Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 5 › Subtitle 50 - TISSUE BANKS › Chapter 10.50.01 - Tissue Banks › Section 10.50.01.03 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "Adverse outcome" means an undesirable
				  effect or untoward complication in a recipient as a result of or reasonably
				  related to a transfusion or transplantation of cells, tissue, or
				  both.
(2) "Allogeneic tissue" means
				  tissue from a human donor intended for use within or upon the body of an
				  individual other than the donor.
(3) "Allograft" means cells, tissue, or both
				  intended for transplantation into another individual of the same
				  species.
(4) "Autogeneic tissue"
				  means tissue from a human donor intended for use within or upon the body of
				  that same donor.
(5)
				  "Cardiovascular tissue" means:
(a) Human
				  heart valves;
(b) Aorta and great
				  vessels;
(c) Pericardium;
(d) Saphenous vein;
(e) Umbilical vein; or
(f) Other tissues of the cardiovascular
				  system.
(6) Collection.
(a) "Collection" means an activity involved
				  in obtaining allogeneic or autogeneic tissue for the purpose of
				  transplantation, transfusion, or transfer into or upon a human being.
(b) "Collection" includes the removal,
				  acquisition, recovery, harvesting, or retrieval of donor tissue by any means,
				  including:
(i) Phlebotomy;
(ii) Hemapheresis;
(iii) Surgical excision; and
(iv) Biopsy.
(7) "Department" means the Department of
				  Health and Mental Hygiene.
(8)
				  "Distribution" means the removal of tissue or tissue products from the tissue
				  bank originally collecting, storing, or processing the tissue for shipment to
				  another person or facility for processing, storage, or a diagnostic,
				  therapeutic, or prophylactic purpose.
(9) "Donor" means a human being, living or
				  dead, who is the source of tissue for:
(a)
				  Transplantation;
(b)
				  Transfer;
(c) Transfusion;
				  or
(d) Implantation.
(10) "Eye" means a human cornea or
				  other ocular tissue.
(11)
				  "Hematopoietic progenitor cells" means human precursor stem or progenitor
				  hematopoietic cells derived from bone marrow, peripheral blood, or other tissue
				  sources.
(12) Leukocyte.
(a) "Leukocyte" means a nucleated white blood
				  cell or a colorless blood corpuscle that:
(i)
				  Is found throughout the human body, including the blood, lymphatic system, and
				  lymphoidal tissue;
(ii) Is produced
				  and derived from hematopoietic progenitor cells in the bone marrow;
				  and
(iii) Functions to protect the
				  body against infectious microorganisms that cause disease by phagocytosis of
				  the microorganisms and by producing antibodies.
(b) "Leukocyte" includes any of the various
				  white blood cells classified as a granulocyte or agranulocyte that collectively
				  make up the human immune system, including:
(i) Neutrophils, also known as
				  polymorphonuclear leukocytes;
(ii)
				  Eosinophils;
(iii)
				  Basophils;
(iv)
				  Monocytes;
(v) Lymphocytes;
				  and
(vi) Thrombocytes, also known
				  as platelets.
(13) Leukocyte-poor Tissue.
(a) "Leukocyte-poor tissue" means tissue that
				  does not contain a significant or substantial number of potentially viable
				  leukocytes.
(b) "Leukocyte-poor
				  tissue" includes but is not limited to:
(i)
				  Corneas;
(ii) Sclera;
(iii) Skin;
(iv) Heart valves;
(v) Dura mater;
(vi) Oocytes; and
(vii) Musculoskeletal tissue, including bone,
				  tendons, ligaments, and cartilage oocytes, if cleansed, washed, and rendered
				  leukocyte-reduced.
(14) Leukocyte-rich Tissue.
(a) "Leukocyte-rich tissue" means tissue that
				  may contain a significant or substantial number of potentially viable
				  leukocytes.
(b) "Leukocyte-rich
				  tissue" includes but is not limited to:
(i)
				  Blood, blood components, and products prepared after blood
				  collection;
(ii) Hematopoietic
				  progenitor cells, also known as stem cells;
(iii) Bone marrow;
(iv) Musculoskeletal tissue containing blood
				  or marrow elements, including unprocessed, fresh or frozen, or whole or partial
				  bone;
(v) Musculoskeletal tissue
				  allografts in which the bone end and subchondral bone element have not been
				  cleansed, washed, and rendered leukocyte-reduced; and
(vi) Semen.
(15) "Medical director" means a physician
				  who:
(a) Meets the requirements set forth in
				  Regulation .10 of this chapter; and
(b) Is responsible for all medical aspects of
				  the tissue bank's services.
(16) "Milk" means human milk for ingestion by
				  a child other than the milk donor's child.
(17) "Musculoskeletal tissue" means:
(a) Bone;
(b) Tendon;
(c) Ligament;
(d) Muscle;
(e) Fascia;
(f) Cartilage; or
(g) Other tissue in the musculoskeletal
				  system.
(18) "OHCQ"
				  means the Office of Health Care Quality in the Department.
(19) "Owner" means a person with an ownership
				  interest in a tissue bank.
(20)
				  Permit.
(a) "Permit" means a license issued
				  by the Secretary to:
(i) Operate a tissue bank
				  in this State; or
(ii) Represent or
				  service in this State a tissue bank that is in this State or outside this
				  State.
(b) "Permit"
				  includes a provisional permit, except as otherwise indicated in Regulation .06
				  of this chapter.
(21)
				  "Processing" means an activity necessary to:
(a) Prepare or preserve a tissue for
				  storage;
(b) Remove a tissue from
				  storage; or
(c) Conduct testing to
				  assure the potency, quality, or sterility of a tissue.
(22) "Recipient" means an individual who
				  receives a tissue through:
(a)
				  Transplantation;
(b)
				  Transfusion;
(c) Transfer;
				  or
(d) Implementation.
(23) "Represent or service" means
				  a mechanism, system, method, or activity that provides or offers to provide a
				  tissue bank service to a person in the State.
(24) Reproductive Tissue.
(a) "Reproductive tissue" means tissue from
				  the reproductive tract intended for use in artificial insemination or another
				  assisted reproductive procedure.
(b) "Reproductive tissue" includes, but is
				  not limited to:
(i) Semen;
(ii) Oocytes;
(iii) Embryos;
(iv) Spermatozoa;
(v) Spermatids;
(vi) Ovarian tissue;
(vii) Testicular tissue;
(viii) Epididymal aspirates; and
(ix) Other tissue in the reproductive
				  system.
(25)
				  Quality Control.
(a) "Quality control" means
				  the daily analysis of procedures and materials to assure sterility, accuracy,
				  and reproducibility of tissue and tissue bank products.
(b) "Quality control" includes a documented
				  system to assure that instruments, equipment, reagents, and supplies function
				  properly.
(26)
				  "Secretary" means the Secretary of the Department.
(27) "Storage" means holding tissue for
				  subsequent:
(a) Transplantation;
(b) Transfusion;
(c) Transfer; or
(d) Implantation.
(28) "Technical director" means an individual
				  who:
(a) Meets the requirements set forth in
				  Regulation .10 of this chapter; and
(b) Is responsible for supervising the
				  technical, scientific, and administrative operations of a tissue
				  bank.
(29) Tissue.
(a) "Tissue" means a visceral or nonvisceral
				  collection of human cells and their associated intracellular
				  substances.
(b) "Tissue" includes,
				  but is not limited to, human:
(i) Blood, blood
				  components, and products prepared after collection;
(ii) Cardiovascular tissue;
(iii) Cornea and other ocular
				  tissue;
(iv) Hematopoietic
				  progenitor cells;
(v)
				  Milk;
(vi) Musculoskeletal
				  tissue;
(vii) Reproductive cells
				  and tissue; and
(viii)
				  Skin.
(30)
				  Tissue Bank.
(a) "Tissue bank" means a person
				  or facility that provides or engages in one or more services involving tissue
				  from living or cadaveric donors for:
(i)
				  Transplantation;
(ii)
				  Transfusion;
(iii) Transfer;
				  or
(iv) Implementation
				  purposes.
(b) "Tissue
				  bank" includes, but is not limited to, the following classes:
(i) Blood bank;
(ii) Cardiovascular tissue bank;
(iii) Eye bank;
(iv) Hematopoietic progenitor cell
				  bank;
(v) Human milk
				  bank;
(vi) Musculoskeletal tissue
				  bank;
(vii) Reproductive tissue
				  bank; and
(viii) Skin
				  bank.
(31)
				  Tissue Bank Service.
(a) "Tissue bank
				  service" means an activity or pursuit that involves tissue intended for human:
(i) Transplantation;
(ii) Transfusion;
(iii) Transfer; or
(iv) Implementation.
(b) "Tissue bank service" includes, but is
				  not limited to, an activity or means of donor selection or tissue:
(i) Collection;
(ii) Preparation;
(iii) Preservation;
(iv) Storage;
(v) Allocation;
(vi) Transportation; or
(vii) Distribution.