811-015-0070 Scope of Practice Regarding Examinations, Tests, Substances, Devices and Procedures (1) The Board may examine any diagnostic and/or therapeutic examination, test, substance, device or procedure (ETSDP) to determine its acceptability for patient care. The Board may require a chiropractic physician to provide information on any ETSDP for determination of its status, taking into account all relevant factors and practices, including, but not limited to: the practices generally and currently followed and accepted by persons licensed to practice chiropractic in the state, the teachings at chiropractic schools accredited by the Council on Chiropractic Education or its successor, relevant technical reports published in recognized journals, and the desirability of reasonable experimentation in the furtherance of the chiropractic arts and sciences. (2) A chiropractic physician may use any diagnostic and/or therapeutic ETSDP which is considered standard. A standard diagnostic and/or therapeutic ETSDP is one in which one or more of the following criteria have been satisfied: (a) Is taught or has been taught by a chiropractic school accredited by the Council on Chiropractic Education or its successor, or health professions’ courses taught by regionally accredited colleges with subject matter that is within the scope of chiropractic practice and has not been disapproved by the Board; or (b) Has been approved by the Board through the petition process: (A) The petition requires a formalized agreement of 10% or more of the chiropractic physicians, holding an active chiropractic license in Oregon, attesting to the safety and efficacy of a particular ETSDP. The petition shall be submitted in writing to the Board by any party wishing to establish any ETSDP as standard. It is the responsibility of the petitioner to gather the required evidence and supporting statements. It is the sole responsibility and discretion of the Board to review the sufficiency of the evidence in the petition and to make a determination whether to concur and affirm the ETSDP as standard or to deny the petition. The Board may, but is not required to, hold a public hearing on any petition. The Board shall make its determination and reply to the petitioner within 180 days of receipt of the petition unless the Board and the petitioner mutually agree to extend the deadline. (B) The petition shall specifically address the following issues: (i) The kind of ETSDP that is the subject of the petition, i.e., whether it is an examination, a test, a substance, a device, a procedure, or a combination thereof; (ii) A detailed description of the proposed ETSDP; (iii) The clinical justification for the ETSDP; (iv) A method for determining appropriate termination of care and/or consultation with other providers with special skills/knowledge for the welfare of the patient; (v) Whether the proposed ETSDP is to be used by itself or used in addition to any other generally accepted or standard ETSDP; (vi) A description of known or anticipated contraindications, risks, and benefits; (vii) A description of any subpopulations for which greater risk or benefit is expected; (viii) A description of any standard ETSDP for the equivalent condition together with its relative risks and benefits; and (ix) An assessment of the expected consequences of withholding the proposed ETSDP. (c) Is supported by adequate evidence of clinical efficacy as determined by the Board. In determining adequacy, the Board may consider whether the ETSDP: (A) Has clinical justification; (B) Has valid outcome assessment measures; (C) Is supported in peer reviewed literature; (D) Is consistent with generally recognized contraindications to chiropractic procedures; and (E) The potential benefit outweighs the potential risk to the patient. (3) A chiropractic physician may use any diagnostic and/or therapeutic ETSDP that has not met the criteria of subsections (2)(a) - (c) of this rule as investigational. It must show potential merit for effectiveness and be of acceptable risk. Documentation requirements are based on potential risk to the patient. All investigational diagnostic ETSDPs must include or be accompanied by standard diagnostic procedures until full Board approval is attained under the criteria cited in subsections (2)(a) - (c) of this rule. Nothing in this section is intended to interfere with the right of any patient to refuse standard or investigational ETSDPs. In determining risk, the Board may use the following criteria: (a) For minimal risk procedures, defined as those which, when properly or improperly performed on the general population, would have a slight chance of a slight injury and, when properly performed on select populations, have an extremely remote chance of serious injury: (A) Informed consent is suggested but not required; and (B) The chiropractic physician is recommended, but not required, to participate in or conduct a formal investigation of the procedure. (b) For low risk procedures, defined as those which, when properly performed on the general population have a slight chance of mild injury; when improperly performed on the general population have a mild chance of mild to moderate injury, and when properly performed on select populations have a remote chance of serious injury: (A) Informed consent is required; and (B) The chiropractic physician is recommended, but not required, to participate or conduct a formal investigation of the procedure. (c) For moderate risk procedures, defined as those which, when properly performed on the general public have a significant chance of mild injury and a slight chance of moderate injury; when improperly performed on the general population have a slight chance of severe injury; and when properly performed on select populations have a slight chance of serious injury: (A) Written informed consent is required; and (B) The chiropractic physician is recommended, but not required, to participate or conduct a formal investigation of the procedure. (d) For high risk procedures, those which, when properly performed on the general population have a significant chance of moderate injury and a slight chance of serious injury; when improperly performed on the general population have a significant chance of serious injury; and when properly performed on select populations have a significant chance of serious injury: (A) Written informed consent is required; and (B) The chiropractic physician is required to participate in or conduct a formal investigation of the procedure under the auspices of, or in conjunction with, any other health care professionals knowledgeable and competent in the care and treatment of potential serious injuries. (e) Board approval is required of all moderate or high risk procedures. (4) The Board shall maintain a list of ETSDPs which have been reviewed and have been determined to be unacceptable or approved as investigational. (5) A chiropractic physician may not use any diagnostic and/or therapeutic ETSDPs which have been determined by the Board to be unacceptable. Statutory/Other Authority: ORS 684 Statutes/Other Implemented: ORS 684.155 History: BCE 9-2019, amend filed 07/31/2019, effective 07/31/2019 CE 6-1995, f. & cert. ef. 12-19-95 CE 3-1987, f. 8-14-87, ef. 9-1-87