1. A. In this chapter, the following terms have the meanings indicated.

2. B. Terms Defined.

   1. (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. (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. (3) “Allograft” means cells, tissue, or both intended for transplantation into another individual of the same species.
   4. (4) “Approval of the removal plan” means that the OHCQ has determined that the tissue bank's removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.
   5. (5) “Autogeneic tissue” means tissue from a human donor intended for use within or upon the body of that same donor.

   6. (6) “Cardiovascular tissue” means:

      1. (a) Human heart valves;
      2. (b) Aorta and great vessels;
      3. (c) Pericardium;
      4. (d) Saphenous vein;
      5. (e) Umbilical vein; or
      6. (f) Other tissues of the cardiovascular system.

   7. (7) Collection.

      1. (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.

      2. (b) “Collection” includes the removal, acquisition, recovery, harvesting, or retrieval of donor tissue by any means, including:

         1. (i) Phlebotomy;
         2. (ii) Hemapheresis;
         3. (iii) Surgical excision; and
         4. (iv) Biopsy.
   8. (8) “Designated qualified employee” means an employee who has been delegated one or more responsibilities by the technical director or medical director and who possesses the training and experience to perform the delegated responsibility.
   9. (9) “Department” means the Maryland Department of Health.
   10. (10) “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.

   11. (11) “Donor” means a human being, living or dead, who is the source of tissue for:

       1. (a) Transplantation;
       2. (b) Transfer;
       3. (c) Transfusion; or
       4. (d) Implantation.
   12. (12) “Eye” means a human cornea or other ocular tissue.
   13. (13) “Hematopoietic progenitor cells” means human precursor stem or progenitor hematopoietic cells derived from bone marrow, peripheral blood, or other tissue sources.
   14. (14) “Immediate corrective action” means all actions the tissue bank has taken or will take to immediately address the noncompliance that resulted in or made serious harm or death likely.
   15. (15) “Immediate jeopardy” means a situation in which immediate corrective action is necessary because the tissue bank's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious harm or death, to individuals served by the tissue bank or to the health or safety of the general public.
   16. (16) “Informal dispute resolution (IDR)” means an informal process that provides a tissue bank the opportunity to dispute one or more deficiencies cited in a written statement of deficiencies issued by the Department or the Department’s designee related to a recent survey.

   17. (17) Leukocyte.

       1. (a) “Leukocyte” means a nucleated white blood cell or a colorless blood corpuscle that:

          1. (i) Is found throughout the human body, including the blood, lymphatic system, and lymphoidal tissue;
          2. (ii) Is produced and derived from hematopoietic progenitor cells in the bone marrow; and
          3. (iii) Functions to protect the body against infectious microorganisms that cause disease by phagocytosis of the microorganisms and by producing antibodies.

       2. (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:

          1. (i) Neutrophils, also known as polymorphonuclear leukocytes;
          2. (ii) Eosinophils;
          3. (iii) Basophils;
          4. (iv) Monocytes;
          5. (v) Lymphocytes; and
          6. (vi) Thrombocytes, also known as platelets.

   18. (18) Leukocyte-Poor Tissue.

       1. (a) “Leukocyte-Poor tissue” means tissue that does not contain a significant or substantial number of potentially viable leukocytes.

       2. (b) “Leukocyte-Poor tissue” includes but is not limited to:

          1. (i) Corneas;
          2. (ii) Sclera;
          3. (iii) Skin;
          4. (iv) Heart valves;
          5. (v) Dura mater;
          6. (vi) Oocytes; and
          7. (vii) Musculoskeletal tissue, including bone, tendons, ligaments, and cartilage oocytes, if cleansed, washed, and rendered leukocyte-reduced.

   19. (19) Leukocyte-Rich Tissue.

       1. (a) “Leukocyte-Rich tissue” means tissue that may contain a significant or substantial number of potentially viable leukocytes.

       2. (b) “Leukocyte-Rich tissue” includes but is not limited to:

          1. (i) Blood, blood components, and products prepared after blood collection;
          2. (ii) Hematopoietic progenitor cells, also known as stem cells;
          3. (iii) Bone marrow;
          4. (iv) Musculoskeletal tissue containing blood or marrow elements, including unprocessed, fresh or frozen, or whole or partial bone;
          5. (v) Musculoskeletal tissue allografts in which the bone end and subchondral bone element have not been cleansed, washed, and rendered leukocyte-reduced; and
          6. (vi) Semen.

   20. (20) “Medical director” means a physician who:

       1. (a) Meets the requirements set forth in Regulation .10 of this chapter; and
       2. (b) Is responsible for all medical aspects of the tissue bank's operations, unless the technical director meets the qualifications stated in Regulation .10B of this chapter.
   21. (21) “Milk” means human milk for ingestion by a child other than the milk donor's child.

   22. (22) “Musculoskeletal tissue” means:

       1. (a) Bone;
       2. (b) Tendon;
       3. (c) Ligament;
       4. (d) Muscle;
       5. (e) Fascia;
       6. (f) Cartilage; or
       7. (g) Other tissue in the musculoskeletal system.
   23. (23) “Need for immediate corrective action” means immediate corrective action is necessary to remove the jeopardy.
   24. (24) “Noncompliance” means the tissue bank is not compliant with one or more licensure requirements.
   25. (25) “OHCQ” means the Office of Health Care Quality in the Department.
   26. (26) “Owner” means a person with an ownership interest in a tissue bank.

   27. (27) Permit.

       1. (a) “Permit” means a license issued by the Secretary to:

          1. (i) Operate a tissue bank in this State; or
          2. (ii) Represent or service in this State a tissue bank that is in this State or outside this State.
       2. (b) “Permit” includes a provisional permit, except as otherwise indicated in Regulation .06 of this chapter.
   28. (28) “Plan of correction” means a written plan submitted by the tissue bank to the OHCQ which documents steps the tissue bank will take to come into compliance with the licensure requirements.

   29. (29) “Processing” means an activity necessary to:

       1. (a) Prepare or preserve a tissue for storage;
       2. (b) Remove a tissue from storage; or
       3. (c) Conduct testing to assure the potency, quality, or sterility of a tissue.

   30. (30) “Recipient” means an individual who receives a tissue through:

       1. (a) Transplantation;
       2. (b) Transfusion;
       3. (c) Transfer; or
       4. (d) Implementation.

   31. (31) “Removal plan” means the tissue bank's written plan that documents:

       1. (a) The immediate corrective action a tissue bank will take to prevent serious harm from occurring or recurring;
       2. (b) All actions to remove past, present, and future jeopardy; and
       3. (c) The date by which the entity asserts the likelihood for serious harm to any recipient no longer exists.
   32. (32) “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.

   33. (33) Reproductive Tissue.

       1. (a) “Reproductive tissue” means tissue from the reproductive tract intended for use in artificial insemination or another assisted reproductive procedure.

       2. (b) “Reproductive tissue” includes, but is not limited to:

          1. (i) Semen;
          2. (ii) Oocytes;
          3. (iii) Embryos;
          4. (iv) Spermatozoa;
          5. (v) Spermatids;
          6. (vi) Ovarian tissue;
          7. (vii) Testicular tissue;
          8. (viii) Epididymal aspirates; and
          9. (ix) Other tissue in the reproductive system.

   34. (34) Quality Control.

       1. (a) “Quality control” means the daily analysis of procedures and materials to assure sterility, accuracy, and reproducibility of tissue and tissue bank products.
       2. (b) “Quality control” includes a documented system to assure that instruments, equipment, reagents, and supplies function properly.
   35. (35) “Secretary” means the Secretary of the Department.
   36. (36) “Serious harm” means the situation has already caused, is causing, or is likely to cause, at any time, serious injury, serious impairment, or death, to individuals served by the tissue bank or to the health or safety of the general public.

   37. (37) “Storage” means holding tissue for subsequent:

       1. (a) Transplantation;
       2. (b) Transfusion;
       3. (c) Transfer; or
       4. (d) Implantation.
   38. (38) “Statement of Deficiencies” means the written notification that the OHCQ issues to the provider that contains a listing of deficiencies cited that require correction.

   39. (39) “Technical director” means an individual who:

       1. (a) Meets the requirements set forth in Regulation .10 of this chapter; and
       2. (b) Will oversee and be responsible for all technical aspects of the tissue bank's operations..

   40. (40) Tissue.

       1. (a) “Tissue” means a visceral or nonvisceral collection of human cells and their associated intracellular substances.

       2. (b) “Tissue” includes, but is not limited to, human:

          1. (i) Blood, blood components, and products prepared after collection;
          2. (ii) Cardiovascular tissue;
          3. (iii) Cornea and other ocular tissue;
          4. (iv) Hematopoietic progenitor cells;
          5. (v) Milk;
          6. (vi) Musculoskeletal tissue;
          7. (vii) Reproductive cells and tissue; and
          8. (viii) Skin.

   41. (41) Tissue Bank.

       1. (a) “Tissue bank” means an establishment that obtains, stores, processes, distributes, or sells human blood or other human tissue for use in the human body.

       2. (b) “Tissue bank” includes a person or facility that provides or engages in one or more services involving tissue from living or cadaveric donors for:

          1. (i) Transplantation;
          2. (ii) Transfusion;
          3. (iii) Transfer; or
          4. (iv) Implementation purposes.

       3. (c) “Tissue bank” includes, but is not limited to, the following classes:

          1. (i) Blood bank;
          2. (ii) Cardiovascular tissue bank;
          3. (iii) Eye bank;
          4. (iv) Hematopoietic progenitor cell bank;
          5. (v) Human milk bank;
          6. (vi) Musculoskeletal tissue bank;
          7. (vii) Reproductive tissue bank; and
          8. (viii) Skin bank.

   42. (42) Tissue Bank Service.

       1. (a) “Tissue bank service” means an activity or pursuit that involves tissue intended for human:

          1. (i) Transplantation;
          2. (ii) Transfusion;
          3. (iii) Transfer; or
          4. (iv) Implementation.

       2. (b) “Tissue bank service” includes, but is not limited to, an activity or means of donor selection or tissue:

          1. (i) Collection;
          2. (ii) Preparation;
          3. (iii) Preservation;
          4. (iv) Storage;
          5. (v) Allocation;
          6. (vi) Transportation; or
          7. (vii) Distribution.

Authority: Health-General Article, Annotated Code of Maryland

Effective date: July 1, 1970

Regulations .01—.12 repealed and new Regulations .01—.06 adopted effective May 5, 1986 (13:9 Md. R. 1030)

Regulation .03 amended effective March 20, 1989 (16:5 Md. R. 629)

Regulation .06B amended effective June 11, 1990 (17:11 Md. R. 1343)

Regulation .06D amended effective March 20, 1989 (16:5 Md. R. 629); amended and recodified to Regulation .07 effective June 11, 1990 (17:11 Md. R. 1343)

Regulation .06E adopted effective March 20, 1989 (16:5 Md. R. 629); recodified to Regulation .06D effective June 11, 1990 (17:11 Md. R. 1343)

Regulation .08 adopted effective June 11, 1990 (17:11 Md. R. 1343)

COMAR 10.10.02 recodified to COMAR 10.50.01 effective December 13, 1999 (26:25 Md. R. 1897)

Regulations .01—.08 repealed and new Regulations .01—.12 adopted effective March 15, 2004 (31:5 Md. R. 449)

Regulation .03B amended effective April 4, 2011 (38:7 Md. R. 432); September 15, 2025 (52:18 Md. R. 923)

Regulation .04B amended effective April 4, 2011 (38:7 Md. R. 432); August 15, 2016 (43:16 Md. R. 901); September 15, 2025 (52:18 Md. R. 923)

Regulation .05 repealed effective September 15, 2025 (52:18 Md. R. 923)

Regulation .06 amended effective November 25, 2013 (40:23 Md. R. 1934)

Regulation .06 repealed and new Regulation .06 adopted effective September 15, 2025 (52:18 Md. R. 923)

Regulation .07B amended effective September 15, 2025 (52:18 Md. R. 923)

Regulation .07D adopted effective September 15, 2025 (52:18 Md. R. 923)

Regulation .08 recodified to be Regulation .09 effective September 15, 2025 (52:18 Md. R. 923)

Regulation .08 adopted effective September 15, 2025 (52:18 Md. R. 923)

Regulation .09 repealed effective September 15, 2025 (52:18 Md. R. 923)

Regulation .09 recodified from Regulation .08 effective September 15, 2025 (52:18 Md. R. 923)

Regulation .10 amended effective September 15, 2025 (52:18 Md. R. 923)

Regulation .10C amended effective January 9, 2012 (38:27 Md. R. 1764)

Regulation .11A amended effective September 15, 2025 (52:18 Md. R. 923)

Regulation .11A, C amended effective April 4, 2011 (38:7 Md. R. 432)