333-700-0075 Administrative Authority and Management (1) Every facility shall be organized, equipped, and administered to provide adequate care for each person admitted. (2) The governing body, the owner, or the person or persons designated by the owner or governing body shall be the authority responsible for the management and control of the facility, and shall not: (a) Permit, aid or abet the commission of any unlawful act relating to the securing of a license, or the operation of the facility; and (b) With the exception of abusive or disruptive patients, refuse to admit and treat, on the basis of medical need, alcohol and substance abusers, mentally ill or intellectually disabled patients solely on the basis of their substance abuse or mental illness. Discharge of patients exhibiting violent, threatening, disruptive, or abusive behavior shall be handled as outlined in OAR 333-700-0115(2)(f). (3) The governing authority shall formulate and implement a written set of bylaws or other appropriate policies and procedures for the operation of the facility. These shall: (a) State the purpose of the facility; (b) Specify by title the person who is responsible for the operation and maintenance of the facility, and methods established by the governing body for holding that person responsible; (c) Provide for at least annual meetings of the governing body; and (d) Provide a policy and procedure manual that is designed to ensure professional and safe care for patients including, but not limited to: (A) Admission criteria; (B) Rights and responsibilities of patients; (C) Care of patients; (D) Patient grievance procedures; (E) Infection control policies; (F) Personnel qualifications and training requirements; (G) Consultant qualifications, functions, and responsibilities; (H) Reprocessing of hemodialyzers; (I) Emergency management of patients; (J) Annual reviews of the facilities policies, procedures and operation; and (K) A facility-wide Quality Assessment and Performance Improvement (QAPI) program to evaluate the provision of patient care. The program shall have a written plan of implementation. Quality data shall be reviewed and analyzed quarterly. The QAPI program shall be reviewed at least annually. It shall be designed to effectively identify and correct problems. Written documentation of QAPI activities shall be available at the facility. (4) The governing body shall review implementation of these policies at least annually to ensure that the intent of the policies is carried out. These policies shall be developed by the physician responsible for supervising and directing the provision of dialysis services, or the facility's organized medical staff, with the advice from a group of professional personnel associated with the facility, including, but not limited to, one or more physicians and one or more registered nurses experienced in rendering dialysis care. (5) An administrator shall be appointed by the governing body, shall be responsible for the management of the facility, and shall assure adherence to facility policies and procedures. The required full time nurse manager may serve as the administrator. Any change in the administrator shall be reported to the Division in writing within 30 days. The administrator must have sufficient experience in the management of dialysis facilities, or appropriate education so as to assure that they are qualified to carry out their responsibilities. (6) The following documents shall be available at the facility: (a) Appropriate documents showing control and ownership; (b) Bylaws, policies and procedures of the governing body; (c) Minutes of the governing body meetings; (d) Minutes of the facility's professional staff meetings; (e) Reports of inspections, reviews, and corrective actions taken related to licensure; (f) Minutes of the facility's quality improvement meetings; and (g) Contracts and agreements to which the facility is a party. (7) Medical Staff: (a) If more than one physician practices at the facility, the physicians shall be organized as a Medical Staff with appropriate bylaws approved by the governing body. The medical staff shall meet at least once a year, and minutes shall be maintained at the facility of such meetings; (b) The Governing Body shall designate a qualified physician as the physician-director of the facility. The physician-director shall be responsible for the development and implementation of patient care policies and medical staff bylaws, rules, and regulations; (c) A qualified physician with demonstrated experience in the care of patients receiving dialysis shall be on call and available to patients within a reasonable time frame; (d) The facility shall require and the medical director shall ensure that any adverse medical patient outcomes are communicated to the patient's physician, and that the facility takes appropriate corrective action. (8) Transfer Agreement: Each facility shall have in effect an agreement with one or more hospitals, for the provision of inpatient care or other hospital services. The transfer agreement shall provide the basis for an effective working agreement under which the services of the hospital are promptly available to the facility's patients as needed. The facility shall have on file documentation of this agreement. There shall be reasonable assurances that: (a) Transfer of patients must be effected between the hospital and the facility whenever such transfer is deemed medically necessary by the physician, with timely acceptance and admission; (b) There shall be interchange, within one working day, of medical or other necessary information useful in the medical care of the patient transferred to a hospital, or to another facility; and (c) Security and accountability are assured for the patient's personal effects. (9) The patient care policies shall cover the following: (a) Scope of services provided by the facility (either directly or under arrangement); (b) Admission and discharge policies (in relation to both in-facility care and home care); (c) Medical supervision and physician services; (d) Patient care plans, frequency of review, and methods of implementation; (e) Care of patients in medical and other emergencies; (f) Pharmaceutical services; (g) Medical records (including those maintained onsite, maintained offsite by the facility, maintained in the patients' homes); (h) Administrative records; (i) Use and maintenance of the physical plant and equipment; and (j) The provision of home dialysis support services, if offered. (10) The physician-director of the facility must be designated in writing and must be responsible for the execution of patient care policies. If the responsibility for day-to-day execution of patient care policies has been delegated by a physician-director to a registered nurse, the physician-director shall provide medical guidance in such matters. (11) The facility policy shall provide that, whenever feasible, hours for dialysis are scheduled for patient convenience and that arrangements are made to accommodate employed patients who wish to be dialyzed during their non-working hours. (12) The governing body shall adopt policies to ensure there is evaluation of the progress each patient is making toward the goals stated in the patient's care plan. Such evaluations shall be carried out through regularly scheduled conferences, with participation by the staff involved in the patient's care. (13) Medical supervision and emergency coverage: The governing body of the facility shall ensure that the health care of every patient is under the continuing supervision of a physician. (14) The physician responsible for the patient's medical supervision shall evaluate the patient's immediate and long-term needs and shall prescribe a planned regimen of care which covers indicated dialysis and other treatments, services, medications, diet, special procedures recommended for the health and safety of the patient, and plans for continuing care and discharge. Such plans are made with input from other professional personnel involved in the care of the patient. The facility staff must ensure the physician orders are implemented appropriately. (15) The governing body must ensure that medical care is available for emergencies during the hours the facility is in operation. The facility shall post at the nursing/monitoring station a roster with the names of the physicians to be called and how they can be reached. There shall be a system in place that must direct patients who call during non-operational hours to appropriate assistance. Statutory/Other Authority: ORS 441.015 & 441.025 Statutes/Other Implemented: ORS 441.025 & 441.055 History: PH 4-2012, f. 3-30-12, cert. ef. 4-1-12 PH 7-2003, f. & cert. ef. 6-6-03