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    1. 1. Patient Safety Issues in Sedation: Pitfalls and Best Practices Thursday, September 28, 2006 12:00 – 1:00 p.m. EDT
    2. 2. Moderator: Marlene R. Miller, MD, MSc, FAAP Director of Quality and Safety Initiatives Johns Hopkins Children’s Center Baltimore, Maryland
    3. 3. This activity was funded through an educational grant from the Physicians’ Foundation for Health Systems Excellence.
    4. 4. Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities Grid The AAP CME program aims to develop, maintain, and increase the competency, skills, and professional performance of pediatric healthcare professionals by providing high quality, relevant, accessible and cost-effective educational experiences. The AAP CME program provides activities to meet the participants’ identified education needs and to support their lifelong learning towards a goal of improving care for children and families (AAP CME Program Mission Statement, August 2004). The AAP recognizes that there are a variety of financial relationships between individuals and commercial interests that require review to identify possible conflicts of interest in a CME activity. The “AAP Policy on Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities” is designed to ensure quality, objective, balanced, and scientifically rigorous AAP CME activities by identifying and resolving all potential conflicts of interest prior to the confirmation of service of those in a position to influence and/or control CME content. The AAP has taken steps to resolve any potential conflicts of interest. All AAP CME activities will strictly adhere to the 2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. In accordance with these Standards, the following decisions will be made free of the control of a commercial interest: identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the CME activity. The purpose of this policy is to ensure all potential conflicts of interest are identified and mechanisms to resolve them prior to the CME activity are implemented in ways that are consistent with the public good. The AAP is committed to providing learners with commercially unbiased CME activities.
    5. 5. DISCLOSURES Activity Title: Safer Health Care for Kids - Webinar Patient Safety Issues in Sedation: Pitfalls and Best Practices Activity Date: September 28, 2006 DISCLOSURE OF FINANCIAL RELATIONSHIPS All individuals in a position to influence and/or control the content of AAP CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider of commercial services discussed in CME activities. Name Name of Commercial Interest(s)* (*Entity producing health care goods or services) Nature of Relevant Financial Relationship(s) (If yes, please list: Research Grant, Speaker’s Bureau, Stock/Bonds excluding mutual funds, Consultant, Other - identify) CME Content Will Include Discussion/ Reference to Commercial Products/Services Disclosure of Off-Label (Unapproved)/Investigational Uses of Products AAP CME faculty are required to disclose to the AAP and to learners when they plan to discuss or demonstrate pharmaceuticals and/or medical devices that are not approved Timothy E. Corden, MD, FAAP No No Not sure Yes - most of the drugs used for children, sedation agents and just about everything else, have not been officially approved for children, yet the agents are part of the standard of care. Greg Hollman, MD, FAAP No No No No
    6. 6. DISCLOSURES SAFER HEALTH CARE FOR KIDS - PROJECT ADVISORY COMMITTEE AND STAFF DISCLOSURE OF FINANCIAL RELATIONSHIPS All individuals in a position to influence and/or control the content of AAP CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider of commercial services discussed in CME activities. Name Name of Commercial Interest(s)* (*Entity producing health care goods or services) Nature of Relevant Financial Relationship(s) (If yes, please list: Research Grant, Speaker’s Bureau, Stock/Bonds excluding mutual funds, Consultant, Other - identify) CME Content Will Include Discussion/ Reference to Commercial Products/Services Disclosure of Off-Label (Unapproved)/Investigational Uses of Products AAP CME faculty are required to disclose to the AAP and to learners when they plan to discuss or demonstrate pharmaceuticals and/or medical devices that are not approved Karen Frush, MD, FAAP (PAC Member) No No No No Uma Kotagal, MD, MBBS, MSc, FAAP (PAC Member) No No No No Christopher Landrigan, MD, MPH, FAAP (PAC Member) No No No No Marlene R. Miller, MD, MSc, FAAP (PAC Chair) No No No No Paul Sharek, MD, MPH. FAAP (PAC Member) No No No No Erin Stucky, MD, FAAP (PAC Member) No No Not sure No Nancy Nelson (AAP Staff) No No No No Melissa Singleton, MEd (Project Manager – AAP Consultant) No No No No Junelle Speller (AAP Staff) No No No No Linda Walsh, MAB (AAP Staff) No No No No
    7. 7. DISCLOSURES AAP COMMITTEE ON CONTINUING MEDICAL EDUCATION (COCME) DISCLOSURE OF FINANCIAL RELATIONSHIPS All individuals in a position to influence and/or control the content of AAP CME activities are required to disclose to the AAP and subsequently to learners that the individual either has no relevant financial relationships or any financial relationships with the manufacturer(s) of any commercial product(s) and/or provider of commercial services discussed in CME activities. Name Name of Commercial Interest(s)* (*Entity producing health care goods or services) Nature of Relevant Financial Relationship(s) (If yes, please list: Research Grant, Speaker’s Bureau, Stock/Bonds excluding mutual funds, Consultant, Other - identify) CME Content Will Include Discussion/ Reference to Commercial Products/Services Disclosure of Off-Label (Unapproved)/Investigational Uses of Products AAP CME faculty are required to disclose to the AAP and to learners when they plan to discuss or demonstrate pharmaceuticals and/or medical devices that are not approved Ellen Buerk, MD, FAAP No No No No Meg Fisher, MD, FAAP No No No No Robert A. Wiebe, MD, FAAP No No Not sure No Jack Dolcourt, MD, FAAP No No No No Thomas W. Pendergrass, MD, FAAP No No No No Beverly P. Wood, MD, FAAP No No No No
    8. 8. CME CREDIT The American Academy of Pediatrics (AAP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.   The AAP designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.   This activity is acceptable for up to 1.0 AAP credit. This credit can be applied toward the AAP CME/CPD Award available to Fellows and Candidate Fellows of the American Academy of Pediatrics.
    9. 9. OTHER CREDIT This webinar is approved by the National Association of Pediatric Nurse Practitioners (NAPNAP) for 1.2 NAPNAP contact hours of which 0.0 contain pharmacology (Rx) content. The AAP is designated as Agency #17. Upon completion of the program, each participant desiring NAPNAP contact hours should send a completed certificate of attendance, along with the required recording fee ($10 for NAPNAP members, $15 for nonmembers), to the NAPNAP National Office at 20 Brace Road, Suite 200, Cherry Hill, NJ 08034-2633.   The American Academy of Physician Assistants accepts AMA PRA Category 1 Credit(s)TM from organizations accredited by the ACCME .
    10. 10. Featured Speaker: Greg Hollman, MD, FAAP Medical Director, Pediatric Sedation Program Director, Pediatric Critical Care Fellowship Program University of Wisconsin Children’s Hospital Madison, Wisconsin
    11. 11. Featured Speaker: Timothy E. Corden, MD, FAAP Associate Professor of Pediatrics Associate Director, Pediatric Critical Care Medicine Co-Director, Policy Core, Injury Research Center Medical College of Wisconsin Milwaukee, Wisconsin
    12. 12. OBJECTIVES Upon completion of this activity, participants will be able to:  Identify all key critical patient safety risk issues in pediatric sedation.  Describe key personnel and system components necessary for delivery of safe pediatric sedation services, and explain the role of each.  Propose a “best practice” model for pediatric sedation, and analyze the differences between this and the existing model at the participant’s institution.
    13. 13. PATIENT SAFETY ISSUES IN SEDATION ~ preview ~ 1. The importance of respiratory depression in sedation adverse events. 2. The different levels of sedation. 3. The AAP and ASA Guidelines for sedation. 4. The essential components required to conduct safe pediatric sedation. 5. The importance of a systematic approach to sedation that promotes safety and efficacy.
    14. 14. SEDATIVE DRUGS 1. All sedative drugs suppress the CNS 2. Respiratory depression: the most significant adverse effect following sedative drug administration a. Impaired airway control - the single most serious adverse event b. Hypoventilation • Depth of sedation is a continuum mild sedation general anesthesia 4. The greater depth of sedation the greater risk
    15. 15. Pharyngeal Segment Nasal Segment Tracheal Segment THE UPPER AIRWAY Pharyngeal collapse during sedation ←inhibition→ IX X P(-)P(O)
    16. 16. pCO2 Minute ventilation (l/min) VENTILATION HYPOVENTILATION DURING SEDATION sedation
    17. 17. AAP and ASA Practice Guidelines for Sedation ~ Expert Opinion and Consensus ~ Developed in response to: the growing number of sedations performed by non-anesthesiologists outside the operating room setting & adverse sedation events
    18. 18. - AAP -- AAP - GUIDELINES FOR MONITORING ANDGUIDELINES FOR MONITORING AND MANAGEMENT OF PEDIATRIC PATIENTSMANAGEMENT OF PEDIATRIC PATIENTS DURINGDURING AND AFTER SEDATION FOR DIAGNOSTICAND AFTER SEDATION FOR DIAGNOSTIC ANDAND THERAPEUTIC PROCEDURESTHERAPEUTIC PROCEDURES * Pediatrics 1985: defined Conscious and Deep Sedation * Pediatrics 1992: Pulse Oximetry monitoring included * Pediatrics 2002: Addendum to 1992 * Pediatrics 2006 ?: Conscious and Deep Sedation redefined as Minimal, Moderate and Deep Sedation -- ASA -ASA - PRACTICE GUIDELINES FOR SEDATIONPRACTICE GUIDELINES FOR SEDATION ANDAND ANALGESIA BY NONANALGESIA BY NON ANESTHESIOLOGISTSANESTHESIOLOGISTS
    19. 19. • General Description • Responsiveness • Airway • Ventilation • Cardiovascular SEDATION LEVELS
    20. 20. Minimal • General Description “Anxiolysis” • Responsiveness • Airway • Ventilation • Cardiovascular “appropriate” unaffected unaffected unaffected SEDATION LEVELS Risk of Adverse Event No Sedation Mild Sedation
    21. 21. Minimal Moderate • General Description “Anxiolysis” “Conscious” • Responsiveness • Airway • Ventilation • Cardiovascular “appropriate” unaffected unaffected unaffected “Purposeful” to light stimulation No intervention Adequate Maintained SEDATION LEVELS Risk of Adverse Event No Sedation Mild Sedation Moderate Sedation
    22. 22. Minimal Moderate Deep • General Description “Anxiolysis” “Conscious” “Deep sleep” • Responsiveness • Airway • Ventilation • Cardiovascular “appropriate” Unaffected Unaffected Unaffected “Purposeful” to light stimulation No intervention Adequate Maintained “Purposeful” to pain stimulation (±) Intervention (±) Inadequate (±) Maintained SEDATION LEVELS Risk of Adverse Event No Sedation Mild Sedation Moderate Sedation Deep Sedation
    23. 23. SYSTEMS ANALYSIS OF ADVERSE DRUG EVENTS JAMA 1995; 274: 35-43 334 errors led to 264 ADEs “REASON” FOR OCCURANCE *1. Lack of knowledge of drug: dose, choice (29%) *2. Lack of patient information (18%) 3. Rule violation (10%) 4. Slips and memory lapses 5. Transcription errors 6. Faulty system 7. Communication among services *1 & 2 involved in ~ 50% of errors
    24. 24. ANALYSIS OF 2000 ANESTHETIC INCIDENTS ~ the AIMS Report ~ Anaesth Intens Care 1993;21:506-520 Report of 2000 unintended incidents which reduced or had potential to reduce patient safety. Active Error≡ immediate precursors 1. Knowledge based 35% 2. Rule - based 33% 3. Technical 13% 4. Slips - Lapses 10% 5. No error 9% Latent Errors≡ “weakness” in system
    25. 25. ANALYSIS OF 2000 ANESTHETIC INCIDENTS ~ the AIMS Report ~ Anaesth Intens Care 1993;21:506-520 Factors Reducing Occurrence of Adverse Outcomes 1. Experience (knowledge) 35% 2. Monitor Detection 36% 3. Equipment re 15%√ 4. Skilled assistance 12% 5. Supervisor 9% 6. Staff ∆
    26. 26. ADVERSE SEDATION EVENTS IN CHILDREN BY NONANESTHESIOLOGISTS Anesth Analg 1997;85:1207 1. Total sedations: 1140 (~ 75% Chloral) - prospective assessment of QA tool 2. 239 (20 %) adverse events • 13%: inadequate sedation • 5.5%: oxygen desaturation (< 90%) 3. Oxygen desaturation in 46 (5.4%) of 854 chloral hydrate sedations
    27. 27. PEDIATRIC SEDATION the1990’s = sedation safety concerns Adverse Sedation Events in Pediatrics National volunteer reporting of adverse sedation events in children. Cote CJ, et al. Pediatrics, 2000 represents the“tip of the ice berg”
    28. 28. ADVERSE SEDATION EVENTS IN PEDIATRICS ~ Sources ~ • FDA Adverse Drug Event Report • US Pharmacopoeia • Pediatric specialist survey 95 events reported (1) Cote CJ, et al. Pediatrics 2000;105:805 Critical Incident Analysis (2) Cote CJ,et al. Pediatrics 2000;106:633
    29. 29. ADVERSE SEDATION EVENTS n=95 ~ Critical Incident Analysis ~ Pediatrics 2000;105:805 • 60 deaths / permanent CNS injury • 80%: 1st event respiratory • Poor outcome associated with: 1. Inadequate resuscitation (outpt >> inpt) 2. Inadequate monitoring, particularly SpO2 3. Inadequate initial evaluation 4. Inadequate recovery phase
    30. 30. ADVERSE SEDATION EVENTS n=95 ~ Sedative Drug Analysis ~ Pediatrics 2000;106:633 1. Drug - drug interaction (n=44), especially >3 drugs 2. Drug overdose (n=39) 3. Drug administration at home and by non- medical personnel 4. Deaths after discharge associated with drugs with long elimination half life 5. No association with drug class or route
    31. 31. 1. THE TEAM - Knowledge/Skills a. Nurse b. Physician THE STRUCTURETHE TEAMTHE SETTING THE FOUNDATION PERFORMING SAFE AND EFFECTIVE SEDATION 2. THE SETTING - Resources a. Medications b. Equipment c. The “Milieu” 3. THE STRUCTURE - Organization and Process a. Protocols b. Policy
    32. 32. FOUNDATIONS OF SEDATION THE TEAM 1. Personnel a. The Practitioner b. Support Personnel 2. Specific Training a. Pharmacology of sedatives - analgesics b. Pharmacology of antagonists c. Basic Life Support
    33. 33. JCAHO© 2000 1. Evaluating patients prior to moderate or deep sedation 2. Rescuing patients who slip into a “deeper than desired” level of sedation or anesthesia. 3. Managing a compromised airway during a procedure. 4. Handling a compromised cardiovascular system during a procedure. Revisions to Anesthesia Care Standards Comprehensive Accreditation Manual for Hospitals “Qualified individuals” conducting sedations must possess education, training and experience in:
    34. 34. FOUNDATIONS OF SEDATION THE SETTING Conducive environment to conducting safe and effective sedation S - Suction O - Oxygen A - Airway equipment P - Pharmacologic agents M - Monitors S - Special equipment
    35. 35. FOUNDATIONS OF SEDATION THE STRUCTURE Pre-Sedation/Procedure Phase 1. Evaluation a. History: medical diagnoses, sedation - anesthesia history, medications, allergies, airway history b. Exam: airway, lungs, heart, CNS (other relevant) 2. Patient - Family counseling: risks, alternatives, informed consent 3. Fasting status
    36. 36. FOUNDATIONS OF SEDATION THE STRUCTURE Sedation/Procedure Phase Monitoring & Personnel
    37. 37. • General Description • Responsiveness • Airway • Ventilation • Cardiovascular • Monitoring • Personnel SEDATION LEVELS
    38. 38. Minimal • General Description “Anxiolysis” • Responsiveness • Airway • Ventilation • Cardiovascular “appropriate” Unaffected Unaffected Unaffected • Monitoring Observation & intermittent assessment • Personnel Responsible practitioner SEDATION LEVELS
    39. 39. Minimal Moderate • General Description “Anxiolysis” “Conscious” • Responsiveness • Airway • Ventilation • Cardiovascular “appropriate” Unaffected Unaffected Unaffected “Purposeful” to light stimulation No intervention Adequate Maintained • Monitoring Observation & intermittent assessment • Pulse oximetry- continuous • Heart rate (SpO2)- continuous • Intermittent recording of RR and BP • Personnel Responsible practitioner * Practitioner - immediately available * Support personnel - present, may conduct interruptible tasks SEDATION LEVELS
    40. 40. Minimal Moderate Deep • General Description “Anxiolysis” “Conscious” “Deep sleep” • Responsiveness • Airway • Ventilation • Cardiovascular “appropriate” Unaffected Unaffected Unaffected “Purposeful” to light stimulation No intervention Adequate Maintained “Purposeful” to pain stimulation (±) Intervention (±) Inadequate (±) Maintained • Monitoring Observation & intermittent assessment • Pulse oximetry- continuous • Heart rate (SpO2)- continuous • Intermittent recording of RR and BP • Pulse oximetry - continuous • ECG - continuous • BP every 3 minutes • (±) EtCO2, precordial stethoscope • Personnel Responsible practitioner * Practitioner - immediately available * Support personnel - present, may conduct interruptible tasks * Practitioner - present * Support Personnel - present SEDATION LEVELS
    41. 41. GENERAL APPROACH TO CONDUCTING SAFE AND EFFECTIVE PEDIATRIC PROCEDURAL SEDATION
    42. 42. FOUNDATIONS OF SEDATION STRUCTURE Post Sedation Phase 1. Recover phase 2. Discharge criteria 3. Followup
    43. 43. THE STRUCTURETHE TEAMTHE SETTING THE FOUNDATION PERFORMING SAFE AND EFFECTIVE SEDATION TH E PR O C ED U R E TH E SED ATIVE THE PATIENT
    44. 44. SAFE AND EFFECTIVE SEDATION THE VARIABLES 1. THE PATIENT a. Medical Diagnosis b. ASA level 2. THE PROCEDURE a. Non-invasive b. Invasive 3. THE SEDATIVE a. Sedative - Hypnotic b. Sedative - Analgesic
    45. 45. PEDIATRIC SEDATION PATIENT ASA DEFINITIONS: Class Description Examples Sedation Suitability 1 A normally healthy patient Unremarkable medical history Excellent 2 A patient with mild Mild asthma, controlled Generally good systemic disease (no seizure disorder, anemia, functional limitation) controlled diabetes mellitus 3 A patient with severe Moderate-to-severe asthma, Intermediate to systemic disease (definite poorly controlled seizure, poor; consider functional limitation) pneumonia, poorly controlled benefits relative IDDM, moderate obesity. to risks 4 A patient with severe Severe bronchopulmonary Poor, benefits systemic disease that is a dysplasia, sepsis, advanced rarely outweigh constant threat to life degrees of pulmonary, risks cardiac, hepatic, renal, or endocrine insufficiency
    46. 46. SEDATION RISK FACTORS ~ Patient Characteristics ~ 1. Airway obstruction history (snoring, stridor) 2. OSA 3. Poor control of airway secretions 4. Craniofacial anomalies 5. Chronic lung disease 6. Myocardial dysfunction 7. Mental status changes 8. Poorly controlled seizures 9. Hydrocephalous, Increased ICP 10. Acute illness - URI, cough, GI symptoms 11. GERD 12. Bowel obstruction
    47. 47. PEDIATRIC SEDATION THE PROCEDURE 1) What are the desired clinical effects? 2) How quickly are effects desired? 3) What is the desired duration of effects? 4) Any adverse “other” clinical effects?
    48. 48. A B DRUGCONCENTRATION THERAPEUTIC WINDOW ADVERSE EFFECTS INADEQUATE EFFECTS DESIRED EFFECTS TIME THERAPEUTIC
    49. 49. SAFE-EFFECTIVE PEDIATRIC SEDATION LOW DEGREE OF IMMOBILITY HIGH DEGREE OF IMMOBILITY HIGH DEGREE OF PAIN LOW DEGREE OF PAIN ANXIETY - FEAR Anxiolytic/”Light” Sleeper SLEEP Hypnotic ANXIETY-FEAR/ DISCOMFORT (pain) Analgesic and/or Anxiolytic SLEEP/PAIN Analgesic + Sedative/Hypnotic
    50. 50. DOES APPLICATION OF THE AAP/ASA GUIDELINES DECREASE THE RISK OF PEDIATRIC PROCEDURAL SEDATION? Pediatrics 2002;109:236-243 1) Prospective QI evaluation of coded sedation records (prospective data collection, retrospective analysis) 2) 960 records reviewed: 4.2% complication rate a. Conscious Sedation complication rate - 3.8% b. Deep Sedation complication rate - 9.2% 3) Risk reduction a. Pre-sedation risk assessment b. Adherence to guidelines (e.g. monitoring) c. Avoidance of Deep Sedation
    51. 51. DOES A STRUCTURED SEDATION PROGRAM- #1 Improve Sedation Efficacy? #2 Improve Sedation Safety?
    52. 52. INCIDENCE AND NATURE OF ADVERSE EVENTS DURING PEDIATRIC SEDATION/ANESTHESIA FOR PROCEDURES OUTSIDE THE OPERATING ROOM: Report From the Pediatric Sedation Research Consortium Pediatrics 2006;118:1087 1. Prospective database collection - 26 institutions 30,037 sedation/anesthesia encounters 2. Adverse events - a. Total - 1 per 29 sedations b. SpO2 < 90% (> 30 sec) - 1 per 63 sedations 3. Unplanned treatments a. Total - 1 per 89 sedations b. Airway/Ventilation - 1 per 200 sedations 4. No deaths
    53. 53. INCIDENCE AND NATURE OF ADVERSE EVENTS DURING PEDIATRIC SEDATION/ANESTHESIA FOR PROCEDURES OUTSIDE THEOPERATING ROOM: Report From the Pediatric Sedation Research Consortium Pediatrics 2006;118:1087 ~ Conclusions ~ 1. Most common adverse events a. Airway obstruction, apnea b. Secretions c. Vomiting 2. Core competencies identified a. Management of airway obstruction b. Management of respiratory depression • Sedation risk and ASA status - showed importance
    54. 54. SAFE AND EFFECTIVE PEDIATRIC SEDATION: ~ What we have learned ~ 1. Takes EDUCATION 2. Takes ORGANIZATION 3. Requires a safe and effective SETTING 4. Takes WORK, TIME, and COMMITTMENT
    55. 55. Appendix: Joint Commission Sedation Related Standards, 2006 • Reference: Comprehensive Accreditation Manual for Hospitals: The Official Handbook 2006 (camh) • Abbreviations: – PC: section on Provision of Care, Treatment and Services – PI: section on Improving Organization Performance – IM: section on Management of Information – LIP: Licensed Independent practitioner – EP: Element of Performance – components of each standard, scored during survey.
    56. 56. Standard PC.13.20 Operative or other procedures and/or administration of moderate or deep sedation or anesthesia. • Elements of Performance (EP) 1. Sufficient numbers of qualified staff, to evaluate the patient, help with the procedure, provide sedation or anesthesia, monitor, and recover the patient.
    57. 57. Standard PC 13.20 EP’s Continued 2. Individuals administering moderate or deep sedation and anesthesia are qualified and have the appropriate credentials to manage patients at whatever level of sedation or anesthesia is achieved, either intentionally or unintentionally. – Notes: at a minimum: competency-based education, training and experience in the following – Evaluating patients before performing moderate or deep sedation and anesthesia – Performing the moderate or deep sedation and anesthesia, including rescuing patients who slip into a deeper-than-desired level of sedation or analgesia. – Moderate Sedation – Qualified to rescue from deep sedation – can manage a compromised airway and provide adequate oxygenation and ventilation – Deep Sedation- Qualified to rescue from general anesthesia, competent to mange an unstable cardiovascular system as well as a compromised airway and inadequate oxygenation and ventilation.
    58. 58. PC.13.20, EP’s Continued 3. A registered nurse supervises perioperative nursing care. 4. Appropriate equipment to monitor the patient’s physiologic status is available. (also see PC.13.30) 5. Appropriate equipment to administer IV fluids and drugs, including blood and blood components, is available as needed. 6. Resuscitation capabilities are available.
    59. 59. PC.13.20, EP’s Continued EP-s 7-10 must occur prior to administration of moderate, deep sedation and anesthesia 7. The anticipated needs of the patient are assessed to plan for the appropriate level of post procedure care. 8. Perprocedural education, treatments, and services are provided according to the plan of care, treatment and services.
    60. 60. PC.13.20, EP’s Continued 9. Conduct a “time out” immediately before starting the procedure as described in the Universal Protocol. • National Patient Safety Goals – Goal 9, Preoperative verification • Final verification of the correct patient, procedure, site and, implants • Active Communication among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a “fail- safe” mode, that is, the procedure is not started until any questions or concerns are resolved.
    61. 61. PC.13.20, EP’s Continued 10. A presedation or preanesthesia assessment is conducted 11. Before sedating or anesthetizing a patient, a licensed independent practitioner with appropriate clinical privileges plans or concurs with the planned anesthesia. 12. The patient is reevaluated immediately before moderate or deep sedation and before anesthesia induction.
    62. 62. Standard PC. 13.30 Monitoring, Patients are monitored during the procedure and or administration of moderate or deep sedation or anesthesia. 1. Appropriate methods are used to continuously monitor oxygenation, ventilation, and circulation during procedures that may affect the patient’s physiological status. • Notes - VS – HR, pulse ox, BP, at regular intervals. EKG or use of continuous cardiac monitoring device, in patients with significant cardiovascular disease or when dysrhythmias are anticipated or detected. 2. The procedure and/or administration of moderate or deep sedation or anesthesia for each patient is documented in the medical record. (also see Standard IM.6.30)
    63. 63. Standard PC.13.40 Post Sedation, Anesthesia Monitoring EP’s 1. The patient’s status is assessed immediately after the procedure and/or administration of moderate or deep sedation or anesthesia. 2. Each patient’s physiological status, mental status, and pain level are monitored 3. Monitoring is at a level consistent with the potential effect of the procedure and/or sedation or anesthesia. 4. Patients are discharged from the recovery area and the hospital by a qualified licensed independent practitioner or according to rigorously applied criteria approved by the clinical leaders. 5. Patients who have received sedation or anesthesia in the outpatient setting are discharged in the company of a responsible, designated adult.
    64. 64. Standard IM.6.30 The medical record thoroughly documents operative or other high risk procedures and the use of moderate or deep sedation or anesthesia. • EP 6. – Postoperative documentation records the patient’s discharge from the postsedation or postanesthesia care area by the responsible licensed independent practitioner or according to discharge criteria. • EP 7 – The use of approved discharge criteria to determine the patient’s readiness for discharge is documented in the medical record. • EP 8 – Postoperative documentation records the name of the LIP responsible for discharge.
    65. 65. Standard PI.2.20 Undesirable patterns or trends in performance are analyzed • EP 8. An analysis is performed for adverse events or patterns of adverse events during moderate or deep sedation and anesthesia use.

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