CORPORATE CLINICAL POLICY AND PROCEDURE Approved For: X CHE X CHN X CHS X CHVH Page 1 of 10 CANCELS: 8/6/07; 10/26/10; 5/1/13 EFFECTIVE: 10/23/13

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1 Approved For: X CHE X CHN X CHS X CHVH Page 1 of 10 TITLE: MODERATE/CONSCIOUS SEDATION Purpose This policy assures the standard of care is consistent for all patients receiving moderate/conscious sedation. This standard is achieved by defining types and levels of sedation and establishing procedures to be followed in the care of patients. 1. Moderate/Conscious Sedation practice throughout the organization will be reviewed, monitored, and evaluated by the Department of Anesthesia. 2. DEFINITIONS: a. Minimal sedation (anxiolysis): A drug-induced state during which patients respond normally to verbal commands. Cognitive function and coordination may be impaired, but ventilatory and cardiovascular functions are not affected. b. Moderate/Conscious sedation/analgesia: A medically controlled state of depressed consciousness that allows protective reflexes to be maintained, retains the patient s ability to maintain a patent airway independently and continuously, and permits appropriate response by the patient to physical stimulation or verbal command. Moderate/Conscious sedation has the potential for substantially reducing a patient s anxiety or level of pain. There is a reasonable expectation that the manner used will not result in loss of consciousness or loss of protective reflexes for a significant percentage of patients. 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. Independent ventilatory function may be impaired and patients may require assistance in maintaining a patent airway. Cardiovascular function is usually maintained. d. General Anesthesia: Drug-induced loss of consciousness in which a patient cannot be aroused, even with repeated or painful stimulation. The patient usually cannot breathe without artificial assistance and commonly experiences impaired cardiovascular function. 3. PERSONNEL: a. Non-anesthesiologist physicians with clinical privileges, and RN s, LPN s (specified by policy NPP#: I-14, I-12, Intravenous Medication and Fluid Administration) under direct physician supervision may administer moderate/conscious sedation medications. Nursing personnel who administer moderate/conscious sedation are Basic Life Support Certified and have demonstrated competence in airway management, resuscitation, pulse oximetry, basic EKG skills, and are IV qualified. They must also have passed the Basic Proficiency in Medication Administration test and have knowledge of the medications used in moderate/conscious sedation which includes recommended dosages, contraindications, administration, and adverse reactions. b. Registered Nurses are responsible for the assessment, observation and judgements made in relation to the effectiveness of sedation. Under the direct supervision of a Registered Nurse, Licensed Practice Nurses, Clinical Technicians, Student Externs, Radiology Technicians, and Cardiac Cath Technicians may be responsible for patient data collection (eg, obtain vital signs), documentation of this data, and reporting information to the Registered Nurse. c. Competency is exhibited by successful completion of the Moderate/Conscious Sedation Lap Pak. Policy Statements: 1. This policy applies to any area within the organization where moderate/conscious sedation is administered by non-anesthesiologists during procedures. These procedures may consist of endoscopic examinations, radiologic studies such as computerized tomography, magnetic resonance

2 Approved For: X CHE X CHN X CHS X CHVH Page 2 of imaging, cardiac procedures, interventional procedures, other in-hospital procedures such as those performed in the emergency department, special procedure s area, and procedures performed in the operating room without the involvement of members of the Department of Anesthesia. 3. This policy specifically excludes the following: 1) patients who are not undergoing a diagnostic or therapeutic procedure (eg, post-op analgesia, treatment for insomnia, etc.). 2) situations where the anticipated level of sedation will eradicate purposeful response to verbal commands or tactile stimulation. These patients require a greater level of care. 4. It is not the intent of this policy to limit narcotics, sedatives, or hypnotics being used appropriately in a variety of patient care areas. Medications used for the therapeutic management of pain control, anxiety, seizures or sedation for mechanically ventilated patients are not within the scope and intent of this policy. 5. Pre-administration of any medication intended to provide moderate/conscious sedation should not occur prior to the patient being assessed in the appropriate department. Procedure: 1. PRE-SEDATION a. Medical Assessment/Accountability 1.) The patient or legal guardian must be informed about the risks, benefits, and alternatives to moderate/conscious sedation as a component of the planned procedure. Documentation of procedural consent must be placed in the patient s record prior to the procedure. 2.) Patients receiving moderate/conscious sedation will have a history and physical, including a pre-sedation risk assessment performed by a physician. A list of current medications and a history of any adverse or allergic reactions with anesthesia, sedation or analgesia is also required. The ASA (American Society of Anesthesiologists) system should be used (see below) for the pre-sedation risk assessment. (NOTE: A pre-sedation risk assessment must be performed immediately prior to the administration of moderate/conscious sedation medication). ASA: 1 Normal healthy patient 2 Patient with mild systemic disease 3 Patient with severe systemic disease 4 patient with severe systemic disease that is a constant threat to life 5 Moribund patient who is not expected to survive without the operation/procedure 6 Declared brain dead, patient whose organs are being removed for donor purposes b. Nursing Assessment/Accountability 1.) Patients receiving moderate/conscious sedation must have a nursing assessment performed. This must include, but is not limited to, the following: a) Blood pressure, heart rate, ventilatory function, temperature, and oxygen saturation. b) Level of consciousness (LOC) c) NPO status. 2.) Appropriate reversal medications as well as age-appropriate resuscitation equipment should be immediately available in every location where moderate/conscious sedation is administered. This includes at least the following: ambu bag, oxygen and associated equipment and supplies, airways, suction device, defibrillator, intubation equipment, and ECG monitor. 3.) Personnel must assure that a responsible adult is available to provide the patient with transportation home following the procedure and recovery. If this assurance cannot be ascertained, the physician and the patient must reschedule. 2. INTRA-SEDATION

3 Approved For: X CHE X CHN X CHS X CHVH Page 3 of 10 a. A physician and a registered nurse competent to administer and assess moderate/conscious sedation must be immediately available at the onset of intravenous medication administration. b. Establish and maintain intravenous access. c. Continuous cardiac and respiratory monitoring for all patients. d. The registered nurse s primary responsibility is to monitor the patient and record the following: 1.) Blood pressure, heart rate, ventilatory function, and level of consciousness with verbal response within one minute of initial drug administration, then at least every 5 minutes and with any significant change in patient condition. 2.) Continuous pulse oximetry with recordings at least every 5 minutes and with any significant change in patient condition. 3.) Medications given including drug, dose, route, time, and response. e. All drugs should be titrated to provide adequate sedation. Variations in dosage requirements are expected based on patient size, age, response to medication, procedure, etc. 3. MARGINS OF MODERATE/CONSCIOUS SEDATION: The margin of moderate/conscious sedation has been exceeded when any of the following occur: Loss of protective reflexes (defined in an inability to handle secretions without aspiration or to maintain a patent airway independently) Loss of consciousness or unarousable sleep Sustained oxygen desaturation Need for assisted ventilation and/or jaw lift Airway obstruction 4. POST SEDATION/RECOVERY CRITERIA a. The Registered Nurse will assess and record the initial recovery vital signs; blood pressure, heart rate, ventilatory function, oxygen saturation, and level of consciousness. b. Blood pressure, heart rate, ventilatory function, oxygen saturation and level of consciousness will continue to be monitored and recorded until the patient has returned to pre-sedation status. A minimum of three consecutive readings, 15 minutes apart, is needed to deem the patient stable. c. Patients who have had reversal agents will be observed for a minimum of 120 minutes with maintenance of IV access until discharge criteria met. 5. DISCHARGE CRITERIA - - These guidelines should concentrate on a patient s return to safe parameters of psychophysiological functioning. a. Patient may transfer to a nursing unit when: 1.) Blood pressure plus/minus 20% of pre-sedation 2.) Exhibits patent airway independently 3.) 0 saturation within 2% to 4% of pre-sedation. 4.) Level of consciousness approaching pre-sedation status. 5.) Able to tolerate oral fluids. 6.) Nausea/vomiting/dizziness controlled and tolerated consistent with pre-sedation status. b. Outpatients may be discharged from the hospital when: 1.) Compliance with all parameters listed in 5.a. above is achieved. 2.) Able to ambulate with minimal assistance, consistent with pre-sedation status. 3.) Patient and/or responsible adult understands review of written discharge instructions regarding diet, medications, activities, and signs and symptoms of complications with course of action to take if any complications develop. 4.) Patient and/or responsible adult signs written discharge instructions. c. If a patient is outside of above parameters (5. A or B) notify physician. d. Hospital personnel will work with patient/family to assure transportation arrangements are in place. 6. PERSONNEL EDUCATION REQUIREMENTS

4 Approved For: X CHE X CHN X CHS X CHVH Page 4 of 10 An annual competency is required in all areas where moderate/conscious sedation is administered. For those members of the medical staff that will perform sedation where there is a reasonable chance that the patient will achieve a state of deep sedation as defined below, please refer to the Deep Sedation Addendum below. DEEP SEDATION ADDENDUM STATEMENT OF PURPOSE: To provide guidelines and privileging to those non-anesthesiologist medical staff members that may from time to time require patients to enter a state of deep sedation for therapeutic procedures. The clinician must have completed the Sedation and Analgesia credentialing packet and be granted sedation and analgesia privileges prior to applying for deep sedation privileges. GENERAL STATEMENT: Deep sedation implies the intent to depress consciousness often with associated loss of airway reflexes, depressed respiratory and cardiovascular function. It therefore requires a higher-level of training and more stringent guidelines for the non-anesthesiologists. Therefore, the sedation and analgesia guidelines will apply to deep sedation with the following additions: 1. Pre-procedure Same as Sedation and Analgesia Packet with special attention to the following: -Documentation of directed history and physical -ASA status (Consideration should be given to consultation of an anesthesiologist for ASA III or above patients). -Pre-procedure counseling of patients regarding risks, benefits, and alternatives to sedation and analgesia with signed consent -American Society of Anesthesiologists Guidelines for Preoperative Fasting should be followed. In urgent or emergent situations where gastric emptying is impaired, the potential for pulmonary aspiration must be considered in determining the level of sedation and delaying of the procedure. Consideration should be given to consultation of anesthesiologists for these patients. a. Monitoring -Continuous oximetry with appropriate audible alarms -Continuous EKG -Monitor and record blood pressure every 5 minutes b. Staffing and Personnel -The clinician administering deep sedation MUST have current ACLS certification or maintain board certification recognized by the ACEP. -A designated individual with no other task than to deliver medicine and monitor the patient will be present. This person must be at least BLS certified. -Current deep sedation privileging will be open to ER physicians, board certified critical care physicians or those clinicians that maintain board certification in emergency medicine or can prove completion of at least six (6) months anesthesia training. These privileges will only apply to preapproved procedures (see Appendix). c. Equipment -Supplemental oxygen should be delivered unless specifically contraindicated for a particular patient or procedure. d. Induction agents

5 Approved For: X CHE X CHN X CHS X CHVH Page 5 of 10 -The choice of agent for deep sedation is dependant upon the experience and preference of the individual practitioner, requirements, or constraints imposed by the patient or procedure and the likelihood of producing a deeper level of sedation than anticipated. It is cautioned that methohexital, propofol etomidate, and ketamine can produce a rapid profound decrease in level of consciousness and cardiorespiratory function, potentially culminating in a state of general anesthesia e. IV access -IV access is to be maintained at all times including during recovery. f. Quality Management -The department s QA chair as well as the Sedation and Analgesia overseer for the Anesthesia Department will review all untoward events. Monthly reports of deep sedation by non-anesthesiologists will be submitted to the QA chair of the Anesthesia Department.

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7 Approved For: X CHE X CHN X CHS X CHVH Page 7 of 10 MINIMAL SEDATION/ANXIOLYSIS MODERATE/CONSCIOUS SEDATION DEEP (UNCONSCIOUS) SEDATION - Intact, protective reflexes - Wide awake, no depression of consciousness - Stable vital signs - Normal response to verbal commands - Easily aroused - Independent maintenance of patent airway - Protective reflexes maintained - Stable vital signs - Responds appropriately to verbal or physical stimuli, eg, Open your eyes - May substantially reduce patient anxiety - Sedation scale 1,2 - Sedation scale 2,3,4 - Sedation scale 4,5 Sedation Scale Sedation Scale 1. Wide awake, alert and oriented x3 1. Wide awake, alert and oriented x3 2. Drowsy, oriented x3, responds to verbal 2. Drowsy, oriented x3, responds to verbal stimuli, stimuli, drifts off to sleep easily drifts off to sleep easily 3. Responds to mild tactile stimuli, drifts off 3. Responds to mild tactile stimuli, drifts off to to sleep easily, confused, sleeps 50% of sleep easily, confused, sleeps 50% of the time the time 4. Responds to moderate or strong tactile stimuli 4. Responds to moderate or strong tactile 5. Not arouseable, protective reflexes altered stimuli 5. Not arouseable, protective reflexes altered Assessment Medical Assessment Medical Assessment - Medical N/A - Informed consent for procedure - History & Physical - ASA risk assessment Assessment Nursing Assessment Nursing Assessment Nursing - By an RN - Frequent reassessment LOC (as indicated) - Monitoring equipment per assessment - BP, HR, RR as indicated by assessment - By an RN - BP, HR, ventilatory function, temperature, O2 saturation - Level of consciousness - Continuous presence of nurse not required - Continuous presence of RN required Intrasedation Intrasedation Intrasedation N/A - Physician/RN immediately available at onset of IV medication - IV access - Not easily aroused - Partial or complete loss of protective reflexes, includes inability to independently maintain patent airway - Purposeful response to verbal or physical stimulation may not occur - Vital signs potentially labile Sedation Scale 1. Wide awake, alert and oriented x3 2. Drowsy, oriented x3, responds to verbal stimuli, drifts off to sleep easily 3. Responds to mild tactile stimuli, drifts off to sleep easily, confused, sleeps 50% of the time 4. Responds to moderate or strong tactile stimuli 5. Not arouseable, protective reflexes altered - Informed consent for procedure - History & Physical - ASA risk assessment - By an RN - BP, HR, ventilatory function, temperature, O2 saturation - Level of consciousness - Continuous presence of RN required - Physician/RN immediately available at onset of IV medications - IV access

8 Approved For: X CHE X CHN X CHS X CHVH Page 8 of 10 LIGHT SEDATION (Continued) CONSCIOUS SEDATION/ANALGESIA (Cont.) DEEP (UNCONSCIOUS) SEDATION (Cont.) Personnel who may administer medications CRNAs, RNs, LPNs, (specified by policy NPP# I-14, I-12) - RN s primary responsibility is to assess and monitor patient - Continuous cardiac monitor for patients - BP, HR, ventilatory function, LOC within 1 minute of drug administration and then at least every 5 minutes - Continuous pulse oximetry - Reversal medications immediately available - Age appropriate resuscitation equipment immediately available Personnel who may administer medications - Non-anesthesiologist physicians with clinical privileges - CRNA s, RN s, LPN s, (specified by policy NPP # I-14, I-12) Documentation Documentation Documentation Medications - Document in the Sedation Narrator: - Informed consent in medical record - Pre-sedation risk assessment prior to administration of sedation per physician - Medications - All monitoring parameters, pre, intra, and post procedure - Discharge instructions - RN s primary responsibility is to assess and monitor patient - Continuous cardiac monitor for all patients - BP, HR, ventilatory function, LOC within 1 minute of drug administration and then at least every 5 minutes - Continuous pulse oximetry - Reversal medications immediately available - Age appropriate resuscitation equipment immediately available - Supplemental oxygen unless contraindicated Personnel who may administer medications - Non-anesthesiologist physicians with clinical privileges who are ACLS certified - CRNAs, RNs, LPNs, (specified by policy NPP # I-14, I-12) - Document in the Intra OP Navigator where appropriate - Informed consent in medical record - Pre-sedation risk assessment prior to administration of sedation per physician - Medications - All monitoring parameters, pre, intra, and post procedure - Discharge instructions Post sedation/recovery criteria Post sedation/recovery criteria Post sedation/recovery criteria N/A - RN will assess and record initial vital signs (BP, HR, ventilatory function, O2 saturation and LOC). Monitor recovery vital signs until patient has returned to presedation status. Minimum of 2 consecutive readings 15 minutes apart needed to deem patient stable. - Patients who have had reversal agents will be observed for a minimum of 120 minutes and maintain IV access until discharge criteria met - RN will assess and record initial vital sings (BP, HR, ventilatory function, O2 saturation and LOC). Monitor recovery vital signs until patient has returned to pre-sedation status. Minimum of 2 consecutive readings 15 minutes apart needed to deem patient stable. - Patients who have had reversal agents will be observed for a minimum of 120 minutes and maintain IV access until discharge criteria met.

9 REFERENCES: CORPORATE CLINICAL POLICY AND PROCEDURE Approved For: X CHE X CHN X CHS X CHVH Page 9 of 10 Algren, Chris L. EdD, MSN, RN, and John T. Algren, MD, FAAP, Pediatric Sedation Essentials for the Perioperative Nurse;, Nursing Clinics of North America, Volume 32, Number 1, August 1997, pp (Classic) Benjamin, Stanley B., MD, FACP, Complications of Conscious Sedation:, Gastrointestinal Endoscopy Clinics of North America, Volume 6, Number 2, April 1996, pp (Classic) Cote, Charles J. MD, Sedation for the Pediatric Patient, Pediatric Anesthesia, Col. 41, no. 1, Feb. 1994, pp (Classic) Fruit, Donald P., MD and Bissett III, George S., MD, Sedation of Children for Emergency Imaging, Radiologic Clinics of North America, Volume 35, Number 4, July 1997, pp (Classic) Gross, Jeffrey B. MD, Chairman, Task Force on Sedation and Analgesia by Non-Anesthesiologists, Guidelines for Sedation & Analgesia by Non-Anesthesiologists, American Society of Anesthesiologists Higgins, Thomas L. MD, Hearn, Charles J., MD, Maurer, Walter G., MD, and Vidt, Donald G., MD, Conscious sedation: what an internist needs to know, Cleveland Clinic Journal of Medicine, Volume 63, Number 6, October 1996, pp (Classic) Holtzman, Robert S., et all, Guidelines for Sedation by Non-Anesthesiologists During Diagnostic and Therapeutic Procedures, Journal of Clinical Anesthesia, Vol. 6, July/August 1994, pp (Classic) Kost, Michael MSN, CRNA, Manual of Conscious Sedation, American Academy of Pediatrics Committee on Drugs, Guidelines for Monitoring and Management of pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures, W.B. Saunders, Company, 1998, Appedix E, pp (Classic) Messinger, Jeffrey, RN, Hoffman, Leslie, RN, Donnell, John O., RN, Dunworth, Brent, RN, Conscious Sedation, American Journal of Nursing, Volume 99, Number 12, December 1999 (Classic) Miocha, Anil MD, FACP, FACG, and Radhika Srinivansan, MD, Conscious Sedation, Pearls and Perils, Digestive Diseases and Sciences, Vol. 43, Number 8, August 1998, pp (Classic) Poe, Stephanie S., MScN, RN, Nolan, Marie T., DNSc, RN, Dang Deborah, MS, RN, Schauble, James, MD, Oechsle, Denise G., MSN, RN, Kress, Laura, MAS, RN, Larkins, Jane, RN, Feroli, E. Robert, PharmD, Walker, Allen, MD, and Maxwell, Lynne G., MD, Ensuring Safety of Patients Receiving Sedation for Procedures: Evaluation of Clinical Practice Guidelines, Journal on Quality Improvement, Volume 27, Number 1, January 2001, pp (Classic) Rayhorn, Nancy BSN, RN, CGRN, Sedating and Monitoring Pediatric Patients, MCN, Volume 23, Number 2, March/April 1998, pp (Classic) Schakenback, Linda H., Guidelines for Conscious Sedation, Supplement #4, Chapter 7A, October 1995, pp. 1-8 (Classic) Sectish, Theodore C., MD, Use of Sedation and Local Anesthesia to Prepare Children for Procedures: American Family Physician, Volume 55, Number 3, February 15, 1997, pp (Classic) Smith, Dean F., MD Sedation, Anesthesia, and the JCAHO, Opus Communications, 2001 (Classic) Somerson, Steven, J., CRNA, MS, CEN; Craig W. Husted, CRNA, BSN, and Michael R. Sicilia, RN, BSN, CEN, Insights Into Conscious Sedation, American Journal of Nursing, June 1995, pp (Classic)

10 Approved For: X CHE X CHN X CHS X CHVH Page 10 of 10 Waegerle, LCDR John D., CRNA, MSNA, NC, USN, Practical Consideration of Intravenous Sedation for the Perioperative Nurse, Seminars in Perioperative Nursing, Volume 7, Number 1, January 1998, pp (Classic) Warner, Terese M., CRNA, MSN, LCDR, USN, Clinical Applications for Pediatric Sedation, CRNA: The Clinical Forum for Nurse Anesthetists, Volume 8, Number 4, November 1997, pp (Classic) Watson, Donna S., RN, MSN, CNOR, Conscious Sedation/Analgesia, American Associationi of Nurse Anesthetists Position Statement: Qualified Providers of Conscious Sedation, Moshy, 1997, Appendix D, pp (Classic) Watson, Donna S., RN, MSN, CNOR, Conscious Sedation/Analgesia, American Society of Anesthesiologists Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists, Mosby, 1997, Appendix E.pp (Classic) Watson, Donna S., RN, MSN, CNOR, Conscious Sedation/Analgesia, Association of Operating Room Nurses Recommended Practices for Managing the Patient Receiving Conscious Sedation/Analgesia, Mosby, 1997, Appendix F, pp (Classic) Watson, Donna S., RN, MSN, CNOR, Conscious Sedation/Analgesia, Pediatric Sedation, Moshy, 1997, Chapter VIII, pp (Classic) Watson, Donna S., RN, MSN, CNOR, Conscious Sedation/Analgesia, Position Statement on the Role of the Registered Nurse (RN) in the Management of Patients Receiving Intravenous Conscious Sedation for Short-Term Therapeutic, Diagnostic, or Surgical Procedures, Mosby, 1997, Appendix C, pp (Classic) Whitaker, Karen, RT Image Associate Editor, Confronting Conscious Sedation, RT Image, Feb. 26, 1996, pp (Classic) Woodin, Linda M., RN, MSN, Resting Easy, How to Care for Patients Receiving I.V. Conscious Sedation, June, Nursing 96, pp (Classic) Owned By: Regulatory Coordinator CHI Surgical Services Approved By: Regulatory Coordinator CHI Surgical Services Date: 4/13 Pharmacy and Therapeutics Committee CHN Anesthesia Department Head Date: 3/13 Date: 3/13 CHS Anesthesia Department Head Date: 3/13 CHE Anesthesia Department Head Date: 3/13 Infection Prevention Date: 4/13 Risk Management Date: 4/13 CNO Designee Date: 4/13 Community Heart & Vascular Hospital Medical Executive Council Community Hospital South Medical Executive Council Community Hospitals East & North Medical Executive Council Date: 4/13 Date: 4/13 Date: 4/13 Approved: Chief Operations Executive Date: