808

LAWS OF MARYLAND

Ch. 21

is added to clarify the functions of these tissue
banks. Similarly, the phrase "for use in the
human body" is added to avoid inadvertently
including entities that obtain and process human
tissue for some other reason, such as medical
laboratory tests.

Also in item (1) of this subsection, the phrase
"human blood or other human tissue" is
substituted for the reference to "human tissue",
to incorporate the former definition of "tissue",
which included blood. As the term "tissue" is
used only in this definition of "tissue bank",
the former, separate definition is unnecessary.

Defined term: "Includes"/"including" § 1-101

17-302. STANDARDS AND INSPECTIONS OF TISSUE BANKS.

(A)  STANDARDS.

(1)  THE SECRETARY SHALL ADOPT RULES AND
REGULATIONS THAT SET STANDARDS FOR TISSUE BANKS.

(2)  THE RULES AND REGULATIONS SHALL CONTAIN THE
STANDARDS THAT THE SECRETARY CONSIDERS NECESSARY TO ASSURE
THE CITIZENS OF THIS STATE THAT TISSUE BANKS PROVIDE SAFE
AND RELIABLE SERVICES.

(B)  INSPECTIONS.

TO ASSURE COMPLIANCE WITH THE STANDARDS ADOPTED UNDER
THIS SUBTITLE, THE SECRETARY SHALL:

(1)  HAVE AN INSPECTION MADE OF EACH TISSUE BANK
FOR WHICH A PERMIT TO OPERATE IS SOUGHT; AND

(2)  HAVE AN INSPECTION MADE PERIODICALLY OR MAKE
AN AGREEMENT WITH AN ORGANIZATION TO DO, AT NO COST TO THIS
STATE, A PERIODIC INSPECTION OF EACH TISSUE BANK FOR WHICH A
PERMIT HAS BEEN ISSUED.

REVISOR'S NOTE: This section is new language derived
without substantive change from the first
sentence, as that sentence related to standards,
the first clause of the third sentence, and the
entire fourth and fifth sentences of former
Article 43, § 34(a).

In subsection (a)(1) of this section, the former
reference to tissue banks "in the counties of the
State and in Baltimore City" is deleted as
inaccurate in light of § 17-306 of this subtitle,
which makes these standards applicable to
out-of-state tissue banks represented or serviced