Regulatory & Compliance

Because of the increasing demand for available organs for transplant in the United States, federal and state legislative bodies have enacted laws to monitor all processes associated with organ donation, thus ensuring that organs are recovered and shared equitably and fairly. These laws clearly define and establish the legal boundaries for individuals wishing to become organ donors upon their death; as well as set regulatory and safeguard standards for organ procurement organizations, healthcare providers and hospital partners. For specific information about state and federal laws, please see the details and documents provided below:

UNIFORM ANATOMICAL GIFT ACT (UAGA) of 1968, 1987, 2006

The UAGA establishes the legality of organ and tissue donation and donor designation for transplantation or other uses (research and/or therapy); as well as defines the priority of legal next of kin for authorization in the absence of donor designation. In addition, the UAGA outlines the following:

  • Requirements that the physician pronouncing or certifying death may not in any way participate in the procedures for removing or transplanting anatomical gifts
  • Protection for healthcare professionals from liability associated with organ and tissue donation
  • Requirements that hospitals establish agreements with an organ procurement organization to facilitate the procurement process
  • Strict prohibition of the sale or purchase of organs or tissues
  • Defines the list of legal next of kin who can provide authorization for donation in the absence of donor designation

Oregon UAGA

Washington UAGA

Idaho UAGA

National Association of Medical Examiners Position Paper

DONOR DESIGNATION (Implemented 2008)

Oregon, Washington and Idaho have all adopted legislation which defines donor designation indicated on the state issued driver’s license or ID card to represent legally binding, first person consent for organ and tissue donation at the time of death. Designation may only be legally revoked by the decedent prior to their death. In addition, this legal consent may also be documented on: a state ID card, a donor card, a will or advanced directive, or the state online registry.

The anatomical gift act for each state (which includes unequivocal detail regarding authorization, amending and revoking donor designation) can be found in their entirety at:

https://www.oregonlegislature.gov/

http://legislature.idaho.gov/idstat/Title39/T39CH34.htm

http://apps.leg.wa.gov/RCW/default.aspx?cite=68.64

UNIFORM DETERMINATION OF DEATH ACT (1980)

The Uniform Determination of Death Act is the federal act designed to clearly define death. This act states that an individual who has either (a) irreversible cessation of circulatory and respiratory functions, or (b) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. Determinations of death made within these definitions must be made in accordance with acceptable medical standards. Since 1980, states in PNTB’s service area have adopted similarly phrased acts into their state statutes.

Uniform Determination of Death Act

NATIONAL ORGAN TRANSPLANT ACT OF 1984

The National Organ Transplant Act of 1984 prohibits the buying and/or selling of organs. This act required the establishment of the governing body Organ Procurement and Transplantation Network (OPTN), which in turn regulates organ recovery and transplant in the United States. As a result the United Network for Organ Sharing (UNOS) was awarded the contract to manage the distribution and allocation of organs in this country. In addition, The National Organ Transplant Act created a task force which published a report outlining medical, legal and ethical recommendations for guidelines and regulations of the transplantation system in the United States still used today.

National Organ Transplant Act

OMNIBUS BUDGET RECONCILIATION ACT OF 1986

The Omnibus Budget Reconciliation Act of 1986 is legislation that outlines provisions and requires all hospitals to be affiliated with a federally mandated Organ Procurement Organization (OPO). It is the federal mandate that OPOs are responsible for the coordination of the procurement and transplantation process at local levels. Additionally, it is the directive that:

  • Regulates that there will be no more than one OPO per service area
  • Requires all hospitals participating in a Medicare or Medicaid reimbursement program to establish written protocols for donation in order to maintain certification
  • Requires that all families of potential donors be given information about their opportunity to donate
  • Mandated compliance with the United Network for Organ Sharing (UNOS)

CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS) – CONDITIONS OF PARTICIPATION (1998)

The Health Care Financing Administration revised the Medicare Conditions of Participation (COP) in 1998 to further outline required hospital standards for quality patient care and ensure that organ, tissue and cornea donation and transplantation can occur when possible. The revised COP provides federal mandates for:

  • Hospitals to refer all deaths (imminent or cardiac) to the local organ recovery organization (OPO) in a timely manner (ideally 1 hour)
  • Hospitals to determine who makes the request to potential donor families and requires requestors to be OPO employees or OPO-trained.
  • Hospitals to have a contractual agreement with an eye and tissue bank in addition to the OPO
  • Hospitals to work collaboratively with OPOs to ensure that the families of all potential donors are informed of their options to donate organs, eyes or tissue
  • Hospitals to partner with local donation programs to educate staff regarding donation issues, review death records to improve identification of potential donors and medically support potential donor candidates throughout testing and placement processes

CMS COP

CMS Interpretive Guidelines

CMS Regulations Specific to Donation

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT REGULATIONS (HIPAA)

Hospitals frequently question whether disclosing “protected health information” to Pacific Northwest Transplant Bank (PNTB) without patient consent or authorization is in violation of HIPAA. All organ procurement organizations (OPOs) like PNTB in the United States are subject to two regulatory exemptions in the HIPAA privacy policy. The first exemption provides that hospitals are allowed to release protected information if and as is required by law. This exemption allows both OPOs and hospitals to comply with the Centers for Medicare and Medicaid (CMS) conditions of participation 42CFR § 482.45 which requires timely referrals of all deaths (including those that are imminent) and medical record audits.

While OPOs are not considered Covered Entities or Business Associates as defined by HIPAA, they are similarly not considered health care providers when performing the core responsibilities related to donation and transplantation, thus OPOs are not subject to HIPAA. In light of this, the second HIPAA exemption §164.512(h) allows Covered Entities (hospitals)  to disclose protected information to OPOs or other organizations engaged in the procurement, banking, or transplantation of cadaveric organs, eyes, or tissue for the purpose of facilitating donation and transplantation. This exemption specifically permits Covered Entities like donor hospitals in PNTB’s service area to release information to organ and tissue procurement organizations such as PNTB. As a result of this exemption, Covered Entities are not constrained by HIPAA’s consent and authorization requirements for disclosure of protected health information and can feel confident they do not need patient release to share information with OPOs, transplant centers, UNOS, tissue banks, eye banks or laboratories involved in testing for donation purposes.

HIPAA Exemption Letter

HIPAA Privacy Rule

HIPAA and Procurement Organizations

JCAHO/CMS/ NIAHO (DNV)/ DEPARTMENT OF HEALTH SURVEYS

As a reflection of quality and commitment to high performance standards, healthcare organizations and programs in the United States work tirelessly to obtain accreditation and compliance from JCAHO, CMS, NIAHO and/or the Department of Health. In recent years, hospitals across the country have discovered that surveyors are focusing more attention on the compliance to organ and tissue donation related standards. The Pacific Northwest Transplant Bank (PNTB) is committed to supporting our hospital partners as you prepare for your accreditation and compliance site reviews. With adequate time to prepare, PNTB’s hospital services team can assist you in preparing the following information:

  • Data reports reflecting rate of timely referral of all deaths; number of potential donors, number of actual donors, conversion rate and consent rate
  • Copy of your hospital contract to partner with PNTB as your organ procurement organization
  • Documentation of annual strategic plan and progress toward mutually agreed upon goals

The links below will provide additional explanation and assistance in preparing and monitoring donation-related quality performance measures.

Joint Commission Revised Standard 2007

Joint Commission Revised Standard 2009

Joint Commission Compliance Guide (Organ & Tissue)

JCAHO White Paper on Organ Donation

DNV Organ and Tissue Standards

NIAHO Interpretive Guidelines

LINKS TO ADDITIONAL RESOURCES

http://www.unos.org/

http://www.jointcommission.org/

http://www.ama-assn.org/

http://www.nlm.nih.gov/medlineplus/organdonation.html

http://www.ustransplant.org/

http://www.organdonationnow.org