Section 485.528 - Condition of participation: Staffing and staff responsibilities(a)Standard: Emergency department staffing. The emergency department of the REH must be staffed 24 hours a day, 7 days a week by an individual or individuals competent in the skills needed to address emergency medical care. This individual(s) must be able to receive patients and activate the appropriate medical resources to meet the care needed by the patient.(b)Standard: Staffing.(1) The REH must have a professional health care staff that includes one or more doctors of medicine or osteopathy, and may include one or more physician assistants, nurse practitioners, or clinical nurse specialists.(2) Any ancillary personnel are supervised by the professional staff.(3) The staff is sufficient to provide the services essential to the operation of the REH.(4) A registered nurse, clinical nurse specialist, or licensed practical nurse is on duty whenever the REH has one or more patients receiving emergency care or observation care.(c)Standard: Responsibilities of the doctor of medicine or osteopathy.(1) The doctor of medicine or osteopathy must -(i) Provide medical direction for the REH's health care activities and consultation for, and medical supervision of, the health care staff.(ii) In conjunction with the physician assistant and/or nurse practitioner member(s), participate in developing, executing, and periodically reviewing the REH's written policies governing the services it furnishes.(iii) In conjunction with the physician assistant and/or nurse practitioner members, periodically review the REH's patient records, provide medical orders, and provide medical care services to the patients of the REH.(iv) Periodically review and sign a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants only to the extent where state law requires record reviews or co-signatures, or both, by a collaborating physician.(2) A doctor of medicine or osteopathy must be present for sufficient periods of time to provide medical direction, consultation, and supervision for the services provided in the REH, and is available through direct radio or telephone communication or electronic communication for consultation, assistance with medical emergencies, or patient referral.(d)Standard: Physician assistant, nurse practitioner, and clinical nurse specialist responsibilities.(1) The physician assistant, the nurse practitioner, or clinical nurse specialist members of the REH's staff must -(i) Participate in the development, execution and periodic review of the written policies governing the services the REH furnishes; and(ii) Participate with a doctor of medicine or osteopathy in a periodic review of the patients' health records.(2) The physician assistant, nurse practitioner, or clinical nurse specialist performs the following functions to the extent they are not being performed by a doctor of medicine or osteopathy:(i) Provides services in accordance with the REH's policies.(ii) Arranges for, or refers patients to, needed services that cannot be furnished at the REH, and assures that adequate patient health records are maintained and transferred as required when patients are referred.(3) Whenever a patient is placed in observation care at the REH by a nurse practitioner, physician assistant, or clinical nurse specialist, a doctor of medicine or osteopathy on the staff of the REH is notified of the patient's status.(e)Standard: Periodic review of clinical privileges and performance. The REH requires that - (1) The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the REH must be evaluated by a member of the REH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the REH.(2) The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the REH must be evaluated by one of the following - (i) One Quality Improvement Organization (QIO) or equivalent entity.(ii) In the case of distant-site physicians and practitioners providing telemedicine services to the REH's patient under an agreement between the REH and a distant-site hospital, the distant-site hospital; or(iii) In the case of distant-site physicians and practitioners providing telemedicine services to the REH's patients under a written agreement between the REH and a distant-site telemedicine entity, one Quality Improvement Organization (QIO) or equivalent entity.(3) The REH staff consider the findings of the evaluation and make the necessary changes as specified in paragraphs (b) through (d) of this section.