This Document Describes the Policy and Procedure Used to Obtain and Document Authorization

/ STANDARD OPERATING PROCEDURE
SOP-0175 / Rev 7
Donation by Donor Designation

Purpose:
This document describes the policy and procedure used to obtain and document authorization for donation through donor designation. It is the intent of LifeSource to honor donor designation that is legally documented by a resident of any state in the United States.
This policy is intended to provide an ethical and legal mechanism for assuring authorization for organ, tissue and eye donation in accordance with state and federal laws and regulations. Authorization consists of any properly executed donor designation that has not been revoked. In the absence of such designation, authorization will be obtained from legal next-of-kin or the person(s) who have legal responsibility for the final disposition of the deceased.
LifeSource will ensure that the family discussion process is facilitated by trained team members in a sensitive, compassionate, and timely manner, consistent with requirements and requisites of donor hospitals, as applicable.
Responsibilities:
It is the responsibility of the Director of Organ Procurement and the Director of Tissue Services and Donor Services Center to ensure that personnel are trained to fulfill donor designation in accordance with this SOP.
Personnel responsible for discussing donation of organs, tissues and eyes are: LifeSource Coordinators and Donor Services Coordinators.
Definitions:
Anatomical gift - A donation of all or part of a human body to take effect after the donor’s death for the purpose of transplant, therapy, research, or education. It is made by:
Document of gift - A document of gift signed by the donor or other person authorized to make the gift according to law. If the person cannot sign, the document of gift must be signed by another individual and by two adults (at least one of whom is a disinterested witness), all of whom have signed at the direction and in the presence of the donor and/or each other, and state that it has been so signed; or
Authorization - A document of gift signed by the classes of persons, in legal order, unless the decedent has made a refusal to make an anatomical gift that is unrevoked at the time of death.The gift must be made by:
A document of gift signed by the person, or
The person’s oral communication that is electronically recorded or is contemporaneously reduced to a record and signed by the individual receiving the oral communication.
Document of gift - Is expressed in any of the following documents:
Driver’s or chauffeur’s license;
Revocation, suspension, expiration, or cancellation of the license does not invalidate the anatomical gift.
State-issued Identification Card;
Advanced Directive;
Will;
Organ, Tissue, and Eye Donation Registry; or
Donor card or other writing intended to make an anatomical gift and that is signed by the potential donor.
Donor - An individual whose body or part is the subject of an anatomical gift.
DD - Donor Designation - A donor’s indicated intent to donate organs/tissues/eyes at the time of death as expressed in a document of gift.
Minor - An individual under 18 years of age.
ME/C – Medical Examiner / Coroner
Emancipated Minor - "Emancipated" minors can give legal consent for any type of medical or mental health service. The emancipated minor must fit one of these three categories:
Living separate and apart from parents of guardian (with or without permission, regardless of duration) who is managing her or his own financial affairs;
Married;
Minor who has given birth to a child.
Revocation - A revocation (i.e. removed “donor” from driver’s license) of a document of gift evidenced by:
A record signed by the donor or other person who was authorized to make a gift during the donor’s lifetime;
An oral statement made during a terminal illness in the presence of two adults at least one of whom is a disinterested witness;
Revocation of a will containing the donor’s designation.
Refusal - A refusal to make an anatomical gift expressed through any writing signed in the same manner as a document of gift, or any other writing used to identify the individual as refusing to make an anatomical gift.
LNOK – Legal next of kin or other person having authority to make an anatomical gift according to the following legal order:
Minnesota: Agent; Spouse; Adult child; Parent; Adult sibling; Adult grandchild; Grandparent; Guardian; Adult exhibiting special care/concern; Other person with authority to dispose of decedent’s body.
All other states, including South Dakota, North Dakota, and Wisconsin: Agent; Spouse; Adult child; Parent; Adult sibling; Adult grandchild; Grandparent; Adult exhibiting special care/concern; Guardian; Other person with authority to dispose of decedent’s body.
Agent - An individual who is:
A health care agent.
Expressly authorized to make an anatomical gift on the principal’s behalf by any other record signed by the principal.
Guardian – A person appointed by a court to make decisions regarding the support, care, education, health, or welfare of an individual. This does not include a guardian ad litem.
Know – To have actual knowledge (not merely a suspicion).
Disinterested Witness – Any adult other than the person making the decision on behalf of the donor and cannot stand to gain from the donation. For example – if the donor’s wife is his LNOK, then his sibling could be the disinterested witness, a donor hospital staff member could be a disinterested witness;
A LC, a transplant physician, or a potential recipient is not to be considered a disinterested witness.
Reasonably Available – able to be contacted by the procurement organization without undue, excessive, or extreme effort; and willing and able to act in a timely manner consistent with existing medical criteria necessary for the making of an anatomical gift.
CDR - Certified Designated Requester - Hospital staff member who has been trained by LifeSource to discuss donation with families.
LS – LifeSource
LifeSource donor record: A record pertaining to any referred patient, donor, or non-donor, which is filed according to a unique LifeSource ID Number, and maintained in electronic and/or paper-based formats.
LC - LifeSource Coordinator: Family Support Coordinator, Donation Coordinator, Advanced Practice Donation Coordinator, Hospital Coordinator, Organ Procurement Manager; or other LifeSource team member trained for this purpose; responsible for obtaining authorization for organ and/or tissue and eye donation.
DRC – Donation Resource Coordinator
TAOC - Tissue Administrator on Call
TRC - Tissue Recovery Coordinator
DSC – Donor Services Coordinator; responsible for obtaining authorization and fulfill donor designation for organ, tissue, and eye donation.
Leadership Team – Chief Executive Officer, Chief Administrative Officer, Director of Procurement, Director of Hospital Services, Director of Quality and Regulatory Affairs, Director of Tissue Services and Donor Services Center, Director of Public Affairs
OPO – Organ Procurement Organization
Referral Source – Entities such as hospitals, medical examiners, coroners and individual allied health care professionals who identity potential donors and refer them, or their next of kin, to LifeSource.
Witness – a person over the age of 18 who is not an team member or agent acting on behalf of LifeSource that listened to or was present for the discussion or a recording of the authorization.
References and/or Associated Documents:
GUI-0046 Process Flowcharts for Donor Designation
SOP-0215 Donor Risk Assessment Interview
SOP-0014 Obtaining Authorization for Donation by Next of Kin
SOP-0093 Donation after Circulatory Death
LifeSource Organ and Tissue Donation Brochure
LifeSource Donor Designation Brochure
Family Conversation Resource
Authorization Form Resource
Designation of Gift Form Resource
Centers for Medicare & Medicaid Services (CMS) - Conditions for Coverage for Organ Procurement Organizations: Final Rule; 42 CFR 486.342 (b)
Joint Statement of the American Association of Tissue Banks, Association of Organ Procurement Organizations, and Eye Bank Association of America: Model Elements of Informed Consent for Organ and Tissue Donation; Adopted November 30, 2000.
MN UAGA: MN Law 525.921-525.9224
ND UAGA: North Dakota Century Code 23-06.6-10
SD UAGA: South Dakota Statute 34-26-48 to 34-26-72
Wisconsin Legislative Council Act Memo: 2005 Wisconsin Act 229; Anatomical Gifts – Consent Regarding Bone and Tissue.
Minnesota Statute 325L Uniform Electronic Transaction Act
South Dakota Codified Laws Chapter 53-12 Electronic Transactions
North Dakota Cent. Code Chapter 9-16 Electronic Transactions
Wisconsin 2003 Act 294 Chapter 137 Authentications and Electronic Transactions and Records
Materials and Equipment as Needed:
FORM-0058 Designation of Gift
FORM-0110 Designation of Gift – DSC Use Only
FORM-0166 Donor Risk Assessment Interview Less than or Equal to 12 Years Old
FORM-0167 Donor Risk Assessment Interview Birth Mother
FORM-0168 Donor Risk Assessment Interview Greater than 12 Years Old
Procedure:
Preliminary Assessment
DSC/DRC/LC will collaborate with referral source to determine the LNOK according to state-specified legal priority. The LNOK priority is based on the laws of the state in which the death occurred. The LNOK must be reasonably available according to state law (see LNOK definition). If not reasonably available, a member of the next class shall be contacted. Before discussing donation with the LNOK, the DSC/DRC/LC will attempt to obtain information regarding:
The potential donor’s clinical status;
The potential for organ, tissue and eye donation;
LNOK’s understanding of the situation; and
Existence of DD.
The DSC/DRC/LC will attempt to locate evidence of DD expressed in a document of gift by contacting:
The appropriate source of information: MN Department of Public Safety, Driver and Vehicle Services (DVS) and the Donate Life Minnesota Organ and Tissue Donation Registry; ND Department of Transportation and State Radio Communications; SD Department of Public Safety and State Radio Communications; WI online donor registry and WI Driver’s License.
If the decedent is a resident of a state not located in the LS donor service area, the state’s OPO will be contacted to assist in the assessment and obtainment of the document of gift;
If applicable, the hospital or emergency facility, law enforcement officers, firefighters, paramedics, other emergency rescuers, medical examiners or coroners; and
Family members when timing is appropriate
When LS team members are informed through a clear description of a document of gift from LNOK (over a recorded phone line) and neither LS nor the referring agency can obtain a copy, LS will:
Honor DD in good faith that the representation of the document of gift explained by the LNOK is factual;
Ask that the LNOK to mail, fax or e-mail a copy of the document of gift to LifeSource. This request is made as a commitment to doing what is reasonable to obtain a copy of the documentation. However, it is not required to obtain this copy; we may proceed with the donation in good faith that DD exists. There is no requirement to follow up with the LNOK if we do not receive a copy of the document of gift as requested.
Document family’s description of DD on FORM-0058 Designation of Gift or FORM-0110 Designation of Gift - DSC Use Only, under considerations and family wishes, in the LifeSource donor record, and in the hospital medical record, as applicable.
If there is no LNOK, the DSC/LC will contact the DRC for further guidance.
If the LNOK of highest priority is not reasonably available, the DSC/DRC/LC should document this information in the LifeSource donor recordand in the hospital medical record, as applicable. Documentation should include at a minimum the reason for unavailability of a LNOK, and a description attempt/s that were made to contact them.
In such cases, the DSC/DRC/LC should then determine the LNOK of the next class using legal order (See 3.10) and conduct the authorization with them.
LNOK order will be determined based on the state in which the death occurred (See 3.10.1 and 3.10.2).
If DD is not located, the DSC/DRC/LC will seek authorization for donation per SOP-0014 Obtaining Authorization for Donation by Next of Kin.
Determination of Existence Revocation and/or Refusal
The DSC/DRC/LC will seek evidence of any:
Refusal to donate
If documentation of refusal exists, donation will not proceed, even if the LNOK desires to authorize donation.
Revocation of the document of gift
If potential donor has revoked a previously made document of gift, DSC/DRC/LC will seek donation pursuant to LNOK authorization.
If there is any doubt as to the clarity of a potential donor’s intent with respect to donation, the DSC/LC should:
Consult with the DRC; the DRC may consult the Administrator On-Call, Donor Services Management Team, LifeSource Leadership Team and/or legal counsel as needed.
Assess the dates of documentation, if documentation of the deceased’s intent is inconsistent, the document with the most recent date will prevail.
Include hospital administration in discussions as directed by any of the previously mentioned parties in 6.2.2.1.
Provide documentation of designation and any subsequent revocation, amendment, or refusal; and include any photocopies, faxes, electronic transmissions, and DVS or other appropriate agency documents in the LS donor record, if one is created, and in the potential donor’s hospital medical record.
Family Discussion Regarding Donor Designation
All discussions shall be carried out with sincerity, compassion and respect to the circumstances, views and beliefs of the family. The discussion will be completed in a confidential, sensitive, and professional manner.
For organ, tissue and eye referrals triaged to an LC, it is important for the LC to collaborate with hospital staff for discussing donor designation and donation with the family (e.g. pastoral care, nursing staff). Ideally donation conversations should take place in an appropriately private setting.
For tissue and eye referrals, DSC shall arrange with the referral source to connect with the family via telephone.
All telephone LNOK authorization and DD conversations must be recorded.
If English is not the primary language of the LNOK, an interpreter will be offered. Document the offer and response in the LifeSource donor record.
The DSC/DRC/LC will communicate to the LNOK the donor’s known intent through DD and provide a copy of the Document of Gift.
The DSC/DRC/LC will discuss the implications of the DD and that it is LS’s responsibility to comply with donor intent.
If needed, the DSC/DRC/LC may describe the law to emphasize the legal mandate to fulfill the donor’s intent.
The DSC/DRC/LC will discuss the donation process with the LNOK and offer the LifeSource Organ and Tissue Donation Brochure and the LifeSource Donor Designation Brochure to the LNOK.
If the conversation is via telephone, DSC/DRC/LC will offer to review the brochures with the LNOK. Inform them that they will receive a copy of the brochures along with a letter discussing the outcome of the decedent’s gift.
DSC/DRC/LC may also provide the family with information about where they can review the brochures electronically or offer to send it to them via electronic mail.
The DSC/DRC/LC will offer condolences and may discuss and/or provide information to the LNOK (dependent upon LNOK interest in and understanding of the following):
Family’s understanding of the death;
General description of the organs, tissues and eyes that may be donated and for what general purpose, including transplantation, research and medical education;
Estimated time requirements;
Donor screening and recovery processes;
Laboratory evaluations including testing for certain transmissible diseases;
Uses and distribution of the organs, tissues and eyes;
Potential impact donation has on funeral preparations such as timing and viewing;
LS’s responsibility for donation-related fees;
Other organizations likely to be involved in the recovery, processing, and distribution of this donor’s organs, tissues and eyes;
Release of donor’s current and past medical records;
Address questions and provide additional information about donation as requested by the family; and
LS contact information if family has questions or concerns about the donation.
DSC/DRC/LC will conduct the Donor Risk Assessment Interview using SOP-0215 Donor Risk Assessment Interview using FORM-0166 Donor Risk Assessment Interview Less than or Equal to 12 Years Old, FORM-0167 Donor Risk Assessment Interview Birth Mother or, FORM-0168 Donor Risk Assessment Interview Greater than 12 Years Old
In cases where the ME/C has assumed jurisdiction, DSC/DRC/LC will explain that the ME/C must release the gifts for donation and is responsible for the release of the body to the funeral home.
The DSC/DRC/LC will ask the family how they can be supported as the donor’s intent is carried out (i.e. answering questions, connecting them with clergy, physicians or others). The DSC/DRC/LC will facilitate such support in collaboration with hospital staff.
If the family does not support the donor’s designation and resists donation, the DSC/DRC/LC shall explore reasons with sensitivity, compassion and respect toward the family. In a positive manner, the following resources shall be offered, as appropriate:
The DSC/DRC/LC shall explore the family’s understanding of the gift and offer the following resources, as appropriate:
Information that the family requests or that may assist the family in supporting the donor’s decision;
Explanation that LS’s practice is based on the donor’s decision and wishes in accordance with state and federal legal requirements;
Family conference including extended family members who might be able to help facilitate support;
Opportunity to meet with others who may be able to address family concerns, including clergy, donor advocates, transplant recipients, cultural liaisons, and health professionals; and
Information on the benefits of donation.
If the LNOK remains unsupportive for organ donation, the LC will consult the DRC and follow GUI-0046 Process Flowcharts for Donor Designation.
Before any decision is made to not pursue organ donation when DD is present, the referral should be reviewed with a member of the Organ Procurement Management Team anda Leadership Team member.
If there are legal questions pending, LS legal counsel should be consulted.
It is recommended that the appropriate LS party communicates with an Administrative representative of the donor hospital when determining the course of action in the presence of DD and family opposition. Such collaborative discussions will determine how donation will be pursued in light of legal, moral, ethical, or other good faith considerations. Appropriate hospital personnel should be kept informed of such happenings.
Other donation agencies (i.e. eye bank) shall be notified before any deferral is made for their respective agencies.
If it is deemed that donation will not be pursued; document the reason(s) in the LifeSource donor recordand the hospital medical record, as applicable. The DSC/DRC/LC should inform the LNOK and offer support.
If it is deemed that organ donation should be pursued despite family resistance to the donor’s designation, the DSC/DRC/LC will communicate to the LNOK that LS will proceed with donation to honor the donor’s wishes in accordance with applicable law. The DSC/DRC/LC will offer the LNOK any support deemed appropriate.
Such situations may require additional support for LC and/or hospital staff.
Director of Public Affairs shall be notified of such cases.
Document information related to donation in the presence of family resistance to DD in the LifeSource donor record.
Whenever a decision is reached to pursue donation, assess if:
The document of gift specifies only a general intent to make an anatomical gift by words such as “donor”, “organ donor”, or “body donor” or by a symbol or statement of similar import, the gift may be used only for transplantation or therapy,
The intent to donate organs, tissues and eyes for purposes of research will not be presumed,
If the document of gift is specific as to which organs, tissue, eyes may be recovered, LS will follow the documented wishes to the best of our knowledge.
The DSC/DRC/LC will facilitate authorization for research and medical education by completing FORM-0058 Designation of Gift Form or FORM-0110 Designation of Gift –DSC Use Only with the LNOK.
The form will be read as it is worded (verbatim) to the LNOK.
The LNOK will be asked to indicate a “yes” or “no” response to each question. If the LNOK offers any other response or a lack of response (i.e. silence or “I suppose”) the DSC/DRC/LC will seek clarification - i.e. “is that a yes?” or by repeating the question and/or asking if further clarification is needed to make a decision.
Only the LNOK signature is necessary. Additional family members should not sign in the LNOK section of the Authorization Form; additional family member(s) may serve as a witness(es).The DSC/DRC/LC conducting the Authorization will sign in the “person receiving authorization” portion of the form, along with one other witness. All telephone authorizations shall be recorded and are made available to the family upon request.

6.3.16.1.1.When a recorded line is used as a witness, check the box, if appropriate, on the bottom of the form and draw a line through the second witness section.