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THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

Policy No: S-50-31 GREENVILLE HOSPITAL SYSTEM MANUAL OF POLICY DIRECTIVES TITLE:

Consents

DATE:

February 15, 2003 Revised: January 18,2005

I.

Policy Statement: Patients will have informed consents and documentation of such before any operative or invasive procedure or treatment is provided.

II. General Guidelines: A. The physician is responsible for informing the patient or their legally authorized representative about any procedure to be performed. Nursing personnel are responsible for making sure consents are present and have appropriate signatures. The physician performing the procedure must determine wording for the consent form. B. Telephone consents and authorizations are valid if monitored by a third party as a witness. Both witnesses must sign the consent describing the authorized person's verbal consent. C. When the patient signs with a mark, two witnesses are required. D. When the procedure is to be performed by a consultant physician, the name of the consultant physician performing the procedure, not the attending physician shall be on the consent. E. Abbreviations should not be used on consents. Consents completed outside the hospital and signed by the physician performing the procedure shall not be altered or rewritten by GHS personnel.

F. In cases of extreme emergency, operations or other procedure may be performed without written consent, only if such is essential to the health or life of such patient in the opinion, certified in writing, of the performing physician and consultant, both of whom must be members of the Greenville Hospital System Medical Staff, per the Medical Staff Rules & Regulations. G. If the patient is a minor or there is a question as to the patient's ability to consent (due to court determination or a medical determination of incapacity) the procedures in Part Ill,Authorized Signatures should be followed. Ill.

Procedures or Treatments Requiring Informed Consent A. A consent on admission that covers examinations and treatments, personal valuables, and release of information is to be signed for all patients on

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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admission. It provides evidence of the patient's voluntary submission to treatment but generally does not document the informed consent necessary for specific medical and surgical procedures.

B. Written consent forms are required for the following: 1. Any non-routine therapeutic, diagnostic or operative and invasive procedures, including anesthesia, performed by a member of the medical staff or other persons approved by GHS that places a patient at more than minimal risk.

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2. Transfusion of blood products or refusal of such (administrative policy 100.148) 3. Experimental procedures 4. Research procedure and medication 5. Sexual assault examinations

6. . Sterilization

7. Abortion (administrative policy 100.108) 8. HlV testing C. Consent Forms Available and Their Appropriate Use 1. Consent Form for Autopsies ordered autopsies.

- Special consent is required for no-coroner

2. Consent Form for Anatomical Giftstorgan Procurement - The Uniform Anatomical Gift Act provides that the next of kin may give authorization for removal of organs, "after or immediately before death." 3. Consent Form for Blood or Blood Product Administration - Consents for the planned transfusion of blood or blood products must be obtained prior to administration of these products. Only one (1) consent form is required per hospitalization. 4. Consent Form for Disposal Permit

a. When an amputation is performed, the limb, after pathological examination, may be disposed of by the hospital or arrangements may be made for burial. A permit must be signed if the hospital is to dispose of the limb.

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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Consents

b. Following the death of non- viable infants or stillborn, the family may elect to have disposal by the hospital or arrangements may be made for burial. A disposal permit is to be signed if the hospital is to dispose of the infant.

5. Consent Form for HIV-Antibody Testing - Any person to receive HIVantibody testing at the Greenville Hospital System will have an informed and signed consent obtained. A GHS consent form for HIV-antibody testing will be signed. The patient's physician is responsible for obtaining consent. 6. Consent Form for Leaving Against Medical Advice -A release form is to be signed by patients leaving against medical advice.

7. Consent Form for Operative, Anesthesia or other lnvasive Procedures Used for all procedures not defined by a separate consent. This includes selected radiology procedures that place a patient at more than minimal risk. 8. Consent Form for Observers in the Operating Room - Any person who is not a member of the operating room team or a student affiliate of the Greenville Hospital System must have the patient's permission to be present in the operating room.

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9. Consent Forms for Photographs The hospital or Marketing department must have consent for taking and publicizing photographs of a patient or parts of his body must be signed by the patient or his legal guardian in accordance with GHS Policy 5-50-3 and with the permission of the attending physician.

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10. Consent Form for Sterilization by Hysterectomy Patients of childbearing age are to sign the specialty sterilization statement relative to hysterectomy.

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11. Consent Form for Sterilization of Medical Recipients A special consent provided by the Department of Social Services is required. A least 30 days, but not more than 180 days, must pass between the signing of the informed consent and the date of the sterilization procedure, subject to exceptions in cases of emergency. This consent is the responsibility of the surgeon. The forms are available in Outpatient Surgery and Pre-Op Assessment. The form must be submitted for billing coverage. 12.Consent Form for Sterilization by Tubal or Vas Ligation - Patients desiring sterilization by tubal or vas ligation must sign the specialty consent relative to these procedures.

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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Consents

13.The physician performing the procedure must determine wording for consent. Wording for consents should not be determined by looking at the operative schedule. This list may not be inclusive of all procedures. See departmental policy manuals for consent policies specific to one department. IV.

Authorized Sianatures A.

Hospital and Physician Obligations The hospital is charged with ensuring that procedures are performed with the informed consent of the Patient. It is the physician's duty to obtain the consent! Hospital forms are merely an affirmation that the physician has already obtained the appropriate informed consent. Consent is valid until the patient's physical or mental condition changes or unless sufficient time has passed that a reasonable person would not remember the details from the conversation about consent.

B.

Adults According to South Carolina law, competent persons 18 years or age or older may make decisions about their own health care, including signing consents. If, however, an adult is "unable to consentn,as that term is defined by statute, then another person may make health care decisions on behalf of the patient. 1.

Determining inability to consent

A patient is "unable to consent" if: the patient cannot appreciate the nature and implications of hisher condition and proposed care; the patient cannot make a reasoned decision concerning proposed care; -OR-

* the patient cannot communicate hisher decision concerning proposed care in an unambiguous manner. Inability to consent must be determined: by two (2) licensed physicians who have examined the patient; -OR-

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

Consents

Policy S-50-31 Page 5 by a licensed physician who has examined the patient and certified in writing that the delay in getting two physicians would be detrimental to the patient's health.

3. Determiningwho will make health care decisions for the patient if an adult patient has been determined to be unable to consent as described above, then the following ("surrogate decision-makersn),in the following order, may make decisions regarding the patient's care:

a.) Guardian appointed by Probate Court, if within scope of appointment; b.) Attorney-in-fact (agent) appointed by the patient under a health care power of attorney, if within the scope of the agency; c.) Anyone otherwise given authority by statute; d.) Spouse (unless divorced, signed written property or marital settlement agreement, or legally separated); e.) Parent or adult child; f.) Adult sibling or grandchild, or grandparent; g.) Any other relative (blood or marriage) who the physician reasonably believes has a close personal relationship with the patient; h.) A person given the authority to make health care decisions under a statutory provision, placing them in last priority. Medical treatment necessary to prevent a significant detriment to the patient's health should not be delayed while searching for a decision. maker listed above. Common Law Spouses: To be a common-law spouse, there must be evidence of the parties living together and holding themselves out as a married couple. Statements like "we were going to get married next summer" negate common-law marriage. Cohabitation does not equal common-law marriage. Ask how long the couple has been living as husband and wife, or do you consider yourselves married. Common-law spouse equals "spousenunder (d) above. 4. Making Treatment Decisions

Surrogate decision-makers must base decisions on the patient's wishes to the extent that those wishes can be determined. Where the patient's wishes cannot be determined, the person must base the decision on the patient's best interest.

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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C. Minors If less than 18 years of age, parents or legal guardian must consent to any procedure except: Necessary Services. Health services of any kind may be rendered to minors of any age without the consent of a parent or legal guardian when, in the professional medical judgment of the provider legally authorized to perform the service, the service is deemed necessary. If the necessary service involves an operation, the operation may only be performed without consent if the operation is essential to the life of the minor in the opinion of the physician performing the operation and, if available, a consultant physician.

2.

Minors 16 Years of Age or Older. A minor 16 years of age or older may consent to any health service unless the service is an operation. Operations require parental consent, or may be performed without consent if the operation is essential to the life of the minor, in the opinion of the physician performing the operation and, if available, a consultant physician.

3.

Married Minors and Their Spouses. Married minors may consent to diagnostic, therapeutic, surgical or postmortem procedures, regardless of their age. If the minor is unable to consent, the minor's spouse, regardless of age, has the legal authority to consent to treatment for the minor. If the minor is unable to consent and the minor's spouse is unavailable, then necessary care may be provided without consent, as can essential surgical care. The legal surrogate determined in accordance with the Adult Health Care Consent Act should make other treatment decisions. In special situations where neither the minor nor the minor's spouse will consent to necessary treatment, Quality Management should be contacted immediately to assist in formulating an appropriate medical response. Children Born to Minors. Minors may consent to health services for their children. If the child is legitimate, either parent's consent will suffice. If the child is illegitimate, only the mother may give consent.

4.

5.

Parents Withholding Necessary Care. Parents may not withhold consent to medical care for their minor children in a manner that endangers the health and welfare of a minor child. The child abuse reporting statutes allow DSS to indicate such a case for medical neglect. Where consent is withheld for religious reasons or other

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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reasons reflecting an exercise of judgment by the parent as to the best interests of the child, the Children's Code also permits DSS to petition the Family Court for an order finding that care is necessary to prevent death or permanent harm to the child.

Note: In instances where care is, in the provider's opinion, "necessary", the law also pennits the provider to act without consent. The minor patient's parent should be advised of the provider's treatment decision and advised that the provider intends to render medically necessary care over the parent's objection. Withholding blood or blood products from children on religious grounds is not necessariy the basis for an allegation of abuse or medical neglect. Always contact Qualify Management about these issues. D.

Abortions and Sterilization

The general rule is that a pregnant woman's consent is required in every case where she is capable of giving consent. If the woman is adjudicated by the Probate Court as mentally incompetent, consent must be obtained from her spouse or legal guardian. If unmarried, consent must be obtained from one parent or a legal guardian. 1.

Abortions and Minors If the woman is a minor (legally incapable of giving consent to an "operationn),consent of the minor plus one of the following must be obtained: a.) b.) c.) d.)

e.)

One parent; A legal guardian; A grandparent; Any person standing in loco parentis to the minor for a period of not less than 60 days (must sign an affidavit, indicating the nature and length of relationship to the minor); Exception #l:Competent, emancipated minor can give informed written consent on hislher own. Exception #2: Minor can seek a court ordered abortion without the consent of a parent or legal Guardian; patient should consult DSS or legal counsel for assistance. The consent requirement can be waived for any patient if: 1.) The physician determines there is a medical emergency involving the life of the woman, regardless of age; OR

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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2.) If the pregnancy of the minor is the result of incest, in which case the physician performing the abortion must report incest to DSS or law enforcement agency in the county where the minor resides or is found. Failure to report is a violation of the Child Abuse Reporting Law. E. Sterilization

1.

Federally Funded Sterilization Elective Sterilization. The "Sterilization for Medicaid Recipients" consent form must be submitted with every billing for smices related to an elective sterilization. Consent Form Requirements. For Medicaid financial coverage of elective sterilization for male or female, the following requirements must be met: a)

The individual must have reached her 21* birthday at the time the consent form is signed.

b)

The individual cannot be institutionalized or mentally incompetent.

c)

The individual must voluntarily give informed consent. An individual has given informed consent only if an offer has been made to allow a witness of the recipient's choice to be present during the consent interview. A copy of the consent form must be given to the individual. Additionally, all topics covered in the consent form must be discussed verbally between the individual and the person obtaining the consent. Informed Consent may not be obtained while the individual to be sterilized is:

1) 2)

3)

In active labor or childbirth; Seeking to obtain an abortion; or Under the influence of alcohol or other substance(s) that affect the individual's state of awareness.

d) Waiting Period. At least 30 days, but not more than 180 days, must pass between the signing of the informed consent and the date of the sterilization procedure, subject to exceptions in case of emergency.

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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2.

Medically Necessary Sterilization For medically necessary sterilization, the Sterilization consent form is not required.

3.

Minors and Mentally Incompetent Patients The hospital does not perform non-therapeutic sterilization on minors and persons who are mentally incompetent. Cases involving the therapeutic sterilization of a minor or mentally incompetent patient require consent of the parent or legal guardian, or an order from the Family or Probate Court. In the event judicial consent cannot be obtained due to time constraints, the attending surgeon must consult with another physician to document that the procedure is essential to the health and life of the patient. A statement to this effect must be recorded in the individual's medical record.

Organ Donation Written consent must be obtained from the next-of-kin before organ or tissue donation can occur, if the decedent has not indicated whether helshe wishes to donate histher organs or tissue. The S. C. Uniform Anatomical Gift Act provides that any individual of sound mind and eighteen (18) years of age or more may give all or any part of hislher body, the gift to take effect upon death. If a deceased patient has made an inter vivos gift of all or any part of hislher body either by will or written document (including an organ donation card), next-of-kin consent is not necessary. A copy of the document indicating the gift should be made part of the patient's medical record. In the absence of a pre-death gift by the decedent, next-of-kin who may consent to organ or tissue donation are, in order of priority: 1.

2. 3. 4. 5. 6. 7.

An agent under a health care power of attorney (if within the scope of the agent's powers); The patient's spouse; The patient's adult son or daughter; Either parent of the patient; Any of the patient's adult siblings; The patient's guardian; Any other person authorized or under obligation to dispose of the body, which might include grandparents, uncles, aunts or cousins.

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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If the hospital or person legally authorized to consent to the organ donation has knowledge that the decedent did not wish to donate organs, or another next-of-kin is opposed to the donation, the gift cannot be accepted. In addition, a donor may amend or revoke a gift in the manner set forth in the Uniform Anatomical Gift Act. If a death is under the jurisdiction of the medical examiner or coroner, written or verbal permission must be obtained from that office before organ or tissue recovery commences. In all instances, the consent to organ donation should specify dearly which organs andlor tissues are being donated. It should be clear to the person consenting to the donation what is involved in the donation procedure (i.e., removal of bones for bone marrow donation). The original signed consent form should be included as part of the donor's medical record. According to state law, a statement concerning whether a family is approached concerning organ or tissue donation and the reasons leading to that decision, as well as the disposition of any referral to an Organ Procurement Organization (OPO) and that organization's acceptance or rejection of the donor, must be documented in the medical record of any patient who is identified by the hospital as a potential organ or tissue donor. The Administrative Supervisor at GMH or Nursing personnel as designated at other GHS facilities is responsible, according to Hospital policy, for ensuring that proper consent and documentation is obtained for organs or tissue to be procured. A patient with a health care power of attorney can give hislher agent power to make anatomic gifts. G.

Hemodialysis and Peritoneal Dialysis Patients undergoing hemodialysis andlor peritoneal dialysis shall sign the Special Consent to Operation, Anesthesia or Other Procedure form on admission or when treatment is initiated at Greenville Memorial Hospital. If treatment is continuous and the patient remains under the medical supervision of the same group of physicians, the consent will be valid for a period not to exceed the current hospitalization, unless revoked by the patient or indicated otherwise by the physician.

H.

Patients on PCA Pain Management Patients receiving PCA pain management should be evaluated at the time of proposed treatment to determine whether they are capable of giving consent. The standard set forth in the Adult Health Care Consent Act

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.

THIS POLICY HAS BEEN REISSUED SINCE JULY 2004.

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Policy S-50-31 Page II

should be used to determine the patient's ability to consent. If the inability to consent arises due to the effects of the pain medication, the provider should assess whether the treatment can be delayed until such time as the patient is capable of giving consent. If the treatment cannot be so delayed, the Act should be followed in determining a surrogate decisionmaker and obtaining consent from that individual.

+*Lm.u~\ Fr nk D. Pinckney

NOTE: This policy was originally in the Nursing Policy Mariual and was created by combining NS-2-3, NS-23a and NS-2-3b.

THIS INDIVIDUALLY ISSUED AND DISTRIBUTED POLICY DOES NOT CREATE A CONTRACT OF EMPLOYMENT BETWEEN GHS AND THE EMPLOYEE. EMPLOYMENT AT GHS IS AT WILL. ALL PREVIOUSLY ISSUED VERSIONS OF THIS POLICY ARE HEREBY REVOKED.