U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jan 21, 2026

All TitlesTitle 42Chapter IVPart 486Subpart G - Subpart G—Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations

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

RE-CERTIFICATION AND DE-CERTIFICATION
§ 486.312 - De-certification.
§ 486.314 - Appeals.
§ 486.316 - Re-certification and competition processes.

ORGAN PROCUREMENT ORGANIZATION OUTCOME REQUIREMENTS
§ 486.318 - Condition: Outcome measures.

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