S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  8966--A
 
                             I N  S E N A T E
 
                               April 3, 2024
                                ___________
 
 Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
   printed to be committed  to  the  Committee  on  Health  --  committee
   discharged, bill amended, ordered reprinted as amended and recommitted
   to said committee
 
 AN  ACT  to  amend the public health law, in relation to certificates of
   qualification for clinical laboratories and blood banks

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Section 572 of the public health law, as amended by chapter
 436 of the laws of 1993,  is amended to read as follows:
   § 572. Certificates of qualification.  No person shall act as a direc-
 tor  in a clinical laboratory located in or accepting specimens from New
 York state or in a blood bank  located  in  or  collecting,  processing,
 storing  or distributing blood products in New York state unless a valid
 certificate of qualification has been issued as provided in section five
 hundred seventy-three of this title.   [A certificate  shall  be  issued
 authorizing  the  holder  to perform or direct one or more procedures or
 one or more categories of such procedures.]
   § 2. Section 573 of the public health law, as amended by  chapter  436
 of the laws of 1993,  is amended to read as follows:
   §  573.  Issuance  of  certificates  of  qualification. 1. [The public
 health council shall prescribe minimum qualifications for  directors  in
 areas of testing, including, but not limited to, microbiology, immunolo-
 gy, chemistry, hematology, biophysics, cytology, pathology, genetics and
 blood banking.
   2.]  The  department shall issue a certificate of qualification to any
 person who meets [such] PRESCRIBED minimum qualifications UNDER  FEDERAL
 REGULATIONS, INCLUDING BOARD CERTIFICATION AS REQUIRED and who otherwise
 demonstrates to the department that such person possesses the character,
 competence,  training  and  ability to administer properly the technical
 and scientific operation of a clinical laboratory or blood bank, includ-
 ing supervision of procedures and reporting of findings of tests.
   [3.] 2. Application for a certificate of qualification shall  be  made
 on forms provided by the department [and shall contain the procedures or

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD14434-05-4
 S. 8966--A                          2

 categories  of  procedures for which the certificate is sought] and such
 other information as the department may require.
   [4.]  3. The certificate shall be valid for a period of two years from
 the date of issuance and may be renewed for successive [two  year]  TWO-
 YEAR  periods  thereafter.  The  original  application  and each renewal
 application shall be accompanied by a registration fee  of  [forty]  ONE
 HUNDRED FIFTY dollars.
   [5.]  4.  Notwithstanding  the provisions of this section, the commis-
 sioner may issue a temporary certificate of qualification to any  person
 pending  the  issuance  of  a certificate as provided in this section. A
 temporary certificate shall be valid for a period of  thirty  days  from
 the  date  of  its  issuance  and  may  be renewed for a maximum of four
 successive periods of thirty days.
   § 3. Subdivision 2 of section 575 of the public health law, as amended
 by section 19 of part A of chapter 59 of the laws of 2011, is amended to
 read as follows:
   2. A permit [or permit category] shall not be issued  unless  a  valid
 certificate  of  qualification  [in the category of procedures for which
 the permit is sought] has been issued [to the director] pursuant to  the
 provisions  of  section five hundred seventy-three of this title, unless
 all fees and outstanding penalties, if any,  have  been  paid,  and  the
 department  finds  that  the clinical laboratory or blood bank is compe-
 tently staffed and properly equipped, and will be operated in the manner
 required by this title.
   § 4. Section 576-a of the public health law, as amended by chapter 436
 of the laws of 1993, is amended to read as follows:
   § 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  specializ-
 ing  in the analysis of cytopathology samples, including Pap smears, for
 cervical cancer and related diseases who meets the qualifications speci-
 fied 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  cytotechnolo-
 gist  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  gyneco-
 logic  slides shall be correspondingly reduced, in accordance with writ-
 ten 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.]  THE
 DEPARTMENT MAY ESTABLISH REGULATIONS FOR CYTOTECHNOLOGIST WORKLOAD STAN-
 DARDS 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 cytotechnolo-
 gist examines gynecologic slides for a clinical laboratory.
 S. 8966--A                          3
 
   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 cytotech-
 nologist to exceed the applicable  cytotechnologist  work  standard.  In
 determining  whether a cytotechnologist exceeds the applicable cytotech-
 nologist 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  regis-
 trant of his or her identification number.
   4.  Employment of registered cytotechnologists. No clinical laboratory
 shall employ a cytotechnologist unless the  cytotechnologist  is  regis-
 tered 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  regu-
 lation.
   (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 exam-
 ined  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 regu-
 lation.
   (c)] Such records of clinical laboratories and cytotechnologists shall
 be made available for inspection and  copying  by  the  department  upon
 request.
   [6.] 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.
   [7.] 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 unsat-
 isfactory  for  testing  or  that  it  is  inappropriate  for  the  test
 requested;
 S. 8966--A                          4
 
   (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 diagno-
 sis 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 unsatisfac-
 tory and request the submission of a new slide.
   [8.]  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.
   [9.  Regulations.  The  department may, by regulation, establish cyto-
 technologist 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 clin-
 ical laboratory in proficiency testing programs conducted by the depart-
 ment. 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 stand-
 ards  promulgated  under  the  federal  clinical  laboratory improvement
 amendments of nineteen hundred eighty-eight.
   10.] 7. Notwithstanding any provisions of  [subdivisions]  SUBDIVISION
 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 examina-
 tion  or  preparation  technology  approved by the federal food and drug
 administration, provided that such standards shall be at least as strin-
 gent as federal standards promulgated under the federal clinical labora-
 tory improvement amendments of nineteen hundred  eighty-eight  or  other
 applicable federal law.
   [11.]  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 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.
   § 5. This act shall take effect immediately.