42 C.F.R. Subpart D—Optional Hospital Services
Title 42 - Public Health
If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. (a) Standard: Organization and staffing. The organization of the surgical services must be appropriate to the scope of the services offered. (1) The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy. (2) Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may serve as “scrub nurses” under the supervision of a registered nurse. (3) Qualified registered nurses may perform circulating duties in the operating room. In accordance with applicable State laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the surpervision of a qualified registered nurse who is immediately available to respond to emergencies. (4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. (b) Standard: Delivery of service. Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. (1) There must be a complete history and physical work-up in the chart of every patient prior to surgery, except in emergencies. If this has been dictated, but not yet recorded in the patient's chart, there must be a statement to that effect and an admission note in the chart by the practitioner who admitted the patient. (2) A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies. (3) The following equipment must be available to the operating room suites: call-in-system, cardiac monitor, resuscitator, defibrillator, aspirator, and tracheotomy set. (4) There must be adequate provisions for immediate post-operative care. (5) The operating room register must be complete and up-to-date. (6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. (a) Standard: Organization and staffing. The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by— (1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c)of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or (5) An anesthesiologist's assistant, as defined in §410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed. (b) Standard: Delivery of services. Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of preanesthesia and post anesthesia responsibilities. The policies must ensure that the following are provided for each patient: (1) A preanesthesia evaluation by an individual qualified to administer anesthesia under paragraph (a) of this section performed within 48 hours prior to surgery. (2) An intraoperative anesthesia record. (3) With respect to inpatients, a postanesthesia followup report by the individual who administers the anesthesia that is written within 48 hours after surgery. (4) With respect to outpatients, a postanesthesia evaluation for proper anesthesia recovery performed in accordance with policies and procedures approved by the medical staff. (c) Standard: State exemption. (1) A hospital may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (a)(4) of this section, if the State in which the hospital 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 of CRNAs. The letter from the Governor must attest that he or she has consulted with 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. (2) 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. [51 FR 22042, June 17, 1986 as amended at 57 FR 33900, July 31, 1992; 66 FR 56769, Nov. 13, 2001] If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice. (a) Standard: Organization and staffing. The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered. (1) There must be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine. (2) The qualifications, training, functions, and responsibilities of nuclear medicine personnel must be specified by the service director and approved by the medical staff. (b) Standard: Delivery of service. Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice. (1) In-house preparation of radiopharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or a doctor of medicine or osteopathy. (2) There is proper storage and disposal of radioactive material. (3) If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services specified in §482.27. (c) Standard: Facilities. Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be— (1) Maintained in safe operating condition; and (2) Inspected, tested, and calibrated at least annually by qualified personnel. (d) Standard: Records. The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures. (1) The hospital must maintain copies of nuclear medicine reports for at least 5 years. (2) The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests. (3) The hospital must maintain records of the receipt and disposition of radiopharmaceuticals. (4) Nuclear medicine services must be ordered only by practitioner whose scope of Federal or State licensure and whose defined staff privileges allow such referrals. [51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992] If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice. (a) Standard: Organization. Outpatient services must be appropriately organized and integrated with inpatient services. (b) Standard: Personnel. The hospitals must— (1) Assign an individual to be responsible for outpatient services; and (2) Have appropriate professional and nonprofessional personnel available. The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. (a) Standard: Organization and direction. If emergency services are provided at the hospital— (1) The services must be organized under the direction of a qualified member of the medical staff; (2) The services must be integrated with other departments of the hospital; (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. (b) Standard: Personnel. (1) The emergency services must be supervised by a qualified member of the medical staff. (2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients. (a) Standard: Organization and staffing. The organization of the service must be appropriate to the scope of the services offered. (1) The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services. (2) Physical therapy, occupational therapy, or speech therapy, or audiology services, if provided, must be provided by staff who meet the qualifications specified by the medical staff, consistent with State law. (b) Standard: Delivery of services. Services must be furnished in accordance with a written plan of treatment. Services must be given in accordance with orders of practitioners who are authorized by the medical staff to order the services, and the orders must be incorporated in the patient's record. The hospital must meet the needs of the patients in accordance with acceptable standards of practice. The following requirements apply if the hospital provides respiratory care service. (a) Standard: Organization and Staffing. The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered. (1) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge experience, and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. (2) There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with State law. (b) Standard: Delivery of Services. Services must be delivered in accordance with medical staff directives. (1) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing. (2) If blood gases or other laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for laboratory services specified in §482.27. (3) Services must be provided only on, and in accordance with, the orders of a doctor of medicine or osteopathy. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 FR 7136, Feb. 28, 1992]
Title 42: Public Health
PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS
Subpart D—Optional Hospital Services
§ 482.51 Condition of participation: Surgical services.
§ 482.52 Condition of participation: Anesthesia services.
§ 482.53 Condition of participation: Nuclear medicine services.
§ 482.54 Condition of participation: Outpatient services.
§ 482.55 Condition of participation: Emergency services.
§ 482.56 Condition of participation: Rehabilitation services.
§ 482.57 Condition of participation: Respiratory care services.
