Community Hospital

1. The Alliance Organ Donation Toolbox: National Legislation Related to Organ, Eye, and Tissue Donation
2. The Alliance Organ Donation Toolbox: State Legislation References Related to the Uniform Determination of Death Act
3. First Person Authorization (FPA) Status by State
4. Physician Orders for Life-Sustaining Treatment (POLST vs. Advance Directive)
5. The Alliance Hospital C-Suite Snapshots Series 6. Terminology Glossary

1. CMS Conditions of participation for hospitals: organ, tissue and eye procurement. Title 42. Chapter IV. Subchapter G. §482.45. Washington, D.C.: U.S. G.P.O.

2. Joint Commission on Accreditation of Healthcare Organizations. Health Care at the Crossroads: Strategies for Narrowing the Organ Donation Gap and Protecting Patients. https://www.jointcommission.org.

LEGISLATIVE RESOURCES

This section is intended to provide a brief and pertinent overview into the regulatory environment of organ donation and procurement, to help and serve organ and tissue donation and procurement within community hospitals.

CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) CONDITIONS OF PARTICIPATION
33856 Federal Register / Vol. 63, No. 119 / Rules and Regulations

These federal regulations apply to hospitals participating in the Medicare Program, where the aim is to establish and guide collaboration their local OPOs, tissue and eye banks, and structure to optimize donation outcomes to meet the critical need for transplantation within our community. The highlights of the regulation (§482.45) are:

1. 1. The hospital must have written policies and procedures to address its organ procurement responsibilities.
   2. As such the hospital must have a written agreement with an OPO and must have a written agreement with at least one tissue and eye bank.
   3. At a minimum, the written agreement must address the following:
      1. Criteria for obligatory referral, including the timely notification to the OPO of all individuals whose death is imminent or who have died in the hospital;
      2. Definitions of “imminent death” and “timely notification”;
      3. The specific responsibility of the OPO to determine medical suitability for organ and tissue/eye donation
      4. Interventions that the hospital will undertake to maintain potential organ donors so that the organs remain viable
      5. OPO notification when the patient or surrogate instructs a Do Not Resuscitate (DNR),before the OPO has had the opportunity to determine medical suitability or discuss the option of donation with the patient or surrogates.
   4. The hospital must collaborate with the OPO to ensure that each family of a potential donor is presented the opportunity for donation. The individual chosen to make the request to the family must be from the OPO, or a ‘designated requestor’ within the hospital (an individual having completed an OPO instructed/approved course in requesting organ/tissue donation). Authorization for donation is more likely when
      1. family members are given time to understand and accept their relative’s death before the donation request is made.
      2. the request is made by the OPO in conjunction with an introduction by hospital staff.
      3. the setting in which the request is made should be quiet and private
   5. The hospital should cooperate with the OPO, eye and tissue bank in
      1. providing staff education on donation;
      2. reviewing death records to improve identification of potential donors;
      3. maintaining potential donors while necessary testing and placement of potential donated organs, tissues and eyes takes place.

UNIFORM ANATOMICAL GIFT ACT (UAGA)
https://www.uniformlaws.org/viewdocument/final-act-with-comments-1?CommunityKey=015e18ad-4806-4dffb011-8e1ebc0d1d0f&tab=librarydocuments

The Uniform Anatomical Gift Act (UAGA) is model legislation adopted in all states and the District of Columbia and addresses authorization for deceased donation, hospital obligations, and OPO responsibilities. Although there is some variation among state laws, the general principles are consistent across states. The following is a high level overview of the provisions of the UAGA:

• The UAGA allows an individual to make a legally binding anatomical gift prior to death. An individual may register their decision through a donor registry (e.g., DMV registry or Donate Life America) or through an alternative document of gift such as an organ donor card/form or advance directive.
• An individual may decide not to donate his or her organs by signing a refusal or revocation of donation, or by communicating their intent during a terminal illness to 2 individuals, one of whom is a disinterested witness (except if donation was authorized in a will).
• If an individual has designated his or herself as a donor, no other individual may override a competent adult’s prior decision to donate.
• If an individual has not made a decision, a surrogate decision maker may authorize donation. The UAGA lists the individuals who may authorize donation in the following order of priority:
  1. Duly authorized healthcare agents with power of attorney;
  2. Parents or guardian of unemancipated minors;
  3. Adult children;
  4. Parents of the adult patient;
  5. Adult siblings;
  6. Adult grandchildren;
  7. Grandparents;
  8. An adult who exhibited special care and concern for the decedent;
  9. Guardians of adult patients at the time of death; and
  10. Any other person having the authority under law to dispose of the patient’s body. This includes coroners and medical examiners.
• The hierarchy of authorizing parties may differ by state. It is recommended that the hospital familiarize themselves with their state’s UAGA.
• If more than one member of a class is reasonably available, the donation is made only if a majority of members support the donation.
• Minors, if eligible under other law to apply for a driver license, or if meeting minimum age to register on their state donor registry, are empowered to be a registered donor. A parent or legal guardian can override their decision.
• When a hospital refers an individual at or near death to an OPO, the OPO may conduct any reasonable examination necessary to ensure the medical suitability for transplantation. During that time, the hospital must maintain the patient to support the possibility of donation, unless the hospital or OPO knows or discovers that the individual expressed a contrary intent.
• If an advance directive seems to conflict with organ donation, the hospital must expeditiously confer with the patient or surrogates, as well as the OPO, to resolve the conflict. During that time, the patient should be maintained to support the possibility of donation.
• Priority is given to the use of organs for transplantation or therapy over education or research, unless a donor expresses a different intent.

*1986—Public Law 99-509, The Omnibus Budget Reconciliation Act of 1986, October 21, 1986—Section 1138 of the Social Security Act – Included new requirements pertaining to organ procurement and transplantation and participation in the Medicare and Medicaid programs.

*1985—Public Law 99-272, The Omnibus Reconciliation Act of 1985, April 7, 1986—Required that states have written standards regarding coverage of organ transplants in order to qualify for federal payments under Title XIX of the Social Security Act.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
(Organ Procurement Transplantation Provisions)
https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html

As Covered Entities, hospitals are subject to HIPAA regulations which address the use and disclosure of protected health information with the patient’s authorization or when the disclosure fits within a regulatory exception to the authorization requirement. There are two regulatory exemptions that permit hospitals to disclose information to the OPO without authorization:

1. 1. • First, a healthcare provider may use or disclose information if and as required by law. This exemption allows OPOs and hospitals to comply with the Medicare Conditions of Participation, 42 C.F.R § 482.45 which specifically require referrals of imminent deaths to an OPO and require hospitals to allow OPOs to conduct audits of death records.
      • Secondly, section §164.512(h) allows information to be released to OPOs or other entities involved in the procurement, banking or transplantation of cadaveric organs, eyes, or tissue for the purposes of facilitating organ, eye or tissue donation and transplantation. This permits the release of information by and to, hospitals, transplant hospitals, UNOS, tissue banks and laboratories, letting OPOs do their core jobs; the coordination of donation and transplant, and the review of records.

The Centers for Medicare and Medicaid Services (CMS) has determined that OPOs are not ‘business associates’ of hospitals, nor are OPOs “healthcare providers” when they are performing OPO functions.

STATE ORGAN DONOR REGISTRIES

State donor registries are managed in accordance with respective state laws. The responsible government agency varies by state. Some registries are contractually operated by state/regional Donate Life organizations. Most registries integrate with their state’s driver license issuing agency to capture donor registrations from driver license transactions. Most registries also allow individuals to register or modify their donation decision online via the state registry website. For information on your state’s donor registry, visit https://www.organdonor.gov/register.html.

NATIONAL DONATE LIFE REGISTRY

Donate Life America is a 501(c)3 nonprofit organization that among its many public awareness campaigns and initiatives, manages the National Donate Life Registry at https://www.RegisterMe.org. Having a national registry allows Donate Life America to work with national partners like Apple and Walgreens to bring the donor registration opportunity to smart phones, pharmacy apps, etc. For more information about the national registry, including FAQs, visit https://www.donatelife.net/national-donate-life-registry/.

If you are interested in a customizable national campaign page at RegisterMe.org for your hospital, please contact Hilary Czarda at Donate Life America (h[email protected]), or let your OPO team know you are interested in a campaign page at RegisterMe.org.

THE JOINT COMMISSION
https://www.jointcommission.org/accreditation/hospitals.aspx

The Joint Commission maintains standards for organ and tissue donation consistent with the CMS regulations (e.g. requirement that hospitals must have a written agreement with an affiliated OPO). Standards LD.3.110 and TS.01.01.01 require that hospitals develop and implement written policies and procedures for the donation and procurement of organs and tissues.

Details of these and other requirements include:

1. 1. • Criteria for identifying potential organ and tissue donors, and directly notifying the OPO or tissue bank of those potential donors (while maintaining records of notification).
      • Mechanisms for notifying the family of potential organ and tissue donors of the possibility to donate or to decline to donate any organs or tissues, as well as a method of recording the decision, for subsequent review. This should be performed by an OPO trained/approved designated requestor.
      • Fulfillment of patient’s wishes on end of life care, including organ donation, within the limits of the law or hospital resources (Standard RI.2.80).
      • Staff education in the use of discretion and sensitivity towards the circumstances, wishes, and beliefs of the families of potential donors.
      • Recognition that the OPO determines medical suitability of organs for donation, while the OPO or tissue/eye bank determine medical suitability for donation of tissues or eyes.

The Joint Commission has clarified that OPOs are not considered contracted services (like HIPAA exemptions above), and details which federal regulations apply to OPOs.

The Healthcare Facilities Accreditation Program (HFAP) and the DNV GL National Integrated Accreditation for Healthcare Organizations (NIAHO) are two other organizations with requirements consistent with the Joint Commission standards and CMS regulations. DNV Organ and Tissue Standards

FIRST PERSON AUTHORIZATION

The 2006 Uniform Anatomical Gift Act (UAGA) is limited in scope to deceased donors, and as identified above, simplifies the document of gift.

It also, however, strengthens the power of an individual to make lasting decisions on the disposition of their body parts after death that cannot be overridden by others after death. This applies to decisions both authorizing or refusing donation. The OPO has legal authority to proceed with organ procurement even over the objection of the registered donor’s family. The hospital has a legal responsibility to support the donor’s instructions and cooperate with the OPO to move forward with donation.

The Physician Orders for Life-Sustaining Treatment (POLST) Paradigm Form is a medical order that instructs emergency healthcare professionals what to do in case of a medical crisis, in circumstances where the patient cannot speak for him or herself.

An Advance Directive is a legal document that supplies a surrogate medical decision maker in circumstances where the patient tells cannot speak for him/herself and gives general direction on treatments the patient does or does not want, in order to help create a treatment plan.