Subpart G. Subpart G—Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations

• § 486.301 - Basis and scope.
• § 486.302 - Definitions.

• Requirements for Certification and Designation

  • SECTION § 486.303 - Requirements for certification.
  • SECTION § 486.304 - Requirements for designation.
  • SECTION § 486.306 - OPO service area size designation and documentation requirements.
  • SECTION § 486.308 - Designation of one OPO for each service area.
  • SECTION § 486.309 - Re-certification from August 1, 2006 through July 31, 2010.
  • SECTION § 486.310 - Changes in control or ownership or service area.

• Re-Certification and De-Certification

  • SECTION § 486.312 - De-certification.
  • SECTION § 486.314 - Appeals.
  • SECTION § 486.316 - Re-certification and competition processes.

• Organ Procurement Organization Outcome Requirements

  • SECTION § 486.318 - Condition: Outcome measures.

• Organ Procurement Organization Process Performance Measures

  • SECTION § 486.320 - Condition: Participation in Organ Procurement and Transplantation Network.
  • SECTION § 486.322 - Condition: Relationships with hospitals, critical access hospitals, and tissue banks.
  • SECTION § 486.324 - Condition: Administration and governing body.
  • SECTION § 486.326 - Condition: Human resources.
  • SECTION § 486.328 - Condition: Reporting of data.
  • SECTION § 486.330 - Condition: Information management.
  • SECTION § 486.342 - Condition: Requesting consent.
  • SECTION § 486.344 - Condition: Evaluation and management of potential donors and organ placement and recovery.
  • SECTION § 486.346 - Condition: Organ preparation and transport.
  • SECTION § 486.348 - Condition: Quality assessment and performance improvement (QAPI).
  • SECTION § 486.360 - Condition for Coverage: Emergency preparedness.