PROPOSED REGULATIONS

Article 28. – Supervision of Certain Allied Health Professionals

K.A.R. 100-28-1. Definitions. (a) “Advanced registered nurse practitioner” and “ARNP” mean a professional nurse who holds a certificate of qualification issued by the state board of nursing to function in an expanded role.
(b) “Allied health professional” means a naturopath registered by the state board of healing arts, an advanced registered nurse practitioner, or a pharmacist registered by the state board of pharmacy.
(c) “Designated physician” means a person licensed to practice medicine and surgery or osteopathic medicine and surgery who agrees to direct and supervise an allied health professional when a responsible physician is unavailable.
(d) “Responsible physician” means a person licensed to practice medicine and surgery or osteopathic medicine and surgery who accepts continuous and ultimate responsibility for professional services provided by an allied health professional under the responsible physician’s direction and supervision. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-_____________.)

K.A.R. 100-28-2. Limitations on delegation of authority to perform services constituting medicine and surgery. (a) Any responsible physician or designated physician may delegate performance of services constituting medicine and surgery to an allied health professional only in the course of a physician-patient relationship between the patient and either the responsible physician or the designated physician.
(b) The responsible physician or designated physician shall communicate the authority to perform those services to the allied health professional only by means of one or more of the following:
(1) By direct verbal or written order, including an order transmitted through an electronic means or through radio, telephone, or another form of telecommunication;
(2) by a written protocol that meets the standards of these regulations for those circumstances in which use of a written protocol is authorized by statute or by rules and regulations of the board; or
(3) by any other reasonable and professionally competent manner in an emergency.
(c)(1) Before using a protocol to delegate to any allied health professional the performance of services constituting the practice of medicine and surgery, the responsible physician shall file with the board a completed protocol form provided by the board.
(2) Before authorizing an ARNP to prescribe any drug or to sign for, receive, and distribute a drug sample, the responsible physician shall file with the board a completed prescription drug protocol form provided by the board.
(3) Before entering into a vaccination protocol with a pharmacist, the responsible physician shall file with the board a completed vaccination protocol form provided by the board.
(d) Each responsible physician or designated physician shall adequately supervise all delegated services constituting medicine and surgery performed by each allied health professional who is under the supervision of that physician. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-_____________.)

K.A.R. 100-28-3. Protocol form contents. (a) The protocol form to be presented to the board as required by K.A.R. 100-28-2 shall contain the following information:
(1) The signatures of the responsible physician and the allied health professional and the date on which they each signed the form;
(2) the license or registration number of both the responsible physician and the allied health professional;
(3) a description of the normal and customary specialty and area of competence of the responsible physician and a description of the acts and functions to be delegated to the allied health professional;
(4) a statement that, while the allied health professional performs services constituting medicine and surgery, either the responsible physician or the designated physician will always be available by some form of telecommunication within 30 minutes of the time at which the allied health professional attempts to contact the physician, unless some provision of law imposes a stricter standard;
(5) the name and address of each practice location, including hospitals, where the allied health professional will routinely perform services that constitute medicine and surgery;
(6) the signature of each designated physician and a description of the procedures to be followed to notify a designated physician in the absence of the responsible physician;
(7) an acknowledgement that the failure to adequately supervise the allied health professional in accordance with regulations of the board and K.S.A. 65-28,127, and amendments thereto, shall constitute grounds for the board to revoke, suspend, or limit the license of the responsible physician or designated physician or to censure or fine the responsible physician or designated physician;
(8) a statement that a current copy of the protocol form will be maintained at each practice location of the allied health professional; and
(9) an acknowledgment that the responsible physician has established and implemented a method for the initial and periodic evaluation of the professional competency of the allied health professional and that these evaluations will be performed at least annually.
(b) The responsible physician shall submit an amended protocol form to the board within 10 days following any change in circumstances that affects the accuracy of the information included in the protocol form. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-______________________.)

K.A.R. 100-28-4. Supervision and direction. Each responsible physician or designated physician who delegates performance of services constituting medicine and surgery to one or more allied health professionals shall supervise each allied health professional in a manner that, at a minimum, meets all of the following requirements: (a) The responsible physician and the designated physician shall actively engage in the practice of medicine and surgery in this state.
(b) The responsible physician shall ensure that each allied health professional maintains a current license or registration issued by the appropriate Kansas regulatory board.
(c) While the allied health professional is performing services constituting medicine and surgery, either the responsible physician or the designated physician shall be available by some form of telecommunication within 30 minutes of the time at which the allied health professional attempts to contact the physician, unless some provision of law imposes a stricter standard.
(d) If the responsible physician has knowledge of any formal or informal disciplinary proceedings that have been instituted or disciplinary actions that have been taken against the allied health professional by the licensure or registration agency of any state or by any professional association, the responsible physician shall report that information to the board within 10 days of first receiving the information.
(e) If the responsible physician has knowledge of any litigation, threatened litigation, or claim alleging professional incompetency or professional negligence on the part of either the allied health professional or the responsible physician, the responsible
physician shall report that information to the board within 10 days of first receiving the information.
(f) At least annually, the responsible physician shall evaluate the allied health professional’s competency to perform professional services constituting medicine and surgery and document the review in the responsible physician’s business record.
(g) At least annually, the responsible physician shall review any protocol that authorizes the allied health professional to perform services constituting medicine and surgery, determine if any modifications are necessary, and document the review in the responsible physician’s business record.
(h) The responsible physician shall require the allied health professional to document patient care in the same manner that the responsible physician is required to document patient care.
(i) The responsible physician shall require the allied health professional to communicate with the responsible physician or the designated physician if a patient’s condition might require treatment that the allied health professional has not been authorized to perform.
(j)(1) The responsible physician shall determine whether or not the allied health professional has performed patient services constituting the practice of medicine and surgery with reasonable skill and safety, including the following specific determinations, as appropriate:
(A) whether or not any drug prescribed by an ARNP was clinically indicated and whether or not the prescription order was appropriate;
(B) whether or not any formulary substance administered by a naturopathic doctor was appropriate; and
(C) whether or not any vaccine administered by a pharmacist was performed according to the vaccine protocol.
(2) To make the determination required under paragraph (j)(1), the responsible physician shall regularly and periodically review an adequate number of patient records documenting treatment provided by the allied health professional. The review shall be considered to be periodic if it occurs at least once every 14 days. The number of records reviewed shall be considered to be adequate if the responsible physician reviews the records for a minimum of 25 percent of the total number of patients treated by the allied health professional during the period under review. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-_____________.)

K.A.R. 100-28-5. Prescription orders by advanced registered nurse practitioners. Any responsible physician or designated physician may authorize any ARNP who is under the physician’s supervision to prescribe or administer a prescription-only drug or to supply a drug sample only as provided in both the prescription drug protocol and this regulation. (a) The responsible or designated physician may authorize an ARNP to issue a written prescription order for a schedule II controlled substance, except that, in an emergency situation, the ARNP may transmit the order by oral communication, including telecommunication. Within seven days after orally transmitting an emergency prescription order, the ARNP shall cause a written prescription, completed in accordance with appropriate federal and state laws, to be delivered to the dispenser of the drug.
(b) The responsible or designated physician may authorize an ARNP to prescribe a controlled substance listed in schedule III, IV, or V or a prescription-only drug not listed in any schedule as a controlled substance and to issue that prescription orally, telephonically, or in writing.
(c) The responsible physician shall require that each written prescription order issued by an ARNP meet the following requirements:
(1) Contains the name, the business address, and the telephone number of the responsible physician and of the ARNP;
(2) is signed by the ARNP with the letters "ARNP" following the signature;
(3) contains any DEA registration number issued to the ARNP, if a controlled substance is prescribed; and
(4) indicates whether the prescription order is being transmitted by direct order of the responsible or designated physician, by the ARNP according to a written protocol, or by the ARNP in an emergency situation.
(d) An ARNP may supply a prescription-only drug to a patient only if all of the following conditions are met:
(1) The drug is supplied to the patient under the same conditions as those in which an ARNP is authorized to administer a prescription-only drug directly.
(2) The drug was provided to the ARNP or to the responsible physician, designated physician, or employer at no cost.
(3) The drug is commercially labeled, and the ARNP supplies the drug to the patient in the original, prepackaged container.
(4) The drug is supplied to the patient at no cost.
(e) An ARNP shall not administer, supply, or prescribe a prescription-only drug for any quantity or strength in excess of the normal and customary practice of the responsible or designated physician. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-_____________.)

K.A.R. 100-28-6. Alternate practice location. Any responsible physician may delegate to any ARNP who is under the direction of the physician the authority to perform professional services constituting medicine and surgery at a location that is not the primary practice location of the responsible physician only as provided by this regulation. (a) Before the ARNP provides services that constitute medicine and surgery at the alternate practice location, the ARNP shall have spent a minimum of 80 hours providing those services under the immediate supervision of a physician who is licensed in this state.
(b) The physician shall periodically see and treat patients at the alternate location.
(c) Written notice stating that the alternate practice location is not staffed routinely by a physician shall be conspicuously posted on the premise. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-_____________.)

K.A.R. 100-28-7. Limitation on the number of supervised professionals. (a)(1) Except for services to be performed in a medical care facility as defined by K.S.A. 65-425 and amendments thereto, a responsible physician shall not utilize a protocol to delegate performance of services constituting medicine and surgery to more than four supervised health professionals, unless the responsible physician obtains the prior approval of the board.
(2) For purposes of this regulation, “supervised health professional” shall mean a licensed physician assistant or an allied health professional.
(b) Each request for approval to supervise more than four supervised health professionals shall meet the following conditions:
(1) Be in writing;
(2) identify all supervised health professionals to be supervised by the responsible physician;
(3) state the reason for the request; and
(4) be signed by the responsible physician.
(c) The grounds for requesting approval to supervise more than four supervised health professionals may include any of the following:
(1) The usual number of hours worked each week by one or more of the supervised health professionals to be supervised is less than 40.
(2) The usual number of days worked each week by one or more of the supervised health professionals to be supervised is less than five.
(3) One or more supervised health professionals that the responsible physician supervises will be absent temporarily.
(4) Extraordinary circumstances exist that make delegation to more than four supervised health professionals necessary for the benefit of the physician’s patients, without diminishing the ability of the responsible physician to provide adequate supervision.
(5) Supervision of more than four supervised health professionals is necessary to preserve the public health and safety. (Authorized by and implementing K.S.A. 2004 Supp. 65-28,127; effective P-_____________.)



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