Ch. 465

1995 LAWS OF MARYLAND

(2) The [rules and] regulations shall contain the standards AND
REQUIREMENTS that the Secretary considers necessary to assure the citizens of this
State that medical laboratories provide safe and reliable services.

(b) To assure compliance with the standards AND REQUIREMENTS adopted
[under] IN REGULATIONS PURSUANT TO this subtitle, the Secretary shall:

(1)     [Have] CONDUCT an inspection [made] of each medical laboratory for
which a [permit] LICENSE to operate is sought; and

(2)     [Have] CONDUCT 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] A LICENSE has been issued.

(C) (1) A MEDICAL LABORATORY ACCREDITED BY AN ORGANIZATION
APPROVED BY THE SECRETARY SHALL BE DEEMED TO MEET THE STATE'S
INSPECTION REQUIREMENTS UNDER SUBSECTION (D)(2) OF THIS SECTION STATE
STANDARDS

(I) STATE'S INSPECTION REQUIREMENTS UNDER SUBSECTION (B)(2)
OF THIS SECTION; OR

(II) STATE'S STANDARDS UNDER THIS SUBTITLE IF THE SECRETARY
DETERMINES THE STANDARDS OF THE ACCREDITING ORGANIZATION EQUIVALENT TO
THE STATE'S REQUIREMENTS.

(2)     THE MEDICAL LABORATORY SHALL SUBMIT THE REPORT OF THE
ACCREDITING ORGANIZATION TO THE SECRETARY WITHIN 30 DAYS OF ITS RECEIPT.

(3)     THE SECRETARY MAY INSPECT A MEDICAL LABORATORY
ACCREDITED BY AN ORGANIZATION FOR THE PURPOSE OF A COMPLAINT
INVESTIGATION OR TO VALIDATE FINDINGS OF ANY INSPECTION CONDUCTED BY
THE ACCREDITING ORGANIZATION.

[(c)](D) (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 cytology, including regulations that:

(i) Limit the number of slides [a cytotechnologist] AN INDIVIDUAL
may examine [per year];

(I) LIMIT THE NUMBER OF SLIDES AN INDIVIDUAL MAY EXAMINE;

(ii) Require [cytotechnologists to examine] THAT THE
EXAMINATION OF cytology slides BE PERFORMED in a medical laboratory that has a
[permit] LICENSE issued by the [Department] 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 [pap smears] GYNECOLOGICAL SLIDES;

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