10.50.01.11

.11 Tissue Bank Standards — Testing to Minimize Disease Transmission.

A. Required Testing.

(1) General — All Donors. A permittee 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 permittee 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 permittee 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 permittee 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.