Deep Sedation Policy - Administration by Non-Anesthesia Providers for Diagnostic, Therapeutic and Surgical Procedures

Sedative and analgesic medications are commonly needed and used in the performance of diagnostic and therapeutic procedures, which can be anxiety producing, uncomfortable, painful, or pose an increased risk for injury with movement without such medication.

This policy outlines the requirements for the administration of deep sedation for diagnostic, therapeutic and minor surgical procedures and defines qualifications for non-anesthesia providers who are involved in the administration of deep sedation. This document applies only to the care of patients undergoing procedural sedation, and it may not be construed as privileges to intentionally administer general anesthesia. Unrestricted general anesthesia shall only be administered by anesthesia professionals within their scope of practice.

1. Inclusion Criteria
   1. These guidelines apply to any patient, adult or pediatric, given any sedative or analgesic medication with the intent of achieving deep level of sedation to facilitate a diagnostic, therapeutic or surgical procedure at the Michigan Medicine hospitals and facilities.
2. Exclusion Criteria
   1. Administration of oral pre-medications or medications given for pain, anxiety, or sleep when not associated with a diagnostic or therapeutic procedure;
   2. Patients who receive continuous IV sedation per protocol to manage conditions requiring mechanical ventilation (e.g., primary lung disease or injury, postsurgical intervention, etc.)
   3. Administration of sedative or anesthetic agents for emergent airway management or patients who are receiving sedation for the purpose of intubation not associated with a diagnostic or therapeutic procedure.

1. Sedation Levels: Sedation occurs over a continuum consisting of four levels each of which has different physiologic components. Patients can experience different levels of sedation over the course of the procedure which might be intentional or unintentional.
   1. Minimal Sedation: A drug induced state during which the patient responds normally to verbal commands. Cognitive function and coordination may be impaired. Ventilation and cardiovascular functions are unaffected.
   2. Moderate Sedation: A drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. A patent airway is maintained without help, spontaneous ventilation is adequate, and cardiovascular function is usually maintained. Loss of consciousness should not occur.
   3. Deep Sedation: A drug induced depression of consciousness during which patients cannot be easily aroused, but respond purposefully to 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 be delivered or supervised by a practitioner as specified in the Code of Federal Regulations 42 CFR 482.52(a). Providers of deep sedation are held to similar standards as those who provide anesthesia services.*
      1. *Monitored Anesthesia Care (“MAC”) does not describe the continuum of depth of sedation, rather it refers to “a specific anesthesia service in which an anesthesiologist has been requested to participate in the care of a patient undergoing a diagnostic or therapeutic procedure.”
   4. General Anesthesia: A drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function 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. If the patient loses consciousness and the ability to respond purposefully, the anesthesia care is a general anesthetic, irrespective of whether airway instrumentation is required.
2. Anesthesia Professional: An anesthesiologist, anesthesiologist assistant (AA), or certified registered nurse anesthetist (CRNA).
3. Deep Sedation Practitioner: A licensed physician (allopathic or osteopathic); or dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under state law.
4. ASA Physical Status: American Society of Anesthesiologists (ASA) physical status classification, as described by the following categories:
   1. ASA Physical Status 1: A normal healthy patient
   2. ASA Physical Status 2: A patient with mild systemic disease
   3. ASA Physical Status 3: A patient with severe systemic disease
   4. ASA Physical Status 4: A patient with severe systemic disease that is a constant threat to life
   5. ASA Physical Status 5: A moribund patient who is not expected to survive without the operation

1. The practice deep sedation is defined, monitored and evaluated by the Sedation Committee. Any permanent or ongoing changes in this practice, as outlined in these guidelines, must be approved by the Sedation Committee.
2. The Service Chief of each division or department practicing deep sedation is responsible for:
   1. Ensuring that all individuals engaged in the practice of deep sedation have the appropriate authorization, competency and/or training;
   2. Ensuring that there is sufficient qualified staff available in the immediate area of deep sedation to rescue the patient from a deeper than intended level of sedation and to provide monitoring during recovery;
   3. Ensuring participation in quality assurance and improvement activities as determined by the Sedation Committee.

1. When providing deep sedation, a deep sedation practitioner must remain physically present with the patient during the entire sedation course.
2. For procedures when deep sedation practitioner is also the primary provider performing the diagnostic, therapeutic, or minor surgical procedure, a team model consisting of at least three individuals, each appropriately trained, is required:
   1. A deep sedation practitioner as specified in Code of Federal Regulations 42 CFR 482.52(a) and defined in Section II C of this policy who functions as a team leader, directs deep sedation and is responsible for global management of the patient, monitoring while the patient is deeply sedated, as well for supervising all involved ancillary personnel.
   2. A second person whose responsibilities include assisting with deep sedation, documentation of monitoring and observation of the patient. This person may be a registered nurse, a nurse practitioner, a physician assistant, a physician or dentist in training, or another credentialed deep sedation practitioner.
   3. A third person whose responsibilities include assisting with the actual procedure being performed. The qualifications of this individual are determined by type of procedure and may vary on a case-to-case basis.
3. For cases when deep sedation practitioner is different from the person performing or supervising the diagnostic, therapeutic, or minor surgical procedure, the deep sedation practitioner must be dedicated entirely to the task of administering sedation and monitoring of the patient. While the team model of sedation may be utilized at the discretion of the deep sedation practitioner, physical presence of additional individuals is not required.
4. A deep sedation practitioner may not be engaged in activities that could prevent him or her from conducting hands-on interventions or rescue if the patient’s conditions require.
5. Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Practitioners intending to produce a deep level of sedation must be able to rescue patients whose level of sedation may exceed the target level and enter a state of general anesthesia. Therefore, individuals requesting privileges to administer deep sedation must be able to:
   1. Recognize that a patient has entered a state of general anesthesia;
   2. Maintain a patient’s vital functions until the patient has been returned to an appropriate level of sedation;
   3. Manage an unstable cardiovascular system as well as a compromised airway and inadequate oxygenation and ventilation.
6. A deep sedation practitioner may participate in teaching of residents or fellows during administration of deep sedation, provided that all of the above responsibilities are met.

A deep sedation practitioner must meet the following qualifications:

1. Current ACLS certification or hold current privileges in Emergency Medicine, Oral and Maxillofacial Surgery, Critical Care (adult or Pediatric) or Neonatology.
2. Be a physician or dentist member of the Medical Staff with active clinical privileges
3. Have a current unrestricted Drug Enforcement Administration (DEA) registration (schedules II-V).
4. Initial privileging criteria include having a written attestation from the Service Chief of provider’s division or department to certify proficiency in advanced airway management for rescue that includes clinical experience of no less than 25 patients or equivalent simulator experience in techniques of bag-valve-mask ventilation, insertion of oro- and nasopharyngeal airways, insertion and ventilation through a laryngeal mask airway, and direct laryngoscopy and endotracheal intubation and five (5) deep sedation procedures within the last year.
5. Successfully complete a deep sedation educational program through MLearning.
6. Focused Professional Practice Evaluation (FPPE) requirements will be based on member’s experience. If no past deep sedation experience, the member is required to complete five (5) deep sedation procedures under direct observation. If the member has experience, two (2) deep sedations procedures must be done under direct observation.
7. Privileging for deep sedation must be renewed every two years. Renewal criteria include completion of 5 deep sedations procedures and 5 airway management procedures (as defined in D. above) within the last two years. In addition, the renewal process includes written recommendation from the Service Chief of provider’s division or department to renew deep sedation privileges and successful biennial completion of a Deep Sedation module by the provider.

1. Deep sedation and analgesia will only occur in the emergency departments, critical care areas and the dental suites. Any additional deep sedation locations must be approved by the Sedation Committee and the Chair of the Department of Anesthesiology.
2. Each location in which deep sedation is administered must have the following provisions that are appropriate for patient age and size:
3. Oxygen supply from a portable or permanent source
4. Airway equipment including nasal cannulas, oral airways, bag and mask ventilation and intubation equipment
5. Continuous suction
6. Emergency cart
7. Physiological monitoring equipment:
   1. Pulse oximetry
   2. Blood pressure
   3. ECG
   4. Capnography with end tidal CO2
8. Stethoscope
9. Reversal agents (flumazenil and naloxone available in appropriate doses)
10. Plan for summoning emergency personnel quickly if needed (Code Team)

1. All patients requiring deep procedural sedation will have a pre-sedation assessment completed and documented within 48 hours prior to the delivery of the first dose of sedation medication(s). The preoperative assessment must be completed by a credentialed deep sedation practitioner or anesthesia professional (does not need to be the actual person providing sedation) and will include at a minimum:
   1. Review of the medical history, including anesthesia, drug and allergy history;
   2. Interview and examination of the patient;
   3. Review of systems specific to cardiopulmonary disease;
   4. Airway problems, either anatomical (i.e. micrognathia) or functional (i.e. obstructive sleep apnea). A Mallampati score will be noted at time of examination when age appropriate;
   5. History of problems with sedation and analgesia, or anesthesia;
   6. Current medications and allergies;
   7. Vital signs and weight;
   8. ASA physical status classification;
   9. NPO status;
   10. Formulation of sedation plan and discussion of the risks and benefits of the plan (including discharge issues when indicated) with the patient or the patient’s legal representative.
2. Patients deemed appropriate candidates for deep sedation will be stratified by the qualified deep sedation practitioner using the American Society of Anesthesiologists (ASA) physical status classification. Outside of the ICU, the services of an anesthesia professional should be considered for patients with a classification score of ASA 3 or greater. Additionally, anesthesia professional services should be considered for patients presenting with any of the following:
   1. History of adverse events associated with sedation and analgesia;
   2. Airway problems: i.e. obstructive sleep apnea, difficult intubation, or syndromes involving airway abnormalities;
   3. Delayed gastric emptying or increased risk of aspiration;
   4. Pregnant or breast feeding females.
      1. Clinician judgment of risk versus benefit should always be evident in the decision making process and documentation when administering sedation to any of the above categories of patients.
3. The following fasting guidelines apply for patients of all ages who are undergoing elective procedures.
   1. Both the amount and type of foods ingested must be considered when determining an appropriate fasting period.
   2. Unless contraindicated, children should be offered clear liquids until 2-3 hours before sedation and procedure to minimize the risk of dehydration

1. 1. In emergent situations or when patients are at risk for pulmonary aspiration of gastric contents, appropriate pharmacologic treatment to reduce gastric volume and increase gastric pH may be of benefit prior to sedation and/or airway protection may be required. In urgent situations when pre-procedure fasting is not practical, consideration should be given for consultation with the anesthesia service. Ultimately, the deep sedation provider should weigh the risks and benefits of proceeding with sedation of patients with shorter that recommended fasting times.

Administration and monitoring of deep sedation may only be performed by a qualified deep sedation practitioner or anesthesia professional. A registered nurse (RN) may assist in the procedure by acting strictly as a “third hand” while the qualified provider administers deep sedation.

1. A pre-sedation timeout will be performed in accordance with the established protocols to ensure that all of the required elements are in place and that it is the right patient, right procedure, right time, etc.
2. Supplemental oxygen will be administered during deep sedation, unless contraindicated.
3. A deep sedation record, at a minimum, will include:
   1. Name and hospital identification number of the patient;
   2. Name(s) of a deep sedation practitioner who administered sedation medications and monitored vital signs;
   3. Name of procedural practitioner;
   4. Name, dosage, route, and time of all administered drugs;
   5. Technique(s) used and patient position(s), including the insertion(s)/use of any intravascular or airway devices;
   6. Name and amounts of IV fluids, including blood or blood products if applicable;
   7. Any complications, adverse reactions, or problems occurring during deep sedation, including time and description of symptoms, vital signs, treatments rendered, and patient’s response to treatment;
   8. Status of the patient at the end of the procedural sedation episode.
4. During all deep sedation procedures, the patient’s oxygenation, ventilation, circulation, temperature, and level of sedation shall be continually evaluated and documented at least every 5 minutes.
   1. Oxygenation: continuous pulse oximetry with appropriate alarms should be monitored
   2. Ventilation: continuous ventilation should be monitored throughout the procedure. Ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for presence of exhaled carbon dioxide with an end tidal CO2 monitor.
   3. Circulation: continuous ECG and non-invasive blood pressure checked at least every 5 minutes or invasive blood pressure in patients with pre-existing arterial lines.
   4. Temperature: body temperature should be monitored when clinically significant changes in body temperature are intended, anticipated or suspected.
   5. Level of Sedation: the patient’s level of sedation, determined by their response to commands and stimulation, should be monitored throughout the procedure using the Michigan Medicine Sedation Scale and recorded at a minimum of every 5 minutes:

      • Score	Description
        0	Awake and alert
        1	Minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or sound
        2	Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation or a simple verbal command
        3	Deeply sedated: deep sleep, arousable only with significant repeated physical stimulation
        4	Unarousable

   6. Children may sometimes be an exception as verbal or tactile stimulation may disrupt an adequate level of sedation and thus disrupt completion of the procedure.
   7. If the procedure is less than 5 minutes, documentation should occur at the minimum:
      1. before the procedure;
      2. following administration of sedative/analgesia agents;
      3. upon completion of the procedure;
      4. during recovery;
      5. at discharge.
   8. Patients will not be transported whilst under deep sedation and analgesia unless that transport is taking place between induction areas, procedural areas, or recovery areas, and monitoring is continuously maintained.
   9. For patients receiving deep sedation, IV access must be maintained until they are no longer at risk for cardio respiratory depression.

1. Patients who received procedural deep sedation must be monitored in accordance with post-anesthesia hospital requirements for equipment, monitoring, and staffing – deep sedation is held to the same standard of care as if the patient received monitored anesthesia care and follows the Anesthesia Guidelines & Policies: IV-010-00: Discharge Criteria – PACU Phase I guideline.
2. Patient must be observed and have 2 sets of vital signs recorded (15 minutes apart); minimum length of stay will be 15 minutes. Patient should remain in PACU Phase I level of care until the systemic criteria are met as outlined in the PACU Phase I guideline.
3. For ICU patients, the patient will be monitored at the same standard as required during sedation with documentation recorded at least every 5 minutes for at least 30 minutes or until the patient has returned to their baseline status, whichever is greater.
4. If a reversal agent (e.g. naloxone or flumazenil) is used, the patient will be monitored for a minimum of two hours after reversal agent administration.
5. The qualified deep sedation practitioner will remain in the clinical area and be immediately available for urgent patient concerns until the patient has met PACU Phase I discharge criteria or has returned to their baseline status.
6. A qualified deep sedation practitioner (may be different from the one administering sedation) will complete a post-sedation evaluation no later than 48 hours following the deep sedation procedure. The calculation of the 48-hour timeframe begins at the point the patient is moved into the designated recovery area. The evaluation generally would not be performed immediately at the point of movement from the procedural area to the designated recovery area. Acceptable standards of care indicate that the evaluation may not begin until the patient is sufficiently recovered from the administration of deep sedation so as to participate in the evaluation (e.g. answer questions appropriately, perform simple tasks). The evaluation can occur in the PACU/ICU or other designated recovery location. For outpatients, the post-anesthesia evaluation must be completed prior to the patient’s discharge. The elements of an adequate post-sedation evaluation should be clearly documented and include the following:
   1. Respiratory function, including respiratory rate, airway patency, and oxygen saturation;
   2. Cardiovascular function, including pulse rate and blood pressure;
   3. Mental status;
   4. Temperature;
   5. Pain;
   6. Nausea and vomiting;
   7. Post-procedure hydration.
7. For inpatients, recovery must be complete before transfer back to the Unit that they came from. The nurse caring for the patient will arrange transport and determine the type of personnel necessary for transport. The nurse caring for the patient will provide a hand-off report in accordance with facility hand-off communication policies to the accepting nurse. Post- procedure orders and documentation of care received during the procedure will accompany the patient to the Unit.
8. For outpatients, the deep sedation practitioner will provide written discharge instructions related to the sedation. The following criteria must also be met:
   1. Patient must be able to sit without assistance or have their mobility at their pre-procedure level;
   2. Discharge planning and patient/family education will be done and documented;
   3. Patient should be instructed to not operate equipment, sign legal papers, make important decisions or drive for at least 24 hours post discharge;
   4. Emergency numbers must be provided to the patient;
   5. Clarification that the patient and accompanying responsible adult understands the written discharge instructions;
   6. Patient released to responsible adult present to escort patient home or to their usual place of residence.

1. Outcome measures are determined by the Michigan Medicine Sedation Committee as necessary for departmental and institutional process improvement, regulatory compliance and patient safety. Unexpected patient responses or outcomes occurring during the peri-procedural period or concerns regarding coordination of care will be documented and submitted electronically via the “Patient Safety Report Form.” These adverse events include, but not limited to:
   1. Allergic reaction requiring intervention
   2. The use of a reversal agent (e.g. naloxone or flumazenil)
   3. Aspiration
   4. Respiratory arrest
   5. Cardiac arrest
   6. Intubation
   7. Death
2. In addition to the above, randomly selected records will be reviewed for compliance with this policy. Procedural sites will be accountable to the Sedation Committee to report QA/QI information. These reports will be reviewed and evaluated by the Sedation Committee and any actions required will be reported to the relevant department or division. Whenever indicated, an appropriate action plan will be developed, implemented, evaluated and results reported to the Sedation Committee.

Purpose: To define the scope of practice and conditions under which a Registered Nurse (RN) may participate in the deep sedation.

The RN, who has completed the following, may assist the physician privileged for deep sedation:

1. Successfully completed a course: Moderate Sedation Analgesia.
2. Successfully completed a course: Deep Sedation.

This RN may assist the physician privileged for deep sedation in the following manner:

1. The RN may deliver (draw up, label, administer parentally and document) the initial dose of the selected medication(s) as ordered in writing by the physician privileged for deep sedation. Any subsequent orders may be verbal. At all times: Medication Administration Policy will be followed.
2. When an RN participates in the team model of deep sedation and assists in the delivery of medications, this will be the primary responsibility of that nurse who will remain at the bedside.
3. The RN may medicate the patient only in the presence of the physician privileged for deep sedation. However; this physician may engage in brief interruptible tasks, for example, brief supervision of a trainee performing the procedure. The RN may not administer medication for deep sedation when the physician is engaged in a brief interruptible task.
4. The RN may further assist the physician by observing and documenting cardiac, blood pressure, pulse oximetry and end tidal CO2 monitor readings.

1. Normal Examination

1. Abnormal Examination
   1. Micrognathia (under-sized mandible)
   2. Retrognathia (mandible posterior to normal position)
   3. Trismus (inability to open the mouth fully)
   4. Mallampati Class III
   5. Limited mouth opening or neck range of motion
   6. High arched palate (in pediatrics)
   7. Low set ears (in pediatrics)
2. Significant History
   1. Stridor
   2. Snoring
   3. Sleep apnea
   4. Advanced rheumatoid arthritis
3. Mallampati Classification

As the Mallampati class increases, the potential for difficult mask ventilation and intubation increases.

Class I: complete view of uvula, tonsillar pillars, soft palate

Class II: partial view of uvula and tonsillar pillars, complete view of soft palate

Class III: view of soft palate only

Class IV: no viewable soft palate, view hard palate only