S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  9763

                          I N  A S S E M B L Y

                              April 5, 2016
                               ___________

Introduced by M. of A. WEPRIN -- 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".
  S 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
of both the TNE and sedated upper endoscopy procedures, elects to under-
go the sedated upper endoscopy procedure.
  S 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-

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

                                                           LBD14716-02-6

A. 9763                             2

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.
  S 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
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.
  S 5. This act shall take effect immediately.