Bill Text: NY A06196 | 2019-2020 | General Assembly | Introduced


Bill Title: Relates to enacting the "Endoscope Reform Act"; requires the commissioner of health to promulgate rules and regulations to govern the practice of all upper endoscopic procedures and to prescribe an upper endoscopic patient's bill of rights.

Spectrum: Moderate Partisan Bill (Democrat 5-1)

Status: (Introduced - Dead) 2020-01-08 - referred to health [A06196 Detail]

Download: New_York-2019-A06196-Introduced.html


                STATE OF NEW YORK
        ________________________________________________________________________
                                          6196
                               2019-2020 Regular Sessions
                   IN ASSEMBLY
                                      March 4, 2019
                                       ___________
        Introduced  by  M.  of  A.  ORTIZ, LAVINE, COLTON, HYNDMAN, McDONOUGH --
          Multi-Sponsored by -- M. of A. WRIGHT -- read once and referred to the
          Committee on Health
        AN ACT relating to enacting the "Endoscope Reform Act"
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
     1    Section  1.  Short  title. This act shall be known and may be cited as
     2  the "Endoscope Reform Act".
     3    § 2. Within one hundred eighty days of the effective date of this act,
     4  the commissioner of health shall promulgate  rules  and  regulations  to
     5  govern  the practice of all upper endoscopic procedures. For the purpose
     6  of this act, "upper endoscopic procedures" shall be  deemed  to  include
     7  all  examinations  of a patient's vocal cords, esophagus, and/or stomach
     8  by the use of a flexible endoscopic instrument.
     9    In order to prevent the dangers of sedation  and  mitigate  the  risks
    10  involved  in  these upper endoscopic procedures, there shall be require-
    11  ment that all upper endoscopic procedures be performed by the use of the
    12  transnasal esophagoscopy, hereinafter referred to as  a  TNE  procedure,
    13  which  is performed with the patient fully awake and upright, instead of
    14  the alternative method of  upper  endoscopic  procedure,  sedated  upper
    15  endoscopy,  which  requires anesthesia, is significantly more dangerous,
    16  and much more expensive than the TNE procedure.
    17    Exception shall be made to the general requirement that  TNE  be  used
    18  instead  of  sedated upper endoscopy in the event that: (a) the treating
    19  physician determines that TNE is not an available or suitable  procedure
    20  in  treating  a  patient;  (b)  the  treating  physician determines that
    21  sedated upper endoscopy is a more suitable or effective  procedure  than
    22  TNE  in  treating a patient; or (c) the patient, after being informed of
    23  the upper endoscopic patient's bill of rights as set  forth  in  section
    24  three of this act and being advised of the respective risks and benefits
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD00933-01-9

        A. 6196                             2
     1  of both the TNE and sedated upper endoscopy procedures, elects to under-
     2  go the sedated upper endoscopy procedure.
     3    § 3. All upper endoscopy patients shall, before undergoing any type of
     4  upper  endoscopic  procedure  for which TNE is an available and suitable
     5  method of procedure, be so advised and informed by their treating physi-
     6  cian that the  upper  endoscopic  procedure  can  be  performed  without
     7  sedation  by the use of the TNE procedure, as opposed to a sedated upper
     8  endoscopic procedure. The patient shall be  further  advised  and  fore-
     9  warned of the risks attendant to sedated upper endoscopic procedures.
    10    The  commissioner  of  health shall promulgate and prescribe an "upper
    11  endoscopic patient's bill of rights", which bill of rights shall be in a
    12  standard written form and shall fully and clearly explain the respective
    13  risks and benefits of both the TNE and sedated upper  endoscopic  proce-
    14  dures,  such  to  include  but  not be limited to the attendant risks of
    15  sedation and the respective costs of the TNE and upper endoscopic proce-
    16  dures. It shall be a  requirement  that  treating  physicians  read  and
    17  advise  all upper endoscopic patients of the "upper endoscopic patient's
    18  bill of rights" in the form prescribed by the commissioner of health.
    19    § 4. Within one hundred eighty days of the effective date of this act,
    20  the commissioner of health shall promulgate  rules  and  regulations  to
    21  govern  the use of flexible fiberoptic endoscopic instruments in accord-
    22  ance with the following provisions. For the purposes of  this  act,  the
    23  term  "flexible  fiberoptic  endoscopic  instrument"  shall be deemed to
    24  include flexible endoscopes together with any  accessory  instrument  or
    25  device  used  in  conjunction with a flexible endoscopic instrument when
    26  such accessory or device comes into contact, or may come  into  contact,
    27  with a patient. Such rules and regulations shall apply to every use of a
    28  flexible  endoscopic  instrument  by any health care provider using such
    29  flexible endoscopic instrument.
    30    In order to prevent the transmission of infectious contagious disease,
    31  and in particular highly contagious pathogens  that  result  in  creutz-
    32  feldt-jakob  disease and tuberculosis, these protocols demand reprocess-
    33  ing by sterilization, or having all surfaces  completely  covered  by  a
    34  protective  single  use  sterile  barrier  device.  Flexible  endoscopic
    35  instruments shall be sterilized or shall have  all  surfaces  completely
    36  covered  by  a  protective single use sterile barrier device before each
    37  use in accordance with such method as the commissioner of  health  shall
    38  prescribe, which shall be no less stringent than that recommended by the
    39  federal  Food and Drug Administration, if such a recommendation has been
    40  made. If sterilization or covering by a protective  single  use  sterile
    41  barrier is not possible, in lieu thereof a high-level disinfection meth-
    42  od  shall be used, which method shall be prescribed by such commissioner
    43  and shall be no less stringent than that recommended by the federal Food
    44  and Drug Administration, if such a recommendation has been made.
    45    When sterilization is not possible,  patients  shall  be  so  informed
    46  prior  to use, and no disinfected but not sterilized flexible endoscopic
    47  instrument shall be used unless the patient executes a written  informed
    48  consent document acknowledging that the difference between sterilization
    49  and  disinfection  has  been explained to and understood by such patient
    50  and that such patient consents to the use of a disinfected but not ster-
    51  ilized flexible endoscopic instrument.
    52    The "upper endoscopic patient's bill of rights", set forth in  section
    53  three  of this act, shall include a provision advising the patient, when
    54  sterilization is not possible, that no disinfected  but  not  sterilized
    55  flexible endoscopic instrument shall be used unless the patient executes
    56  a  written  informed  consent document acknowledging that the difference

        A. 6196                             3
     1  between sterilization and disinfection has been explained to and  under-
     2  stood  by  such  patient  and that such patient consents to the use of a
     3  disinfected but not sterilized flexible endoscopic instrument.
     4    § 5. This act shall take effect immediately.
feedback