REGULATIONS AND LAWS
CMS REQUIREMENTS
An Organ Procurement Organization’s (OPO’s) primary role is to ensure life-saving organs become available to critically ill patients who are on the transplant waiting list. There are many regulating bodies involved to ensure both the OPO and the Hospital follow national best practices to save as many lives as possible. Many of these regulations were first implemented in 1998 under the Conditions of Participation for Medicare Reimbursement (CMS).
The current CMS regulations for Hospitals are summarized below:
• Hospital must have a written contract with their federally designated OPO
○ Within that agreement, the responsibilities of both the OPO and the hospital must address donation after circulatory death (DCD)
• Hospital must report, in a timely manner (within 60 min.), all deaths and imminent deaths (patients who are identified as potential organ donors before death)
• OPO to determine medical suitability of potential donor
• Hospital must maintain potential organ donors while necessary testing and placement of potential donated organs, tissues, and eyes take place
• Only trained requesters from the OPO are to have the donation conversation with families of potential donors
• Hospital and the OPO must collaborate in providing donation education to hospital Physicians and staff
AN INTRODUCATION TO FEDERAL REGULATIONS
The current CMS regulations for Hospitals are summarized below:
• Hospital must have a written contract with their federally designated OPO
○ Within that agreement, the responsibilities of both the OPO and the hospital must address donation after circulatory death (DCD)
• Hospital must report, in a timely manner (within 60 min.), all deaths and imminent deaths (patients who are identified as potential organ donors before death)
• OPO to determine medical suitability of potential donor
• Hospital must maintain potential organ donors while necessary testing and placement of potential donated organs, tissues, and eyes take place
• Only trained requesters from the OPO are to have the donation conversation with families of potential donors
• Hospital and the OPO must collaborate in providing donation education to hospital Physicians and staff
AN INTRODUCATION TO FEDERAL REGULATIONS
UNIFORM ANATOMICAL GIFT ACT (UAGA)
Honoring First-Person Authorization
The Document of Gift is an authorization for anatomical donation made during the life of the individual to take place upon death, in accordance with the Oklahoma Uniform Anatomical Gift Act under Chapter 46 of the Health and Safety Oklahoma Statues.
This Document of Gift is considered an individual’s informed consent for organ and tissue donation to occur upon death and cannot be revoked by his/her legal next-of-kin.
LifeShare works tirelessly with families who don’t support their loved one’s registry status in order to honor the patient’s known wishes; our ultimate goal is to support and educate the family to allow donation to take place without causing the family additional stress.
If an individual is under 18 years of age, consent from his/her legal next-of-kin is needed to make an anatomical gift regardless of registry status.
A copy of the Document of Gift is placed in the front of the patient’s chart if they are found on the Organ & Tissue Donor Registry.
The Document of Gift is an authorization for anatomical donation made during the life of the individual to take place upon death, in accordance with the Oklahoma Uniform Anatomical Gift Act under Chapter 46 of the Health and Safety Oklahoma Statues.
This Document of Gift is considered an individual’s informed consent for organ and tissue donation to occur upon death and cannot be revoked by his/her legal next-of-kin.
LifeShare works tirelessly with families who don’t support their loved one’s registry status in order to honor the patient’s known wishes; our ultimate goal is to support and educate the family to allow donation to take place without causing the family additional stress.
If an individual is under 18 years of age, consent from his/her legal next-of-kin is needed to make an anatomical gift regardless of registry status.
A copy of the Document of Gift is placed in the front of the patient’s chart if they are found on the Organ & Tissue Donor Registry.
HOSPITAL CONTRACTS
Every hospital in Oklahoma is required to maintain an active contract with LifeShare. For more information about your contract, speak to your LifeShare Hospital Liasion or call LifeShare at 405-840-5551.
HIPPA PRIVACY REGULATIONS EXEMPT DONATION AGENCIES
The latest regulations regarding privacy of medical records and other health information, known collectively as HIPAA, do not affect the release of such documents to tissue and organ donation agencies. On December 28, 2000, the Department of Health and Human Services (DHHS) published in the Federal Register a final rule creating new federal privacy rights for personal health information. These “Standards for Privacy of Individually Identifiable Health Information” are intended to ensure patients that the privacy of their medical records is secure, and that the information is used appropriately.
The regulation specifically exempts tissue, eye and organ donation agencies because they are not considered “health care providers” within the meaning of the regulation. In the description of the rules provisions, DHHS notes that the proposed definition of “health care” was changed in the final regulation to:”... care, services or supplies related to the health of an individual.... Therefore, the procurement or banking of organ, blood (including autologous blood), sperm, eyes or any other tissue or human product is not considered to be health care under this rule and the organizations that perform such activities would not be considered health care providers when conducting these functions. As described in 164.512 (h), covered entities are permitted to disclose protected health information without individual authorization, consent, or agreement...as necessary to facilitate cadaveric donation.” (65 Federal Register 82477)
All information provided to the donation agencies is confidential. In addition, consent for release of medical information is included in the Consent for Organ and Tissue Donation, the informed consent document families sign when their loved one becomes a donor.
**In summary, LifeShare is treated as part of the health care team and information can be given freely as such**
The regulation specifically exempts tissue, eye and organ donation agencies because they are not considered “health care providers” within the meaning of the regulation. In the description of the rules provisions, DHHS notes that the proposed definition of “health care” was changed in the final regulation to:”... care, services or supplies related to the health of an individual.... Therefore, the procurement or banking of organ, blood (including autologous blood), sperm, eyes or any other tissue or human product is not considered to be health care under this rule and the organizations that perform such activities would not be considered health care providers when conducting these functions. As described in 164.512 (h), covered entities are permitted to disclose protected health information without individual authorization, consent, or agreement...as necessary to facilitate cadaveric donation.” (65 Federal Register 82477)
All information provided to the donation agencies is confidential. In addition, consent for release of medical information is included in the Consent for Organ and Tissue Donation, the informed consent document families sign when their loved one becomes a donor.
**In summary, LifeShare is treated as part of the health care team and information can be given freely as such**