the physician’s professional opinion, the patient should not receive the information, the physician should inform a legal guardian or spouse. The information must be delivered to and understood by the patient or guardian before the procedure unless it is an emergency. This information should include the risk involved, the alternatives, and the length of time the patient will be “incapacitated.’’ The patient may request more information, and he or she has the right to refuse care.
FEBRUARY 1993, VOL 57, NO 2
Health care facilities should have patient consent policies to protect them from liability. These policies must comply with state laws and JCAHO requirements. Enforcing these policies is the administrator’s responsibility. Facility-specific policies depend on individual state laws. In Maryland, for example, minors (ie, people under the age of 18 years) cannot consent to medical treatment37 unless they are emancipated (ie, are married or have a child).3* Other exceptions exist if there are special circumstances (ie, treatment for drug abuse, alcoholism, venereal disease, pregnancy, abuse, neglect, or mental disorder; contraception other than sterilization; injuries from alleged rape or sexual offense)39or in the case of an emergency where delay in treatment would have an adverse effect on the minor. In Maryland, consent can be substituted for disabled individuals who are not competent to consent to care if two physicians, within two hours of examining the patient, certify that the patient is incapable of making a decision. In the absence of a durable power of attorney or legal guardian, a spouse is the first person asked to grant consent to treat the patient, followed by an adult child, a parent, an adult sibling, a grandparent, and then an adult g r a n d ~ h i l d In .~~ an emergency when a delay in treatment would be harmful to the patient and no one is available to give consent, the physician can proceed without consent. The physician, however, will have to explain and defend the circumstances if a lawsuit is filed.4’ Consent can be be verbal or written. A consent form may provide valid proof of informed consent. The patient rarely remembers all of the information presented at the time of informed consent, and a patient’s statement that he or she lacked an understanding of the information presented will nullify a written consent.42 To document patient consent, two written forms are recommended for use by hospitals and physicians. The first form should be a consent for routine facility treatment. This includes nursing care and routine diagnostic procedures. It should also state that no guarantees of cure have been expressed. The attending physician
AORN JOURNAL
should be named. This consent should also state that the patient understands the planned treatment. The second form is more specific and is used for patients scheduled for surgery, x-ray therapy, radium treatment, anesthesia, or special invasive diagnostic procedure^.^^ Surgical consent must be obtained by the physician because the physician is in the best position to validate informed consent.44This special form should include the name of the authorized physician, the authority for the physician to select assistants, 0 a list of proposed procedures, patient consent for administration of anesthesia and by whom, a statement that the patient has received an explanation of the proposed procedures, and a statement that unforeseen circumstances may arise that may require additional or different procedures from those planned, the decision of which is subject to the professional judgment of the physician.45 Not only does informed consent support the patient’s right to self-determination, but it also protects him or her from “unratified” and “unwanted” procedures. It also protects the facility from the liability of unauthorized proc e d u r e ~ however, ;~~ the health care facility is not responsible for the physician’s failure to secure informed consent unless the physician is an employee or agent of the faci1ity.l’
Conclusion
T
he doctrine of informed consent is the cornerstone of the patient’s decisions regarding his or her individual care. It must be regarded as primary in the patient’s right to self-determination. Patient consent should be used as a tool to foster understanding among the health care facility, the physician, the nurse, and the patient, and this understanding should decrease liability by clarifying health care providers’ responsibilities. ROBINP. NEWHOUSE, RN 509
AORN JOURNAL
Notes 1. S Feutz, Nursing and the LUW (Eau Claire, Wis: Professional Education Systems, Inc, 1989) 39. 2. J Kraut, American Jurisprudence, second ed (Rochester, NY: The Lawyers Co-operative Publishing, 1981) 321. 3. Ibid, 306. , Hospital & 4. A F Southwick, T h e L U M of Health Care Administration, second ed (Ann Arbor, Mich: Health Administration Press, 1988) 380. 5. Feutz, Nursing and the Law. 43. 6. Southwick, The L U Mof~ Hospital & Health Care Administration. 441. 7. A M Rhodes, R D Miller, Nursing and the LUW (Rockville, Md: Aspen Publishers, Inc, 1984) 235. 8. S E Deardorff, “Informed consent, termination of medical treatment, and the Federal Tort Claims Act: A new proposal for the military health care system,” Militar? Law! RevieMI, ed T Feeney (Washington, DC: Department of the Army, 1987) 6. 9. Feutz, Nursing and the Law, 7 1. 10. Southwick. The LUM’of Hospital & Health Care Administration. 376. 1 1. Kraut, American Jurisprudence, 321. 12. G L Bounds, American Law Report, fourth ed (Rochester, N Y : The Lawyers Co-operative Publishing Co, 1985) 902. 13. Southwick, The L U Mo~f Hospital & Health Care Administration. 362. 14. Bounds, American Law Report, 902. 15. Kraut, American Jurisprudence. 323. 16. Ihid. 305. 17. Southwick, The LaMi of Hospital & Health Care Administration, 355. 18. Ibid. 376. 19. Bounds, American LaM. Report, 3 19. 20. Kraut, American Jurisprudence. 320. 2 1. Ihid. 22. Deardorff, “Informed consent, termination of medical treatment, and the Federal Tort Claims Act: A new proposal for the military health care system.” 19. 23. American College of Surgeons, “Care of the surgical patient,” in Elective Care 2 (New York City: Scientific America, Inc, 1988/1989) X-4. 24. Southwick, The LaM, of Hospital & Health Care Administration. 361. 25. American College of Surgeons, “Care of the surgical patient,” X-4. 26. Ibid. 27. Southwick, The LUM’of Hospital & Health Cure Administration. 36 1. 28. Feutz. Nur-sinji and the Lan., 41. 29. Deardorff. “Informed consent. termination of medical treatment. and the Federal Tort Claims Act: A new proposal for the military health care system,” 6. 510
FEBRUARY 1993, VOL 57, NO 2
30. American College of Surgeons, “Care of the surgical patient,” X-6. 3 1. L S Brunner, D S Suddarth, Textbook of Medical Surgical Nursing, sixth ed (Philadelphia: J B Lippincott Co, 1988) 313. 32. D Fogg, “Gas sterilizing medication; using wall suction for evacuating laser plumes; counting needles in multipacks” (Clinical Issues) AORN Journal 52 (August 1990) 412. 33. Ibid. 34. L J Atkinson, M L Kohn, Introduction to Operating Room Technique, sixth ed (New York City: McGraw-Hill, 1986) 43. 35. Joint Commission on Accreditation of Healthcare Organizations, Accr-editation Manual for Ambulatory Health Care 1 (Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations, 1992) 33. 36. American Hospital Association, Statement on A Patient’s Bill of Rights (Chicago: American Hospital Publishing, 1975). 37. A D Kowalsky et al, eds, The Annotated Code of t h e Public General L a w s of Maryland (Charlottesville, Va: Michie C o Department of Legislative Reference, 1989) 20-102. 38. Ibid. 39. E E Hogue, C T Koeler, Maryland Statutes Affecting Nursing Practice (Eau Claire, Wis: Professional Education Systems, Inc, 1990) 6. 40. Kowalsky et al, The Annotated Code of the Public General Laws of Maryland, 20-102. 4 I . Southwick, The Law of Hospital & Health Care Administration, 355. 42. Ibid, 354. 43. Ibid. 44. Ibid, 355. 45. Ibid. 46. Atkinson, Kohn, Introduction to Operating Room Technique, 42. 47. R D Miller, Problems in Hospital L a w (Rockville, Md: Aspen Publishers, Inc, 1983) 241.
AORN JOURNAL
Ethics Physician, nursing, facility implications of informed consent
F
orty years ago, patients relied on their physicians to make decisions about the best treatment alternatives for them. In 1957, as public expectations changed, a court in California enacted the doctrine of informed consent.' It was then that physician negligence rather than the charge of the intentional tort (ie, battery) became the basis for court action. This article explores the doctrine of informed consent and its impact on physicians, health care facilities, and perioperative nurses. Additional discussion includes recommendations for hospital and surgical consents.
the patient has an abject dependence upon and trust in the physician for the information that is relied upon during the decision-making process. Assumptions for this doctrine are that the patient is competent and not under the influence of any drugs. In the absence of an emergency, and with the exception of minors and incompetent adults, patients must consent for t h e m ~ e l v e s In . ~ the case of a minor or an incompetent adult, a legal guardian must consent unless he or she is unavailable and an
Informed Consent
I
nformed consent is given when the physician reveals to the patient the nature of his or her ailment and the proposed treatment and the probability and risks of consequences associated with such treatment. The patient has the right to ask questions and refuse care.2 The premise for informed consent is summarized in Cobbs v Grant (502 P2d 1, 9 [Cal 19721). This case states that 0 patients generally are unlearned in the medical sciences; therefore, except in rare cases, courts safely may assume that the knowledge of the patient and physician are not in parity, 0 a competent adult has the right to exercise control over what medical treatments are personally rendered, to be effective, a patient's consent to treatment must be an informed consent, and
Robin P. Newhouse, RN, MGA, CNOR, is the assistant director of surgical services, Greater Laurel (Md)Beltsville Hospital. At the time this article was written, she was the perioperative supervisor, Anne Arundel Medical Center, Annapolis, Md. She earned her AD in nursing f r o m Anne Arundel Community C o l l e g e , Arnold, Md, her BS degree in nursing from the University of Maryland, Baltimore, and her MGA degree in health care from the University of Maryland at College Park. 505
AORN JOURNAL
emergency exists.4 Competency is the physician’s judgment of the nonsedated patient’s ability to comprehend treatment information, deliberate the choices based on his or her individual needs, and communicate his or her decision.s A patient’s request for voluntary sterilization presents a special responsibility for informed consent. The patient must understand that the procedure will render him or her permanently unable to father or bear children, and the physician must be certain that the patient does not consent to sterilization under “duress, coercion, or deception.”6 This is particularly true when the procedure is paid with federal funds. In these cases, facilities must follow specific rules. The patient, in his or her right to self-determination, may refuse sterilization. This right is based on the common-law right to freedom from nonconsensual invasion of bodily integrity, reflected in the informed consent doctrine and the law of battery; the constitutional right of privacy; and the constitutional right to freedom of religion.’ This may include the right to die as disputed in current medical, ethical, and legal circles. The patient also has the right to make the “wrong” medical decision,* and he or she may withdraw consent while rational and able. The competent patient’s right to refuse care must be honored, even if the patient later becomes incompetent. The potential overriding considerations are the state’s interest in preserving life, preventing suicide, protecting innocent third parties, and maintaining the ethical standards of the health care profes~ion.~ The patient’s right to self-determination, however, outweighs “the interest of society in preserving life.”l0
Physician, Patient Considerations
T
he physician performing the procedure is responsible for obtaining the informed consent. It is the physician’s duty to explain the procedure to the patient and warn him or her of 506
FEBRUARY 1993, VOL 51, NO 2
appropriate risks and dangers and the probability of their occurring so the patient can make an “informed choice.”” The physician also must disclose other diagnosis methods and treatment alternatives, including low-risk and complicated alternatives.’? Court cases involving informed consent can be divided into three categories: 1) the physician misrepresents the nature or character of the procedure, 2) the physician fails to disclose “inevitable” risk, and 3) the physician fails to disclose “collateral” risk. l 3 The physician cannot be held liable for malpractice if alternatives omitted are not appropriate or if the plaintiff cannot establish that he or she would have chosen another method.14 American Jurisprudence lists disclosure as unnecessary if 0 risk is not foreseeable or inherent in the procedure, 0 withholding information is therapeutic with consideration for the patient’s psychological or physical well being, 0 the patient requests that the physician not disclose information, there is improper performance of the procedure, 0 the procedure is an emergency, the information has no relationship to the patient’s decision, 0 the patient would have proceeded with the alternative anyway, 0 the risk is known or obvious, or 0 the physician does not know or should not be aware of the risk.15 Additional liability occurs if the physician performs treatments beyond the consent boundaries. Consent for an operation or treatment arises from the contract between a physician and patient and is given only in connection with what the patient understands is to be done.16As part of informed consent, the patient should understand that the physician may need to modify or extend the procedure to accommodate unforeseen circumstances.17 Potential liability exists when the patient refuses care. The patient’s right to self-determination is foremost in the patient’s treatment
FEBRUARY 1993, VOL 57, NO 2
AORN JOURNAL
Informed consent is not only a legal duty but also a risk management tool for physicians. plan. When the competent patient does not accept the plan of treatment and his or her decision to do so could result in death, the physician’s duty to render care can be considered ended. This eliminates any possible criminal liability.ls This request may not appear rational, but the patient’s decision must be honored with few exceptions, and current law regarding living wills should be considered by the physician. There are two primary schools of thought concerning breach of duty arguments about informed consent. They are the traditional and the lay standard theories. The traditional or professional approach is measured by professional medical standards of customary disclosure practices of other physicians and consideration for reasonable physician disclosure under the same or similar circumstances. This theory postulates that the physician can make a judgment of how much information to disclose based on his or her evaluation of the individual patient’s needs. It applies to general procedures but not to complicated surgeries with a risk of death or bodily injury. The physician’s opinion is not subject to lay rules.19 The lay standard protects the patient’s right to self-determination. The physician’s duty to disclose information is based on the patient’s informational needs (ie, the information a patient needs to make a decision).20It protects the patient against a “conspiracy of silence.” If the patient is to suffer the consequences and expenses of the decision, the patient must know the alternatives and all risks.*’ Other schools of thought include the hybrid standard, which incorporates both the professional and lay theories, and the subjective patient standard, which requires full disclosure of all material facts.** The American College of Surgeons (ACS)
suggests that informed consent is not only a legal duty but also a risk management tool for physician^.^^ The use of consent forms should strengthen the physician/patient relationship via increased cornm~nication.~~ Patients usually expect perfect results from medical care, and informed consent helps establish a risk-assumption mindset in the patient.25According to the ACS, a reasonable approach to informed consent should answer the following patient questions. What do you plan to do to me? Why do you propose that procedure or treatment? Is there any alternative to this plan? Are there things I should worry about? and 0 What are the greatest risks, and what is the worst that could happen?26 Informed consent should include, at minimum, full disclosure of the nature of the diagnosed condition, all significant facts concerning the condition, and an explanation of the more probable consequences and difficulties inherent in the situation.27One researcher breaks this information into five elements: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the material risks; the alternatives and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risk associated with no treatment.28Another researcher suggests a similar list with the addition of information about the primary diagn~sis.*~ To secure a claim of lack of informed consent, the patient must prove that he or she was not informed of a specific risk that developed in the case, that the failure to inform him or her of that risk was negligent or a breach of the physician’s duty to the patient, and that a rea507
FEBRUARY 1993, VOL 51, NO 2
AORN JOURNAL
Witnessing a consent does not imply that the patient actually has given informed consent.
sonable person in the pretreatment position of the patient would have refused the treatment if informed of the risk.?”
Nui-sing Iniplicatioi?s
T
he perioperative nurse’s responsibilities include verifying that an informed consent has been obtained voluntarily from the patient or guardian and addressing any questions or concerns the patient has before surgery. The patient’s informed consent must be included on his or her chart when he or she arrives in the operating room.?’ The consent form should be signed several days before the elective procedure to allow time for the patient to ask questions and voice concerns.“ The consent can be witnessed by any individual specified in health care facility bylaws and regulations. Witnessing a consent verifies that the signature is the patient’s, but it does not imply that the patient actually has given informed consent. The nurse should verify the consent under the assumption that the patient understands the procedure. The physician cannot delegate the responsibility for obtaining informed consent or for the verification of the patient’s understanding of informed consent.” The information on the operative consent must be checked for accuracy preoperatively.3-‘ The perioperative nurse can check the permit for accuracy by comparing the proposed procedure and surgeon listed on the patient’s operative consent to the physician’s order for the procedure. These data should match the information posted on the OR schedule. If the patient consent does not match the physician order and the OR schedule. the nurse must resolve any discrepancies before the patient is sedated to ensure the patient’s understanding and to ensure that the proper instrumentation,
time allocation, and surgical team care plan are present. Additionally, if a patient signs a consent that contains abbreviations, he or she could misunderstand the intended meaning. In such a case, the patient’s misunderstanding could invalidate the consent. The nurse, therefore, should clarify all abbreviations, and the patient and witness should initial the changes on the form. The nurse also should ensure that the consent form contains the procedure to be performed, the operative side if applicable, and the physician’s name. In addition, the nurse ensures that the consent is signed by the patient or legal guardian and a witness and that the dates and times of the signatures are present.
Facility Implications
T
he Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that “the informed consent of the patient or, if applicable, the patient’s representative is obtained before anesthesia is administered and/or surgery is performed.”3s This consent must be present on the medical record. T h e American Hospital Association’s Statement on A Patient’s Bill of Rights discusses informed consent.3hIt includes the patient’s right to obtain current information in understandable terms regarding his or her treating physician, diagnosis, treatment, and prognosis. If, in the physician’s professional opinion, the patient should not receive the information, the physician should inform a legal guardian or spouse. The information must be delivered to and understood by the patient or guardian before the procedure unless it is an emergency. This information should include the risk involved, the alternatives, and the length of time the patient will be “incapacitated.’’ The patient may request more information, and he or she has the right to refuse care.
FEBRUARY 1993, VOL 57, NO 2
Health care facilities should have patient consent policies to protect them from liability. These policies must comply with state laws and JCAHO requirements. Enforcing these policies is the administrator’s responsibility. Facility-specific policies depend on individual state laws. In Maryland, for example, minors (ie, people under the age of 18 years) cannot consent to medical treatment37 unless they are emancipated (ie, are married or have a child).3* Other exceptions exist if there are special circumstances (ie, treatment for drug abuse, alcoholism, venereal disease, pregnancy, abuse, neglect, or mental disorder; contraception other than sterilization; injuries from alleged rape or sexual offense)39or in the case of an emergency where delay in treatment would have an adverse effect on the minor. In Maryland, consent can be substituted for disabled individuals who are not competent to consent to care if two physicians, within two hours of examining the patient, certify that the patient is incapable of making a decision. In the absence of a durable power of attorney or legal guardian, a spouse is the first person asked to grant consent to treat the patient, followed by an adult child, a parent, an adult sibling, a grandparent, and then an adult g r a n d ~ h i l d In .~~ an emergency when a delay in treatment would be harmful to the patient and no one is available to give consent, the physician can proceed without consent. The physician, however, will have to explain and defend the circumstances if a lawsuit is filed.4’ Consent can be be verbal or written. A consent form may provide valid proof of informed consent. The patient rarely remembers all of the information presented at the time of informed consent, and a patient’s statement that he or she lacked an understanding of the information presented will nullify a written consent.42 To document patient consent, two written forms are recommended for use by hospitals and physicians. The first form should be a consent for routine facility treatment. This includes nursing care and routine diagnostic procedures. It should also state that no guarantees of cure have been expressed. The attending physician
AORN JOURNAL
should be named. This consent should also state that the patient understands the planned treatment. The second form is more specific and is used for patients scheduled for surgery, x-ray therapy, radium treatment, anesthesia, or special invasive diagnostic procedure^.^^ Surgical consent must be obtained by the physician because the physician is in the best position to validate informed consent.44This special form should include the name of the authorized physician, the authority for the physician to select assistants, 0 a list of proposed procedures, patient consent for administration of anesthesia and by whom, a statement that the patient has received an explanation of the proposed procedures, and a statement that unforeseen circumstances may arise that may require additional or different procedures from those planned, the decision of which is subject to the professional judgment of the physician.45 Not only does informed consent support the patient’s right to self-determination, but it also protects him or her from “unratified” and “unwanted” procedures. It also protects the facility from the liability of unauthorized proc e d u r e ~ however, ;~~ the health care facility is not responsible for the physician’s failure to secure informed consent unless the physician is an employee or agent of the faci1ity.l’
Conclusion
T
he doctrine of informed consent is the cornerstone of the patient’s decisions regarding his or her individual care. It must be regarded as primary in the patient’s right to self-determination. Patient consent should be used as a tool to foster understanding among the health care facility, the physician, the nurse, and the patient, and this understanding should decrease liability by clarifying health care providers’ responsibilities. ROBINP. NEWHOUSE, RN 509
AORN JOURNAL
Notes 1. S Feutz, Nursing and the LUW (Eau Claire, Wis: Professional Education Systems, Inc, 1989) 39. 2. J Kraut, American Jurisprudence, second ed (Rochester, NY: The Lawyers Co-operative Publishing, 1981) 321. 3. Ibid, 306. , Hospital & 4. A F Southwick, T h e L U M of Health Care Administration, second ed (Ann Arbor, Mich: Health Administration Press, 1988) 380. 5. Feutz, Nursing and the Law. 43. 6. Southwick, The L U Mof~ Hospital & Health Care Administration. 441. 7. A M Rhodes, R D Miller, Nursing and the LUW (Rockville, Md: Aspen Publishers, Inc, 1984) 235. 8. S E Deardorff, “Informed consent, termination of medical treatment, and the Federal Tort Claims Act: A new proposal for the military health care system,” Militar? Law! RevieMI, ed T Feeney (Washington, DC: Department of the Army, 1987) 6. 9. Feutz, Nursing and the Law, 7 1. 10. Southwick. The LUM’of Hospital & Health Care Administration. 376. 1 1. Kraut, American Jurisprudence, 321. 12. G L Bounds, American Law Report, fourth ed (Rochester, N Y : The Lawyers Co-operative Publishing Co, 1985) 902. 13. Southwick, The L U Mo~f Hospital & Health Care Administration. 362. 14. Bounds, American Law Report, 902. 15. Kraut, American Jurisprudence. 323. 16. Ihid. 305. 17. Southwick, The LaMi of Hospital & Health Care Administration, 355. 18. Ibid. 376. 19. Bounds, American LaM. Report, 3 19. 20. Kraut, American Jurisprudence. 320. 2 1. Ihid. 22. Deardorff, “Informed consent, termination of medical treatment, and the Federal Tort Claims Act: A new proposal for the military health care system.” 19. 23. American College of Surgeons, “Care of the surgical patient,” in Elective Care 2 (New York City: Scientific America, Inc, 1988/1989) X-4. 24. Southwick, The LaM, of Hospital & Health Care Administration. 361. 25. American College of Surgeons, “Care of the surgical patient,” X-4. 26. Ibid. 27. Southwick, The LUM’of Hospital & Health Cure Administration. 36 1. 28. Feutz. Nur-sinji and the Lan., 41. 29. Deardorff. “Informed consent. termination of medical treatment. and the Federal Tort Claims Act: A new proposal for the military health care system,” 6. 510
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30. American College of Surgeons, “Care of the surgical patient,” X-6. 3 1. L S Brunner, D S Suddarth, Textbook of Medical Surgical Nursing, sixth ed (Philadelphia: J B Lippincott Co, 1988) 313. 32. D Fogg, “Gas sterilizing medication; using wall suction for evacuating laser plumes; counting needles in multipacks” (Clinical Issues) AORN Journal 52 (August 1990) 412. 33. Ibid. 34. L J Atkinson, M L Kohn, Introduction to Operating Room Technique, sixth ed (New York City: McGraw-Hill, 1986) 43. 35. Joint Commission on Accreditation of Healthcare Organizations, Accr-editation Manual for Ambulatory Health Care 1 (Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations, 1992) 33. 36. American Hospital Association, Statement on A Patient’s Bill of Rights (Chicago: American Hospital Publishing, 1975). 37. A D Kowalsky et al, eds, The Annotated Code of t h e Public General L a w s of Maryland (Charlottesville, Va: Michie C o Department of Legislative Reference, 1989) 20-102. 38. Ibid. 39. E E Hogue, C T Koeler, Maryland Statutes Affecting Nursing Practice (Eau Claire, Wis: Professional Education Systems, Inc, 1990) 6. 40. Kowalsky et al, The Annotated Code of the Public General Laws of Maryland, 20-102. 4 I . Southwick, The Law of Hospital & Health Care Administration, 355. 42. Ibid, 354. 43. Ibid. 44. Ibid, 355. 45. Ibid. 46. Atkinson, Kohn, Introduction to Operating Room Technique, 42. 47. R D Miller, Problems in Hospital L a w (Rockville, Md: Aspen Publishers, Inc, 1983) 241.