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A09235 Summary:

BILL NOA09235
 
SAME ASNo Same As
 
SPONSORPaulin
 
COSPNSR
 
MLTSPNSR
 
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
        ________________________________________________________________________
 
                                          9235
 
                   IN ASSEMBLY
 
                                    February 22, 2024
                                       ___________
 
        Introduced by M. of A. PAULIN -- read once and referred to the Committee
          on Health
 
        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 and who other-
    20  wise demonstrates to the department that such person possesses the char-
    21  acter, competence, training and ability to administer properly the tech-
    22  nical and scientific operation of a clinical laboratory or  blood  bank,
    23  including supervision of procedures and reporting of findings of tests.
    24    [3.]  2.  Application for a certificate of qualification shall be made
    25  on forms provided by the department [and shall contain the procedures or
    26  categories of procedures for which the certificate is sought]  and  such
    27  other information as the department may require.
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD14434-01-4

        A. 9235                             2
 
     1    [4.]  3. The certificate shall be valid for a period of two years from
     2  the date of issuance and may be renewed for successive [two  year]  two-
     3  year  periods  thereafter.  The  original  application  and each renewal
     4  application shall be accompanied by a registration fee  of  [forty]  one
     5  hundred fifty dollars.
     6    [5.]  4.  Notwithstanding  the provisions of this section, the commis-
     7  sioner may issue a temporary certificate of qualification to any  person
     8  pending  the  issuance  of  a certificate as provided in this section. A
     9  temporary certificate shall be valid for a period of  thirty  days  from
    10  the  date  of  its  issuance  and  may  be renewed for a maximum of four
    11  successive periods of thirty days.
    12    § 3. Subdivision 2 of section 575 of the public health law, as amended
    13  by section 19 of part A of chapter 59 of the laws of 2011, is amended to
    14  read as follows:
    15    2. A permit [or permit category] shall not be issued  unless  a  valid
    16  certificate  of  qualification  [in the category of procedures for which
    17  the permit is sought] has been issued [to the director] pursuant to  the
    18  provisions  of  section five hundred seventy-three of this title, unless
    19  all fees and outstanding penalties, if any,  have  been  paid,  and  the
    20  department  finds  that  the clinical laboratory or blood bank is compe-
    21  tently staffed and properly equipped, and will be operated in the manner
    22  required by this title.
    23    § 4. Section 576-a of the public health law, as amended by chapter 436
    24  of the laws of 1993, is amended to read as follows:
    25    § 576-a. Clinical laboratories  and  cytotechnologists  examining  Pap
    26  smears.  1.  Definitions.  As  used  in this section, unless the context
    27  clearly requires otherwise, the following terms shall have the following
    28  meanings:
    29    (a) "Cytotechnologist". A clinical laboratory professional  specializ-
    30  ing  in the analysis of cytopathology samples, including Pap smears, for
    31  cervical cancer and related diseases who meets the qualifications speci-
    32  fied by the department.
    33    (b) "Cytotechnologist work standard". (i) A limitation on  the  number
    34  of  Pap  smears  (also  known as gynecologic slides) and non-gynecologic
    35  slides a cytotechnologist may examine during a particular  time  period,
    36  or  other  limitation on the quantity, speed or manner of examination of
    37  slides by a cytotechnologist, under regulations of the department.
    38    (ii) [Unless otherwise provided by the department,  the  cytotechnolo-
    39  gist  work  standard shall be: No cytotechnologist may examine more than
    40  eighty one-slide gynecologic cases or fifty two-slide gynecologic  cases
    41  per  work  day.    If  a  cytotechnologist also examines non-gynecologic
    42  slides in a given work day the cytotechnologist's workload  for  gyneco-
    43  logic  slides shall be correspondingly reduced, in accordance with writ-
    44  ten guidelines prepared by the clinical laboratory and  filed  with  the
    45  department,  so that a cytotechnologist examines no more than a total of
    46  one hundred gynecologic and non-gynecologic slides per  work  day.]  The
    47  department may establish regulations for cytotechnologist workload stan-
    48  dards that shall be at least as stringent as federal regulations.
    49    (c) "Employ". To employ or contract with a cytotechnologist to examine
    50  gynecologic slides.
    51    (d)  "Clinical  laboratory".  A  clinical  laboratory  issued a permit
    52  pursuant to this title.
    53    (e) "Work day". A twenty-four hour period during which a cytotechnolo-
    54  gist examines gynecologic slides for a clinical laboratory.
    55    2. Compliance with cytotechnologist work standard. No cytotechnologist
    56  shall exceed the applicable cytotechnologist work standard. No  clinical

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

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