936

LAWS OF MARYLAND

Ch. 165

Secretary considers necessary to assure to the citizens of
the State these safe and reliable laboratory or health
services and shall adopt and promulgate rules and
regulations for this purpose. Any person, partnership,
association, or corporation desiring to open or maintain
such a laboratory or tissue bank, except a physician or
group of not more than three individual physicians
performing laboratory examinations on his or their own
patients, shall file with the Secretary an application
setting forth the name of the owner, the types of laboratory
or health services to be performed, and such other
information as the Secretary may require. The Secretary
shall cause an inspection to be made and, if in compliance
with the minimum standards and qualifications, and upon
payment of the fees herein authorized, he shall issue a
permit to operate. The Secretary shall conduct periodic
inspections to assure continuing compliance. THE SECRETARY
MAY ENTER INTO AGREEMENTS WITH AN ORGANIZATION APPROVED BY
THE SECRETARY TO CONDUCT THE PERIODIC INSPECTIONS AT NO COST
TO THE STATE. No person, partnership, association or
corporation may operate such a laboratory or tissue bank
without this permit. The Secretary may refuse to issue,
suspend or revoke a permit to operate, if, after inspection
and due notice, a laboratory or tissue bank fails to comply
with the minimum standards or qualifications or with the
provisions of any rules or regulations regularly adopted by
the Secretary. No person, partnership, association or
corporation may represent or service or maintain in this
State any office, representative or other facilities for the
representation or servicing of any laboratory or tissue bank
situated in this State or any other state which makes
examinations in connection with the diagnosis and control of
human disease or which procures, processes, distributes or
sells human tissue, unless the laboratory or tissue bank so
represented or serviced meets or exceeds the minimum
standards and qualifications adopted by the Secretary under
and pursuant to this section, and before representing or
servicing any laboratory or tissue bank not situated within
this State, each person, partnership, association or
corporation shall make appropriate annual application to the
Secretary on such terms and conditions as are adopted by the
Secretary, the application to show by satisfactory evidence
that any such laboratory or tissue bank not located within
this State meets or exceeds the minimum standards and
qualifications adopted by the Secretary pursuant to this
section for similar laboratories or tissue banks located and
operated within the State of Maryland. The term "tissue
bank" as used in this section includes blood bank and the
term "tissue" includes blood. Physicians exempt from
licensing and inspection under this section are nevertheless
required to demonstrate satisfactory performance in a
proficiency testing program in applicable laboratory
procedures. The State Department of Health and Mental
Hygiene shall establish standards and criteria for
demonstrating satisfactory performance in a proficiency
testing program [and for conducting the programs]. THE
PROFICIENCY TESTING PROGRAM SHALL BE CONDUCTED BY THE