Current Status: Pending PolicyStat ID: Policy- Sedation/Analgesia: Minimal, Moderate, Deep DEFINITIONS

Transcription

1 Current Status: Pending PolicyStat ID: Effective: 7/1/2012 Final Approved: 10/1/2015 Last Revised: 10/1/2015 Next Review: Owner: Policy Area: References: Applicability: 3 years after approval Diane Petruzzella: VP, Surgical Services Administrative California Pacific Medical Center Policy- Sedation/Analgesia: Minimal, Moderate, Deep DEFINITIONS Minimal Sedation (Anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilator and cardiovascular functions are unaffected. Minimal sedation entails minimal risk. Examples of minimal sedation (anxiolysis) includes a single, oral (or rectal) sedative or analgesic medication administered in doses appropriate for the unsupervised treatment of insomnia, anxiety or pain. Monitoring proceeds as appropriate to the patient's level of care. Medications that may be used for Minimal Sedation include sedative-hypnotics, anxiolytics (e.g., Valium, Ativan, Versed orally for children), benzodiazepines (e.g., Valium, Versed orally for children), antihistamines (e.g., Benadryl, Atarax ), and opioids (e.g., Demerol ). Note: none of these drugs may be administered in combination with each other. Sedation of pediatric patients age thirteen and under will follow the Procedure for Moderate Sedation/Analgesia requirements as outlined below. Moderate Sedation/Analgesia 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. Medications that may be used for Moderate Sedation/Analgesia are usually given by IM or IV route. Medications for Moderate Sedation/Analgesia for Adults include: Diazepam (Valium ), Fentanyl (Sublimaze ), Meperidine (Demerol ), Midazolam (Versed ) and Morphine. Medications for Moderate Sedation/Analgesia in Pediatrics include: Diazepam (Valium ), Fentanyl (Sublimaze ), Lorazepam (Ativan ), Meperidine (Demerol ), Midazolam (Versed ) and Morphine Pentobarbital (Nembutal ). See Table 1 for Moderate Sedation Dosing Guidelines. Deep Sedation is a drug-induced depression of consciousness during which patients cannot be easily aroused and may or may not 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 respiration may be inadequate. Cardiovascular function is usually maintained. Deep Sedation is considered a type of Monitored Anesthesia Care (MAC), and is subject to anesthesia administration requirements. See Table 2 for Deep Sedation Dosing Guidelines. Approved medications for DEEP sedation/analgesia by a non-anesthesiologist MD and their respective procedures are limited to the following: Page 1 of 12

2 A. Etomidate: for Adult patients, administered by Emergency Medicine Physicians. Approved procedures: fracture reduction and dislocation reduction in patients who are hypotensive. B. Ketamine (Ketalar ): for Pediatric patients, administered by Emergency Medicine Physicians or Pediatric Intensivists. Approved procedures: including, but not limited to, laceration repair, burn debridement, fracture reduction, dislocation reduction, central line or chest tube placement. For Adult patients, administered by Adult Intensivists. Approved procedure: painful dressing change by an RN. C. Propofol (Diprivan ) for Adult patients: administered by Emergency Medicine Physicians, approved procedures: fracture reduction, dislocation reduction, laceration repair, intractable seizures. Administered by Adult Intensivists, approved procedures: line placement, non-elective cardioversion, diagnostic procedures in uncooperative patients; procedures in clinical situations that require early reevaluation of mental status (e.g. subarachnoid hemorrhage, head injury, increased intracranial pressure, hepatic encephalopathy) D. Propofol (Diprivan ) for Pediatric patients: (age 2 months to 18 Years) administered by Pediatric Intensivists, approved procedures: therapeutic and diagnostic procedures. PICC line placement by an RN. Administered by Emergency Medicine Physicians, approved procedures: diagnostic procedures related to head trauma, i.e. head CT, MRI. Anesthesia consists of general anesthesia and spinal or major regional anesthesia. It does not include local anesthesia. 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. PURPOSE: 1. To establish appropriate standards for the administration and supervision of sedation/analgesia by nonanesthesiologists. 2. To establish standards of anesthesiology supervision for the monitoring and management of patients receiving Moderate or Deep Sedation/Analgesia administered by non-anesthesiologists for diagnostic, therapeutic, or invasive procedures. 3. This policy is used in conjunction with the following policies: Universal Protocol, Process for Verification of Operative or Invasive Procedure; Fasting/NPO Guidelines; Medication Dispensing/Labeling Outside of Pharmacy; and Discharge of Outpatients Who Have Undergone an Invasive Procedure, Surgery, and/or Sedation/Analgesia APPLICABILITY: This policy applies to the administration of moderate or deep sedation/analgesia by non-anesthesiologists for diagnostic, therapeutic, or invasive procedures performed in an area approved by the Department of Anesthesiology (Appendix A). EXCLUSIONS: This policy does not apply to the management of pain and anxiety, control of seizures, preoperative medications, sedation/analgesia for mechanically ventilated patients, or urgent/emergent endotracheal intubation in a critical care unit or emergency room. Page 2 of 12

3 POLICY: 1. It is the policy of California Pacific Medical Center (CPMC) to provide uniform standards of treatment and care for patients receiving sedation/analgesia. 2. This policy applies to all clinical locations where sedation/analgesia is administered. Appropriate clinical locations where deep sedation/analgesia can be administered must be approved by the Department of Anesthesiology (Appendix A). 3. Requirements outlined in this policy are minimum standards. Each location may, at the discretion of the physician or the registered nurse (RN), exceed these guidelines when assessment of the patient warrants additional monitoring. 4. The Department of Anesthesia determines circumstances under which a non-anesthesiologist physician may administer moderate or deep sedation/analgesia. They are the following: A. Non-anesthesiologist providers administering MODERATE Sedation/Analgesia: a. Physician Qualifications: physicians who administer/order moderate sedation/analgesia must apply for privileges from their respective Department Chair at the time of appointment and reappointment with Medical Staff Services. i. Initial credentialing includes: evidence of Sedation and Capnography competency by completing written test with passing score of 90% ii. iii. Reappointment includes: evidence of Sedation competency above AND evidence of ten successfully administered sedation/analgesia cases in previous two years Exceptions: intensivists and emergency medicine physicians are exempt from number of sedation cases required as their training and ongoing experience satisfies these requirements. B. Neonatal and Adult Critical Care Nurse Practitioner Qualifications: nurse practitioners may administer moderate sedation/analgesia who function in accordance with their approved standardized procedures and who have successfully completed the Physician Moderate Sedation privileges process. A neonatologist or intensivist must order the sedation and be readily available for verbal consultation by phone/pager during the procedure and patient recovery. C. Registered Nurse (RN) Qualifications: nurses participating in moderate sedation/analgesia management must have current BLS certification AND have evidence of completing the Sedation and Capnography competency with a passing score of 90% on the written test, annually. 5. Non-anesthesiologist physicians administering DEEP Sedation/Analgesia: 1. Deep Sedation is a type of Monitored Anesthesia Care and must adhere to anesthesia administration requirements which include completion and documentation of a pre-anesthesia/deep sedation evaluation, completion of an intra-operative anesthesia/deep sedation record, and completing and documenting a post-anesthesia/deep sedation evaluation. 2. Physician Qualifications: only Intensivists and Emergency Medicine Physicians may apply for privileges to administer deep sedation/analgesia. The physician administering deep sedation must apply for privileges from their respective Department Chair. This process occurs at the time of appointment and reappointment with Medical Staff Services. Page 3 of 12

4 a. Initial credentialing: the physician must have privilege to practice Critical Care or Emergency Medicine AND complete the Sedation and Capnography competency written test with a passing score of 90% AND be proctored for two deep sedation cases b. Reappointment: the physician must maintain privileges to practice Critical Care or Emergency Medicine AND complete the Sedation Capnography competency written test with a passing score of 90% 3. Registered Nurse (RN) Qualifications: nurses participating in deep sedation/analgesia must have current BLS certification AND have evidence of completing the Sedation and Capnography competency with a passing score of 90% on the written test, annually. 6. Accessing Physician/NP Sedation Privilege Information: 1. All approved privilege lists are available on the CPMC Intranet Home Page. Staff can access this information by logging into CPMC's Intranet -> CPMC Physician Privileges or St. Luke's Physician Privileges (under Directories & Schedules on CPMC Home Page. 2. If questions remain, contact your manager or the respective Department Chairman. PROCEDURES for MODERATE OR DEEP SEDATION/ANALGESIA: A. Providers in Attendance During MODERATE Sedation/Analgesia: 1. The use of agents for sedation/analgesia in normal dosages produces a continuum of responses from minimal sedation to deep sedation. Additional competent personnel will be immediately available to comply with the requirements for the next level of sedation. Rescue Capacity: in an event when advanced airway management is indicated, by activating the Code Blue Team a qualified physician or practitioner will be immediately available to rescue the patient. 2. The person monitoring sedation and analgesia cannot be the same person who performs the procedure unless the procedure is itself that of monitoring (i.e., EEG). 3. A credentialed physician/nurse practitioner AND a qualified RN must be present. 4. A qualified person who is monitoring the patient's vital signs and level of consciousness (LOC) may assist with minor, interruptible tasks. 5. If the procedure in itself does not require the attendance of a physician, (i.e., MRI), a qualified physician or a qualified RN must be in attendance to monitor the patient for the duration of the procedure. If a qualified RN is monitoring the patient, a qualified physician must be immediately available within the department. B. Providers in Attendance During DEEP Sedation/Analgesia: 1. Two physicians, one of whom is credentialed to administer deep sedation/analgesia, will be present during the procedure. 2. In a case where the physician performing the procedure is the one who is credentialed to administer deep sedation/analgesia, a 2 nd qualified physician (see below) may, during the procedure, administer deep sedation/analgesia agents under direct supervision and in the presence of the physician who is privileged to administer deep sedation/analgesia. a. Qualification of the 2 nd physician: An Adult Hospitalist or Pediatric Hospitalist who holds current Adult Cardiac Life Support (ACLS), Pediatric Advanced Life Support (PALS), or Page 4 of 12

5 NRP certification, respectively, and has completed the Sedation and Capnography Competency by completing the written test with a passing score 90%. 3. In the event where administration of deep sedation is for a procedure that is performed by a licensed practitioner other than an MD, the presence of a 2 nd physician is not required. Example: Ketamine used for adult dressing change or Propofol used for Pediatric PICC placement; where the procedure is performed by an RN and deep sedation is administered by an intensivist. 4. The physician who is credentialed to administer deep sedation/analgesia will be in attendance for the duration of the procedure, will complete and document a pre-anesthesia evaluation, and will complete and document a post-anesthesia evaluation. An intra-procedure record will be kept. 5. An qualified RN who has completed the Annual Sedation Competency process as outlined above shall be present. C. Responsibilities: 1. The Physician or NP ordering MODERATE sedation/analgesia and/or performing the procedure with a qualified RN will: a. Ensure that the physician responsibilities, as described in the policy and procedures, are carried out. b. Be present when moderate sedation/analgesia medication is administered. c. Ensure that the patient is appropriately monitored per policy and procedures. d. Obtain informed consent for sedation/analgesia, the procedure, and blood transfusion if applicable. Document that the risks, benefits, and alternatives to sedation/analgesia, the procedure, and blood transfusion have been explained. e. Complete and document a pre-sedation assessment and plan for sedation/analgesia. f. Ensure patient meets NPO criteria. Fasting/NPO status is to be adhered to at all times. Failure to follow these guidelines may result in cancellation or postponement of the procedure. In an event when the procedure is emergent or urgent, the responsible physician must document the situation which warranted bypassing the Fasting/NPO Guidelines policy. Exception: sedation for a radiographic procedure can proceed if oral contrast is administered as part of the radiographic procedure. g. For the patient who is scheduled for an elective outpatient procedure, the availability and appropriateness of transportation home and the accompaniment of a responsible adult home following the procedure should be verified with the patient prior to the administration of sedation/ analgesia. h. Re-evaluate the patient immediately prior to initiation of sedation/analgesia. i. Manage sedation complications. j. Be readily available for verbal consultation by phone/pager during patient recovery until the patient meets post-procedure discharge criteria. k. Write a post-procedure note and discharge orders, as applicable. 2. The Physician credentialed to administer DEEP sedation/analgesia will: a. Ensure that the physician responsibilities, as described in the policy and procedures, are carried out. Page 5 of 12

6 b. Be in attendance during the entire procedure when deep sedation/analgesia medication is administered. c. Determine dosing of the deep sedation medication. d. Be responsible for patient monitoring per policy and procedures; ensure that an intraoperative anesthesia record or deep sedation flow sheet is kept. e. Perform items d-j as listed above. f. Complete and document a post-anesthesia evaluation. 3. In the case where the physician who performs the procedure is the one who is credentialed to administer deep sedation/analgesia, a 2 nd qualified physician present will: a. Administer the medication only under direct supervision and in the presence of the physician who is privileged to administer deep sedation/analgesia. b. Ensure that the patient is appropriately monitored per policy and procedure. c. Manage sedation complications. 4. The Registered Nurse's responsibilities during Moderate or Deep sedation/analgesia include: Verification prior to start of the procedure: a. Pre-anesthesia evaluation is present in the medical record b. Proper consent(s) is/are signed for the procedure, sedation, and blood transfusion, if applicable c. NPO requirement is met d. Allergies identified, if any e. Pregnancy status confirmed, if applicable f. Equipment is functioning properly prior to use (see equipment list below) g. Outpatient has made appropriate post discharge transportation and care arrangements h. Patent IV access is available. Exception: IV access in a patient who receives Ketamine IM is an option as indicated by the patient's clinical condition and determined by the physician Participation in intra- and post-procedure management: i. Administer medications, other than deep sedation medications, as ordered by the qualified physician present j. Report all pertinent observations and/or abnormal findings to the physician k. Document/record vital signs and observations during the procedure and recovery i. During MODERATE sedation the RN may monitor, assess, and evaluate the patient's vital signs, LOC, effectiveness of pain management, general behavior, and general response to the procedure and recovery ii. During DEEP sedation the RN may document/record vital signs and observations; the physician monitors the patient l. Assist in any supportive or resuscitation measures m. Assess the patient and ensure that relevant discharge criteria are met prior to transfer to a nursing unit or discharge to home. Page 6 of 12

7 5. Equipment for Moderate or Deep Sedation/Analgesia: a. Oxygen source and equipment for oxygen administration (nasal cannula, masks) b. Self-inflating resuscitation bag, i.e., Ambu bag or Anesthesia bag c. Functioning suction source d. Crash cart immediately available e. Emergency airway equipment (masks, airways and laryngoscopes with blades) f. Equipment for continuous monitoring including: i. pulse oximeter with capnography ii. iii. automated blood pressure monitor electrocardiogram g. Reversal agents, i.e., Naloxone (Narcan) or Flumazenil (Romazican) are immediately available h. Telephone D. Pre-Anesthesia Evaluation & Documentation: 1. Transportation: For patients scheduled for an elective/out-patient procedure, the availability and appropriateness of transportation home by a responsible adult following the procedure should be verified with the patient prior to the administration of moderate or deep sedation/analgesia. If there is no responsible party to take the patient home, the procedure may be cancelled. 2. FOR MODERATE SEDATION/ANALGESIA: a. An appropriate medical history and physical exam including airway assessment, current medications, and allergies must be performed and documented in the patient's medical record prior to the procedure and before sedation/analgesia is administered to the patient, except in emergencies. b. A pre-sedation assessment and plan for the procedure and sedation/analgesia are completed by the MD and documented in the EHR c. Baseline assessment including heart rate (HR), respiratory rate (RR), blood pressure (BP), oxygen saturation (SaO2), end-tidal carbon dioxide level (EtCO2), LOC, and pain level is performed immediately prior to administration of moderate sedation/analgesia medications. d. Pre-operative Verification Process, Marking of the Operative or Procedural Site (where applicable), and Time Out process (Final Verification Process) are conducted per the Universal Protocol 3. FOR DEEP SEDATION/ANALGESIA: a. A pre-anesthesia evaluation is to be conducted and documented by the physician who is credentialed to administer deep sedation/analgesia. b. The pre-anesthesia evaluation must be performed within 48 hours prior to any inpatient or outpatient procedure requiring deep sedation/analgesia. c. A pre-anesthesia evaluation for deep sedation/analgesia includes, at a minimum: i. Review of the medical history, including anesthesia, drug and allergy history Page 7 of 12

8 ii. iii. iv. Interview and examination of the patient including evaluation of the airway (i.e. Malampatti classification) Notation of anesthesia risk according to established standards of practice (e.g., ASA classification of risk) Identification of potential deep sedation/analgesia problems v. Development of the plan for the patient's deep sedation/analgesia care, including the type of medications for deep sedation/analgesia, maintenance, and post-operative care vi. Discussion with the patient (or patient's representative) regarding the risks, benefits, alternatives for the delivery of deep sedation/analgesia. d. Reevaluation of the patient occurs immediately before administration of moderate or deep sedation medications: i. including HR, RR, respiratory/airway assessment, BP, SaO2, EtCO2, LOC, and pain level ii. Pre-operative Verification Process, Marking of the Operative or Procedural Site (where applicable), and Time Out process (Final Verification Process) are conducted per the Universal Protocol E. Intra-Procedure Monitoring and Documentation: A. The physician who is credentialed to administer moderate or deep sedation/analgesia is responsible for ensuring an intra-procedure anesthesia record or sedation flow sheet is kept for the patient including, at a minimum: 1. Name and Medical Record Number (MRN) of the patient 2. Name(s) of physician who ordered/administered sedation/analgesia 3. Name, dosage, route, and time of administration of drugs and moderate or deep sedation/analgesia agents 4. Techniques(s) used and patient position(s), including the insertion/use of any intravascular or airway devices 5. Name and amounts of IV fluids, including blood or blood products, if applicable 6. Time-based documentation of vital signs, as well as oxygenation and ventilation parameters 7. Any complications, adverse reactions, or problems occurring during sedation/analgesia, including time and description of symptoms, vital signs, treatments rendered, and patient's response to treatment 8. Verification of the patient procedure site and side, when applicable 9. Post-procedure patient condition B. Intra-Procedure Monitoring and Management: the objective of monitoring the patient during moderate or deep sedation/analgesia is to ensure adequacy of ventilation, oxygenation and circulatory function. The following are considered a minimum standard that is required for any patient receiving moderate or deep sedation/analgesia 1. Continuously monitor ECG, pulse oximetry and capnography 2. Monitor and record every 5 minutes: HR, RR, BP, SaO2, ETCO2, LOC 3. Verify that the patient's LOC remains appropriate to the level of sedation/analgesia Page 8 of 12

9 4. Assess level of consciousness, vital signs, pain and/or anxiety prior to administering additional sedation 5. Administer/titrate oxygen by nasal cannula (or face mask), as needed, to maintain pre-procedure oxygen saturation levels 6. Maintain IV access C. Conditions that require medical attention/physician notification: a. Patient is unresponsive to mild physical stimuli b. Any significant change in vital signs from pre-procedure baseline (±20%) c. Patient has severe nausea or vomiting, headache, shortness of breath, or other untoward reaction F. Post-Anesthesia Evaluation, Monitoring, and & Documentation: A. FOLLOWING MODERATE sedation/analgesia, a post-procedure note is to be entered in the patient's medical record prior to transferring the patient from the area of sedation/analgesia unless accompanied by the provider or a progress note is written. B. FOLLOWING DEEP sedation/analgesia, a post-anesthesia evaluation is conducted and documented only by the physician who is credentialed to administer deep sedation/analgesia. 1. A post-anesthesia evaluation must be completed and documented no later than 48 hours after a procedure requiring deep sedation/analgesia. 2. The post-anesthesia evaluation is completed only when the patient has recovered sufficiently from the deep sedation/analgesia to appropriately participate in the assessment, e.g., answer questions appropriately, perform simple tasks. 3. For outpatients, the post-anesthesia evaluation must be completed prior to the patient's discharge. 4. Post-anesthesia evaluation and documentation includes, at a minimum: a. Respiratory function, including respiratory rate, airway patency, and oxygen saturation b. Cardiovascular function, including pulse rate and blood pressure c. Mental status d. Pain e. Nausea and vomiting f. Postoperative hydration g. Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary. Monitoring & Management Following Moderate or Deep Sedation: A. The patient must be monitored every 15 minutes for a minimum of 30 minutes after administration of the last dose of sedation/analgesic medication or until outpatient discharge criteria are met, whichever takes longer. B. Following reversal with naloxone (Narcan) or Flumazenil (Romazican), the patient must be monitored for a minimum of two hours before the patient can be discharged. C. IV access is maintained until the patient is no longer at risk or when vital signs are stable Page 9 of 12

10 D. The physician will be notified immediately for: 1. Any significant change in vital signs (±20% from baseline) 2. Failure to return to baseline LOC 3. Severe nausea, vomiting, or headache 4. Shortness of breath or other untoward reaction during or following the procedur E. Management during recovery may include: 1. Airway respositioning or insertion of oral or nasal airway for obstruction or obtunded patient 2. Administration of oxygen to maintain pre-procedure base line SaO2 3. Administration of positive pressure ventilation (Ambu Bag) if respiratory rate or quality of ventilations is severely depressed 4. Administration of reversal agents, if appropriate, per physician order 5. Activation of Rapid Response or Code Blue, if indicated G. Discharge of Patients: 1. Discharge Criteria: All patients must be discharged from the post-sedation area or post-anesthesia recovery area by a physician or an RN utilizing the Medical Staff approved Out-Patient Discharge Criteria. The RN may obtain a physician order for discharge after the following criteria are met: 1. Vital signs within 20% variance of pre-procedure baseline levels 2. Oxygen saturation within baseline of pre-procedure values 3. Absence of severe nausea and/or vomiting 4. No significant risk of losing protective airway 5. Teaching is provided and understood by patient/family 6. Minimum of 30 minutes of post-procedure observation or 30 minutes following the last dose of sedation / analgesic medication 7. Minimum of two (2) hours observation if reversal agents have been used 8. Patient has returned to pre-procedure level of mobility (unless regional anesthesia has been administered) Written discharge instructions must be given to the patient or the fully responsible party prior to the procedure, or when the patient is fully recovered from sedation/analgesia including verbal and written instructions regarding: A. Diet B. Activities C. Medications D. Expected side effects E. Signs and symptoms of complications, including blood transfusion reaction if transfusion given, and actions required F. Physician follow-up, if necessary G. Emergency phone number of physician Page 10 of 12

11 Transportation/Accompaniment A. If in-patient, patient will be transported via wheelchair, gurney or crib to hospital room/bed B. If outpatient, patient will be accompanied home by a responsible adult and will not be operating a motor vehicle Reporting of Adverse Events: The following events must be reported using an Occurrence Report form by the physician and/or nursing staff and forwarded to Risk Management: 1. All cases in which the reversal agents naloxone or flumazenil is administered. The Adverse Drug Report (ADR) Hotline (extension 74ADR) should also be contacted. 2. All cases in which unanticipated assisted ventilation is required. 3. All unanticipated hospital admissions or increased level of care related to sedation. 4. All cases in which there is significant hypoxemia (defined as a reliable SaO2 < 90% for greater than 5 minutes or significantly below baseline). 5. Any significant new atrial or ventricular dysrrhythmia or hemodynamic instability. 6. All patients who require intubation. 7. Any other untoward patient event or outcome. 8. All cases in which there is a lack of adherence to the Deep Sedation/Analgesia Policy Quality Assessment/Performance Improvement: A. All Deep Sedation cases are reviewed and/or tracked by Pharmacy on a continuous basis. Data report is submitted to the Pharmacy and Therapeutics Agents Committee, the Department of Anesthesiology and appropriate Quality Committee(s) for review, follow up and identification of improvement opportunities. B. Units that perform deep sedation procedures conduct procedure audits, including sedation monitoring elements, at a regular basis. Data report is submitted to the Department of Anesthesiology and appropriate Quality Committees at a regular basis for review, follow up and identification of improvement opportunities. C. Reportable adverse events (listed above) are reviewed and followed up by Pharmacy, Risk Management, Quality Improvement and/or Anesthesiology Department as indicated. D. The Adverse Drug Reaction Reports as related to procedural sedation are reviewed by the Department of Anesthesiology, and presented at appropriate Quality Committee(s). E. Specific performance improvement efforts at the unit level are data driven. Each unit is responsible to track its own performance, and incorporate improvement efforts with its own Department's Performance Improvement plan. Attachments: Appendix A: Approved Areas for Moderate and Deep Sedation Table 1: Pharmacological Agents Approved for Moderate Sedation - Adult and Pediatric Table 2: Pharmacological Agents Approved for Deep Sedation - Adult and Pediatric Page 11 of 12

12 References: 1. American Society of Anesthesiologists. Practice Guidelines for sedation and analgesia by Non- Anesthesiologists: A report by the American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists (1995). Last Amended October, Association of Operating Room Nurses. (2016). 5 Key Practices for Safer Moderate Sedation. AORN Periop Insider, 2016: February 9, Association of Operating Room Nurses (2016). Guideline Essentials, Center for Medicare & Medicaid Services (CMS), Department of Health & Human Services. CMS Memorandum: Clarifications of the Interpretive Guidelines for the Anesthesia Services Condition of Participation (Dec 11, 2009) 5. Joint Commission on Accreditation of Healthcare Organizations. (2004). Standards for Additional Special Procedures in 2015 Hospital Accreditation Standards. 6. Krauss B. & Green, SM. (2000). Sedation and Analgesia for Procedures in Children. New England Journal of Medicine. 342(13): Committee Approver Date All revision dates: 10/1/2015, 10/14/2012, 7/1/2012 Attachments: Appendix A: Approved Areas for Moderate and Deep Sedation Administered by Non- Anesthesiologists Table 1: Pharmacologic Agents Approved for Moderate Sedation Procedures Table 2: Pharmacologic Agents Approved for Deep Sedation Procedures Diane Petruzzella: VP, Surgical Services 3/3/2016 P&P; Committee Cynthia Leahy: Dir, Accreditation 3/11/2016 Medical Executive Committee Rebecca Cohen: Mgr, Medical Staff Srvcs 5/24/2016 Medical Executive Committee Rob Baker: Mgr, Medical Staff Srvcs 5/25/2016 Board Richard D. Falls: Mgr, Accreditation pending Page 12 of 12