333-700-0100 Patient Care Staff (1) The facility shall maintain a personnel record for each staff member which includes, but is not limited to documentation of the following: (a) Hire date; (b) Required current license or certification; (c) Orientation completed prior to commencement of duties; (d) Job description; (e) Employment application; (f) Annual evaluation(s); (g) Education and qualifications; (h) Health status to include at a minimum: (A) Documentation of compliance with OAR 333-019-0041 for assessing the risk of tuberculosis transmission; and (B) Documentation of Hepatitis B (HbsAg) testing according to CDC guidelines; (i) Current CPR certification for direct patient care personnel. (2) Properly trained personnel must be present in adequate numbers to meet the needs of the patients, including those needs arising from medical and nonmedical emergencies. Employees who have not demonstrated competency as defined by facility policy must not be counted in the staff/patient ratios. (3) The facility must employ at least one full time qualified registered nurse responsible for nursing service: (a) This registered nurse may also act as the required full time nurse manager; (b) There shall be a registered nurse or physician, experienced in rendering ESRD care in the facility to supervise care whenever patients are undergoing dialysis treatments; and (c) A registered nurse or physician shall be designated as the charge person in each facility to oversee ESRD patient care. (4) An adequate number of personnel must be present to ensure that the staff/patient ratio is appropriate to the level of dialysis care being provided. The staffing levels must be adjusted based on the individual and aggregate needs of the patients. (5) At a minimum, the staffing level at a facility shall not exceed four patients receiving hemodialysis treatments per licensed nurse or CHDT providing direct patient care. (6) During treatment times, there shall be a minimum of one registered nurse (RN) available for every 16 patients. If more than 16 patients are receiving hemodialysis treatments at one time, there shall be an additional registered nurse present. Should the RN to patient ratio exceed 1 to 12, the RN shall not be counted as part of the 1 to 4 direct patient care ratio. (7) The facility shall have a staffing plan in place that shall allow them to maintain staffing ratios in the event of sick calls, vacations and unscheduled absences. (8) The facility may continue to operate and treat scheduled patients in the event that circumstances temporarily do not allow these staffing levels to be met if the medical director or designee determines this can be done safely: (a) These circumstances shall be documented in the records of the facility; and (b) These circumstances must not occur during more than five percent of the facility's operating hours in any six month period without approval of a waiver by the Division. (9) These staffing ratios do not preclude the use of new technology or experimental models. Application for a waiver may be made to the Division by facilities wishing to implement new technology. (10) The facility shall be responsible for developing and implementing a written facility-wide staffing plan for all patient care staff including registered nurses, licensed practical nurses, hemodialysis technicians, social workers, and dietitians. The facility shall have a process that ensures the consideration of input from patient care staff in the development, implementation, monitoring, evaluation, and modification of the staffing plan. The staffing plan shall include the number, qualifications, and categories of staff needed. The written staffing plan shall be evaluated and monitored for effectiveness, and revised as necessary, as part of the facility's QAPI process. Written documentation of these QAPI activities shall be maintained. (a) The written staffing plan shall be based on the care required by aggregate and individual needs of patients. This care shall be the major consideration in determining the number and categories of personnel needed. The written staffing plan shall be based on the specialized qualifications and competencies of the staff. The skill mix and the competency of the staff shall ensure that the needs of the patient are met and shall ensure patient safety. (b) The written staffing plan shall be consistent with the scopes of practice for RNs, LPNs, hemodialysis technicians, social workers, and dietitians. (c) The facility shall maintain a list of qualified staff that may be called to provide qualified replacement or additional staff in the event of emergencies, sickness, vacations, vacancies and other absences of staff and that provides a sufficient number of replacement staff for the facility on a regular basis. The list shall be available to the individual responsible for obtaining replacement staff. (d) The written staffing plan shall establish minimum numbers of personnel (RNs, LPNs, hemodialysis technicians, social workers and dietitians) on specified shifts. The number of personnel on duty shall be sufficient to assure that the needs of each patient are met. In no case shall fewer than one registered nurse and one other staff member be on duty when a patient is undergoing dialysis treatment. (e) After a facility learns about the need for replacement staff, the facility shall make every reasonable effort to obtain staff for unfilled hours or shifts before requiring a patient care staff member to work overtime. Reasonable effort includes the facility seeking replacement at the time the vacancy is known and contacting all available resources as described in section (2) of this rule. Such efforts shall be documented. (f) The facility shall have a workable plan in place to deal with both medical and non-medical emergencies. (g) If the facility offers self-care dialysis training, a qualified licensed nurse must be in charge of such training. (h) Licensed practical nurses. This chapter does not preclude a licensed practical nurse (LPN) from practicing in accordance with the rules adopted by the Oregon State Board of Nursing. If the LPN is acting in the capacity of a hemodialysis technician, the facility shall ensure that the LPN is functioning within his/her job description and scope of practice. (11) Employee Orientation and Training: Each facility shall have and execute a written orientation and training program to familiarize each employee with his/her job responsibilities. The facility shall maintain documentation that each staff member has attended the orientation program. Each employee shall be evaluated to assure that he/she possesses at least the minimum competencies required to perform his/her job function. (a) The facility orientation program for all staff, approved by the medical director shall include at least: (A) Review of the services provided by the facility; (B) Review of facility policies and procedures, including general infection control procedures and use of universal precautions; (C) The facility's emergency procedures and disaster preparedness plans; (D) Training in the use of fire extinguishers; (E) The facility's Quality Assessment and Performance Improvement Program; (F) Documentation and records requirements; and (G) Job descriptions that adequately describe the duties of every position including: (i) Position; (ii) Title; (iii) Scope of authority; (iv) Specific responsibilities; and (v) Minimum requirements. (b) The facility shall conduct and document a training needs assessment to identify training needs specific to care for the dialysis patients, and shall document the provision of such training by a qualified instructor. (12) Job descriptions shall be given to each employee when assigned to a position or when the job description is revised. A copy of this job description signed by the employee shall be maintained in the employee's file. (13) The facility shall also maintain documentation of the satisfactory completion by each staff member of a skills competency checklist. (14) Trainees must not be counted in staffing ratios until documentation reflects they are qualified to work independently. Patients shall be informed when trainees are participating in their treatment and the trainee shall be supervised at all times. (15) All staff must maintain required current certification and licensure according to the requirements of their profession. (16) The physician-director shall be responsible for ensuring that each patient caregiver has completed the appropriate training and orientation, and has demonstrated competence in their roles. This responsibility may be delegated to the facility's administrative and education staff. There must be documentation to reflect this delegation. (17) The most recent statement of deficiencies resulting from an inspection by the state agency shall be reviewed with the staff and shall be available in the facility for reference. Statutory/Other Authority: ORS 441.015 & 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 14-2020, amend filed 03/24/2020, effective 03/24/2020 PH 4-2012, f. 3-30-12, cert. ef. 4-1-12 PH 7-2003, f. & cert. ef. 6-6-03