PATIENT CARE STANDARD

Sutter Medical Center, Sacramento Nursing POLICY STATEMENT: PATIENT CARE STANDARD It is the policy of hospitals within the Sutter Sacramento Region to provide a uniform, safe, and evidence-based standards for the management of patients who are receiving sedation for the purpose of completion of a procedure, including both moderate and/or deep sedation. The clinical state of sedation is a continuum from minimal sedation, or anxiolysis, to moderate, then deep sedation, and finally to the state of general anesthesia. It is not always possible to predict how an individual patient will respond. The primary causes of morbidity associated with sedation are drug-induced respiratory depression and airway obstruction. Therefore, the physician and the nurse providing care to the patient must be able to recognize a transition from one state of sedation to another and be able to safely rescue the patient. Physicians administering/ordering moderate sedation should be able to rescue patients who enter a state of deep sedation, while those administering/ordering deep sedation should be able to rescue patients who enter a state of general anesthesia. Only non-anesthesiologist physicians who meet medical staff credentialing and privileging criteria for moderate and deep sedation may administer/order procedural sedation. RNs may not administer agents of deep sedation for the purposes of procedural sedation, including the following: Propofol Etomidate (excludes administration for Rapid Sequence Intubation) Ketamine Barbiturates These deeply sedating agents, when used for procedural sedation, must be administered by a physician with current privileges for moderate and deep sedation. The RN may prepare the medication for administration/injection by the physician. EXCLUSIONS: This policy does NOT include sedation agents given for the primary purpose of light sedation or anxiolysis, pain control and pain management, or seizures. This patient care standard does NOT apply when sedation is administered by an anesthesia provider, including ed Anesthesia Care (MAC). MAC does not describe the continuum of depth of sedation; rather it describes 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. (ASA, 2009) I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 1 of 9

DEFINITIONS: Procedural Sedation: Moderate or deep sedation provided during diagnostic or therapeutic procedures. Non-Anesthesiologist providers of procedural sedation: Physicians who are not anesthesia specialists Minimal sedation/light sedation (anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilation and cardiovascular function are unaffected. (ASA, 2002). Moderate sedation is 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. ** Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. (ASA, 2002). Deep sedation is 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. ** Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. (ASA, 2002). General Anesthesia is 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. (ASA, 2009) I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 2 of 9

Continuum of Depth of Sedation 2002, Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists Minimal (Light) Moderate Sedation Sedation (Anxiolysis) Responsiveness Normal response to verbal stimulation Purposeful response to verbal or tactile stimulation Airway Unaffected No intervention required Spontaneous ventilation Cardiovascular function Deep Sedation Purposeful response after repeated or painful stimulation Intervention may be required General Anesthesia Unarousable, even with painful stimulus Intervention often required Unaffected Adequate May be inadequate Frequently inadequate Unaffected Adequate May be inadequate May be Usually maintained Usually maintained impaired LEVEL OF SEDATION SCALE: The patient s level of sedation will be documented using a sedation scale. Various sedation scales are used within the region as identified in Appendix A. Pre-Procedural NPO Guidelines (Recommendations from the Department of Anesthesia*) (SMCS): See Medical Staff Policy for Department of Anesthesia Statement Adult and Pediatric NPO Guidelines Infants (0-6 months) Children (7 months 12 months) Children (13 months to 12 years) Solids 8 hours 8 hours 8 hours Breast Milk and Formula Clear Liquids 4 hours 6 hours 8 hours Procedure before 1200 No solids after 2300 the night before 2 hours 2 hours 2 hours Procedure before 1200 Nothing after 2300 the night before Children and Adults (13 years and up) Procedure after 1200 No solids after 2400 the night before Procedure after 1200 May have clear liquids up to 4 hours before scheduled procedure. For all patients, regardless of age: Maximum of 4 ounces (1/2 cup) clear liquids during the one hour prior to beginning complete NPO status. *Please note: these are guidelines only. For purposes of clarification, pediatric clear liquids include water, Pedialyte, Koolaid, Gatorade, grape juice, cranberry juice, apple juice, pulp-free popsicles. No carbonated drinks, no 7-Up or ginger ale, no gelatin (jello), no broth. I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 3 of 9

CLINICAL LOCATIONS FOR SEDATION ADMINISTRATION: REQUIRED EQUIPMENT AND SUPPLIES: Procedural sedation may be administered in areas where the patient can be adequately and safely monitored as outlined in this policy. See Appendix B. To ensure patient safety and the rapid ability to rescue patients, the following equipment and supplies must be readily available: Crash crash/defibrillator age appropriate Oxygen source and equipment/supplies for administering supplemental oxygen (cannula, mask) age appropriate Emergency advanced airway/intubation equipment age appropriate Bag-valve mask age appropriate Working suction source and equipment/supplies required for suctioning Patient monitoring equipment: cardiac monitor, non-invasive blood pressure monitor, pulse oximetry, and end-tidal CO2 monitor Sedation medications and appropriate antagonists/reversal agents. SMCS: Procedure Flowsheet REQUIREMENTS/ RESPONSIBILITES: NON-ANESTHESIOLOGIST PHYSICIAN PROVIDER REQUIREMENTS: The physician ordering/overseeing/administering sedation must: Hold current medical staff credentials for procedural sedation. Hold a valid DEA license to prescribe the selected sedatives and analgesics. RN COMPETENCY REQUIREMENTS: For adult patients: Completion of hospital sponsored Sedation Training course. For pediatric patients less than 14 years of age: Completion of hospital sponsored Adult and Pediatric Sedation Training. Current certification in an age appropriate advanced cardiac life support course, such as ACLS, PALS, NRP. NICU: RN must also have ALS designation. REQUIRED PERSONNEL REQUIRED FOR PROCEDURAL SEDATION: In addition to the practitioner performing the procedure, sufficient numbers of qualified personnel must be present for all procedures requiring moderate or deep sedation. One health care provider (an RN or physician who is competent in sedation management and is not the physician performing the procedure) must have the primary responsibility of monitoring the patient, including vital signs and level of consciousness. This person cannot leave the room/suite during the procedure. For the adult patient, a second health care provider may be required to assist as directed with sedation monitoring. This person must be BLS certified. I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 4 of 9

REQUIREMENTS/ RESPONSIBILITES CONTINUED: For the pediatric patient less than 14 years of age, a second health care provider (RN, RCP, or physician) is required to be present during the procedure to assist as directed with sedation monitoring. When the intent of the procedural sedation is deep sedation, a second health care provider (RN, RCP, or physician) is required to be present during the procedure to assist as directed with sedation monitoring. When the intent of the procedural sedation is deep sedation, the ordering physician must be present in the physical unit and must be immediately available (i.e., not involved in other procedures). PHYSICIAN S PRE-PROCEDURAL SEDATION RESPONSIBILITIES: 1. Perform a pre-sedation assessment that includes a directed/updated history and physical examination including evaluation of the airway, i.e. to assess the patient s ability to open their mouth at least 3 fingerbreadth and ability to tip their head back and forth normally. 2. Notation of patient s ASA classification. 3. Notation of pre-operative diagnosis, and planned procedure. This assessment may be performed within the previous 24 hours of the anticipated procedure. 4. the following in the medical record: a. Assessment findings b. Intent of sedation, whether moderate or deep c. Risks, benefits, and alternatives and provision of informed consent for sedation and the procedure. 5. Immediately prior to the administration of sedation, reassess the patient and document this reassessment in the medical record. 6. Communicate the intent of sedation (moderate or deep) to the staff administering the sedation and monitoring the patient. RN PRE-PROCEDURAL RESPONSIBILITIES: 1. Verify the physician has medical staff privileges to provide procedural sedation. 2. Verify consent has been completed and signed, when applicable. 3. Verify that all required monitoring equipment and supplies are available. 4. Verify that sufficient numbers of qualified personnel are present prior to administering the sedation medication to allow for appropriate monitoring and care of the patient. 5. Assess the patient s NPO status. If the patient does not meet the I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 5 of 9

REQUIREMENTS/ RESPONSIBILITES CONTINUED: recommended NPO guidelines, notify the physician. 6. Review the patient s current medications, allergies, age, weight, general health history including pregnancy status when applicable. Ask the patient about their anesthesia history including prior complications and personal or family history of malignant hyperthermia. 7. Verify patent IV access. 8. Explain the procedure to the patient and provide patient/ parent/ caregiver education. 9. Provide verbal and/or written objectives of the sedation and procedure. 10. Discuss anticipated changes before and after sedation and procedure. 11. Assure availability of a responsible person to accompany the outpatient home, if necessary. 12. Obtain baseline assessment to include the following: a. Vital signs blood pressure, heart rate, respiratory rate, and O2 saturation. b. Heart rhythm. c. Physical exam including evaluation of the patient s heart, lungs, airway and adequacy of ventilation. d. Baseline end tidal CO2 or TCM. 13. baseline assessment findings on the appropriate procedural sedation tool. PATIENT MONITORING REQUIREMENTS: Summarized in Addenda C: 1. The RN can administer/give drugs for moderate sedation when the procedural physician is present and at the bedside and all preprocedural sedation requirements as described above have been met. The RN cannot administer/inject agents of deep sedation, including propofol, etomidate, and ketamine, for the purposes of completing a procedure. The RN may prepare the medication for administration/injection by the physician. 2. The RN will be in attendance during all phases of the procedure to monitor the patient. Continuous assessment and monitoring (prolonged, without interruption at any time): Pulse oximetry, heart rate, heart rhythm, airway patency, adequacy of ventilation, and end tidal CO2 or transcutaneous monitor (TCM).. 3. Every 5 during the procedure, the following will be I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 6 of 9

REQUIREMENTS/ RESPONSIBILITES CONTINUED: documented: a. Blood pressure, pulse oximetry, end tidal CO2 or TCM, respiratory rate, heart rate and level of sedation. 4. If assessing level of sedation compromises and/or disrupts the procedure, the reason must be documented. 5. It is the responsibility of the RN to keep the physician informed of patient status throughout the duration of the sedation. This includes: a. Patient assessment information. b. Loss of protective reflexes. c. Inability to maintain a patent airway. d. Variations in vital signs indicating potential change in patient status. e. Amount of medication given per physician order. 6. The RN is to notify the physician immediately if the patient experiences: a. Baseline oxygen saturation of less than 93%, a decrease in oxygen saturation from a low saturation baseline, or a fall in oxygen saturation of 5% or greater. b. Inadequate ventilation and/or inability to maintain a patent airway. c. Inability to respond appropriately to physical stimulation/verbal commands. d. Hemodynamic instability, as evidenced by hypotension, arrhythmia, chest pain, shortness of breath. e. Other adverse reactions to drugs administered. 7. Should any of the above changes occur, implement the following measures: a. Give supplemental oxygen as ordered by the physician. 8. If saturation does not improve: a. Stimulate the patient. b. Halt procedure. c. Attempt to improve the airway with jaw thrust and/or oral/nasopharyngeal airway. d. Initiate or assist ventilation with bag/valve/mask and oxygen. e. Administer reversal agents as ordered. f. Initiate cardiopulmonary resuscitation procedures as needed. 1) If endotracheal intubation is employed, determine correct tube placement by carbon dioxide detection, presence of equal breath sounds and presence of chest rise. When appropriate, tube position should be verified by x-ray. PHYSICIAN REQUIREMENTS FOLLOWING PROCEDURAL SEDATION I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 7 of 9

REQUIREMENTS/ RESPONSIBILITES CONTINUED: ADMINISTRATION: 1. At the conclusion of the procedure, the physician ordering the procedural sedation reviews and signs the sedation record. Physician signature indicates agreement with information recorded on the form, including medication and dosages given for sedation. 2. The physician documents a post-sedation, post-procedure note to include diagnosis, procedure findings, complications, blood loss or specimen removal, and plan of care. 3. The physician must document criteria for discharge from the hospital, if outpatient. RN REQUIREMENTS FOLLOWING PROCEDURAL SEDATION: 1. Following the completion of the procedure, the patient remains monitored and immediately enters the recovery phase of care. 2. at a minimum of : pulse oximetry, heart rate, heart rhythm, airway patency, adequacy of ventilation, end tidal CO2 or TCM and blood pressure until the patient returns to his/her baseline level of consciousness and is able to independently maintain their airway and oxygen saturation, follow verbal commands, and vital signs are consistent with pre-procedure vital signs. 3. If the patient required reversal of sedation, (i.e. use of narcan (nalaxone) and/or romazicon (flumazenil), recovery time is extended by one additional hour to monitor for re-sedation. 4. For outpatients, provide written post-sedation discharge instructions that indicate: a. Potential/anticipated sedation effect. b. Activity limitations. c. Dietary precautions. d. 24-hour emergency and follow-up contact numbers. REPORTABLE CONDITIONS: REPORTABLE Reportable conditions include any of the following: 1. Unexpected intubation or need for mechanical ventilation 2. Cardiac arrest 3. Unplanned transfer to higher level of care, including inpatient admission 4. Suspected aspiration 5. Use of reversal agents 6. Adverse medication reaction 7. Patient, family, or staff complaint regarding quality of sedation I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 8 of 9

CONDITIONS CONTINUED: 8. Inappropriate level of sedation (too high or too low) 9. Hemodynamic instability, chest pain EVALUATION OF PATIENT OUTCOMES: REFERENCES: The Department of Anesthesia is responsible for reviewing aggregate data related to procedural sedation with indicators identified through the continuous quality improvement process. Standards for Basic Anesthetic ing 2011 PDF file http://www.rn.ca.gov/pdfs/regulations/npr-b-06.pdf Continuum Of Depth Of Sedation: Definition Of General Anesthesia And Levels Of Sedation/Analgesia, Asa, 2007. http://www.csahq.org/pdf/news/deepsedation_06_08_final.pdf, California Society of Anesthesiologists: GUIDELINES FOR DEEP SEDATION BY NON- ANESTHESIOLOGISTS, 2008 Gross JB et al. (2002). Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists: An updated report by the American Society of Anesthesiologists task force on sedation and analgesia by nonanesthesiologists. Origination Date: March 2011 Revision Date: 04/12 Written by: Revised by: Brenda McCulloch, CNS Brenda McCulloch, CNS Information Only: Critical Care Committee Ob/Gyn Administrative Committee Surgery Administrative Committee Cardiovascular Disease Administrative Committee Pediatric Administrative Committee Medicine Administrative Committee Family Medicine Administrative Committee Pharmacy Therapeutic Team Emergency Medicine Administrative Committee D.I.R.O. Administrative Committee Approval Date: February 26, 2012 March 27, 2012 April 13, 2012 Approved by: Anesthesia Administration Committee Medical Executive Committee Shelly McGriff, Chief Nurse Executive I:ProceduralSedationNonAnesthProviders.doc (April 2012) Page 9 of 9

PROCEDURAL SEDATION ADMINISTERED BY NON-ANESTHESIOLOGIST PROVIDERS ADDENDA A SEDATION SCALES IN USE IN THE REGION Level of Sedation (LOS) 1 Awake and alert 2 Awake but sleepy 3 Asleep, easily arouses 4 Asleep, not easily arousable 5 Asleep, not arousable Used at SMCS Ramsey Sedation Scale Used at SRMC 1 Patient awake, anxious and agitated; or both 2 Patient awake, cooperative, oriented, and tranquil. 3 Patient awake but drowsy, sleepy, tranquil, responds to verbal commands only. Eyes may be closed but responds to commands without tactile stimulation. Patient will still be able to answer questions about pain or discomfort to determine need for analgesia. 4 Patient asleep but briskly responds to loud auditory stimulus gently shaking or light glabellar tap (light tap between the eyes). Drifts back to sleep during conversation. 5 Patient asleep and responds only to noxious stimuli or has sluggish response to loud auditory stimulus or light glabellar tap (light tap between the eyes). 6 Patient asleep and has no response to firm nail bed pressure or other noxious stimuli. Richmond Agitation Sedation Scale (RASS) Used at SDH Target RASS Description +4 Combative, violent, danger to staff +3 Pulls or removes tube(s) or catheters, aggressive +2 Frequent non-purposeful movement, fights ventilator +1 Anxious, apprehensive, but not aggressive 0 Alert and calm -1 Awakens to voice (eye opening/contact) > 10 seconds -2 Light sedation, briefly awakens to voice (eye opening/contact) < 10 seconds -3 Moderate sedation, movement or eye opening???, no eye contact -4 Deep sedation, no response to voice, but movement or eye opening to physical stimulation -5 Unarousable, no response to voice or physical stimulation I:ProceduralSedationNonAnesthProviders.doc (April 2012)

PROCEDURAL SEDATION ADMINISTERED BY NON-ANESTHESIOLOGIST PROVIDERS SAFH Sutter Auburn Faith Hospital Special Procedures/OR/PACU ICU/CCU/TCU Emergency Department Diagnostic Imaging Services Cardiac Cath Lab Cardiopulmonary Services ADDENDA B LOCATIONS WHERE SEDATION MAY BE ADMINISTERED SDH Sutter Davis Hospital Special Procedures/Bronchoscopy Procedure Room Critical Care Nursing Units Emergency Department Endoscopy Room Diagnostic Imaging (ED patients only/monitored by ED staff) SMCS Sutter Medical Center Sacramento Procedural sedation can be provided in clinical locations where all requirements of this patient care standard can be met. SRMC Sutter Roseville Medical Center Special Procedures and Bronchoscopy Procedure Room Telemetry and Critical Care Units Emergency Departments Diagnostic Imaging Services Outpatient Services Operating Room, Post Anesthesia Care Unit, Surgical Preparation Area (SPA) Endoscopy Laboratory Angiography and Cardiac Catheterization Laboratory SSMC Sutter Solano Medical Center Surgical Services Endoscopy PACU ICU ED Radiology I:ProceduralSedationNonAnesthProviders.doc (April 2012)

PROCEDURAL SEDATION ADMINISTERED BY NON-ANESTHESIOLOGIST PROVIDERS ADDENDA C PATIENT MONITORING REQUIREMENTS Moderate Sedation Deep Sedation During procedure After procedure During procedure After procedure B/P Heart Rate Respiratory Rate very 15 Sa02 02 sat End Tidal C02 - Sedation Score I:ProceduralSedationNonAnesthProviders.doc (April 2012)