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A09235 Summary:

Amd 572, 573, 575 & 576-a, Pub Health L
Amends various provisions governing certificates of qualification for clinical laboratories and blood banks; provides for the department of health to prescribe minimum qualifications; provides that certificates shall cover all laboratory work; increases fees; requires work standards for cytotechnologists to be as stringent as federal regulations; removes registration requirement.
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A09235 Text:

                STATE OF NEW YORK
                   IN ASSEMBLY
                                    February 22, 2024
        Introduced by M. of A. PAULIN -- read once and referred 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:
     1    Section 1. Section 572 of the public health law, as amended by chapter
     2  436 of the laws of 1993,  is amended to read as follows:
     3    § 572. Certificates of qualification.  No person shall act as a direc-
     4  tor in a clinical laboratory located in or accepting specimens from  New
     5  York  state  or  in  a  blood bank located in or collecting, processing,
     6  storing or distributing blood products in New York state unless a  valid
     7  certificate of qualification has been issued as provided in section five
     8  hundred  seventy-three  of  this title.   [A certificate shall be issued
     9  authorizing the holder to perform or direct one or  more  procedures  or
    10  one or more categories of such procedures.]
    11    §  2.  Section 573 of the public health law, as amended by chapter 436
    12  of the laws of 1993,  is amended to read as follows:
    13    § 573. Issuance of  certificates  of  qualification.  1.  [The  public
    14  health  council  shall prescribe minimum qualifications for directors in
    15  areas of testing, including, but not limited to, microbiology, immunolo-
    16  gy, chemistry, hematology, biophysics, cytology, pathology, genetics and
    17  blood banking.
    18    2.] The department shall issue a certificate of qualification  to  any
    19  person  who meets [such] prescribed minimum qualifications under federal
    20  regulations, including board certification as required and who otherwise
    21  demonstrates to the department that such person possesses the character,
    22  competence, training and ability to administer  properly  the  technical
    23  and scientific operation of a clinical laboratory or blood bank, includ-
    24  ing supervision of procedures and reporting of findings of tests.
    25    [3.]  2.  Application for a certificate of qualification shall be made
    26  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.

        A. 9235--A                          2

     1  categories of procedures for which the certificate is sought]  and  such
     2  other information as the department may require.
     3    [4.]  3. The certificate shall be valid for a period of two years from
     4  the date of issuance and may be renewed for successive [two  year]  two-
     5  year  periods  thereafter.  The  original  application  and each renewal
     6  application shall be accompanied by a registration fee  of  [forty]  one
     7  hundred fifty dollars.
     8    [5.]  4.  Notwithstanding  the provisions of this section, the commis-
     9  sioner may issue a temporary certificate of qualification to any  person
    10  pending  the  issuance  of  a certificate as provided in this section. A
    11  temporary certificate shall be valid for a period of  thirty  days  from
    12  the  date  of  its  issuance  and  may  be renewed for a maximum of four
    13  successive periods of thirty days.
    14    § 3. Subdivision 2 of section 575 of the public health law, as amended
    15  by section 19 of part A of chapter 59 of the laws of 2011, is amended to
    16  read as follows:
    17    2. A permit [or permit category] shall not be issued  unless  a  valid
    18  certificate  of  qualification  [in the category of procedures for which
    19  the permit is sought] has been issued [to the director] pursuant to  the
    20  provisions  of  section five hundred seventy-three of this title, unless
    21  all fees and outstanding penalties, if any,  have  been  paid,  and  the
    22  department  finds  that  the clinical laboratory or blood bank is compe-
    23  tently staffed and properly equipped, and will be operated in the manner
    24  required by this title.
    25    § 4. Section 576-a of the public health law, as amended by chapter 436
    26  of the laws of 1993, is amended to read as follows:
    27    § 576-a. Clinical laboratories  and  cytotechnologists  examining  Pap
    28  smears.  1.  Definitions.  As  used  in this section, unless the context
    29  clearly requires otherwise, the following terms shall have the following
    30  meanings:
    31    (a) "Cytotechnologist". A clinical laboratory professional  specializ-
    32  ing  in the analysis of cytopathology samples, including Pap smears, for
    33  cervical cancer and related diseases who meets the qualifications speci-
    34  fied by the department.
    35    (b) "Cytotechnologist work standard". (i) A limitation on  the  number
    36  of  Pap  smears  (also  known as gynecologic slides) and non-gynecologic
    37  slides a cytotechnologist may examine during a particular  time  period,
    38  or  other  limitation on the quantity, speed or manner of examination of
    39  slides by a cytotechnologist, under regulations of the department.
    40    (ii) [Unless otherwise provided by the department,  the  cytotechnolo-
    41  gist  work  standard shall be: No cytotechnologist may examine more than
    42  eighty one-slide gynecologic cases or fifty two-slide gynecologic  cases
    43  per  work  day.    If  a  cytotechnologist also examines non-gynecologic
    44  slides in a given work day the cytotechnologist's workload  for  gyneco-
    45  logic  slides shall be correspondingly reduced, in accordance with writ-
    46  ten guidelines prepared by the clinical laboratory and  filed  with  the
    47  department,  so that a cytotechnologist examines no more than a total of
    48  one hundred gynecologic and non-gynecologic slides per  work  day.]  The
    49  department may establish regulations for cytotechnologist workload stan-
    50  dards that shall be at least as stringent as federal regulations.
    51    (c) "Employ". To employ or contract with a cytotechnologist to examine
    52  gynecologic slides.
    53    (d)  "Clinical  laboratory".  A  clinical  laboratory  issued a permit
    54  pursuant to this title.
    55    (e) "Work day". A twenty-four hour period during which a cytotechnolo-
    56  gist examines gynecologic slides for a clinical laboratory.

        A. 9235--A                          3
     1    2. Compliance with cytotechnologist work standard. No cytotechnologist
     2  shall exceed the applicable cytotechnologist work standard. No  clinical
     3  laboratory  shall  require, authorize, encourage or permit any cytotech-
     4  nologist to exceed the applicable  cytotechnologist  work  standard.  In
     5  determining  whether a cytotechnologist exceeds the applicable cytotech-
     6  nologist work standard, all work done by the cytotechnologist  during  a
     7  given  work  day  shall  be considered, without regard to which clinical
     8  laboratory or other person for which or whom it was performed.
     9    3. [Registration of cytotechnologist. All  cytotechnologists  who  are
    10  employed by a clinical laboratory must register with the department. The
    11  department  shall, by regulation, prescribe a form and procedure for the
    12  registration of cytotechnologists. The registration form  shall  include
    13  at  least  the  name,  address,  and an individual identification number
    14  determined by the department. The department shall  notify  each  regis-
    15  trant of his or her identification number.
    16    4.  Employment of registered cytotechnologists. No clinical laboratory
    17  shall employ a cytotechnologist unless the  cytotechnologist  is  regis-
    18  tered under this section.
    19    5.]  Record-keeping.  (a)  Each  clinical  laboratory  shall  maintain
    20  records, in a form prescribed by the department, which  set  forth,  for
    21  each cytotechnologist employed by the clinical laboratory:
    22    (i) the name [and identification number] of the cytotechnologist;
    23    (ii)  the  number of hours worked by the cytotechnologist in each work
    24  day;
    25    (iii) the number of  gynecologic  slides  and  non-gynecologic  slides
    26  examined  by the cytotechnologist[, and how many were one-slide and two-
    27  slide cases,] during each work day; and
    28    (iv) such other information as the department  may  require  by  regu-
    29  lation.
    30    (b)   [Each   cytotechnologist  shall  maintain  records,  in  a  form
    31  prescribed by the department, which set forth:
    32    (i) the number of hours worked by the cytotechnologist  in  each  work
    33  day;
    34    (ii) the number of gynecologic slides and non-gynecologic slides exam-
    35  ined  and  how many were one-slide and two-slide cases, during each work
    36  day;
    37    (iii) the name and address of the clinical laboratory or other  person
    38  for which or whom the slides were examined; and
    39    (iv)  such  other  information  as the department may require by regu-
    40  lation.
    41    (c)] Such records of clinical laboratories and cytotechnologists shall
    42  be made available for inspection and  copying  by  the  department  upon
    43  request.
    44    [6.] 4. Multiple employers. Whenever a cytotechnologist is employed by
    45  more than one clinical laboratory or other person during a work day, the
    46  cytotechnologist  shall  advise each clinical laboratory of any previous
    47  employment during the work day and the  amount  of  work  performed,  to
    48  insure  that  the  applicable  cytotechnologist  work  standard  is  not
    49  exceeded.
    50    [7.] 5. Standards for gynecologic slides. (a) A gynecologic slide of a
    51  Pap smear shall not be tested or reported on if:
    52    (i) the apparent condition of the specimen indicates that it is unsat-
    53  isfactory  for  testing  or  that  it  is  inappropriate  for  the  test
    54  requested;

        A. 9235--A                          4
     1    (ii) it has been collected, labeled, preserved or otherwise handled in
     2  such  a manner that it has become unsatisfactory or unreliable as a test
     3  specimen;
     4    (iii) the slide is broken;
     5    (iv)  it  contains  insufficient  cells  or  the cells are obscured by
     6  inflammation, blood or lubricating ointment, so that an adequate diagno-
     7  sis cannot be made; or
     8    (v) the slide is otherwise unsatisfactory, as  defined  by  department
     9  regulations.
    10    (b)  If  the slide is unsatisfactory as set forth in this subdivision,
    11  the clinical laboratory shall have an affirmative  duty  to  advise  the
    12  collecting physician or other practitioner that the slide is unsatisfac-
    13  tory and request the submission of a new slide.
    14    [8.]  6.  Re-examination of slides. The department shall prescribe, by
    15  regulation, a system of targeted re-examination  of  gynecologic  slides
    16  examined and found to be not abnormal or questionable. The factors to be
    17  considered  in  the  targeted  re-examination  may  include, but are not
    18  limited to, the prior cancer and  other  history  of  the  patient,  the
    19  results  of  previous slide examinations, and the experience and ability
    20  of the cytotechnologist.  Each  clinical  laboratory  shall  follow  the
    21  prescribed re-examination system.
    22    [9.  Regulations.  The  department may, by regulation, establish cyto-
    23  technologist work standards. Those standards may include, but shall  not
    24  be  limited  to,  standards  which  take into account the experience and
    25  qualifications of the cytotechnologists and the performance of the clin-
    26  ical laboratory in proficiency testing programs conducted by the depart-
    27  ment. However, those standards shall not  exceed  by  more  than  twenty
    28  percent  the  maximum  numbers of slides which may be examined in a work
    29  day under clause (ii) of  paragraph  (b)  of  subdivision  one  of  this
    30  section. Such standards shall be at least as stringent as federal stand-
    31  ards  promulgated  under  the  federal  clinical  laboratory improvement
    32  amendments of nineteen hundred eighty-eight.
    33    10.] 7. Notwithstanding any provisions of  [subdivisions]  subdivision
    34  one  [and  nine]  of  this  section to the contrary, the department may,
    35  pursuant to regulation, increase the maximum number of slides which  may
    36  be examined in a work day for clinical laboratories using slide examina-
    37  tion  or  preparation  technology  approved by the federal food and drug
    38  administration, provided that such standards shall be at least as strin-
    39  gent as federal standards promulgated under the federal clinical labora-
    40  tory improvement amendments of nineteen hundred  eighty-eight  or  other
    41  applicable federal law.
    42    [11.]  8.  Violations.  (a) Sections twelve, twelve-a, and twelve-b of
    43  this chapter shall apply to violations of this section, except that  the
    44  civil  penalty  for  a  violation  of this section by a cytotechnologist
    45  shall not exceed five hundred dollars.
    46    (b) [If a cytotechnologist violates this section, the  department  may
    47  suspend   or  revoke  the  cytotechnologist's  registration  under  this
    48  section, pursuant to department regulations  including  appropriate  due
    49  process protections for the cytotechnologist.
    50    (c)] If any clinical laboratory or other person violating this section
    51  is  licensed,  certified  or  registered  by  the department under other
    52  provisions of law, the violation of this  section  may  be  grounds  for
    53  disciplining the person under such law.
    54    § 5. This act shall take effect immediately.
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