§ 485.524 Condition of participation: Additional outpatient medical and health services. If the REH provides outpatient medical and health services in addition to providing emergency services and observation care, the medical and health services must be appropriately organized and meet the needs of the patients in accordance with acceptable standards of practice. ( a ) *Standard: Patient services.* The REH may provide outpatient and medical health diagnostic and therapeutic items and services that are commonly furnished in a physician's office or at another entry point into the health care delivery system that include, but are not limited to, radiology, laboratory, outpatient rehabilitation, surgical, maternal health, and behavioral health services. If the REH provides outpatient and medical health diagnostic and therapeutic items and services, those items and services must align with the health needs of the community served by the REH. If the REH provides outpatient medical and health services in addition to providing emergency services, the REH must— ( 1 ) Provide items and services based on nationally recognized guidelines and standards of practice;
( 2 ) Have a system in place for referral from the REH to different levels of care, including follow-up care, as appropriate;
( 3 ) Have effective communication systems in place between the REH and the patient (or responsible individual) and their family, ensuring that the REH is responsive to their needs and preferences;
( 4 ) Have established relationships with hospitals that have the resources and capacity available to deliver care that is beyond the scope of care delivered at the REH; and
( 5 ) Have personnel providing these services who meet the requirements at paragraph (b) of this section.
( b ) *Standard:* Personnel for additional outpatient and medical health services. The REH must— ( 1 ) Assign one or more individuals to be responsible for outpatient services.
( 2 ) Have appropriate professional and nonprofessional personnel available at each location where outpatient services are offered, based on the scope and complexity of outpatient services.
( 3 ) For any specialty services offered at the REH, have a doctor of medicine or osteopathy, nurse practitioner, clinical nurse specialist, or physician assistant providing services with experience and training in the specialty service area and in accordance with their scope of practice.
( c ) Standard: Orders for outpatient medical and health services. Outpatient medical and health services must be ordered by a practitioner who meets the following conditions: ( 1 ) Is responsible for the care of the patient.
( 2 ) Is licensed in the state where they provide care to the patient.
( 3 ) Is acting within their scope of practice under state law.
( 4 ) Is authorized in accordance with state law and policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services. This applies to the following: ( i ) All practitioners who are appointed to the REH's medical staff and who have been granted privileges to order the applicable outpatient services.
( ii ) All practitioners not appointed to the medical staff, but who satisfy the requirements of paragraphs (c)(1) through (4) of this section for authorization by the medical staff and the REH for ordering the applicable outpatient services for their patients.
( d ) *Standard: Surgical services.* If the REH provides outpatient surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the REH in accordance with the designation requirements under paragraph (a) of this section. ( 1 ) *Designation of qualified practitioners.* The REH designates the practitioners who are allowed to perform surgery for REH patients, in accordance with its approved policies and procedures, and with state scope of practice laws. Surgery is performed only by— ( i ) A doctor of medicine or osteopathy, including an osteopathic practitioner recognized under section 1101(a)(7) of the Act;
( ii ) A doctor of dental surgery or dental medicine; or
( iii ) A doctor of podiatric medicine.
( 2 ) Anesthetic risk and evaluation. ( i ) A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed.
( ii ) A qualified practitioner, as specified in paragraph (d)(3) of this section, must examine each patient before surgery to evaluate the risk of anesthesia.
( iii ) Before discharge from the REH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (d)(3) of this section.
( 3 ) *Administration of anesthesia.* The REH designates the person who is allowed to administer anesthesia to REH patients in accordance with its approved policies and procedures and with state scope-of-practice laws. ( i ) Anesthesia must be administered by only— ( A ) A qualified anesthesiologist;
( B ) A doctor of medicine or osteopathy other than an anesthesiologist; including an osteopathic practitioner recognized under section 1101(a)(7) of the Act;
( C ) A doctor of dental surgery or dental medicine;
( D ) A doctor of podiatric medicine;
( E ) A certified registered nurse anesthetist (CRNA), as defined in § 410.69(b) of this chapter;
( F ) An anesthesiologist's assistant, as defined in § 410.69(b) of this chapter; or
( G ) A supervised trainee in an approved educational program, as described in § 413.85 or §§ 413.76 through 413.83 of this chapter.
( ii ) In those cases in which a CRNA administers the anesthesia, the anesthetist must be under the supervision of the operating practitioner except as provided in paragraph (e) of this section. An anesthesiologist's assistant who administers anesthesia must be under the supervision of an anesthesiologist.
( 4 ) *Discharge.* All patients are discharged in the company of a responsible adult, except those exempted by the practitioner who performed the surgical procedure.
( 5 ) *Standard: State exemption.* ( i ) An REH may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (d)(3) of this section, if the state in which the REH is located submits a letter to CMS signed by the Governor, following consultation with the state's Boards of Medicine and Nursing, requesting exemption from physician supervision for CRNAs. The letter from the Governor must attest that they have consulted with the state Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the state and has concluded that it is in the best interests of the state's citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with state law.
( ii ) The request for exemption and recognition of state laws and the withdrawal of the request may be submitted at any time, and are effective upon submission.