[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.344]



[Page 654-655]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  486.344  Condition: Evaluation and management of potential donors



and organ placement and recovery.



    The OPO must have written protocols for donor evaluation and 

management and organ placement and recovery that meet current standards 

of practice and are designed to maximize organ quality and optimize the 

number of donors and the number of organs recovered and transplanted per 

donor.

    (a) Potential donor protocol management. (1) The medical director is 

responsible for ensuring that potential donor evaluation and management 

protocols are implemented correctly and appropriately to ensure that 

potential donors are thoroughly assessed for medical suitability for 

organ donation and clinically managed to optimize organ viability and 

function.

    (2) The OPO must implement a system that ensures that a qualified 

physician or other qualified individual is available to assist in the 

medical management of a potential donor when the surgeon on call is 

unavailable.

    (b) Potential donor evaluation. The OPO must do the following:

    (1) Verify that death has been pronounced according to applicable 

local, State, and Federal laws.

    (2) Determine whether there are conditions that may influence donor 

acceptance.

    (3) If possible, obtain the potential donor's medical and social 

history.

    (4) Review the potential donor's medical chart and perform a 

physical examination of the donor.

    (5) Obtain the potential donor's vital signs and perform all 

pertinent tests.

    (c) Testing. The OPO must do the following:

    (1) Arrange for screening and testing of the potential donor for 

infectious disease according to current standards of practice, including 

testing for the human immunodeficiency virus.

    (2) Ensure that screening and testing of the potential donor 

(including point-of-care testing and blood typing) are conducted by a 

laboratory that is certified in the appropriate specialty or 

subspecialty of service in accordance with part 493 of this chapter.

    (3) Ensure that the potential donor's blood is typed using two 

separate blood samples.

    (4) Document potential donor's record with all test results, 

including blood type, before organ recovery.

    (d) Standard: Collaboration with transplant programs.

    (1) The OPO must establish protocols in collaboration with 

transplant programs that define the roles and responsibilities of the 

OPO and the transplant program for all activities associated with the 

evaluation and management of potential donors, organ recovery, and organ 

placement, including donation after cardiac death, if the OPO has 

implemented a protocol for donation after cardiac death.

    (2) The protocol must ensure that:

    (i) The OPO is responsible for two separate determinations of the 

donor's blood type;

    (ii) If the identify of the intended recipient is known, the OPO has 

a procedure to ensure that prior to organ recovery, an individual from 

the OPO's staff compares the blood type of the donor with the blood type 

of the intended recipient, and the accuracy of the comparison is 

verified by a different individual;

    (iii) Documentation of the donor's blood type accompanies the organ 

to the hospital where the transplant will take place.

    (3) The established protocols must be reviewed regularly with the 

transplant programs to incorporate practices that have been shown to 

maximize organ donation and transplantation.

    (e) Documentation of recipient information. If the intended 

recipient has been identified prior to recovery of an organ for 

transplantation, the OPO must have written documentation from the OPTN 

showing, at a minimum, the intended organ recipient's ranking in 

relation to other suitable candidates and the recipient's OPTN 

identification number and blood type.

    (f) Donation after cardiac death. If an OPO recovers organs from 

donors after cardiac death, the OPO must have protocols that address the 

following:

    (1) Criteria for evaluating patients for donation after cardiac 

death;

    (2) Withdrawal of support, including the relationship between the 

time of consent to donation and the withdrawal of support;



[[Page 655]]



    (3) Use of medications and interventions not related to withdrawal 

of support;

    (4) Involvement of family members prior to organ recovery;

    (5) Criteria for declaration of death and the time period that must 

elapse prior to organ recovery.

    (g) Organ allocation. The OPO must have a system to allocate donated 

organs among transplant patients that is consistent with the rules and 

requirements of the OPTN, as defined in Sec.  486.320 of this part.

    (h) Organ placement. The OPO must develop and implement a protocol 

to maximize placement of organs for transplantation.