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. LBD00933-01-9A. 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 differenceA. 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.