Title: Section 405.13 - Anesthesia services
405.13 Anesthesia services. If anesthesia services are provided within a hospital, the hospital shall develop, implement and keep current effective written policies and procedures regarding staff privileges consistent with provisions set forth in section 405.4 of this Part, the administration of anesthetics, the maintenance of safety controls and the integration of such services with other related services of the hospital to protect the health and safety of the patients in accordance with generally accepted standards of medical practice and patient care. Such policies and procedures shall be reviewed and updated as necessary, but at a minimum biennially. Hospitals providing living liver donor transplants shall also comply with the provisions contained in Section 405.31(p)(2). (a) Organization and direction. Anesthesia services shall be directed by a physician who has responsibility for the clinical aspects of organization and delivery of all anesthesia services provided by the hospital. That physician or another individual qualified by education and experience shall direct administrative aspects of the service.
(1) The director shall be responsible, in conjunction with the medical staff, for recommending to the governing body privileges to those persons qualified to administer anesthetics, including the procedures each person is qualified to perform and the levels of required supervision as appropriate. Anesthesia shall be administered in accordance with their credentials competencies and privileges by the following:
(ii) physicians granted anesthesia privileges;
(iii) dentists, oral surgeons, or podiatrists who are qualified to administer anesthesia under State law;
(iv) certified registered nurse anesthetists (CRNA's) under the supervision of an anesthesiologist who is immediately available as needed or under the supervision of the operating physician who has been found qualified by the governing body and the medical staff to supervise the administration of anesthetics and who has accepted responsibility for the supervision of the CRNA; or
(v) a student enrolled in a school of nurse anesthesia accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs may administer anesthesia as related to such course of study under the direct personal supervision of a certified registered nurse anesthetist or an anesthesiologist.
(2) Anesthesia service policies shall clearly outline requirements for orientation and continuing education programs for all staff, and staff compliance with such requirements shall be considered at the time of reappointment or performance evaluation. Such training clinical competencies and continuing education programs shall be established that are relevant to care provided but must, at a minimum, include instruction in safety precautions, equipment usage and inspections, infection control requirements and any patients' rights requirements pertaining to surgical/anesthesia consents.
(3) The director shall, in conjunction with the medical staff, monitor the quality and appropriateness of anesthesia related patient care and ensure that identified problems are reported to the quality assurance committee and are resolved.
(b) Operation and service delivery. Policies governing anesthesia services shall be designed to ensure the achievement and maintenance of generally accepted standards of medical practice and patient care.
(1) All anesthesia machines shall be numbered and reports of all equipment inspections and routine maintenance shall be included in the anesthesia service records. Policies and procedures shall be developed and implemented regarding notification of equipment disorders/malfunctions to the director, to the manufacturer and, in accordance with section 405.8 of this Part, to the department.
(2) Written policies regarding anesthesia procedures shall be developed and implemented which shall clearly delineate pre-anesthesia and post-anethesia responsibilities. These policies shall include, but not be limited to, the following elements:
(i) Pre-anesthesia physical evaluations shall be performed by an individual qualified to administer anesthesia and recorded within 48 hours, prior to surgery.
(ii) Routine checks shall be conducted by the anesthetist prior to every administration of anesthesia to ensure the readiness, availability, cleanliness, sterility when required, and working condition of all equipment used in the administration of anesthetic agents.
(iii) All anesthesia care shall be provided in accordance with generally accepted standards of practice and shall ensure the safety of the patient during the administration, conduct of and emergence from anesthesia. The following continuous monitoring is required during the administration of general and regional anesthetics. Such continuous monitoring is not required during the administration of anesthetics administered for analgesia or during the administration of local anesthetics unless medically indicated.
(a) An anesthetist shall be continuously present in the operating room throughout the administration and the conduct of all general anesthetics, regional anesthetics, and monitored anesthesia care. If there is a documented hazard to the anesthetist which prevents the anesthetist from being continuously present in the operating room, provision must be made for monitoring the patient. (b) All patients must be attended by the anesthetist during the emergence from anesthesia until they are under the care of qualified post-anesthesia care staff or longer as necessary to meet the patient's needs.
(c) During all anesthetics, the heart sounds and breathing sounds of all patients shall be monitored through the use of a precordial or esophogeal stethoscope. Such equipment or superior equipment shall be obtained and utilized by the hospital.
(d) During the administration and conduct of all anesthesia services the patient's oxygenation shall be continuously monitored to ensure adequate oxygen concentration in the inspired gas and the blood through the use of a pulse oximeter or superior equipment that is age and size appropriate. During every administration of general anesthesia using an anesthesia machine, the concentration of oxygen in the patient's breathing system shall be measured by an oxygen analyzer with a low oxygen concentration limit alarm.
(e) All patients' ventilation shall be continuously monitored during the conduct of anesthesia. During regional anesthesia, monitored anesthesia care and general anesthesia with a mask, the adequacy of ventilation shall be evaluated through the continual observation of the patient's qualitative clinical signs. For every patient receiving general anesthesia with an endotracheal tube, the quantitative carbon dioxide content of expired gases shall be monitored through the use of endtidal carbon dioxide analysis or superior technology. In all cases where ventilation is controlled by a mechanical ventilator, there shall be in continous use an alarm that is capable of detecting disconnection of any components of the breathing system.
(f) The patient's circulatory functions shall be continuously monitored during all anesthetics. This monitoring shall include the continuous display of the patient's electrocardiogram, from the beginning of anesthesia until preparation to leave the anesthetizing location, and the evaluation of the patient's blood pressure and heart rate at least every five minutes.
(g) During every administration of anesthesia, there shall be immediately available a means to continuously measure the patient's temperature.
(iv) All equipment and services provided shall be age and size appropriate. (v) Intraoperative anesthesia records shall document all pertinent events that occur during the induction, maintenance, and emergence from anesthesia. These pertinent events shall include, but not be limited to, the following: intraoperative abnormalities or complications, blood pressure, pulse, dosage and duration of all anesthetic agents, dosage and duration of other drugs and intravenuous fluids, and the administration of blood and blood components. The record shall also document the general condition of the patient.
(vi) With respect to inpatients a post-anesthetic follow-up evaluation and report by the individual who administered the anesthesia or by an individual qualified to administer anesthesia shall be written not less than three or more than 48 hours after surgery and shall note the presence or absence of anesthesia related abnormalities or complications, and shall evaluate the patient for proper anesthesia recovery and shall document the general condition of the patient.
(vii) With respect to outpatients, a post-anesthesia evaluation for proper anesthesia recovery performed in accordance with policies and procedures approved by the medical staff shall be documented for each patient prior to hospital discharge.
(3) Safety precautions shall be clearly identified in written policies and procedures specific to the department and include, but not be limited to:
(i) safety regulations posted;
(ii) routine inspection and maintenance of equipment;
(iii) use and maintenance of shockproof equipment;
(iv) proper grounding; and
(v) infection control.
VOLUME C (Title 10)