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Patient Safety Issues in Sedation: Pitfalls and Best Practices

Thursday, September 28, 200612:00 – 1:00 p.m. EDT

Moderator: Marlene R. Miller, MD, MSc, FAAPDirector of Quality and Safety InitiativesJohns Hopkins Children’s CenterBaltimore, Maryland

This activity was funded through an educational grant from the

Physicians’ Foundation for Health Systems Excellence.

Disclosure of Financial Relationships and Resolution of Conflicts of Interest for AAP CME Activities

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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.

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

DISCLOSURESSAFER 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.


(*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)


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

DISCLOSURESAAP 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.


(*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)


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

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.

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 .

Featured Speaker: Greg Hollman, MD, FAAPMedical Director, Pediatric Sedation ProgramDirector, Pediatric Critical Care Fellowship ProgramUniversity of Wisconsin Children’s HospitalMadison, Wisconsin

Featured Speaker: Timothy E. Corden, MD, FAAPAssociate Professor of PediatricsAssociate Director, Pediatric Critical Care MedicineCo-Director, Policy Core, Injury Research CenterMedical College of WisconsinMilwaukee, Wisconsin

OBJECTIVESUpon 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.

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.

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

PharyngealSegment

NasalSegment

TrachealSegment

THE UPPER AIRWAYPharyngeal collapse during sedation

inhibition

IX X

P(-)P(O)

pCO2

Minute

ventilation

(l/min)

VENTILATIONHYPOVENTILATION DURING SEDATION

sedation

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

- - AAP -AAP - GUIDELINES FOR MONITORING GUIDELINES FOR MONITORING AND AND MANAGEMENT OF PEDIATRIC PATIENTS MANAGEMENT OF PEDIATRIC PATIENTS DURINGDURING AND AFTER SEDATION FOR DIAGNOSTIC AND AFTER SEDATION FOR DIAGNOSTIC AND AND THERAPEUTIC PROCEDURES THERAPEUTIC 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 SEDATION PRACTICE GUIDELINES FOR SEDATION ANDAND ANALGESIA BY NON ANALGESIA BY NON ANESTHESIOLOGISTSANESTHESIOLOGISTS

* Anesthesiology 2002; 96:1004-1017 - Defined Sedation Levels: Minimal, Moderate and Deep

• General Description

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

SEDATION LEVELS

Minimal


“Anxiolysis”

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

“appropriate”

unaffected

unaffected

unaffected

SEDATION LEVELS

Riskof

AdverseEvent

NoSedation

MildSedation

Minimal Moderate


“Anxiolysis” “Conscious”

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

“appropriate”

unaffected

unaffected

unaffected

“Purposeful” to light stimulation

No intervention

Adequate

Maintained

SEDATION LEVELS

Riskof

AdverseEvent

NoSedation

MildSedation

ModerateSedation

Minimal Moderate Deep


“Anxiolysis” “Conscious” “Deep sleep”

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

“appropriate”

Unaffected

Unaffected

Unaffected


No intervention

Adequate

Maintained

“Purposeful” to pain stimulation

(±) Intervention

(±) Inadequate

(±) Maintained

SEDATION LEVELS

Riskof

AdverseEvent

NoSedation

MildSedation

ModerateSedation

DeepSedation

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

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 precursors1. Knowledge based 35%2. Rule - based 33%3. Technical 13%4. Slips - Lapses 10%5. No error 9%

Latent Errors “weakness” in system Equipment, personnel, communication,

faculty, etc.

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 ∆

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

4. Risk factors: ASA III, IV and age < 1 yo

PEDIATRIC SEDATIONthe1990’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”

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;105:805Critical Incident Analysis

(2) Cote CJ,et al. Pediatrics 2000;106:633Sedative Medication Analysis

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 evaluation4. Inadequate recovery phase

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

1. THE TEAM - Knowledge/Skillsa. Nurseb. Physician

THE STRUCTURETHE TEAMTHE SETTING THE FOUNDATION

PERFORMING SAFE AND EFFECTIVE SEDATION

2. THE SETTING - Resourcesa. Medicationsb. Equipmentc. The “Milieu”

3. THE STRUCTURE - Organization and Processa. Protocolsb. Policy

FOUNDATIONS OF SEDATIONTHE TEAM

1. Personnel a. The Practitioner b. Support Personnel2. Specific Training

a. Pharmacology of sedatives - analgesicsb. Pharmacology of antagonistsc. Basic Life Supportd. Advanced Life Support

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:

FOUNDATIONS OF SEDATIONTHE SETTING

Conducive environment to conducting safe and effective sedation

S - SuctionO - OxygenA - Airway equipmentP - Pharmacologic agentsM - MonitorsS - Special equipment

FOUNDATIONS OF SEDATIONTHE STRUCTURE

Pre-Sedation/Procedure Phase1. Evaluation

a. History: medical diagnoses, sedation - anesthesia history, medications, allergies, airway historyb. Exam: airway, lungs, heart, CNS (other relevant)

2. Patient - Family counseling: risks, alternatives, informed consent

3. Fasting status

FOUNDATIONS OF SEDATIONTHE STRUCTURE

Sedation/Procedure Phase

Monitoring & Personnel


• Responsiveness

• Airway

• Ventilation

• Cardiovascular

• Monitoring

• Personnel

SEDATION LEVELS

Minimal


“Anxiolysis”

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

“appropriate”

Unaffected

Unaffected

Unaffected

• Monitoring Observation & intermittent assessment

• Personnel Responsible practitioner

SEDATION LEVELS

Minimal Moderate


“Anxiolysis” “Conscious”

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

“appropriate”

Unaffected

Unaffected

Unaffected


No intervention

Adequate

Maintained


• Pulse oximetry-

continuous

• Heart rate (SpO2)-

continuous

• Intermittent recording

of RR and BP


* Practitioner - immediately available

* Support personnel - present, may

conduct interruptible tasks

SEDATION LEVELS

Minimal Moderate Deep


“Anxiolysis” “Conscious” “Deep sleep”

• Responsiveness

• Airway

• Ventilation

• Cardiovascular

“appropriate”

Unaffected

Unaffected

Unaffected


No intervention

Adequate

Maintained

“Purposeful” to

pain stimulation

(±) Intervention

(±) Inadequate

(±) Maintained


• 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


* Practitioner - immediately available

* Support personnel - present, may

conduct interruptible tasks

* Practitioner - present

* Support Personnel -

present

SEDATION LEVELS

GENERAL APPROACH TO CONDUCTING SAFE AND EFFECTIVE PEDIATRIC PROCEDURAL SEDATION

FOUNDATIONS OF SEDATION

STRUCTURE

Post Sedation Phase

1. Recover phase2. Discharge criteria3. Followup

THE STRUCTURETHE TEAMTHE SETTING THE FOUNDATION

PERFORMING SAFE AND EFFECTIVE SEDATION

THE PROCEDURETHE SEDATIVE

THE PATIENT

SAFE AND EFFECTIVE SEDATION THE VARIABLES

1. THE PATIENTa. Medical Diagnosisb. ASA level

2. THE PROCEDUREa. Non-invasiveb. Invasive

3. THE SEDATIVEa. Sedative - Hypnoticb. Sedative - Analgesic

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 severeModerate-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, orendocrine insufficiency

(from N Engl J Med 2000;342:913)

SEDATION RISK FACTORS~ Patient Characteristics ~

1. Airway obstruction history (snoring, stridor)

2. OSA3. Poor control of airway secretions4. Craniofacial anomalies5. Chronic lung disease6. Myocardial dysfunction7. Mental status changes8. Poorly controlled seizures9. Hydrocephalous, Increased ICP10. Acute illness - URI, cough, GI

symptoms11. GERD12. Bowel obstruction13. Obesity

PEDIATRIC SEDATIONTHE 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?

A

B

DRUG CONCENTRATION

THERAPEUTICWINDOW

ADVERSE EFFECTS

INADEQUATE

EFFECTS

DESIRED EFFECTS

TIME

THERAPEUTIC WINDOW

SAFE-EFFECTIVE PEDIATRIC SEDATIONLOW DEGREE

OF IMMOBILITYHIGH DEGREEOF IMMOBILITY

HIGHDEGREEOF PAIN

LOWDEGREEOF PAIN

ANXIETY - FEAR

Anxiolytic/”Light” Sleeper

SLEEP

Hypnotic

ANXIETY-FEAR/DISCOMFORT (pain)

Analgesic and/or Anxiolytic

SLEEP/PAIN

Analgesic + Sedative/Hypnotic

DOES APPLICATION OF THE AAP/ASA GUIDELINES DECREASE THE RISK OF PEDIATRIC PROCEDURAL SEDATION?

Pediatrics 2002;109:236-2431) Prospective QI evaluation of coded sedation

records (prospective data collection, retrospective analysis)

2) 960 records reviewed: 4.2% complication ratea. Conscious Sedation complication rate - 3.8%b. Deep Sedation complication rate - 9.2%

3) Risk reductiona. Pre-sedation risk assessmentb. Adherence to guidelines (e.g. monitoring)c. Avoidance of Deep Sedation

DOES A STRUCTURED SEDATION PROGRAM-

#1Improve Sedation Efficacy?

#2Improve Sedation Safety?

INCIDENCE AND NATURE OF ADVERSE EVENTSDURING 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 encounters2. Adverse events -

a. Total - 1 per 29 sedationsb. SpO2 < 90% (> 30 sec) - 1 per 63 sedations

3. Unplanned treatmentsa. Total - 1 per 89 sedationsb. Airway/Ventilation - 1 per 200 sedations

4. No deathsSerious morbidity - 2 cases with high ASA level

INCIDENCE AND NATURE OF ADVERSE EVENTS DURING PEDIATRIC SEDATION/ANESTHESIA

FOR PROCEDURES OUTSIDE THEOPERATING ROOM:Report From the Pediatric Sedation Research

ConsortiumPediatrics 2006;118:1087

~ Conclusions ~

1. Most common adverse eventsa. Airway obstruction, apneab. Secretionsc. Vomiting

2. Core competencies identifieda. Management of airway obstructionb. Management of respiratory depression

• Sedation risk and ASA status - showed importance of:

a. “rescue” capabilities b. patient risk assessment

SAFE AND EFFECTIVEPEDIATRIC SEDATION:

~ What we have learned ~

1.Takes EDUCATION

2.Takes ORGANIZATION

3.Requires a safe and effective SETTING

4.Takes WORK, TIME, and COMMITTMENT

5.Is SERIOUS BUSINESS

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.

Standard PC.13.20Operative 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.

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.

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.


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.


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.


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.

Standard PC. 13.30Monitoring, 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)

Standard PC.13.40Post 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.

Standard IM.6.30The 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.

Standard PI.2.20Undesirable 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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