PARRIS N. GLENDENING, Governor                             Ch. 465

(v) Require that THE cytology [reviewing] REVIEW be performed by
AN INDIVIDUAL WHO QUALIFIES AS a supervisory [level] cytotechnologist or a
[cytopathologist] PATHOLOGIST;

(vi) Require the [pathologist] INDIVIDUAL who directs the
[cytopathology] laboratory to establish and administer an ongoing quality assurance
program using standards [accepted by professional cytology organizations]
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 [for disease or disease agents];

(ix) Require all cytology reports to be retained for at least 10 years;

(x) Prohibit [physicians] ANY PERSON from sending [pap smear]
CYTOLOGY specimens to A LABORATORY, INCLUDING out-of-state laboratories not
licensed by the Department; [and]

(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

[(xi)] (XII) Establish any additional standards the Secretary considers
necessary to assure that medical laboratories engaged in cytology provide safe and
reliable services [to the citizens of the State].

(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.

[(d)](E) (1) To assure compliance with standards adopted under subsection
[(c)] (D) of this section, the Secretary shall adopt regulations to establish and conduct a
cytology proficiency testing program for all cytology personnel [in the State] that
examine GYNECOLOGICAL cytology specimens.

(2) All cytology proficiency tests [conducted] under the State cytology
proficiency testing program shall be [handcarried, on site and under the supervision of an
official] CONDUCTED BY AN EMPLOYEE [of the Laboratories Administration] 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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