Date Written or Last Revision: Feb Page 1 of 24

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1 Page 1 of 24. Contents: I. Purpose II. Policy: III. Definitions: A. Minimal Sedation B. Moderate Sedation C. Deep Sedation D. Anesthesia IV. Equipment V. Medication VI. Process/Procedures Moderate vs Deep Sedation: A. Locations B. Process 1. Pre-procedure Physician Responsibility 2. Pre-procedure Nursing Responsibility 3. Intra-procedure Monitoring and Care Requirements 4. Post-procedure Monitoring and Care Requirements 5. Management of Emergency Situations VII. Staffing Requirements: A. Credentialing B. Personnel VIII. Performance Improvement IX. Related Documents X. Appendices XI. Document Information I. PURPOSE The administration of drugs to produce sedation can have the unintended effect of compromising a patient's protective reflexes, therefore this policy is intended to create the framework and outline the operational requirements to facilitate a standardized approach to provide patients at Packard with the benefits of sedation/analgesia while minimizing the associated risks. For the purposes of this document, a clear distinction has been made between minimal, moderate, and deep sedation, but moving from a state of consciousness to deep sedation and further to general anesthesia is a continuum. This continuum depends on individual response, age, health status, and drug combinations used.

2 Page 2 of 24 II. POLICY STATEMENT Administration of any drug or drugs to sedate a patient in association with a procedure requires implementation of the sedation policy. III. DEFINITIONS A. Minimal sedation/analgesia (anxiolysis): A drug-induced state during which patients remain conscious and respond to verbal commands. Although cognitive function and coordination may be impaired, consciousness, ventilatory and cardiovascular functions are unaffected. Gag reflex and other protective airway reflexes are maintained. This state may be referred to as anxiolysis. B. Moderate sedation/analgesia: 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. Gag reflex and other protective airway reflexes are maintained. Cardiovascular function is usually maintained. Reflex withdrawal from a painful stimulus is not considered a purposeful response. C. 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, and gag reflex and other protective airway reflexes may be impaired or absent. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Gag reflex and other protective airway reflexes may be impaired. Cardiovascular function is usually maintained. Reflex withdrawal from a painful stimulus is not considered a purposeful response.

3 Page 3 of 24 D. 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 druginduced depression of neuromuscular function. Gag reflex and other protective airway reflexes are absent. Cardiovascular function may be impaired. IV. EQUIPMENT A. Use equipment that monitors and measures the following 1. Respiratory rate 2. Heart rate 3. EKG 4. Blood Pressure 5. Blood Oxygen saturation 6. ET CO2 levels (for patients receiving moderate or deep sedation) B. Emergency equipment immediately available: 1. Code cart 2. Suction equipment 3. Resuscitation bag and mask 4. Oral and nasopharyngeal airways, endotracheal tubes, laryngoscopes of appropriate sizes, and a qualitative or quantitative CO 2 detection device. V. Medication A. A variety of medications in several classes, including but not limited to Benzodiazepines, Barbiturates, Opioids, and Dissociative Agents may be used to produce a state of moderate or deep sedation. The LPCH House Staff Manual may be used to provide examples of medications often used to produce these levels of sedation. B. For the purpose of procedural sedation, drugs that can be used as anesthetic agents, such as propofol (Diprivan ), and ketamine (Ketalar ), etc., must be administered by an appropriately credentialed anesthesiologist, or by a credentialed physician using a written protocol

4 Page 4 of 24 that has been approved by the Sedation Committee (see Appendix E). VI. CONSIDERATIONS LOCATIONS: Sedation for procedures will be completed whenever possible in locations as specified in the Location Matrix for Sedation at LPCH (See appendix F) These standards apply to all LPCH patients in all locations where invasive and/or diagnostic procedures are performed under sedation, with the following clarifications: A. Locations staffed by Anesthesiologists: When general anesthesia, regional anesthesia, or sedation is administered by an anesthesiologist at LPCH or SHC, the Sedation Policy is superceded by the policies and practice standards of the Department of Anesthesiology and Pain Medicine, pertinent to specific locations. B. Pediatric, Cardiovascular, and Neonatal Intensive Care Units: 1. When patients who are not intubated or mechanically ventilated receive sedation for any procedure, the provisions of the Sedation Policy will apply When patients who are intubated and currently receiving sedation require a deeper level of sedation in order to have a procedure performed, the documentation requirements of the will apply, including the need for obtaining consent. The process for Critical Care Medicine physicians to administer deep sedation is listed in appendix H 4. The provisions of the do not apply to patients who are administered sedatives either by continuous infusion or by intermittent boluses for the purpose of maintaining a continuously sedated state to facilitate mechanical ventilation or other routine ICU therapy that does not itself require an informed consent. C. For infants receiving sedation the sedation policy applies; please see the LPCH Policy on Admission of Infants after Anesthesia or Sedation for additional considerations related to recovery after sedation

5 Page 5 of 24 VII. PROCESS/PROCEDURE The standards below apply to the administration of moderate sedation and deep sedation. Note that the standards for practitioner [Physician or Allied Health Professional] presence and practitioner completion of preparation and evaluation differ for moderate and deep sedation. These standards do not apply to the administration of minimal sedation (i.e., anxiolysis). Moderate Sedation: requires either a physician credentialed in moderate sedation, or a moderate sedation credentialed physician assistant or nurse practitioner who is working under a protocol with the supervision of a responsible physician. Deep Sedation: requires an intensive care physician credentialed for deep sedation or an anesthesiologist A. Pre-Procedure Practitioner Responsibility: 1. Ensure there is a complete History and Physical Examination documented as specified in the hospital bylaws. Complete and document a pre-procedure assessment, with a focus on the following elements of the H&P, within 48 hours of the planned sedation: a. History: (1) Acute and chronic medical problems (2) History of adverse reactions to anesthesia or sedative medication, potential risks or problems (3) Allergies (4) History of airway anomalies (see Appendix A) (5) Any history of apnea (6) Current medications (6) Recent dosing of sedative and/or opioid medications (7) Last food and fluid intake b. Physical Examination: (1) Airway evaluation (2) Cardiovascular evaluation (3) Pulmonary evaluation (4) the patient's general condition/neurologic status c. Assign American Society of Anesthesiologists Physical Status (see Appendix B)

6 Page 6 of For a patient with unstable or poorly controlled systemic disease or organ dysfunction (ASA 3), obtain a consultation with a member of one of the following departments or divisions as appropriate to the child s underlying disease state and condition: a. Department of Anesthesiology and Pain Medicine b. Division of Critical Care c. Division of Pediatric Cardiology d. Division of Neonatology 3. Referral to, or consultation by, the Department of Anesthesiology and Pain Medicine is required for ASA Physical Status 4 or 5 patients (see Appendix B) and all patients with congenital or acquired airway abnormalities (see Appendix A), unless under the care of an intensivist or a neonatologist in an intensive care environment. 4. Practitioner responsible for and ordering sedation must obtain and document informed consent for sedation. 5. Establish and document a plan for sedation, and write or enter orders in the Electronic Health Record for a. NPO status, (See Appendix C), b. sedative medications, and c. intravenous access if required. 6. Immediately prior (within 1 hour) to administering the sedation, review and reassess the following: a. the pre-sedation assessment, b. sedation plans, c. current patient condition including recent dosing of sedative and opioid medications and last food and fluid intake. d. Document this reassessment.

7 Page 7 of 24 B. Pre-Procedure Nurse Responsibility 1. Initiate the pre-procedure checklist and Universal Protocol, located in the Electronic Health Record (EHR). Outpatients also require documentation of nursing assessment. 2. Notify the manager if the appropriately trained/credentialed staff is not available or if additional medical evaluation is required. 3. If an outpatient, ensure that the patient has transportation home and will be accompanied by a responsible adult. 4. Verify that a completed history, physical, pre-sedation assessment, and sedation informed consent are documented. Also if needed, consultation from an anesthesiologist or appropriate intensive care, neonatology, or cardiology specialist. (See A. 2. and 3 above) 5. Confirm and document NPO status. If not in compliance with guidelines, notify the responsible physician, physician s assistant, or nurse practitioner. 6. Assess and document the pre-sedation condition of the patient in the EHR. This includes: a. Baseline level of consciousness b. Baseline level of pain c. Baseline Sp02 d. Baseline capillary refill e. Baseline level of nausea or vomiting f. Baseline vitals 7. Ensure that patients have patent IV access; mandatory for those undergoing deep sedation, suggested for all patients undergoing sedation but at the discretion of the attending physician or practitioner ordering the sedation 8. Ensure that the Universal Protocol is followed and documented in the EHR. (See Appendix G for the Checklist Used in the Perioperative Environment for the Universal Protocol completion) C. Intra-Procedure Monitoring and Care Requirements ( see Appendix D for further details) 1. An RN, charged with assisting with sedation for a patient during a procedure and/or recovery, either by administering sedation medications or monitoring the patient, must be Sedation Level II competent. 1. Continuous observation and monitoring of the patient during administration of sedation for:

8 Page 8 of 24 a. Airway patency and respiratory rate (including ETCO 2 value for moderate and deep sedation) b. Hemoglobin oxygen saturation and pulse rate using pulse oximetry c. Electrocardiogram d. Level of consciousness e. Occurrence of adverse reactions 2. Intermittent blood pressure monitoring as follows: a. For moderate sedation: measurement and documentation in the EHR of blood pressure after administering the sedative drugs, and intermittent monitoring of blood pressure as follows: (1) Blood pressure will be recorded every 15 minutes except for the following patients, for whom blood pressure will be recorded every 5 minutes: (a) Patients with a history of hypertension, whether treated or not at the time of the procedure (b) Patients who have had a renal transplant (c) Patients with acquired or congenital heart disease (d) Patients with a history of cardiac arrhythmias (e) Patients who have or are at risk for dehydration. (f) Patients less than 52 weeks post-conceptional age (g) Patients with a history of sleep apnea b. For deep sedation: measurement and documentation in the EHR of blood pressure after administering the sedative drugs, and intermittent monitoring of blood pressure every 5 min. 3. Documentation will be made of observations and monitoring, the names, dosage, route, and time of all drugs administered and patient s response to medication on the paper or interactive flowsheet and MAR.

9 Page 9 of All medications that are administered will be documented in the EHR, by either the administering physician/nurse or the supporting nurse. When a physician administers the medication and a nurse completes the documentation, he/she will also note who administered the drug. 5. Documentation for patients receiving sedation or anesthesia by an anesthesiologist will comply with Anesthesia Department processes 6. The practitioner responsible for the sedation must be immediately available during the administration of the sedative medication, or designate another qualified practitioner who will be so available. The identity and pager number and/or direct phone link for the responsible practitioner must be communicated to the nurse administering the sedation. 7. If deep sedation is planned, a responsible physician must be present at the bedside, with no other conflicting immediate responsibilities. D. Post-Procedure Monitoring and Care Requirements 1. A practitioner, credentialed in sedation, a. Must remain immediately available throughout the recovery period. b. If the patient requires reversal medications and/or does not meet discharge criteria within 1 hour of admission to recovery, the practitioner must evaluate the patient and order their transfer to the next appropriate level of care. c. If no recovery (PACU) or sedation-level-2 competent nursing staff is available, a practitioner credentialed in sedation will remain with the patient until he/she is recovered. 2. A nurse, [recovery (PACU) or sedation-level-2 competent], will remain with the patient through the recovery period and complete the following: a. Using the same protocol as during the procedure, continually assess and monitor the patient for a minimum of 30 minutes postprocedure, and continue until the patient meets the following postprocedure discharge criteria. (see appendix D for frequency of monitoring required during recovery from sedation). b. The following criteria indicate that the patient has recovered sufficiently to safely return home if an outpatient, or if an inpatient, to return to pre-procedure level of care.

10 Page 10 of 24 c. d. i. Able to independently maintain an airway ii. SpO 2 at the patient s baseline level iii. Stable cardiovascular status. An adequate post-procedure blood pressure must be recorded. iv. Easily aroused, able to talk (if age appropriate), or is at pre-procedure baseline level of consciousness v. If reversal agent given, you must monitor the patient for 1 hour before transfer/discharge. vi. For outpatients: (1) The patient s discharge from the hospital must be ordered by a physician, or meet established discharge criteria. (2) A responsible adult must be present to escort the patient home. (3) The patient or parent/guardian must be given written post-procedure instructions. Document the post-procedure assessment in the EHR. If the patient does not return to the documented baseline assessment within one hour, continue to monitor frequently and notify the MD. NOTE: For moderate sedation, continue to monitor every 15 minutes. For deep sedation, continue to monitor every 5 minutes. d. For infants receiving sedation, please see the LPCH Policy on Admission of Infants after Anesthesia or Sedation for additional requirements related to length of recovery. E. Management of Emergency Situations 1. Any practitioner ordering, responsible for, or supervising a trainee ordering or responsible for sedation, and any practitioner monitoring the patient must be competent to institute appropriate emergency care if the patient s airway, breathing, or circulation becomes compromised. 2. Immediately report all untoward effects (e.g. respiratory or hemodynamic instability, adverse reaction to drugs, altered level of consciousness, prolonged drug effect, etc.) to the responsible practitioner and intervene as ordered by the responsible practitioner. 3. If a patient s condition deteriorates, STAT page or call the direct contact phone line for the responsible practitioner; consider calling the rapid response or code team if appropriate.refer to the following policies: Rapid Response, OB STAT, Anesthesia ASAP, and FAST-RRT Policy; Code Blue Management

11 Page 11 of For urgent or emergent assistance for patients receiving sedation or anesthesia by an anesthesiologist, emergency protocols delineated in the perioperative policies and procedures will apply. VIII. Staffing Requirements Individuals ordering, administering, and/or supervising minimal, moderate and/or deep sedation to facilitate procedures for patients must be qualified and have the appropriate credentials to manage patients at whatever level of sedation is achieved, either intentionally or unintentionally. Residents ordering sedation must be supervised by an attending physician who is also credentialed to manage that planned level of sedation. A. Physician, Physician s Assistant, and Nurse Practitioner Competency Requirements 1. Privileges for Minimal (Anxiolysis) or Moderate Sedation: a. Completion of a sedation teaching module. b. Successful completion of a written examination to test the knowledge of medications being given, and principles of physiologic monitoring including the interpretation of ECG and arrhythmia recognition. c. Must have PALS, ACLS, NRP or equivalent certification requiring training in airway management skills and cardiopulmonary resuscitation d. Maintenance of privileges for moderate sedation will require a minimum volume of cases per medical staff office credentialing guidelines 2. Privileges for Deep Sedation a. Must meet all criteria for Moderate Sedation b. Must be board certified or eligible in pediatric critical care, neonatology, or adult critical care, or board certified or board eligible in anesthesiology. 3. Physician Trainees a. Must meet all criteria for minimal sedation

12 Page 12 of 24 b. Must be immediately supervised by a physican credentialed in the level of sedation planned for the procedure B. Nursing Competency Requirements: For Minimial Sedation (Anxiolysis): 1. RN must have completed the Sedation Level I Healthstream Module 2. RN must be PALS or NRP certified For Moderate Sedation: 1. Sedation Level II competency: all Sedation Level I requirements plus validation of sedation skills through supervised demonstration (ICU units). Initial training will be completed through a simulation-based course and testing curricula (General care units) 2. Competency validation will be performed by observation of skill by a Sedation Level II competent RN or certified provider 3. Maintenance of competency outside of critical care units will require performing 10 moderate sedations every 2 years. If unable to meet the requirements, the RN may be proctored again. C. Personnel 1. Responsible practitioner [Physician or Allied Health Professional]: Each patient undergoing sedation must have a credentialed practitioner immediately available to respond to adverse events occurring during the sedation or during recovery from sedation. The responsible practitioner must have at a minimum competency-based education, training, and experience in evaluating patients before moderate or deep sedation and anesthesia, and in performing moderate or deep sedation, including rescuing patients who slip into a deeper than desired level of sedation or analgesia. This includes the following: a. Moderate sedation: qualification to rescue patients from deep sedation, and competence to manage a compromised airway and provide adequate oxygenation and ventilation. b. Deep sedation: qualification to rescue patients from general anesthesia and are competent to manage an unstable cardiovascular system as well as a compromised airway and inadequate oxygenation and ventilation.

13 Page 13 of Designated sedation monitor: A designated physician, physician s assistant, nurse practitioner, Sedation Level II RN, or licensed practitioner other than the person performing the procedure must be present to administer sedative drugs, observe the patient, measure and document the required physiologic parameters throughout the procedure, and assist in any supportive or resuscitative measures as required. 3. Additional personnel is required for procedural support and holding. VIII. Performance Improvement: Å. There will be periodic quality management evaluations of policy compliance, performance and outcome. B. Related to sedation, all of the following adverse events or adverse drug reactions will be reported via occurrence report and reviewed; in addition, items to be reviewed, tracked, or audited will include cases in which the following occur: 1. Administration of reversal agent. 2. Manual intervention to support airway or breathing 3. Unplanned admission to a higher level of care, including unplanned admission of an outpatient 4. Cancellation of a procedure due to unsuccessful sedation. 5. Cardiopulmonary resuscitation 6. Death. IX. RELATED DOCUMENTS

14 Page 14 of 24 LPCH Policies and Bylaws that May Apply to Sedation Cases A. Universal Protocol: Verification of Patient Identity, Correct Surgical Site and Time Out B. Discharge by Criteria, Outpatients and PACU Transfers Only C. Code Blue Management D. Rapid Response, OB STAT, Anesthesia ASAP, and FAST-RRT Policy E.. F.. G.. H.. I.. Anesthesia; Intra-Operative Care and Monitoring Informed Consent Policy Protocol for use of intravenous anesthetic agents by Critical Care Medicine physicians to facilitate procedures in non-intubated patients. Housestaff Manual: Medications Policy : Admission of Infants after Anesthesia and Sedation X. APPENDICES A. Example of Airway Assessment for Sedation and Analgesia B. American Society of Anesthesiologists Physical Status (PS) Classifications C. NPO Policy D. Intra-procedure Monitoring Requirements E. Request for Sedation Strategy That Differs from F. Matrix for Sedation Locations at LPCH G. H. I. Pediatric WHO Checklist Providing Sedation via Administration of IV Anesthetics by Intensivists Use of Ketamine by LPCH General Pediatric Hospitalist Service XI. DOCUMENT INFORMATION A. Legal Authority/References 1. American Academy of Pediatric Dentistry (1997). Guidelines for the elective use of pharmacologic conscious sedation and deep sedation in pediatric dental patients. Pediatric Dental Journal. 19:48-52.

15 Page 15 of American Academy of Pediatric Dentistry (1985). Guidelines for the elective use of conscious sedation, deep sedation, and general anesthesia in pediatric patients. Committee on Drugs Section on Anesthesiology. Pediatrics, 76(5) American Academy of Pediatrics Committee on Drugs (2006). Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 118(6) American College of Emergency Physicians. (1998)Clinical policy for procedural sedation and analgesia in the emergency department Annals of Emergency Medicine American Dental Society of Anesthesiologists (1998). A. D. S. A. guidelines of intra-operative monitoring of patients undergoing conscious sedation, deep sedation and general anesthesia. Journal of Connecticut State Dental Association 62: American Medical Association Council on Scientific Affairs: The use of pulse oximetry during conscious sedation (1993). JAMA 270: ,. 7. American Society of Anesthesiologists (2002). Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 96: American Society of Anesthesiologists.(2009) Standards: Continuum of Depth of Sedation/Definition of General Anesthesia and Levels of Sedation/analgesia. Accessed at: 9. Chudnofsky CR (1997). Safety and efficacy of flumazenil in reversing conscious sedation in the emergency department; Emergency medicine conscious sedation study group. Academic Emergency Medicine. 4: Coté CJ, et al. (2000). Adverse Sedation Events in Pediatrics: A critical Incident analysis of contributing factors. Pediatrics 105: Coté CJ: Sedation for the pediatric patient (1994). Pediatric Clinics of North America 41: Holzman RS, et al. (1994). Guidelines for the sedation by nonanesthesiologists during diagnostic and therapeutic procedures. Journal of Clinical Anesthesia 6; Kao et al. (1999). A survey of post-discharge side effects of conscious sedation using chloral hydrate in pediatric CT and MR imaging. Pediatric Radiology. 29:

16 Page 16 of Macpherson CF, Lundblad LA (1997). Conscious sedation of pediatric oncology patients for painful procedures: development and implementation of a clinical practice protocol. Journal of Pediatric Oncology Nursing. 14: Malviya S et al. (1997). Adverse events and risk factors associated with the sedation of children by nonanesthesiologists. Anesthesia & Analgesia 85: Mayers, DJ, et al. (1991). Chloral hydrate disposition following single-dose administration to critically ill neonates and children. Developmental Pharmacology and Therapeutics 16: Morton NS, et al. (1998). Development of a selection and monitoring protocol for safe sedation of children. Pediatric Anesthesia 8: Nelson, Jr. MD (1994). Commentary: Guidelines for the monitoring and care of children during and after sedation for imaging studies. American Journal of Radiology 160: Pediatric Committee of the American College of Emergency Physicians.(1994) Pediatric analgesia and sedation. Annals Emergency Medicine February 23: Somerson SJ, et al. (1995). Insights into conscious sedation. American of Journal of Nursing 95(6) 26-33,. 21. Yaster M, et al. (1997). The Pediatric Pain and Sedation Handbook. St. Louis, MO: Mosby-Yearbook, Inc. B. Author/Original Date LPCH Sedation Committee; 5/04 C. Distribution and Training Requirements 1. This policy resides in the Patient Care Manual of Lucile Packard Children s Hospital. Web URL: ide/ patient Care/sedationPolicy.html 2. New documents or any revised documents will be distributed to Patient Care Manual holders. The department/unit/clinic manager will be responsible for communicating this information to the applicable staff. D. Review and Renewal Requirements

17 Page 17 of 24 This policy will be reviewed and/or revised every three years or as required by change of law or practice. E. Review and Revision History 1/05; 11/06, Stephanie Martian, RN, Clinical Transformation, 09/07 E. Krane, 05/10, 6/2014 A. Honkanen, , 6/2011, 6/2014 F. Approvals Sedation Committee; 11/06, 6/2014 Medical Board Committee: 01/07 Clinical Practice Committee; 1/07, 05/10 Policy Committee; 7/2014 Medical Executive Committee; 7/2014, 2/2015 Governing Board; 2/2015 This document is intended for use by staff of Stanford Hospital & Clinics and/or Lucile Packard Children s Hospital. No representations or warranties are made for outside use. Not for outside reproduction or publication without permission.

18 Page 18 of 24 Appendix A: Example of Airway Assessment for Sedation and Analgesia A. History 1. Previous problems with anesthesia or sedation 2. Stridor, snoring, or sleep apnea 3. Dysmorphic facial features (e.g. Pierre-Robin syndrome, Trisomy 21) 4. Advanced rheumatoid arthritis B. Physical examination 1. Habitus - Obesity (especially involving the neck and facial structures) 2. Head and neck - Short neck - Limited neck extension - Decreased hyoid-mental distance (<3cm in an adult) - Neck mass - Cervical spine disease or trauma - Tracheal deviation 3. Mouth - Small opening (< 3cm in an adult) - Protruding incisors - Loose or capped teeth - High arched palate - Macroglossia - Tonsillar hypertrophy - Uvula obscured by base of tongue or tonsils 4. Jaw - Micrognathia - Retrognathia - Trismus - Significant malocclusion

19 Page 19 of 24 Appendix B: American Society of Anesthesiologists Physical Status (PS) Classifications PS-1: PS-2: A healthy patient without illness or disease A patient with localized disease or a systemic disease in good control (examples: VSD without CHF, juvenile onset diabetes mellitus in good control, asymptomatic reactive airway disease, localized or systemic infection under treatment) PS-3: A patient with systemic disease that is not controlled (examples: VSD with CHF, cystic fibrosis, cyanotic congenital heart disease, uncontrolled hypertension, infection with fever or sepsis) PS-4: A patient with a localized or systemic disease that represents an immediate threat to life; a patient who is not expected to survive without the planned procedure (examples: acute or end-stage organ failure, hypotension or shock, DKA, coma of any cause) PS-5: A moribund patient who is not expected to survive with or without the planned procedure. E: Added to above classifications to designate an unplanned emergency procedure (example: PS-2E)

20 Page 20 of 24 Appendix C: NPO Policy All patients should be NPO prior to moderate and/or deep sedation, and should not have any risk factors for aspiration. The use of sedation must be preceded by an evaluation of food and fluid intake. Refer to LPCH Policy for Perioperative Services: Preoperative Processes, Appendix A. * NPO here indicates nothing by mouth, nasogastric tube, or gastrostomy tube. Please note that the above instructions are meant to guide the practitioner. Many patients have special needs and these must be considered in regard to preparing them for anesthesia and / or sedation. The anesthesia nurse practitioner or the anesthesia resident ( after 5pm ) should be consulted for questions related to NPO instructions.

21 Page 21 of 24 Appendix D: Intraprocedure Sedation Level Recovery Parameter Minimal Moderate Deep (Anxiolysis) Continuous Observation Continuous Pulse Oximetry Continuous ECG ETCO2 Blood Pressure q-15 min Blood Pressure q-5 min Documentation q5m Documentation q15m Appendix E: Request for Sedation Strategy That Differs from The introduction of a new sedation technique or procedure that differs from this policy that improves the quality of care for patients, or the use of medications, commonly used as anesthetic agents, such as propofol, ketamine, sodium thiopental, or etomidate, for sedation, requires that a written request be formally submitted to the Sedation Committee. The following information and criteria must be included in a department's or division's request. Requests may be submitted to the Sedation Committee Chair via the LPCH Medical Staff Office 1. Names of supervising physician(s). 2. Location of the practice change. 3. Procedures for which the new procedure will be used. 4. Desired level of sedation. 5. Patient inclusion/exclusion criteria. 6. Proposed regimen: drug(s), dosage(s), route, and frequency of administration. 7. Education plan for staff responsible for drug administration.

22 Page 22 of Desired outcome and monitoring plan: a. Purpose statement including pertinent background information. b. How will you measure an improvement over current practice? (1) Include a summary of baseline measures that will be used to determine the effectiveness of the changes (i.e. chart review of x patients). (2) Specify the desired goal and outcome. 9. Results: Data must be presented to the Committee 6 months after implementation. All aspects of the current policy will apply unless a specific change in practice is proposed within the request. The Sedation Committee will review the request at its next meeting, at which the requesting provider(s) may be asked to appear for discussion. Requests that are conditionally approved will undergo a 6-month pilot period, after which pilot results must be presented to the Committee for final review and approval. If the request is approved, it will be reviewed by the Policy Committee as an addendum to the, and confirmed through the Medical Executive Committee. Requests for use of medications in novels ways will also be reviewed by the Pharmacy and Therapeutics committee. Appendix F: Matrix for Sedation Requirements and Locations Requirements Requirements Minimal Sedation (Anxiolysis) Moderate Sedation Deep Sedation Documentation Requirements 1.Credentialed MD: to order medications, document procedure in patient's medical record. 2. RN to document medications given in MAR 1.Credentialed MD to place order for medications, complete Consent, Procedure Record and Sedation Record 2.RN to complete time out, Universal Protocol, RN portion of Sedation Record, 3. Credentialed MD or Sedation Level II competent RN Medication administration in the MAR 1.Credentialed MD to place order for medications, complete Consent, Procedure Record and Sedation Record, Medication administration in the MAR 2.RN to complete time out, Universal Protocol, RN portion of Sedation Record,

23 Page 23 of 24 PreOp Initiation None Bedside RN Bedside RN Schedule 3N Treatment Room; APU Scheduler for, APU or Bass Center APU APU Scheduler for 3N Treatment Room, APU or Bass Center APU APU Scheduler (or Bass Center Scheduler) Location Bedside, 3N Treatment Room, APU, Bass Center APU or Radiology, 3N Treatment Room, APU, Bass Center APU or Radiology, Critical Care Units APU, Bass Center APU or Radiology, Critical Care Units Sedation Drugs Medication for procedural anxiolysis ordered using the Minimal Sedation Order Set. Medication ordered using the Moderate Sedation Order Set Examples: titrated doses of IV Versed/Fentanyl /Dexmedetomidine or titrated doses of Ketamine or Propofol per approved Protocols Staff MD (resident, fellow, hospitalist); Sedation Level I competent RN MD (fellow, hospitalist, attending); Sedation Level II competent RN Sedation Level II RN may administer moderate sedation only. Credentialed MD, working under approved protocol,is required to be present for deep sedation. The credentialed MD may not perform procedure if giving deep sedation. Recovery by NONE Credentialed MD or Sedation Level II competent RN Intensivist, Anesthesiologist or Critical Care RN for deep sedation

24 Page 24 of 24 Appendix G: WHO Surgical Safety Checklist: