Ch. 731

LAWS OF MARYLAND

(1)  Have an inspection made of each medical
laboratory 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 medical laboratory for which that
permit has been issued.

(C) (1) IN ADDITION TO THE RULES AND REGULATIONS ADOPTED
UNDER SUBSECTION (A) OF THIS SECTION, THE SECRETARY SHALL ADOPT
REGULATIONS ESTABLISHING SPECIFIC STANDARDS FOR MEDICAL
LABORATORIES ENGAGED IN CYTOPATHOLOGY CYTOLOGY, INCLUDING
REGULATIONS THAT:

(I) LIMIT THE NUMBER OF SLIDES A

CYTOTECHNOLOGIST MAY EXAMINE PER DAY TO THE PER DAY LIMIT
RECOMMENDED BY THE AMERICAN SOCIETY OF CYTOTECHNOLOGY.

(II) REQUIRE A CYTOTECHNOLOGIST TO STOP

EXAMINING SLIDES EVERY HOUR FOR A PERIOD OF 5 MINUTES;

(II) MAINTAIN AND STORE ANY GYNECOLOGICAL

SLIDE EXAMINED FOR 3 YEARS FROM THE DATE OF EXAMINATION;

(IV) REQUIRE 1 GYNECOLOGICAL SLIDE IN EVERY
GROUP OF 20 GYNECOLOGICAL SLIDES DETERMINED TO BE RETESTED;

(V) PROHIBIT THE OFF-SITE EXAMINATION OF

GYNECOLOGICAL SLIDES; AND

(I) LIMIT THE NUMBER OF SLIDES A
CYTOTECHNOLOGIST MAY EXAMINE PER YEAR;

(II) REQUIRE CYTOTECHNOLOGISTS TO EXAMINE
CYTOLOGY SLIDES IN A MEDICAL LABORATORY THAT HAS A PERMIT ISSUED
BY THE DEPARTMENT;

(III) PROHIBIT PAYMENT TO CYTOTECHNOLOGISTS ON
A PIECEWORK BASIS;

(IV) REQUIRE CYTOLOGY LABORATORIES TO REVIEW NO
LESS THAN 10 PERCENT OF ALL NEGATIVE PAP SMEARS;

(V) REQUIRE THAT CYTOLOGY REVIEWING BE
PERFORMED BY A SUPERVISORY LEVEL CYTOTECHNOLOGIST OR A
CYTOPATHOLOGIST;

(VI) REQUIRE THE PATHOLOGIST WHO DIRECTS THE
CYTOPATHOLOGY LABORATORY TO ESTABLISH AND ADMINISTER AN ONGOING
QUALITY ASSURANCE PROGRAM USING STANDARDS ACCEPTED BY
PROFESSIONAL CYTOLOGY ORGANIZATIONS;

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