2023 New York Laws › PBH - Public Health › Article 5 - Laboratories › Title 5 - Clinical Laboratory and Blood Banking Services › 576-A - Clinical Laboratories and Cytotechnologists Examining Pap Smears.

§  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.