[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: 42CFR486.330]



[Page 653]

 

                         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.  486.330  Condition: Information management.



    An OPO must establish and use an electronic information management 

system to maintain the required medical, social and identifying 

information for every donor and transplant recipient and develop and 

follow procedures to ensure the confidentiality and security of the 

information.

    (a) Donor information. The OPO must maintain a record for every 

donor. The record must include, at a minimum, information identifying 

the donor (for example, name, address, date of birth, social security 

number or other unique identifier, such as Medicare health insurance 

claim number), organs and (when applicable) tissues recovered, date of 

the organ recovery, donor management data, all test results, current 

hospital history, past medical and social history, the pronouncement of 

death, and consent and next-of-kin information.

    (b) Disposition of organs. The OPO must maintain records showing the 

disposition of each organ recovered for the purpose of transplantation, 

including information identifying transplant recipients.

    (c) Data retention. Donor and transplant recipient records must be 

maintained in a human readable and reproducible paper or electronic 

format for 7 years.

    (d) Format of records. The OPO must maintain data in a format that 

can readily be transferred to a successor OPO and in the event of a 

transfer must provide to CMS copies of all records, data, and software 

necessary to ensure uninterrupted service by a successor OPO. Records 

and data subject to this requirement include donor and transplant 

recipient records and procedural manuals and other materials used in 

conducting OPO operations.