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2006 LAWS OF MARYLAND
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Ch. 232
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(ii) Require that the examination of cytology slides be performed in
a medical laboratory that has a license issued by the Secretary;
(iii) Prohibit payment to cytotechnologists for the examination of
cytology specimens or slides on a piecework basis;
(iv) Require cytology laboratories to review no less than 10 percent
of all negative gynecological slides;
(v) Require that the cytology review be performed by an individual
who qualifies as a supervisory cytotechnologist or a pathologist;
(vi) Require the individual who directs the laboratory to establish
and administer an ongoing quality assurance program using standards acceptable to
the Secretary;
(vii) Require cytology laboratories to reject unsatisfactorily prepared
specimens, make appropriate comments regarding the quality of the specimen, and
maintain records on unsatisfactorily prepared specimens for 5 years subject to review
by the Department;
(viii) Require cytology laboratories to maintain and store for 5 years
from the date of examination any slide that was examined;
(ix) Require all cytology reports to be retained for at least 10 years;
(x) Prohibit any person from sending cytology specimens to a
laboratory, including out-of-state laboratories, not licensed by the Department;
(xi) Require all individuals who examine gynecological slides
acquired from persons in this State to demonstrate satisfactory performance in an
approved cytology proficiency testing program; and
(xii) Establish any additional standards the Secretary considers
necessary to assure that medical laboratories engaged in cytology provide safe and
reliable services.
(2) The requirements of paragraph (1) of this subsection are in addition
to any other relevant provision of this subtitle or relevant regulation adopted in
accordance with any other provision of this subtitle governing medical laboratories.
[(e)] (D) (1) To assure compliance with standards adopted under subsection
[(d)] (C) of this section, the Secretary shall adopt regulations to establish and conduct
a cytology proficiency testing program for all cytology personnel that examine
gynecological cytology specimens.
(2) All cytology proficiency tests under the State cytology proficiency
testing program shall be conducted by an employee of the Department of Health and
Mental Hygiene who shall:
(i) Hand carry all testing materials to the testing site; and
(ii) Directly supervise the on—site proficiency testing.
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