15.1 General
1. If the healthcare organization furnishes anesthesia services, they shall be provided in a well- organized manner under the direction of a qualified Doctor of Medicine. The service is responsible for policy for delivery of all anesthesia and sedation administered in the healthcare organization.
NOTE 1 Areas where anesthesia services are furnished may include but are not limited to:
a) operating room suites, both inpatient and outpatient;
b) obstetrical suites;
c) radiology department;
d) clinics;
e) emergency department;
f) psychiatry department;
g) special procedure areas (endoscopy, pain management clinics, etc.).
2. Anesthesia services shall be appropriate to the scope of the services offered. Policy and procedures shall be in keeping with recognized national/international standards of care and supervision, statutory and regulatory requirements, and the organizational Governing Body and medical staff.
3. The anesthesia services shall be under the direction of an individual who is a qualified Doctor of Medicine. This individual shall be approved by the healthcare organization’s Governing Body upon the recommendation of the medical staff. Documentation of this individual’s qualifications shall be consistent with the recommendations of recognized national/international standards.
4. The anesthesia department shall be responsible for the development of specific criteria granting delineated privileges to those members of the medical staff and other qualified LIPs, who deliver anesthesia and/or sedation services within the healthcare organization.
5. Privileges for various classes of delivery shall be approved by the Governing Body upon the recommendation of the medical staff.
NOTE 2 The definitions below illustrate distinctions among the various types of "anesthesia services" and sedation that may be offered by a healthcare organization. Anesthesia
a) General anesthesia: a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory support is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. For example, a patient undergoing major abdominal surgery involving the removal of a portion or all of an organ would require general anesthesia in order to tolerate such an extensive surgical procedure. General anesthesia is used for those procedures when loss of consciousness is required for the safe and effective delivery of surgical services.
b) Regional anesthesia: the delivery of anesthetic medication at a specific level of the spinal cord and/or to peripheral nerves, including epidurals and spinals and other central neuraxial nerve blocks, is used when loss of consciousness is not desired but sufficient analgesia and loss of voluntary and involuntary movement is required. Regional anesthesia is not anesthesia, however, given the potential for the conversion and extension of regional to general anesthesia in certain procedures, it is necessary that the administration of regional and general anesthesia be delivered or supervised by a practitioner.
c) Monitored anesthesia care (MAC): anesthesia care that includes the monitoring of the patient by a practitioner who is qualified to administer anesthesia. Indications for MAC depend on the nature of the procedure, the patient’s clinical condition, and/or the potential need to convert to a general or regional anesthetic. Deep sedation/analgesia is included in MAC.
d) Deep sedation/analgesia: a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Because of the potential for the inadvertent progression to general anesthesia in certain procedures, it is necessary that the administration of deep sedation/analgesia be delivered or supervised by a practitioner. Sedation
a) Moderate sedation/analgesia: ("conscious sedation"): a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
b) Minimal sedation: a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilator and cardiovascular functions are unaffected. This is also not anesthesia.
c) Topical or local anesthesia: the application or injection of a drug or combination of drugs to stop or prevent a painful sensation to a circumscribed area of the body where a painful procedure is to be performed. There are generally no systemic effects of these medications, which also are not anesthesia, despite the name.
d) Analgesia: involves the use of a medication to provide relief of pain through the blocking of pain receptors in the peripheral and/or central nervous system and does in and of itself meet the definition of anesthesia. The patient does not lose consciousness and does not perceive pain to the extent that may otherwise prevail. However, if additional pain control or sedation is anticipated, it is likely that the requirements of anesthesia supervision would be indicated.
NOTE 3 Healthcare organizations shall address whether the sedation typically provided in the emergency department or other procedure areas involves anesthesia or analgesia in order to serve the patient in a safe manner. Practitioners should not exceed their clinical privileges granted by the Governing Body.
NOTE 4 Healthcare organization anesthesia services policies and procedures are expected to also address the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia and sedation services, particularly moderate sedation.
15.2 Rescue Capacity
1. In order to provide patient care in a safe setting, healthcare organizations shall ensure that procedures are in place to rescue patients whose level of sedation becomes deeper than initially intended, specifically, patients who inadvertently enter a state of deep sedation/analgesia when moderate sedation was intended.
2. Anesthesia policy and procedure shall address the requirement that any staff administering medications for analgesia shall be appropriately qualified and credentialed, and that the medications are administered in accordance with accepted standards of practice.
NOTE 1 Rescue from a deeper level of sedation than intended requires an intervention by a practitioner with expertise in airway management, advanced life support, and the qualifications to correct the adverse physiologic consequences of the deeper-than-intended level of sedation so as to return the patient to the originally intended level of sedation.
15.3 Monitoring and Measuring Responsibility of Anesthesia Services
1. The anesthesia services policies and procedures shall undergo periodic review and re-evaluation at least annually.
2. Analysis of significant unexpected adverse events, medication errors (See also 21.2.and 21.2.3.), and other quality or safety concerns related not only to anesthesia, but also to those clinical activities defined as sedation and analgesia, shall be done. Results of this activity shall be reported to Top Management and medical staff (See 4.7).
3. Ongoing monitoring and measurement of specified relevant clinical and administrative quality indicators shall be performed. These indicators shall be chosen with priority to the impact and effect of risk involved.
4. Selected indicators shall include oversight in collaboration with other clinical and support disciplines (e.g., surgery, pharmacy, nursing, infection prevention/control, life safety, material management, etc.) that are involved in delivering anesthesia services to patients in the various areas in the healthcare organization.
5. Results of this monitoring and measuring shall be reviewed by the medical staff and Top Management of healthcare organization. Records of corrections, corrective actions or modifications for continual improvement made as a result of this activity shall be maintained and retained as a documented information as required by the healthcare organization.
NOTE 1 Healthcare organizations are free to develop their own specific organizational arrangements in order to deliver all anesthesia services in a well-organized manner. Although not required under the standard to do so, a well-organized anesthesia service would develop the healthcare organization’s anesthesia policies and procedures in collaboration with several other healthcare organization disciplines (e.g., surgery, pharmacy, nursing, safety experts, material management, etc.) that are involved in delivering these services to patients in the various areas in the healthcare organization.
15.4 Delivery of Services
1. Anesthesia shall be administered only by:
a) a qualified anesthesiologist;
b) a Doctor of Medicine other than an anesthesiologist according to healthcare organization policy;
c) a dentist, oral surgeon, who is qualified to administer anesthesia according to healthcare organization policy;
d) a CRNA under the supervision of a credentialed anesthesiologist not otherwise involved in a procedure and who is immediately available for assistance.
2. No anesthetic shall be delivered by an RN, supervised or otherwise.
NOTE 1 An credentialed anesthesiologist is considered "immediately available for assistance" only when he or she is physically located within the same area as the CRNA, e.g., in the same operative suite, or in the same labor and delivery unit, or in the same procedure room, and not otherwise occupied in a way that prevents him/her from immediately conducting hands-on intervention, when required.
NOTE 2 Please see 17.2.1., 17.2.2. re obstetrical anesthesia and NOTE 1 in 15.4.1. above.
15.5 Organization and Staffing
1. Anesthesia service shall be integrated into the healthcare organization’s management system in order to assure the provision of safe care to patients.
2. Anesthesia services shall be consistent with needs, resources, healthcare organization mission specifically addressing continual improvement and patient satisfaction.
3. Policies on anesthesia procedures shall include the delineation of pre-anesthesia and post- anesthesia responsibilities.
4. The policies shall ensure that the following are provided for each patient:
a) patient informed consent consistent with the required elements of an informed consent as defined previously in STANDARD 11.2.4, specifically addressing the documentation of direct physician and patient discussions of risk, benefit and alternatives;
b) infection control measures;
c) safety practices in all anesthetizing areas;
d) protocol for supportive life functions;
e) quality and outcome reporting requirements;
f) documentation requirements;
g) equipment requirements, as well as the monitoring, inspection, testing, and maintenance of anesthesia equipment in the healthcare organization’s biomedical equipment program.
5. A pre-anesthesia, and post anesthesia evaluation shall be performed for each patient who receives general, regional, or monitored anesthesia care by a credentialed practitioner qualified to give anesthesia. This standard shall not permit practitioners who are not qualified to administer anesthesia to assume this responsibility.
6. A pre-anesthesia evaluation shall:
a) include a review of the medical history;
b) include an interview and examination of the patient;
c) include a documented airway assessment;
d) include an anesthesia risk assessment such as an ASA risk classification;
e) include an anesthesia medication and allergy history;
f) utilize consultation data no older than 30 days in origin;
g) be performed within 48 hours prior to the patient's anesthetic induction.
7. There shall be an intra-operative anesthesia record or report for each patient who receives general, regional, or monitored anesthesia. Current standard of care stipulates that an intra-operative anesthesia record, at a minimum, includes:
a) name and healthcare organization identification number of the patient;
b) name(s) of practitioner(s) who administered anesthesia, and as applicable, the name and profession of the supervising anesthesiologist or operating practitioner;
c) name, dosage, route and time of administration of drugs and anesthesia agents;
d) techniques(s) used and patient position(s), including the insertion/use of any intravascular or airway devices;
e) name and amounts of IV fluids, including blood or blood products if applicable;
f) timed-based documentation of vital signs as well as oxygenation and ventilation parameters;
g) any complications, adverse reactions, or problems occurring during anesthesia, including time and description of symptoms, vital signs, treatments rendered, and patient’s response to treatment.
8. A post-anesthesia evaluation shall be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia services.
9. The post-anesthesia evaluation shall be completed in accordance with National law and with healthcare organization policies and procedures that have been approved by the medical staff and that reflect current standards of anesthesia care. The elements of an adequate post-anesthesia evaluation shall be clearly documented and include:
a) respiratory function, including respiratory rate, airway patency, and oxygen saturation;
b) cardiovascular function, including pulse rate and blood pressure;
c) mental status;
d) temperature;
e) level of pain;
f) presence of nausea and/or vomiting;
g) hydration requirements ;
h) any additional type of monitoring or assessment as may be reasonably indicated by standard of care and the specific surgery or procedure performed including any requirement of the opioid oversight and use committee.
NOTE 1 The calculation of the 48-hour timeframe begins at the time of entry to the PACU or ICU if indicated. This evaluation shall occur when the patient is sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation if possible. (e.g., answer questions appropriately, perform simple tasks, etc.). While the evaluation should begin in the PACU/ICU or other designated recovery location, it may be completed a later time after the patient arrives in that location. In the case of outpatient surgeries, it may occur after the patient is discharged, so long as it is completed within 48 hours. For those patients who are unable to participate in the post-anesthesia evaluation (e.g., post-operative sedation, mechanical ventilation, etc.), a post-anesthesia evaluation should be completed and documented within 48 hours with notation that the patient was unable to participate. This documentation should include the reason for the patient’s inability to participate as well as expectations for recovery time, if applicable. An additional follow-up note should then be included in the patient record at a later time reflecting current recovery progress and physical condition if possible.
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