S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   6196
 
                        2019-2020 Regular Sessions
 
                           I N  A S S E M B L Y
 
                               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:

   Section  1.  Short  title. This act shall be known and may be cited as
 the "Endoscope Reform Act".
   § 2. Within one hundred eighty days of the effective date of this act,
 the commissioner of health shall promulgate  rules  and  regulations  to
 govern  the practice of all upper endoscopic procedures. For the purpose
 of this act, "upper endoscopic procedures" shall be  deemed  to  include
 all  examinations  of a patient's vocal cords, esophagus, and/or stomach
 by the use of a flexible endoscopic instrument.
   In order to prevent the dangers of sedation  and  mitigate  the  risks
 involved  in  these upper endoscopic procedures, there shall be require-
 ment that all upper endoscopic procedures be performed by the use of the
 transnasal esophagoscopy, hereinafter referred to as  a  TNE  procedure,
 which  is performed with the patient fully awake and upright, instead of
 the alternative method of  upper  endoscopic  procedure,  sedated  upper
 endoscopy,  which  requires anesthesia, is significantly more dangerous,
 and much more expensive than the TNE procedure.
   Exception shall be made to the general requirement that  TNE  be  used
 instead  of  sedated upper endoscopy in the event that: (a) the treating
 physician determines that TNE is not an available or suitable  procedure
 in  treating  a  patient;  (b)  the  treating  physician determines that
 sedated upper endoscopy is a more suitable or effective  procedure  than
 TNE  in  treating a patient; or (c) the patient, after being informed of
 the upper endoscopic patient's bill of rights as set  forth  in  section
 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
 
 of both the TNE and sedated upper endoscopy procedures, elects to under-
 go the sedated upper endoscopy procedure.
   § 3. All upper endoscopy patients shall, before undergoing any type of
 upper  endoscopic  procedure  for which TNE is an available and suitable
 method of procedure, be so advised and informed by their treating physi-
 cian that the  upper  endoscopic  procedure  can  be  performed  without
 sedation  by the use of the TNE procedure, as opposed to a sedated upper
 endoscopic procedure. The patient shall be  further  advised  and  fore-
 warned of the risks attendant to sedated upper endoscopic procedures.
   The  commissioner  of  health shall promulgate and prescribe an "upper
 endoscopic patient's bill of rights", which bill of rights shall be in a
 standard written form and shall fully and clearly explain the respective
 risks and benefits of both the TNE and sedated upper  endoscopic  proce-
 dures,  such  to  include  but  not be limited to the attendant risks of
 sedation and the respective costs of the TNE and upper endoscopic proce-
 dures. It shall be a  requirement  that  treating  physicians  read  and
 advise  all upper endoscopic patients of the "upper endoscopic patient's
 bill of rights" in the form prescribed by the commissioner of health.
   § 4. Within one hundred eighty days of the effective date of this act,
 the commissioner of health shall promulgate  rules  and  regulations  to
 govern  the use of flexible fiberoptic endoscopic instruments in accord-
 ance with the following provisions. For the purposes of  this  act,  the
 term  "flexible  fiberoptic  endoscopic  instrument"  shall be deemed to
 include flexible endoscopes together with any  accessory  instrument  or
 device  used  in  conjunction with a flexible endoscopic instrument when
 such accessory or device comes into contact, or may come  into  contact,
 with a patient. Such rules and regulations shall apply to every use of a
 flexible  endoscopic  instrument  by any health care provider using such
 flexible endoscopic instrument.
   In order to prevent the transmission of infectious contagious disease,
 and in particular highly contagious pathogens  that  result  in  creutz-
 feldt-jakob  disease and tuberculosis, these protocols demand reprocess-
 ing by sterilization, or having all surfaces  completely  covered  by  a
 protective  single  use  sterile  barrier  device.  Flexible  endoscopic
 instruments shall be sterilized or shall have  all  surfaces  completely
 covered  by  a  protective single use sterile barrier device before each
 use in accordance with such method as the commissioner of  health  shall
 prescribe, which shall be no less stringent than that recommended by the
 federal  Food and Drug Administration, if such a recommendation has been
 made. If sterilization or covering by a protective  single  use  sterile
 barrier is not possible, in lieu thereof a high-level disinfection meth-
 od  shall be used, which method shall be prescribed by such commissioner
 and shall be no less stringent than that recommended by the federal Food
 and Drug Administration, if such a recommendation has been made.
   When sterilization is not possible,  patients  shall  be  so  informed
 prior  to use, and no disinfected but not sterilized flexible endoscopic
 instrument shall be used unless the patient executes a written  informed
 consent document acknowledging that the difference between sterilization
 and  disinfection  has  been explained to and understood by such patient
 and that such patient consents to the use of a disinfected but not ster-
 ilized flexible endoscopic instrument.
   The "upper endoscopic patient's bill of rights", set forth in  section
 three  of this act, shall include a provision advising the patient, when
 sterilization is not possible, that no disinfected  but  not  sterilized
 flexible endoscopic instrument shall be used unless the patient executes
 a  written  informed  consent document acknowledging that the difference

 A. 6196                             3

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