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Healthcare Policy and Regulation

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Chydelette Edouard

on 7 December 2015

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Transcript of Healthcare Policy and Regulation

Healthcare Policy and Regulation
HCMG 3340-N1
Fall 2015
Kasilyn Jay
Bridgette Thompson
Chydelette Edouard

Healthcare Policy and Regulation
Overview
§ 121.13 Definition of Organ of Human Organ Under section 301 of the National Organ Transplant Act, as amended.
"Human Organ," as covered by section 301 of the National Organ Transplant Act, as amended, means the human (including fetal) kidney, liver, lung, pancreas, bone marrow, cornea, eye, bone, skin, and intestine, including esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.
Rule was amended to change the definition of "human organ," specifically, bone marrow to incorporate stem cells in peripheral blood in the definition pf bone marrow regardless of how it was obtained, whether by aspiration or apheresis. This is Federal regulation.
Oversight by Department of Health and Human Services.
Healthcare Policy and Regulation
Target population
All; including fetus
Public health advancement:
Protection of donation of blood for unintended uses. For example, if donor is against stem cell transplants, their stem cells cannot be extracted through peripheral donation and used for transplant or research purposes without their knowledge.
Healthcare Policy and Regulation
§ 121.13
Definition of human organ under section 301 of the National Organ Transplant Act of 1984, as amended.
"Human organ," as covered by section 301 of the National Organ Transplant Act, as amended, means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow and other hematopoietic stem/progenitor cells without regard to the method of their collection, cornea, eye, bone, skin, and intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.
Healthcare Policy and Regulation
Resources:
http://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/xml/CFR-2007-title42-vol1-sec121-13.xml

http://www.regulations.gov/#!documentDetail;D=HRSA-2013-0002-0001
Full transcript