Code of Federal Regulations > Title 42 > Chapter IV > Part 486 > Subpart G - Subpart G—Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Feb 11, 2026

REQUIREMENTS FOR CERTIFICATION AND DESIGNATION

§ 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.