Title 42

PART 486 SUBPART G

Subpart G - Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations Source:71 FR 31046, May 31, 2006, unless otherwise noted.

• 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.
• Source:

42:5.0.1.1.5.5.13	SUBJGRP 13	Requirements for Certification and Designation
42:5.0.1.1.5.5.13.1	SECTION 486.301	486.301 Basis and scope.
42:5.0.1.1.5.5.13.2	SECTION 486.302	486.302 Definitions.
42:5.0.1.1.5.5.13.3	SECTION 486.303	486.303 Requirements for certification.
42:5.0.1.1.5.5.13.4	SECTION 486.304	486.304 Requirements for designation.
42:5.0.1.1.5.5.13.5	SECTION 486.306	486.306 OPO service area size designation and documentation requirements.
42:5.0.1.1.5.5.13.6	SECTION 486.308	486.308 Designation of one OPO for each service area.
42:5.0.1.1.5.5.13.7	SECTION 486.309	486.309 Re-certification from August 1, 2006 through July 31, 2010.
42:5.0.1.1.5.5.13.8	SECTION 486.310	486.310 Changes in control or ownership or service area.
42:5.0.1.1.5.5.14	SUBJGRP 14	Re-Certification and De-Certification
42:5.0.1.1.5.5.14.9	SECTION 486.312	486.312 De-certification.
42:5.0.1.1.5.5.14.10	SECTION 486.314	486.314 Appeals.
42:5.0.1.1.5.5.14.11	SECTION 486.316	486.316 Re-certification and competition processes.
42:5.0.1.1.5.5.15	SUBJGRP 15	Organ Procurement Organization Outcome Requirements
42:5.0.1.1.5.5.15.12	SECTION 486.318	486.318 Condition: Outcome measures.
42:5.0.1.1.5.5.16	SUBJGRP 16	Organ Procurement Organization Process Performance Measures
42:5.0.1.1.5.5.16.13	SECTION 486.320	486.320 Condition: Participation in Organ Procurement and Transplantation Network.
42:5.0.1.1.5.5.16.14	SECTION 486.322	486.322 Condition: Relationships with hospitals, critical access hospitals, and tissue banks.
42:5.0.1.1.5.5.16.15	SECTION 486.324	486.324 Condition: Administration and governing body.
42:5.0.1.1.5.5.16.16	SECTION 486.326	486.326 Condition: Human resources.
42:5.0.1.1.5.5.16.17	SECTION 486.328	486.328 Condition: Reporting of data.
42:5.0.1.1.5.5.16.18	SECTION 486.330	486.330 Condition: Information management.
42:5.0.1.1.5.5.16.19	SECTION 486.342	486.342 Condition: Requesting consent.
42:5.0.1.1.5.5.16.20	SECTION 486.344	486.344 Condition: Evaluation and management of potential donors and organ placement and recovery.
42:5.0.1.1.5.5.16.21	SECTION 486.346	486.346 Condition: Organ preparation and transport.
42:5.0.1.1.5.5.16.22	SECTION 486.348	486.348 Condition: Quality assessment and performance improvement (QAPI).
42:5.0.1.1.5.5.16.23	SECTION 486.360	486.360 Condition for Coverage: Emergency preparedness.

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