§ 576-a. Clinical laboratories and cytotechnologists examining Pap
smears. 1. Definitions. As used in this section, unless the context
clearly requires otherwise, the following terms shall have the following
meanings:

(a) "Cytotechnologist". A clinical laboratory professional
specializing in the analysis of cytopathology samples, including Pap
smears, for cervical cancer and related diseases who meets the
qualifications specified by the department.

(b) "Cytotechnologist work standard". (i) A limitation on the number
of Pap smears (also known as gynecologic slides) and non-gynecologic
slides a cytotechnologist may examine during a particular time period,
or other limitation on the quantity, speed or manner of examination of
slides by a cytotechnologist, under regulations of the department.

(ii) The department may establish regulations for cytotechnologist
workload standards that shall be at least as stringent as federal
regulations.

(c) "Employ". To employ or contract with a cytotechnologist to examine
gynecologic slides.

(d) "Clinical laboratory". A clinical laboratory issued a permit
pursuant to this title.

(e) "Work day". A twenty-four hour period during which a
cytotechnologist examines gynecologic slides for a clinical laboratory.

2. Compliance with cytotechnologist work standard. No cytotechnologist
shall exceed the applicable cytotechnologist work standard. No clinical
laboratory shall require, authorize, encourage or permit any
cytotechnologist to exceed the applicable cytotechnologist work
standard. In determining whether a cytotechnologist exceeds the
applicable cytotechnologist work standard, all work done by the
cytotechnologist during a given work day shall be considered, without
regard to which clinical laboratory or other person for which or whom it
was performed.

3. Record-keeping. (a) Each clinical laboratory shall maintain
records, in a form prescribed by the department, which set forth, for
each cytotechnologist employed by the clinical laboratory:

(i) the name of the cytotechnologist;

(ii) the number of hours worked by the cytotechnologist in each work
day;

(iii) the number of gynecologic slides and non-gynecologic slides
examined by the cytotechnologist during each work day; and

(iv) such other information as the department may require by
regulation.

(b) Such records of clinical laboratories and cytotechnologists shall
be made available for inspection and copying by the department upon
request.

4. Multiple employers. Whenever a cytotechnologist is employed by more
than one clinical laboratory or other person during a work day, the
cytotechnologist shall advise each clinical laboratory of any previous
employment during the work day and the amount of work performed, to
insure that the applicable cytotechnologist work standard is not
exceeded.

5. Standards for gynecologic slides. (a) A gynecologic slide of a Pap
smear shall not be tested or reported on if:

(i) the apparent condition of the specimen indicates that it is
unsatisfactory for testing or that it is inappropriate for the test
requested;

(ii) it has been collected, labeled, preserved or otherwise handled in
such a manner that it has become unsatisfactory or unreliable as a test
specimen;

(iii) the slide is broken;

(iv) it contains insufficient cells or the cells are obscured by
inflammation, blood or lubricating ointment, so that an adequate
diagnosis cannot be made; or

(v) the slide is otherwise unsatisfactory, as defined by department
regulations.

(b) If the slide is unsatisfactory as set forth in this subdivision,
the clinical laboratory shall have an affirmative duty to advise the
collecting physician or other practitioner that the slide is
unsatisfactory and request the submission of a new slide.

6. Re-examination of slides. The department shall prescribe, by
regulation, a system of targeted re-examination of gynecologic slides
examined and found to be not abnormal or questionable. The factors to be
considered in the targeted re-examination may include, but are not
limited to, the prior cancer and other history of the patient, the
results of previous slide examinations, and the experience and ability
of the cytotechnologist. Each clinical laboratory shall follow the
prescribed re-examination system.

7. Notwithstanding any provisions of subdivision one of this section
to the contrary, the department may, pursuant to regulation, increase
the maximum number of slides which may be examined in a work day for
clinical laboratories using slide examination or preparation technology
approved by the federal food and drug administration, provided that such
standards shall be at least as stringent as federal standards
promulgated under the federal clinical laboratory improvement amendments
of nineteen hundred eighty-eight or other applicable federal law.

8. Violations. (a) Sections twelve, twelve-a, and twelve-b of this
chapter shall apply to violations of this section, except that the civil
penalty for a violation of this section by a cytotechnologist shall not
exceed five hundred dollars.

(b) If any clinical laboratory or other person violating this section
is licensed, certified or registered by the department under other
provisions of law, the violation of this section may be grounds for
disciplining the person under such law.