Regulatory and accreditation standards guide hospitals in the requirements for quality patient care and ensure that organ, tissue, and cornea donation and transplantation can occur when possible. Following is further information about the different regulatory and accreditation organizations, along with other links to their websites.
- Centers for Medicare and Medicaid Services – CMS
- Food and Drug Administration (FDA)
- The Joint Commission – JCAHO
- Health Insurance Portability and Accountability Act (HIPAA)
- Uniform Anatomical Gift Act
Conditions of Participation on Organ Procurement
There are numerous federal regulations impacting hospital deaths and how hospitals must work with organ procurement organizations. Most of these are contained within the Conditions of Participation for Hospitals, which are summarized below.
The Centers for Medicare & Medicaid Services (CMS) regulate all hospitals that receive any type of federal reimbursement for care provided. Virtually all 6,000 U.S. hospitals are impacted and must take certain actions to remain compliant with CMS regulations.
These regulations are described in rules called “CMS Conditions of Participation for Hospitals” which are published in the Federal Register.
Numerous regulations exist within the “Conditions of Participation for Hospitals Regarding Organ, Tissue and Eye Donation.” First published in 1998, current regulations make hospitals accountable to CMS for their donation programs in an effort to increase the number of organs and tissues available for transplantation.
Organ procurement organizations (OPOs) are assigned geographic service areas by CMS and are obligated to serve all hospitals in their assigned area. Under these regulations, hospitals must contract with their federally designated OPO. Hospitals may not choose which OPO to work with.
Hospitals also must have a contract with an eye bank and a tissue bank. If the OPO also recovers tissues, the hospital may prefer to work with a single agency and have a dual agreement with the OPO for organ and tissue donation. They also must have a separate contract with the eye bank in their area.
Key points of the Conditions of Participation for Hospitals regarding Organ, Tissue and Eye Donation include:
Hospitals must report ALL deaths to the OPO in a timely manner.
The purpose of this condition is to allow the OPO to screen ALL hospital deaths for the potential for organ, tissue and eye donation.
Timeliness is defined by the hospital. However, CMS recognizes that hospital notification of the OPO within one hour of cardiac death is ideal for preserving the opportunity for donation of tissues and eyes.
Timely notification of imminent deaths requires that hospital staff notify the OPO of patients who are potential organ donors before death. Certain clinical signs indicate impending neurological death and hospitals set parameters to notify their OPO within one hour of a patient meeting those criteria.
The OPO determines medical suitability. No physician or nurse or any other caregiver in the hospital is allowed to make decisions about patient medical suitability for any type of organ, tissue or eye donation.
Only an OPO staff member or a trained, designated requester may approach the family of a potential donor for consent for organ, tissue or eye donation. This regulation recognizes that training and skill are required to guide a family through this crucial decision.
- The FDA requires that IDS obtain medical record copies of tissue donors before the tissue can be released for transplantation.
- HIPAA regulations allow for this action.
- Delays or lack of pertinent records could prevent tissue recovery and transplantation and the loss of the donor’s gift.
The Joint Commission’s 2007 Comprehensive Accreditation Manual for Hospitals contains standards that are very similar to the CMS Conditions of Participation. Organ procurement is addressed in Leadership (LD) standard 3.110 and the companion elements of performance, which was newly amended in January of 2007. Any Joint Commission-accredited facility, including hospitals, outpatient clinics, and nursing homes, must adhere to the Joint Commission standards in order to retain accreditation.
The Joint Commission does not require hospitals to ask patients about their organ donation wishes unless required by law, regulation, organization policy or procedure, or by agreement with an Organ Procurement Organization. If organ donation is specified in a patient’s advance directive or verbally expressed by the patient, the hospital should approach this wish as it would all other portions of an advance directive. This includes honoring the patient’s wishes within the limits of the facility’s capacity. (43) (See Section One for Joint Commission standards regarding advance directives.)
The following Joint Commission standards address organ procurement:
Leaders implement policies and procedures developed with the medical staff’s participation for procuring and donating organs and other tissues. Organ procurement policies and procedures apply to all potential organ donors.
- have an agreement with an appropriate organ procurement organization (OPO) and follows its rules and regulations;
- have an agreement with at least one tissue bank and at least one eye bank (so long as the process does not interfere with organ procurement) to cooperate in retrieving, processing, preserving, storing, and distributing tissues and eyes;
- belong to the organ procurement and transplantation network (OPTN) and follow its rules and regulations if the hospital transplants organs;
- provide all organ transplant-related data upon request of the OPTN, the Scientific Registry, or the hospital’s designated OPO.
The hospital must have policies and procedures for organ and tissue procurement and donation, including the following elements:
- the OPO with which the hospital is affiliated;
- the OPO is notified of a patient who has died or whose death is imminent prior to the withdrawal of life-sustaining therapies, within the time jointly agreed upon by the hospital and OPO, and according to the triggers mutually agreed upon;
- the OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, for tissue and eye donation;
- procedures, mutually developed with the OPO, for notifying the family of each potential donor of the option to donate (or decline to donate) organs, tissues, or eyes;
- written documentation by the hospital’s designated requestor showing that a patient or family accepts or declines the opportunity to donate organs or tissues;
- staff education includes training in the use of discretion and sensitivity to the circumstances, beliefs, and desires of the families of potential donors;
- the hospital maintains records of potential donors whose names have been sent to the OPO and tissue and eye banks.
The hospital works cooperatively with the OPO, tissue, and eye banks in order to:
- review death records to improve identification of potential donors;
- ensure the necessary testing and placement of potentially donated organs, tissues, and eyes takes place to maximize viability;
- educate staff about donation issues;
- develop a donation policy that addresses opportunities for asystolic recovery, based on an organ potential for donation that is mutually agreeable by the OPO, hospital, and medical staff.
The hospital addresses the wishes of the patient relating to end-of-life decisions. The hospital documents and honors the patient’s wishes concerning organ donation within the limits of the law or hospital capacity.
The hospital provides initial orientation.
Training should include:
- hospital-wide policies and procedures (including safety and infection control) and relevant unit, setting, or program-specific policies and procedures;
- specific job duties and responsibilities and service, setting, or program-specific job duties and responsibilities related to safety and infection control;
- cultural diversity and sensitivity;
- education about patient safety and ethical aspects of care, treatment, and services and the process used to address ethical issues.
Ongoing education, including in-services, training, and other activities, maintains and improves competence.Ongoing education must be documented and ought to:
- increase staff knowledge of work-related issues, laws, regulations, and the needs of the patient population;
- occur when job responsibilities or duties change;
- emphasize specific job-related aspects of safety and infection prevention and control;
- who can make an anatomical gift before the donor’s death and the manner of making a gift before death;
- procedures for amending or revoking an anatomical gift before death;
- procedures for refusal to make an anatomical gift and effect of refusal;
- the preclusive effect of an anatomical gift, amendment, or revocation;
- who may make a gift of a decedent’s body or part;
- the manner or making, amending, or revoking an anatomical gift of a decedent’s body or part;
- persons that may receive an anatomical gift;
- which persons should make a reasonable search for documents of gift;
- rights and duties of procurement organizations and others;
- coordinates procurement and use;
- prohibits the sale or purchase of parts and other certain acts;
- provides limited immunity to a person that acts in accordance with the act;
- provides choice of laws as to execution of document and a presumption of validity;
- authorizes the Department of Public Safety to establish or contract with another to establish a donor registry;
- establishes the effect of an anatomical gift on an advanced health care directive;
- requires certain cooperation between the medical examiner and a procurement organization;
- establishes relationship of the act with electronic global and national electronic signatures act;
- makes technical and conforming amendments.
Organ and Tissue procurement organizations are exempt from HIPAA
Privacy regulations contained in the Health Insurance Portability and Accountability Act (HIPAA) are followed by IDS with two regulatory exemptions. The first one allows a health care provider to disclose information required by law, ensuring that IDS and hospitals comply with the Medicare Conditions of Participation, 42CFR 482.45, that authorizes referrals and records audits.
The second exemption, 164.512(h), allows information to be released to IDS and organizations involved in the recovery, banking or transplantation of organ, cornea or tissue for the purpose of performing organ, cornea or tissue donation and transplantation. This releases the information by and to donor hospitals, transplant hospitals, United Network for Organ Sharing (UNOS), tissue banks and laboratories.
STATE OF UTAHUtah Uniform Anatomical Gift Act
This bill defines: