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e-CFR data is current as of November 25, 2020

Title 42 → Chapter IV → Subchapter G → Part 486

TITLE 42—Public Health

CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER G—STANDARDS AND CERTIFICATION

PART 486—CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS

Subpart A—GENERAL PROVISIONS

Basis and scope.

Subpart B—[RESERVED]

Subpart C—CONDITIONS FOR COVERAGE: PORTABLE X-RAY SERVICES

Condition for coverage: Compliance with Federal, State, and local laws and regulations.

Condition for coverage: Supervision by a qualified physician.

Condition for coverage: Qualifications, orientation and health of technical personnel.

Condition for coverage: Referral for service and preservation of records.

Condition for coverage: Safety standards.

Condition for coverage: Inspection of equipment.

Subparts D-F [Reserved]

Subpart G—REQUIREMENTS FOR CERTIFICATION AND DESIGNATION AND CONDITIONS FOR COVERAGE: ORGAN PROCUREMENT ORGANIZATIONS

Basis and scope.

Definitions.

Requirements for Certification and Designation

Requirements for certification.

Requirements for designation.

OPO service area size designation and documentation requirements.

Designation of one OPO for each service area.

Re-certification from August 1, 2006 through July 31, 2010.

Changes in control or ownership or service area.

Re-Certification and De-Certification

De-certification.

Appeals.

Re-certification and competition processes.

Organ Procurement Organization Outcome Requirements

Condition: Outcome measures.

Organ Procurement Organization Process Performance Measures

Condition: Participation in Organ Procurement and Transplantation Network.

Condition: Relationships with hospitals, critical access hospitals, and tissue banks.

Condition: Administration and governing body.

Condition: Human resources.

Condition: Reporting of data.

Condition: Information management.

Condition: Requesting consent.

Condition: Evaluation and management of potential donors and organ placement and recovery.

Condition: Organ preparation and transport.

Condition: Quality assessment and performance improvement (QAPI).

Condition for Coverage: Emergency preparedness.

Subpart H—[RESERVED]

Subpart I—REQUIREMENTS FOR HOME INFUSION THERAPY SUPPLIERS

General Provisions

Basis and scope.

Definitions.

Standards for Home Infusion Therapy

Plan of care.

Required services.

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