Chapter 01. Tissue Banks
Regulation .01 Purpose.LinkCopy Citation
The intent of this chapter is to protect the public and individual health by requiring that all tissue banks operating or providing services in Maryland operate under qualified supervision, reliable procedures, and appropriate quality assurance.
Regulation .02 Scope.LinkCopy Citation
This chapter does not apply to a tissue bank operated:
A.
By the federal government; or
B.
Solely for research and teaching purposes, if human tissue and tissue products from the research or teaching are not transplanted, transfused, or used within or upon a human.
Regulation .03 Definitions.LinkCopy Citation
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)
“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)
“Autogeneic tissue” means tissue from a human donor intended for use within or upon the body of that same donor.
(6)
“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.
(7)
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.
(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)
“Department” means the Maryland Department of Health.
(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)
“Donor” means a human being, living or dead, who is the source of tissue for:
(a)
Transplantation;
(b)
Transfer;
(c)
Transfusion; or
(d)
Implantation.
(12)
“Eye” means a human cornea or other ocular tissue.
(13)
“Hematopoietic progenitor cells” means human precursor stem or progenitor hematopoietic cells derived from bone marrow, peripheral blood, or other tissue sources.
(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)
“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)
“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)
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.
(18)
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.
(19)
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.
(20)
“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 operations, unless the technical director meets the qualifications stated in Regulation .10B of this chapter.
(21)
“Milk” means human milk for ingestion by a child other than the milk donor's child.
(22)
“Musculoskeletal tissue” means:
(a)
Bone;
(b)
Tendon;
(c)
Ligament;
(d)
Muscle;
(e)
Fascia;
(f)
Cartilage; or
(g)
Other tissue in the musculoskeletal system.
(23)
“Need for immediate corrective action” means immediate corrective action is necessary to remove the jeopardy.
(24)
“Noncompliance” means the tissue bank is not compliant with one or more licensure requirements.
(25)
“OHCQ” means the Office of Health Care Quality in the Department.
(26)
“Owner” means a person with an ownership interest in a tissue bank.
(27)
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.
(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)
“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.
(30)
“Recipient” means an individual who receives a tissue through:
(a)
Transplantation;
(b)
Transfusion;
(c)
Transfer; or
(d)
Implementation.
(31)
“Removal plan” means the tissue bank's written plan that documents:
(a)
The immediate corrective action a tissue bank will take to prevent serious harm from occurring or recurring;
(b)
All actions to remove past, present, and future jeopardy; and
(c)
The date by which the entity asserts the likelihood for serious harm to any recipient no longer exists.
(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)
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.
(34)
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.
(35)
“Secretary” means the Secretary of the Department.
(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)
“Storage” means holding tissue for subsequent:
(a)
Transplantation;
(b)
Transfusion;
(c)
Transfer; or
(d)
Implantation.
(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)
“Technical director” means an individual who:
(a)
Meets the requirements set forth in Regulation .10 of this chapter; and
(b)
Will oversee and be responsible for all technical aspects of the tissue bank's operations..
(40)
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.
(41)
Tissue Bank.
(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.
(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:
(i)
Transplantation;
(ii)
Transfusion;
(iii)
Transfer; or
(iv)
Implementation purposes.
(c)
“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.
(42)
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.
Regulation .04 Incorporation by Reference.LinkCopy Citation
A.
In this chapter, the following documents are incorporated by reference.
B.
Documents Incorporated.
(1)
Standards for Tissue Banking (American Association of Tissue Banks, 14th Edition), Sections C, D, E, F, G, H, J, K, L, and M1-8 only;
(2)
Standards for Blood Banks and Transfusion Services [(American Association of Blood Banks, 29th Edition);] (Association for the Advancement of Blood & Biotherapies), 34th Edition;
(3)
International Quality Plasma Program (IQPP) (Plasma Protein Therapeutics Association):
(a)
Community-based Donor Standard V5 (2020);
(b)
Cross Donation Management Standard V3 (2014);
(c)
Recording Donor Adverse Events V2 (2018);
(d)
Donor Education Standard V3 (2014);
(e)
Donor Fluid Administration Standard V1 (2014);
(f)
Use of National Donor Deferral Registry Standard V3 (2008);
(g)
Qualified Donor Standard V5 (2020);
(h)
Viral Marker Standard V5 (2022);
(i)
Personnel Education and Training Standard V5 (2019);
(j)
Plasma Collection Facility Standard V4 (2019);
(k)
Quality Assurance Standard V5 (2020); and
(4)
42 U.S.C. §§1320d et seq., as amended;
(5)
42 U.S.C. §§17921 et seq., as amended; and
(6)
45 CFR Parts 160, 162, and 164, as amended.
Regulation .05 Responsibilities of the OHCQ. — Repealed.LinkCopy Citation
Regulation .06 Permitting Procedure.LinkCopy Citation
A.
Application. An application is not complete until the OHCQ has received the completed permit application and all required documents.
B.
Initial Inspection. The OHCQ shall inspect or have an inspection conducted by an accreditation organization for each tissue bank when an initial Maryland permit to operate is sought.
C.
Issuance of a Permit. The Secretary shall issue a permit to an applicant who meets the requirements of this chapter to:
(1)
Operate a tissue bank in the State; or
(2)
Represent for service in the State a tissue bank that is inside the State or outside the State.
D.
Issuance of a Permit and Provisional Permit.
(1)
Permit and Provisional Permit Content. A permit and provisional permit shall state:
(a)
The name of the tissue bank;
(b)
The name of the tissue bank's medical director;
(c)
The name of the tissue bank's owner or owners; and
(d)
The class or classes of the tissue bank.
(2)
Provisional Permit.
(a)
The Secretary may issue a provisional permit before or after an initial inspection.
(b)
A provisional permit:
(i)
Is valid for 180 calendar days or a lesser period as determined by the Secretary;
(ii)
May not be renewed; and
(iii)
Shall automatically expire without notice upon the sooner of the date set for its expiration or upon issuance of a permit.
E.
Permit Requirement. A person shall hold a permit issued by the Secretary before the person may:
(1)
Operate a tissue bank in this State; or
(2)
Represent or service in this State a tissue bank that is:
(a)
In this State; or
(b)
Outside this State.
F.
Operating Without a Permit.
(1)
Unless a person has a permit issued by the Secretary to operate, represent, or service a tissue bank in this State, a person may not:
(a)
Operate a tissue bank in this State; or
(b)
Represent or service in this State a tissue bank that is in this State or outside this State.
(2)
A permit holder may not operate, represent, or service a tissue bank class other than that authorized in the permit.
G.
Cessation of Operations. If a tissue bank ceases operation for 180 calendar days, then:
(1)
The OHCQ will void the permit to operate a tissue bank in the State; and
(2)
The tissue bank shall return the permit to the OHCQ.
H.
Permit Application Administratively Closed.
(1)
After 180 calendar days from the date of initial receipt, the OHCQ may deem an incomplete permit application inactive and administratively close the application.
(2)
An applicant whose application is administratively closed may reapply for a permit by submitting a new application.
I.
Change of Medical Director, Name, or Location of a Tissue Bank. A tissue bank undergoing a change in medical director, name, or location shall:
(1)
Notify the OHCQ 10 calendar days before a change occurs; and
(2)
Apply to the OHCQ for an amended permit or provisional permit within 30 calendar days after a change takes place.
J.
Nontransferability. A permit or provisional permit may not be transferred from one owner of a tissue bank to another.
K.
Denial, Suspension, Revocation — Causes. The Secretary may deny, suspend, or revoke a permit or provisional permit if the tissue bank or the tissue bank's technical director, medical director, or both fail to meet requirements of this chapter, including, but not limited to:
(1)
Failure within a specified time to correct a cited deficiency identified during an inspection;
(2)
Repetitive or consistent errors;
(3)
Deliberate falsehood; or
(4)
Failure to apply for an amended permit or provisional permit within 30 calendar days after a tissue bank undergoes a change in tissue bank class, medical director, name, or location.
L.
Denial, Suspension, and Revocation — Hearing Requirement.
(1)
When the Secretary denies an application for a permit, the Secretary shall inform the permit applicant in writing:
(a)
Of the date the denial takes effect;
(b)
Of the reason for the denial; and
(c)
That the permit applicant has an opportunity for a hearing on the matter in accordance with State Government Article, §10-226, Annotated Code of Maryland.
(2)
Unless the Secretary finds that a danger to public health, safety, or welfare summarily requires that emergency action be taken to correct a deficiency, the Secretary shall inform the permit holder or provisional permit holder, in writing:
(a)
Of the date a suspension or revocation of the permit or provisional permit takes effect;
(b)
Of the reason for the suspension or revocation; and
(c)
That the permit holder or provisional permit holder has an opportunity for a hearing on the matter before the suspension or revocation takes effect, in accordance with State Government Article, §10-226, Annotated Code of Maryland.
(3)
When a finding is made that the public health, safety, or welfare summarily requires that emergency or immediate corrective action be taken, the Secretary shall inform the permit holder or provisional permit holder in writing:
(a)
Of the date a suspension or revocation of the permit or provisional permit takes effect;
(b)
Of the reason for the suspension or revocation; and
(c)
That the permit holder or provisional permit holder has an opportunity for a hearing on the matter, after the suspension or revocation takes effect, in accordance with State Government Article, §10-226, Annotated Code of Maryland.
(4)
Reapplication After Revocation. A tissue bank that has had its permit or provisional permit revoked may apply for a new permit 30 calendar days after revocation and upon presentation to the Secretary of evidence of capability and intention to comply with the standards and requirements of this chapter.
M.
Return of Permit. If a tissue bank's permit is amended, suspended, or revoked, the original permit is void and the tissue bank's technical director shall return the permit to the OHCQ.
Regulation .07 Accredited Tissue Bank and Accrediting Organization.LinkCopy Citation
A.
Accredited Tissue Bank — Determination. The Secretary may accept as compliance with the inspection requirements of this chapter a tissue bank accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the tissue bank accrediting organization are equivalent to those under this chapter.
B.
Accredited Tissue Bank — Requirements. In addition to meeting the requirements for accreditation, as set forth by a tissue bank's accrediting organization, an accredited tissue bank shall:
(1)
Obtain and maintain a valid permit issued by the Secretary; and
(2)
Be subject to inspection by the OHCQ to:
(a)
Determine if the tissue bank is operating in a manner that does not constitute an imminent and serious risk to public health;
(b)
Investigate complaints;
(c)
Determine whether a permit holder is operating a tissue bank beyond the scope of the permit;
(d)
Validate findings of a tissue bank's accrediting organization; and
(e)
Verify compliance with licensure requirements.
C.
Accrediting Organization.
(1)
A private, nonprofit tissue-bank accrediting organization may inspect and accredit tissue banks in the State for the purpose of a State permit only after applying for and receiving approval of the OHCQ.
(2)
The OHCQ may approve a tissue bank accrediting organization based on a review of that organization, if the review includes (but need not be limited to) an evaluation of:
(a)
Accreditation policies and standards;
(b)
Copies of inspection forms and guidelines;
(c)
Inspection and deficiency writing policies;
(d)
Inspector qualifications; and
(e)
Complaint investigation policies.
(3)
In addition to other requirements set forth in this chapter, an accrediting organization shall provide to the OHCQ:
(a)
Annually, an updated list containing the names, addresses, and accreditation expiration dates of all tissue banks in the State accredited by the accrediting organization;
(b)
Within 30 days after conducting an inspection, a certified written or electronic copy of each inspection report covering each tissue bank applying for or maintaining accreditation in the State;
(c)
At least 30 days before the effective date of the change, written notice of any proposed change to requirements for tissue bank accreditation;
(d)
Within 30 days after a tissue bank's accreditation expires, written or electronic notice if the tissue bank does not renew its accreditation;
(e)
Documentation of a complaint and complaint investigation; and
(f)
On request, a copy of:
(i)
Inspector qualifications; and
(ii)
Other information the Secretary may require relating to the regulation of a tissue bank.
(4)
When the Secretary denies accreditation to a tissue-bank accrediting organization, the Secretary shall inform the accrediting agency in writing that it has an opportunity for a hearing under State Government Article, §10-226, Annotated Code of Maryland.
D.
Change in Accreditation Status. Tissue banks shall report all changes in accreditation status to the OHCQ within seven calendar days of becoming aware of the change.
Regulation .08 Inspection by OHCQ.LinkCopy Citation
A.
Open for Inspection. A permit holder shall allow an on-site inspection by the OHCQ, or any designee by OHCQ, at any time during the tissue bank's regular hours of operation, to evaluate the tissue bank's compliance with the applicable requirements, conditions, and standards of this chapter.
B.
Content of Inspection. An inspection may include, but is not limited to, observation and examination of:
(1)
Tissue bank facilities and physical security;
(2)
Equipment;
(3)
Quality assurance and quality control policies and records;
(4)
Operating procedures, policies, and records;
(5)
Personnel and personnel records;
(6)
Donor documentation and records; and
(7)
Other records and files pertinent to this chapter.
C.
Access to Records. Tissue bank employees shall make data and records accessible within a reasonable time during an inspection by OHCQ or any designee by OHCQ.
D.
Permitted Tissue Bank. A permit holder operating a tissue bank under a provisional permit or a permit shall be subject to:
(1)
An initial inspection conducted by the OHCQ;
(2)
Periodic inspections by the OHCQ; and
(3)
Other inspections by the OHCQ to determine if the tissue bank is in compliance with licensure requirements.
E.
Accredited Tissue Bank. An accredited tissue bank is subject to:
(1)
An initial inspection by an accreditation organization or the OHCQ;
(2)
Periodic inspections by an accreditation organization or the OHCQ; and
(3)
Other inspections by the OHCQ to determine if the tissue bank is in compliance with licensure requirements.
F.
Notice of Deficiencies. If a survey identifies noncompliance with a requirement, the Department shall:
(1)
Issue a written Statement of Deficiencies that cites each deficiency;
(2)
Require the tissue bank to submit an acceptable plan of correction within 10 calendar days of receipt of the Statement of Deficiencies;
(3)
Notify the tissue bank of any sanctions imposed or that failure to correct the violation may result in sanctions; and
(4)
Offer the tissue bank the opportunity for informal dispute resolution (IDR).
G.
Plan of Correction.
(1)
The tissue bank shall submit a written plan of correction to the OHCQ in response to a Statement of Deficiencies documenting the steps the permit holder will take to come into compliance, including:
(a)
How the tissue bank will correct each deficiency;
(b)
The date by which each deficient practice will be corrected;
(c)
How the tissue bank will prevent the deficient practice from recurring; and
(d)
Who will be responsible for ensuring the deficiency will not reoccur.
(2)
Failure of the tissue bank to return an acceptable plan of correction within 10 calendar days after receipt of a Statement of Deficiencies may result in a sanction.
(3)
A tissue bank’s request for an IDR does not change the tissue bank's requirement to submit a plan of correction for all deficiencies within 10 calendar days after receipt of the Statement of Deficiencies.
(4)
If an immediate jeopardy is identified during a survey, the tissue bank’s plan of correction shall completely correct all noncompliance associated with the immediate jeopardy.
H.
Immediate Jeopardy.
(1)
Declaration of Immediate Jeopardy.
(a)
When the Department identifies 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, an immediate jeopardy will be declared.
(b)
The Department shall provide the tissue bank a written notice that includes a description of the situation that constitutes an immediate jeopardy.
(2)
Removal Plan. The tissue bank shall submit a written removal plan to the Department that includes:
(a)
The immediate corrective action a tissue bank will take to prevent serious harm from occurring or recurring;
(b)
All actions to remove past, present, and future jeopardy; and
(c)
The date by which the entity asserts the likelihood for serious harm to any recipient or the general public will no longer exist.
(3)
The Department’s Review of the Removal Plan.
(a)
The OHCQ staff shall review the tissue bank's removal plan to determine if the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.
(b)
The OHCQ shall verify that the tissue bank has implemented the removal plan.
(4)
The Department’s Approval of the Removal Plan. The Department shall approve the removal plan after verifying that all actions the tissue bank took were effective in removing the likelihood that serious harm or death would occur or recur.
I.
Informal Dispute Resolution (IDR).
(1)
A tissue bank may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.
(2)
The tissue bank shall submit the request for an IDR to the OHCQ within 10 calendar days of receiving the Statement of Deficiencies.
(3)
The written request for an IDR shall:
(a)
Fully describe the disagreement with the Statement of Deficiencies; and
(b)
Include all accompanying evidence for the OHCQ’s consideration.
(4)
At the discretion of the OHCQ, the IDR may be held in person, by telephone, by video conference, or in writing.
(5)
IDRs are informal in nature and may not be attended by legal counsel representing the tissue bank or the Department.
(6)
The IDR process may not delay the effective date of any enforcement action.
(7)
In the event a tissue bank requests an IDR for a Statement of Deficiencies written by a designee of the Department, the Department shall request the designee to participate in the IDR process.
(8)
There is no appeal of the Department’s decision in an IDR.
J.
Process of Filing a Complaint. The tissue bank shall have a written process that describes how donors and recipients of tissue bank services are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization.
Regulation .09 Tissue Bank Standards — General.LinkCopy Citation
A.
Applicable Laws. A tissue bank shall comply with all requirements and standards in this chapter as well as with other applicable federal, State, and local laws, regulations, and rules.
B.
Governing Body. Unless provided by the institution of which it is a part, a tissue bank shall have a governing body consisting of individuals from various professions, that determines the scope of activities to be pursued by the tissue bank and is responsible for issues of:
(1)
Liability;
(2)
Ethical considerations;
(3)
Fiduciary responsibility; and
(4)
Compliance with the standards and requirements of this chapter and those of the tissue bank's standard operating procedure manual.
C.
Facilities.
(1)
General. The physical facilities of a tissue bank shall meet all applicable federal, State, and local laws, including but not limited to:
(a)
Engineering;
(b)
Fire;
(c)
Safety;
(d)
Health; and
(e)
Sanitation.
(2)
Physical Plant. The physical plant of a tissue bank shall be designed or arranged to meet operational needs with plumbing, drainage, lighting, ventilation, space, and handwashing facilities for personnel and donors if applicable.
(3)
Designated Space. Personnel of a tissue bank shall perform the following critical tissue bank procedures in designated areas:
(a)
Processing;
(b)
Quarantine storage of in-process materials;
(c)
Other quarantining;
(d)
Labeling;
(e)
Storage of distributable inventory;
(f)
Quality assurance and control functions;
(g)
Receipt and storage of containers, supplies, and reagents;
(h)
Storage of medical waste;
(i)
Irradiation and other sterilization procedures; and
(j)
Final product inspection and distribution activities.
Regulation .10 Tissue Bank Standards — Personnel.LinkCopy Citation
A.
General Requirements. A tissue bank shall employ a technical director, medical director, and sufficient staff to:
(1)
Provide accurate and reliable services;
(2)
Meet all operational needs; and
(3)
Meet all statutory and regulatory requirements and standards.
B.
Medical Director.
(1)
Qualifications. The medical director:
(a)
Shall be a physician licensed to practice medicine by the:
(i)
Maryland Board of Physicians; or
(ii)
Appropriate agency in the state where the tissue bank is located; and
(b)
Shall be qualified by training and experience in evaluating and determining donor suitability, particularly with regard to infectious diseases.
(2)
Serving as Technical Director. The medical director may serve also as the technical director if the medical director remains at the tissue bank site during the tissue bank's regular hours of operation.
(3)
Responsibilities. The medical director shall be responsible for all medical aspects of the tissue bank's operations and shall retain overall responsibility when a task is delegated to a designated qualified employee. The medical director or the designated qualified employee shall:
(a)
Establish donor suitability criteria;
(b)
Evaluate and determine each donor's acceptability;
(c)
Review and approve the standard operating procedures, quality assurance policies, and quality control records for medical efficacy;
(d)
Approve exceptional or extraordinary releases of tissue as specified in the tissue bank's standard operating procedure manual;
(e)
Establish policies and procedures regarding adverse outcomes that include requiring that all potential adverse outcomes are:
(i)
Investigated;
(ii)
Documented;
(iii)
Reviewed; and
(iv)
Reported as required by applicable federal, State, or local law;
(f)
Notify the living donor or, for a cadaveric donor, the cadaveric donor's physician for any legally allowed counseling of next of kin, of confirmed positive infectious disease test results;
(g)
Notify the OHCQ in writing or electronically of each fatal adverse outcome related to:
(i)
Transplantation;
(ii)
Transfusion;
(iii)
Transfer; or
(iv)
Implementation of tissue; and
(h)
Establish look back and recall procedures when tissue is determined to:
(i)
Be defective; or
(ii)
May potentially cause an adverse outcome.
C.
Technical Director.
(1)
Qualifications. The technical director shall be qualified by training and experience for the scope of activities being pursued and have:
(a)
A bachelor's or higher degree in medical technology or a biological science from an accredited college or university and be qualified by training and experience for the scope of activities conducted by the tissue bank;
(b)
A bachelor’s degree in a discipline other than medical technology or a biological science from an accredited college or university and have 5 years of experience overseeing all technical aspects of tissue bank operations under the supervision of a medical director; or
(c)
Licensure as a registered nurse in the state that the tissue bank is operating.
(2)
Responsibilities. The technical director shall oversee and be responsible for all technical aspects of the tissue bank's operations and shall retain overall responsibility when a task is delegated to a designated qualified employee. The technical director or designated qualified employee shall:
(a)
Provide on-site supervision of tissue bank operations and personnel during the tissue bank's regular hours of operation; and
(b)
Participate in and actively supervise the tissue bank's:
(i)
Planning;
(ii)
Organization;
(iii)
Staffing;
(iv)
Training and continuing education;
(v)
Staff competency;
(vi)
Quality control and quality assurance;
(vii)
Standard operating procedures (SOPs);
(viii)
Facilities;
(ix)
Donor selection;
(x)
Equipment;
(xi)
Products;
(xii)
Records;
(xiii)
Services; and
(xiv)
Compliance with the requirements and standards of this chapter.
D.
Technical Staff.
(1)
Qualifications.
(a)
Technical staff shall possess the education, experience, and training necessary and sufficient to assure that assigned tasks are performed in accordance with the tissue bank's established procedures and the standards set forth in this chapter.
(b)
The technical director or the designated qualified employee, and medical director or the designated qualified employee shall train individual staff to accurately and reliably:
(i)
Perform tissue bank services such as collection, retrieval, processing, packaging, and cryopreservation; and
(ii)
Document that training in the individual's employee training file.
(2)
Responsibilities.
(a)
Technical staff shall implement, maintain, and follow the policies and procedures established by the medical director and technical directors.
(b)
A technical director or the designated qualified employee shall list and describe the duties and responsibilities of technical staff in written job descriptions.
(c)
Technical staff shall initially, and at least annually thereafter, demonstrate documented competency in the tasks to which the staff person is assigned.
(d)
Technical staff shall participate in documented training and continuing education to maintain technical competency in the duties described in their written job descriptions.
Regulation .11 Tissue Bank Standards — Testing to Minimize Disease Transmission.LinkCopy Citation
A.
Required Testing.
(1)
General — All Donors. A permit holder shall ensure that a prospective donor of tissue, including both leukocyte-rich and leukocyte-poor cell and tissue, intended to be used as an allograft is tested for biochemical, immunological, or serological evidence of:
(a)
Hepatitis B virus (HBV);
(b)
Hepatitis C virus (HCV);
(c)
Human immunodeficiency virus type 1 (HIV-1);
(d)
Human immunodeficiency virus type 2 (HIV-2); and
(e)
Treponema pallidum (syphilis).
(2)
Specific — Donors of Specific Tissue or Cell Types.
(a)
In addition to those tests set forth in §A(1) of this regulation, a permit holder shall ensure that a prospective donor of specific types of tissue are tested in accordance with the requirements set forth in §A(2)(b)—(c) of this regulation.
(b)
Donors of Leukocyte-Rich Tissue. A permit holder shall ensure that a prospective donor of a leukocyte-rich tissue, as defined in Regulation .03B of this chapter, intended to be used as an allograft, is tested for biochemical, immunological, or serological evidence of:
(i)
Human T-lymphotropic virus type I (HTLV-I);
(ii)
Human T-lymphotropic virus type II (HTLV-II); and
(iii)
Cytomegalovirus (CMV).
(c)
Donors of Reproductive Tissue including Oocytes and Semen. In addition to those applicable tests set forth in §A(1) and (2)(a) of this regulation, a permit holder shall ensure that a prospective donor of reproductive tissue, as defined in Regulation .03B of this chapter, intended to be used as an allograft, is tested for biochemical, immunological, or serological evidence of:
(i)
Chlamydia trachomatis; and
(ii)
Neisseria gonorrhoeae.
B.
Required Laboratory Licensure.
(1)
In-House Testing Services. A tissue bank that conducts its own testing on human specimens shall possess a Maryland license to operate a medical laboratory and comply with all applicable standards as set forth in COMAR 10.10.01—10.10.08.
(2)
Contractual Testing Services. A tissue bank that contracts for laboratory testing services shall obtain and maintain:
(a)
The name and address of a contracted facility and documentation of the inclusive dates of the contract period; and
(b)
Proof of the contracted facility's current:
(i)
Federal certification;
(ii)
Required State laboratory licensure; and
(iii)
Accreditation.
(3)
Other Testing Services. A tissue bank that obtains test results from a noncontracted laboratory, for example, another tissue bank or an organ retrieval organization, shall obtain and maintain the name, address, and licensing and accreditation information for each laboratory from which test results are obtained for the purpose of donor assessment.
C.
Confidentiality and Release of Test Results. A technical director of a tissue bank may release results of laboratory tests performed by the tissue bank holding a medical laboratory license or performed for the tissue bank by another licensed laboratory only:
(1)
To:
(a)
The medical director of the tissue bank;
(b)
An authorized person who requested the test; or
(c)
Another laboratory that requested the test as set forth under COMAR 10.10.06.04; and
(2)
As allowed under the:
(a)
Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and
(b)
Federal:
(i)
Health Insurance Portability and Accountability Act (HIPAA), 42 U.S.C. §§1320d et seq.;
(ii)
Health Information Technology for Economic and Clinical Health (HITECH) Act, 42 U.S.C. §§17921 et seq.; and
(iii)
Implementing rules and regulations for HIPAA and the HITECH Act set forth at 45 CFR Parts 160, 162, and 164.
Regulation .12 Tissue Bank Standards — Technical.LinkCopy Citation
In addition to the requirements and standards in this chapter, a tissue bank shall meet and comply, where applicable, with the following technical requirements and standards:
A.
Records management, in the manner prescribed in Section C of Standards for Tissue Banking;
B.
Tissue acquisition, in the manner prescribed in Section D of Standards for Tissue Banking;
C.
Processing, preservation, quarantine, and storage, in the manner prescribed in Section E of Standards for Tissue Banking;
D.
Release and transfer of tissue, in the manner prescribed in Section F of Standards for Tissue Banking;
E.
Labeling, in the manner prescribed in Section G of Standards for Tissue Banking;
F.
Distribution and dispensing, in the manner prescribed in Section H of Standards for Tissue Banking;
G.
General operations, in the manner prescribed in Section J of Standards for Tissue Banking;
H.
Quality assurance, in the manner prescribed in Section K of Standards for Tissue Banking;
I.
Tissue dispensing services, in the manner prescribed in Section L of Standards for Tissue Banking;
J.
Tissue distribution intermediaries, in the manner prescribed in subsections M1-8 of Standards for Tissue Banking; and
K.
Standards for Blood Banks and Transfusion Services.
Chapter annotations
Authority: Health-General Article, Annotated Code of Maryland
History: Effective date: July 1, 1970
History: Regulations .01—.12 repealed and new Regulations .01—.06 adopted effective May 5, 1986 (13:9 Md. R. 1030)
History: Regulation .03 amended effective March 20, 1989 (16:5 Md. R. 629)
History: Regulation .06B amended effective June 11, 1990 (17:11 Md. R. 1343)
History: 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)
History: 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)
History: Regulation .08 adopted effective June 11, 1990 (17:11 Md. R. 1343)
History: COMAR 10.10.02 recodified to COMAR 10.50.01 effective December 13, 1999 (26:25 Md. R. 1897)
History: Regulations .01—.08 repealed and new Regulations .01—.12 adopted effective March 15, 2004 (31:5 Md. R. 449)
History: Regulation .03B amended effective April 4, 2011 (38:7 Md. R. 432); September 15, 2025 (52:18 Md. R. 923)
History: 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)
History: Regulation .05 repealed effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .06 amended effective November 25, 2013 (40:23 Md. R. 1934)
History: Regulation .06 repealed and new Regulation .06 adopted effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .07B amended effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .07D adopted effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .08 recodified to be Regulation .09 effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .08 adopted effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .09 repealed effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .09 recodified from Regulation .08 effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .10 amended effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .10C amended effective January 9, 2012 (38:27 Md. R. 1764)
History: Regulation .11A amended effective September 15, 2025 (52:18 Md. R. 923)
History: Regulation .11A, C amended effective April 4, 2011 (38:7 Md. R. 432)