Legal Eagle Eye Newsletter for the Nursing Profession (6)8 Aug 98

 

Quick Summary: HCFA’s new regulations take effect August 21, 1998. These new regulations are mandatory for all hospitals participating in Medicare or Medicaid.

HCFA has removed its existing regulations for hospitals’ internal administrative protocols to identify and deal with patients who are potential donors, and has replaced its existing regulations with more elaborate regulations on the same subject.

We are re-printing HCFA’s summary of the new regulations, the old regulations which are being removed, and the new regulations. FEDERAL REGISTER, June 22, 1998 Pages 33856 - 33875.

 

   SUMMARY: This final rule addresses only provisions relating to organ donation and transplantation. It imposes several requirements a hospital must meet that are designed to increase organ donation. One of these requirements is that a hospital must have an agreement with the Organ Procurement Organization (OPO) designated by the Secretary, under which the hospital will contact the OPO in a timely manner about individuals who die or whose death is imminent in the hospital. The OPO will then determine the individual's medical suitability for donation. As well, the hospital must have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes, as long as the agreement does not interfere with organ donation. The final rule requires a hospital to ensure, in collaboration with the OPO with which it has an agreement, that the family of every potential donor is informed of its option to donate organs or tissues or not to donate. Under the final rule, hospitals must work with the OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of organs and tissues take place. In addition, transplant hospitals must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide, if requested, such data directly to the Department.

 

DATES: These regulations are effective on August 21, 1998.

 

FOR FURTHER INFORMATION CONTACT: Marcia Newton, (410) 786-5265.

 

 

Editor’s Note: HCFA is removing the following language from its regulations pertaining to administrative requirements for hospitals participating in Medicare or Medicaid, effective 8/21/98:

 

 

Sec. 482.12

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(c) Standard: Care of patients. In accordance with hospital policy, the governing body must ensure that the following requirements are met:

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(5)(i) To identify potential organ donors as defined in Sec. 485.302 of this chapter, the hospital has written protocols that--

(A) Assure that the family of each potential organ donor knows of its option either to donate organs or tissues or to decline to donate;

(B) Encourage discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors; and

(C) Require that an organ procurement organization designated by the Secretary under Sec. 485.308 of this chapter be notified of potential organ donors.

(ii) In the case of a hospital in which organ transplants are performed, the hospital must be a member of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274)

and abide by its rules. The term "rules of the OPTN" means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the PHS Act. No hospital is considered to be out of

compliance with section 1138(a)(1)(B) of the Act or with the requirements in this paragraph, unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the hospital from the OPTN and has notified the hospital in writing.

(iii) For purposes of this subparagraph, the term "organ" means a human kidney, liver, heart, lung, or pancreas.

 

 

Editor’s Note: The language in italics above which is being removed from HCFA’s regulations is being replaced with the following, effective 8/21/98:

 

Sec. 482.45 Condition of participation: Organ, tissue, and eye procurement

 

(a) Standard: Organ procurement responsibilities. The hospital must have and implement written protocols that:

(1) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose;

(2) Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;

(3) Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes or to decline to donate. The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;

(4) Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;

(5) Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

(b) Standard: Organ transplantation responsibilities. (1) A hospital in which organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term "rules of the OPTN" means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the PHS Act which are enforceable under 42 CFR 121.10. No hospital is considered to be out of compliance with section 1138(a)(1)(B) of the Act, or with the requirements of this paragraph, unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the hospital from the OPTN and has notified the hospital in writing.

(2) For purposes of these standards, the term "organ" means a human kidney, liver, heart, lung, or pancreas.

(3) If a hospital performs any type of transplants, it must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide such data directly to the Department when requested by the Secretary.

FEDERAL REGISTER, June 22, 1998

Pages 33856 - 33875.