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SECTION 576-A
Clinical laboratories and cytotechnologists examining Pap smears
Public Health (PBH) CHAPTER 45, ARTICLE 5, TITLE 5
§ 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) Unless otherwise provided by the department, the cytotechnologist
work standard shall be: No cytotechnologist may examine more than eighty
one-slide gynecologic cases or fifty two-slide gynecologic cases per
work day. If a cytotechnologist also examines non-gynecologic slides in
a given work day the cytotechnologist's workload for gynecologic slides
shall be correspondingly reduced, in accordance with written guidelines
prepared by the clinical laboratory and filed with the department, so
that a cytotechnologist examines no more than a total of one hundred
gynecologic and non-gynecologic slides per work day.

(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. Registration of cytotechnologist. All cytotechnologists who are
employed by a clinical laboratory must register with the department. The
department shall, by regulation, prescribe a form and procedure for the
registration of cytotechnologists. The registration form shall include
at least the name, address, and an individual identification number
determined by the department. The department shall notify each
registrant of his or her identification number.

4. Employment of registered cytotechnologists. No clinical laboratory
shall employ a cytotechnologist unless the cytotechnologist is
registered under this section.

5. 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 and identification number 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, and how many were one-slide and
two-slide cases, during each work day; and

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

(b) Each cytotechnologist shall maintain records, in a form prescribed
by the department, which set forth:

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

(ii) the number of gynecologic slides and non-gynecologic slides
examined and how many were one-slide and two-slide cases, during each
work day;

(iii) the name and address of the clinical laboratory or other person
for which or whom the slides were examined; and

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

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

6. 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.

7. 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.

8. 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.

9. Regulations. The department may, by regulation, establish
cytotechnologist work standards. Those standards may include, but shall
not be limited to, standards which take into account the experience and
qualifications of the cytotechnologists and the performance of the
clinical laboratory in proficiency testing programs conducted by the
department. However, those standards shall not exceed by more than
twenty percent the maximum numbers of slides which may be examined in a
work day under clause (ii) of paragraph (b) of subdivision one of this
section. Such standards shall be at least as stringent as federal
standards promulgated under the federal clinical laboratory improvement
amendments of nineteen hundred eighty-eight.

10. Notwithstanding any provisions of subdivisions one and nine 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.

11. 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 a cytotechnologist violates this section, the department may
suspend or revoke the cytotechnologist's registration under this
section, pursuant to department regulations including appropriate due
process protections for the cytotechnologist.

(c) 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.