Article 22.--DISHONORABLE CONDUCT

          K.A.R. 100-22-1. Release of records. (a) Unless otherwise prohibited by law, each licensee shall, upon receipt of a signed release from a patient, furnish a copy of the patient record to the patient, to another licensee designated by the patient, or to a patient's legally designated representative. However, if the licensee reasonably determines that the information within the patient record is detrimental to the mental or physical health of the patient, then the licensee may withhold the record from the patient and furnish the record to another licensee designated by the patient.
          (b) A licensee may charge a person or entity for reasonable costs to retrieve or reproduce a patient record. A licensee shall not condition the furnishing of a patient record to another licensee upon prepayment of these costs.
          (c) Any departure from this regulation shall constitute prima facie evidence of dishonorable conduct pursuant to K.S.A. 65-2836(b), and any amendments thereto. (Authorized by K.S.A. 65-2865; implementing K.S.A. 1997 Supp. 65-2836, as amended by L. 1998, Ch. 142, Sec. 12; effective May 1, 1985; amended Nov. 13, 1998.)

          K.A.R. 100-22-2. Description of professional activities. (a) Any person applying for an exempt license shall divulge on the application for such license a description of all professional activities related to the healing arts such person intends to perform if issued an exempt license.
          (b) Any person holding an exempt license shall, at the time of renewal, divulge on the renewal application all professional activities related to the healing arts such person intends to perform during the renewal period.
          (c) Any departure from subsection (a) or (b) may constitute evidence of dishonorable conduct pursuant to K.S.A. 1986 Supp. 65-2836(b) as amended by L. 1987, Ch. 176, Sec. 5 as further amended by L. 1987, Ch. 242, Sec. 2 and any amendments thereto. (Authorized by K.S.A. 65-2865; implementing K.S.A. 1986 Supp. 65-2836 as amended by L. 1987, Ch. 176, Sec. 5 as further amended by L. 1987, Ch. 242, Sec. 2; effective, T-88-52, Dec. 16, 1987; effective May 1, 1988.)

          K.A.R. 100-22-3. Business transactions with patients. (a) Non-health-related goods or services. A licensee shall be deemed to engage in dishonorable conduct by offering to sell a non-health-related product or service to a patient from a location at which the licensee regularly practices the healing arts unless otherwise allowed by this subsection. A licensee shall not be deemed to engage in dishonorable conduct by offering to sell a non-health-related product or service if all of the following conditions are met:
          (1) The sale is for the benefit of a public service organization.
          (2) The sale does not directly or indirectly result in financial gain to the licensee.
          (3) No patient is unduly influenced to make a purchase.
          (b) Business opportunity. A licensee shall be deemed to engage in dishonorable conduct if all of the following conditions are met:
          (1) The licensee recruits or solicits a patient either to participate in a business opportunity involving a sale of a product or service, or to recruit or solicit others to participate in a business opportunity.
          (2) The sale of the product or service directly or indirectly results in financial gain to the licensee.
          (3) the licensee recruits or solicits the patient at any time that the patient is present in a location at which the licensee regularly practices the healing arts. (Authorized by K.S.A. 65-2865; implementing K.S.A. 1998 Supp. 65-2836; effective May 5, 2000.)

          K.A.R. 100-22-4. Description of affiliation with specialty board. (a) On and after January 1, 2004, each licensee who represents to the public that the licensee is credentialed by a specialty board other than a state licensing agency, including through the use of the description “board-certified” in connection with the licensee’s name, shall, in the same medium as that in which the representation is made, identify the official name of the specialty board that has granted the credential to the licensee.
          (b) Each violation of this regulation shall constitute prima facie evidence of dishonorable conduct. (Authorized by K.S.A. 65-2865; implementing K.S.A. 2001 Supp. 65-2836; effective May 23, 2003.)

          K.A.R. 100-22-6. Notice to the public of licensure.  (a)  A person licensed to practice a branch of the healing arts shall not perform direct patient care in an office, unless the notice adopted by reference in this subsection is placed in a conspicuous location where the notice is reasonably likely to be seen by persons who receive direct patient care in the office.  The document titled “notice to patients: required signage for K.A.R. 100-22-6,” as prepared by the state board of healing arts and dated April 5, 2007, is hereby adopted by reference.
            (b)  As used in this regulation, “office” shall mean any place intended for the practice of the healing arts.  This term shall not include a medical care facility, as defined by K.S.A. 65-425 and amendments thereto, which is licensed by the Kansas department of health and environment.
            (c)  Each violation of this regulation shall constitute prima facie evidence of dishonorable conduct. (Authorized by K.S.A. 65-2865; implementing K.S.A. 65-2836; effective Nov. 2, 2007.)

          K.A.R. 100-22-7. Orders to dispense prescription-only medical devices. (a) For the purpose of this regulation, “prescription-only medical device” shall mean an apparatus that meets the following conditions:
          (1) May be sold or distributed only upon the authorization of a person licensed by state law to administer or use the device; and
          (2) is intended either to use in diagnosing or treating a disease, injury, or deformity or to affect the structure, action, or physiologic property of any part of the human body.
          (b) Each licensee who issues an order that authorizes the sale, lease, or other method of distribution of a prescription-only medical device to another person for other than self-treatment shall create a written record of the order, signed by the licensee, and shall maintain that record for at least 10 years following the date of the order. The written record shall include, at a minimum, all of the following statements:
          (1) The licensee knows or has reason to know that the person to whom the medical device is to be dispensed is professionally competent and legally authorized to use the device for other than self-treatment.
          (2) The licensee acknowledges that the device is approved for acts and functions that are within the normal and customary specialty, competence, and lawful practice of the licensee.
          (3) The licensee will supervise the use of the device.
          (c) Each violation of this regulation shall constitute prima facie evidence of dishonorable conduct. (Authorized by K.S.A. 65-2865 and K.S.A. 2006 Supp. 65-28,127; implementing K.S.A. 65-2836 and K.S.A. 2006 Supp. 65-28,127; effective July 6, 2007.)

          K.A.R. 100-22-8. (Authorized by K.S.A. 65-2865; implementing K.S.A. 65-2836; effective, T-100-4-24-07, April 24, 2007; effective Sept. 14, 2007; revoked, T-100-12-10-07, December 10, 2007; revoked April 4, 2008.)

        K.A.R. 100-22-8a.  Phosphatidylcholine and sodium deoxycholate.  (a)  As used in this regulation, the following terms shall have the meanings specified in this subsection.
            (1) “Adverse event” means any unfavorable medical occurrence experienced by a patient that reasonably could be related to the administration of PCDC. 
            (2)  “Compounding” means combining component drug ingredients by or upon the order of a physician for the purpose of creating a drug tailored to the specialized needs of an individual patient.
            (3)“Designated physician” means a physician who is professionally competent to compound or order the compounding of PCDC and who agrees to be available on the premises during the administration of PCDC whenever the physician who compounded or ordered the compounding of PCDC is not present.
            (4) “Institutional review board” and “IRB” mean a board or committee designated by a public or private entity or agency to review biomedical research and to ensure protection of the rights and welfare of patients.
            (5) “PCDC” means phosphatidylcholine and sodium deoxycholate prepared for administration individually or in combination.
            (6)  “Physician” means a person licensed in this state to practice medicine and surgery or osteopathic medicine and surgery.
            (b)  Except as specified in subsections (c) and (d), a physician shall not administer or authorize another person to administer PCDC by injection to a human being.
            (c)  This regulation shall not prohibit the administration of PCDC to a research subject during clinical research of PCDC as an investigational new drug.
            (d)  This regulation shall not prohibit a physician from compounding PCDC or from preparing a written prescription order directing a lawfully operating pharmacy to compound PCDC for a specific patient if all of the following conditions are met:  
            (1)  The physician has notified the board in writing of the intent to compound or order the compounding of PCDC in the scope of the physician’s practice and agrees to meet the requirements stated in subsection (e).
            (2)  The physician has a physician-patient relationship with the specific patient.
            (3)  The patient has given the physician written informed consent for the administration of PCDC that includes, at a minimum, all of the following:
            (A) The patient acknowledges that PCDC is a drug and that neither the state of Kansas nor any federal agency has approved PCDC as a drug.
            (B) The patient has been informed that a preponderance of competent medical literature regarding clinical research establishing whether PCDC is safe and effective has not been published.
            (C) The patient has been informed that the clinical data will be submitted to an IRB for peer review.
            (D) The patient has been given a description of the known and potential side effects of PCDC.
            (4) Before compounding or writing an order to compound PCDC, the physician personally performs a physical examination of the patient, records the patient’s medical history in the patient record, performs or orders relevant laboratory tests as indicated, and, based upon the examination, history, and test results, determines that PCDC is indicated for the patient.
            (5)  The physician or designated physician supervises and is personally present on the premises when the PCDC is administered.               
            (6)  The patient record identifies each ingredient, the amount of each ingredient, and the amount of the preparation compounded by the physician, or the order to compound PCDC identifies each ingredient, the amount of each ingredient, and the amount of the preparation to be dispensed.
            (e)  Each physician who compounds or writes an order to compound PCDC shall meet each of the following requirements:
            (1)  Before compounding or writing an order to compound PCDC, the physician shall establish a written procedure that identifies each of the following: 
            (A) A general plan of care applicable to all patients, including indications and contraindications for administering PCDC to patients;
            (B) each designated physician; 
            (C)each person who may administer PCDC upon the order of the physician; and
            (D)  each location within this state at which PCDC will be administered based upon the order of the physician.
            (2)(A)  A physician who has compounded or ordered PCDC to be compounded for a patient under a medical regimen that has not been completed on or before the effective date of this regulation shall, before administering or authorizing the administration of PCDC,  submit a copy of the written procedure and informed consent form to the board and shall, within 60 days following the effective date of this regulation, submit evidence that an IRB has approved the written procedure and the informed consent form that the physician uses. 
            (B)  Each physician not described in paragraph (e)(2)(A) shall obtain approval of the written procedure and informed consent form by an IRB and submit evidence of that approval and a copy of the written procedure and informed consent form to the board, before compounding or writing an order to compound PCDC.
            (3)  The physician shall report each adverse event resulting in medical intervention to the IRB and to the board within 24 hours of receiving notice of the adverse event.  The physician shall report all other adverse events observed by or reported to the physician and all clinical results for each patient to the IRB at least monthly.
            (4) At least monthly, the physician shall prepare or obtain from the compounding pharmacy and shall forward to the IRB the following information:
            (A) Verification that the preparation is sterile;
            (B) a description of the quantity and strength of all ingredients used as components of the preparation;
            (C) documentation of adequate mixing to ensure homogeneity of the preparation; and
            (D) verification of the clarity, completeness, or pH of the solution.
            (f)  Each departure from this regulation shall constitute prima facie evidence of dishonorable conduct.  (Authorized by K.S.A. 65-2865; implementing K.S.A. 65-2836; effective, T-100-12-10-07, December 10, 2007; effective April 4, 2008.)