Md. Code Regs. 10.50.01.03

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.50.01.03 - Definitions

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.

Md. Code Regs. 10.50.01.03

Regulations .03 adopted effective May 5, 1986 (13:9 Md. R. 1030)
Regulation .03 amended effective March 20, 1989 (16:5 Md. R. 629)
Regulations .03 adopted effective March 15, 2004 (31:5 Md. R. 449)
Regulation .03B amended effective April 4, 2011 (38:7 Md. R. 432)