Joint Commission

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Medical Errors,Sentinel Events, andAccreditation

• Association of Anesthesia Program Directors
• October 28, 2000

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Mistakes are at the very base of human thought,
embedded there, feeding the structure like root
nodules. If we were not provided with the knack
of being wrong, we could never get anything
useful done. We are built to make mistakes,
coded for error The capacity to leap across
mountains of information and land lightly on the
wrong side represents the highest of human
endowments.

• Lewis Thomas, 1974

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Accreditation is,at its core,a risk reduction
activity.
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The Joint CommissionsSentinel Event Policy

• Established in January 1996 with the following
  goals
• To have a positive impact in improving care
• To focus attention on underlying causes and risk
  reduction
• To increase the general knowledge about sentinel
  events, their causes and prevention
• To maintain public confidence in the
  accreditation process

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Sentinel Event

• A sentinel event is an unexpected occurrence
  involving death or serious physical or
  psychological injury, or the risk thereof.

• Serious injury specifically includes the loss of
  limb or function.
• The phrase, "or the risk thereof" includes any
  process variation for which a recurrence would
  carry a significant chance of a serious adverse
  outcome.

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To Err Is HumanBuilding a Safer Health System
Institute of Medicine Report, November 1999

• 44,000 98,000 patient deaths annually due to
  error
• Goal 50 reduction in errors over the next 5
  years
• Recommendations
• National Center for Patient Safety within DHHS
• Mandatory reporting to state agencies
• Engage consumers, purchasers, accreditors,
  regulators
• Effect a culture shift to make safety a top
  priority

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Joint Commission Public Policy Position on
Reporting Managing Medical Errors

• In order to measurably improve patient safety,
  the Joint Commission supports
• Creation of an effective national reporting
  system
• (mandatory or voluntary)
• Conditioned on the following
• Limited to well-defined serious adverse events,
  if mandatory
• Standardized definition of a reportable medical
  error or event
• Requirement for in-depth analysis of each
  error/event
• Federal protection from disclosure of the
  resulting information
• Requirement for action plan with follow-up
• Sharing of event-related information with
  oversight bodies

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Experience to Date
Of 983 sentinel events reviewed by the
Accreditation Committee

• 188 inpatient suicides
• 126 events relating to medication errors
• 119 operative/post op complications
• 88 events of surgery at the wrong site
• 51 deaths related to delay in treatment
• 49 patient falls (13 multi-story)
• 42 assault/rape/homicide
• 41 deaths of patients in restraints
• 32 deaths following elopement
• 22 transfusion-related events
• 22 Perinatal death/injury
• 18 infant abductions/wrong discharges
• 18 fires
• 167 other

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Total Reviewed Events by State
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Sources of Sentinel Event Information
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Settings of the Sentinel Events
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Root cause analysis

• . . . a process for identifying the basic or
  causal factors that underlie variation in
  performance, including the occurrence or possible
  occurrence of a sentinel event.

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Classification of Root Causes

• General classification based on Joint Commission
  standards
• Patient care functions
• Organization management functions

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Root Causes of Sentinel Events
(All categories)
HR.4
LD.3.2 / IM.5
PE.1
EC
IM.5
HR.5/MS.5
EC.2.7/EC.2.13
HR.2
TX.3.5/TX.4.3/EC.4.1
Percent of events
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Root Causes of Medication Errors
HR.4
LD.3.2 / IM.5
TX.3.3/3.5
IM.5
HR.5/MS.5
MS.2.5
TX.3.5
EC.4.1
Percent of events
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Root Causes of Wrong Site Surgery
IM.5
PE.1.8
?
?
TX.5.2/PF.1.10
?
IM.5
EC.4.1
HR.5 / MS.5
Percent of events
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Strategies for Reducing the Riskof Wrong Site
Surgery
Percent of events
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Suggestions from the Joint Commission to Reduce
the Risk of Wrong-Site Surgery

• Involve patient and surgeon in pre-op
  identification and marking of operative site
• Implement verbal verification process in O.R.
• Other strategies that may be helpful
• Personal involvement of the surgeon in obtaining
  informed consent
• Ongoing monitoring of compliance with high-risk
  procedures (e.g., site verification procedure)
• Software enhancements to ensure consistent site
  identification and information availability

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(No Transcript)
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Sentinel Event TrendsAll Reviewed Events
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Sentinel Event TrendsPotassium Chloride Events
S. E. Alert 1 February 1998
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Sentinel Event TrendsSuicide Events (Percent of
Total)
S. E. Alert 7 November 1998
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Sentinel Event TrendsRestraint Deaths (Percent
of Total)
S. E. Alert 8 November 1998
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Sentinel Event TrendsWrong-site Surgery
(Percent of Total)
S. E. Alert 6 August 1998
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Proactive Risk Reduction

• RCA is reactive subject to hindsight bias
• The sentinel event can have a blinder effect
• The best RCAs look at all the risk points
• Why wait for the sentinel event?
• Identify the high risk processes
• Conduct proactive risk assessment
• Redesign for safety

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IOM Recommendation forEstablishment of Safety
Programs

• Health care organizations should establish
  patient safety programs with defined executive
  responsibility that
• are clearly focused on patient safety,
• implement non-punitive systems for reporting and
  analyzing medical errors,
• incorporate well-understood safety principles,
  and
• establish interdisciplinary team training for
  providers of patient care which incorporates
  proven methods of team training.

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Governments Responseto the IOM Report

• The Presidents response
• The QuIC Report
• HCFAs response
• New Condition of Participation establishing
  requirement for Patient Safety Programs in
  hospitals

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Standards Relatingto Sentinel Events

• LD.4.3.4 Role of Leadership
• PI.2 Design of new processes
• PI.3.1.1 Data collection
• PI.4.3 Root cause analysis
• PI.4.4 Action plan

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Proposed Revisions to Joint Commission Standards
in Support of Error Reduction Programs in Health
Care Organizations

• Leadership
• Performance Improvement
• Information Management
• Other functions

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Proposed Standards Revisionsfor Error Reduction
Programs

• Leadership standards to emphasize safety
• In response to actual occurrences
• As a component of new design and redesign
  activities
• As an ongoing proactive effort.

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Proposed Standards Revisionsfor Error Reduction
Programs

• Performance Improvement standards to require
• Proactive risk assessment and risk reduction
• . . . Based on available risk-related information
• Focused on high-risk activities selected by the
  organization.

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Proposed Standards Revisionsfor Error Reduction
Programs

• Information Management standards to strengthen
• Aggregation of safety-related information
• Use of knowledge-based information on
  safety-related issues
• Effective communication among participants in
  health care processes

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Proposed Standards Revisionsfor Error Reduction
Programs

• Other standards-based functions, including
• Patient Rights
• Patient and Family Education
• Continuum of Care
• Environment of Care
• Human Resource Management

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Joint Commission Standards

• Are designed to . . .
• Focus on safety and quality of patient care
• Represent consensus on state-of-the-art in
  expected organization performance
• Whenever possible, be evidence-based
• State objectives or principles, rather than
  specific mechanisms for meeting requirements
• Be reasonable and achievable
• Be surveyable

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Standards Development Process

• Ongoing field analysis and literature review
• Preliminary review by Professional Technical
  Advisory Committees (PTACs)
• Internal external workgroups
• Qualified experts in the relevant fields
• Field evaluation of draft standards
• Further revision based on field evaluation
• Review by PTACs
• Approval by SSP Committee of the Board
• Ongoing field assessment (compliance monitoring)

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Standards Relevant to Anesthesia Services

• Patient rights
• Patient assessment
• Anesthesia care
• Medication use
• Leadership
• Performance improvement
• Human resources management
• Information management
• Medical staff

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Sedation and Anesthesia Defined

• Minimal sedation
• Cognitive function coordination affected
• Respond normally to verbal commands
• CP function unaffected
• Moderate sedation / analgesia (conscious
  sedation)
• Drug-induced depression of consciousness
• Purposeful response to verbal stimuli
• Adequate spontaneous ventilation
• Cardiovascular function maintained

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Sedation and Anesthesia Defined

• Deep sedation / analgesia
• Drug-induced depression of consciousness
• Cannot be easily aroused
• Purposeful response to painful stimuli
• Airway / ventilation may be impaired
• Cardiovascular function ususally maintained
• Anesthesia
• General anesthesia
• Spinal anesthesia
• Major regional anesthesia

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Standards Relevant to Anesthesia Services

• Patient rights
• Patient assessment
• Anesthesia care
• Medication use
• Leadership
• Performance improvement
• Human resources management
• Information management
• Medical staff

Revised to apply to Moderate and Deep Sedation
and Anesthesia
Effective January 2001
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Patient Rights

• Informed consent
• Clear explanation of proposed treatments
• Potential benefits and drawbacks
• Likelihood of success
• Alternatives, including non-treatment
• Possible results of alternatives or non-treatment
• Possible need for and risks of transfusion
• Identity/professional status of practitioners
• These are process requirements, not documentation
  requirements

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Patient Assessment

• Pre-anesthesia assessment
• All moderate or deep sedation or anesthesia
• Assess risk select form of sedation/anesthesia
• Determine patient is an appropriate candidate
• Qualified L.I.P. conducts or confirms
• Re-evaluate immediately pre-induction
• Post-anesthesia assessment
• On admission to, during, discharge from PACU
• Discharge by L.I.P. or approved criteria

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Anesthesia Care

• Sedation / anesthesia care is planned
• The need for blood / components is considered
• The plan is communicated among the care providers
• The patients physiologic status is monitored
• Heart respiratory rate
• Oxygenation (continuous pulse oximetry)
• Adequacy of pulmonary ventilation
• BP at regular intervals
• ECG if known CV disease or dysrhythmias

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Medication Use

• Medications are appropriately controlled
• Emergency medications are consistently available,
  controlled, and secure
• Does not require anesthesia carts to be locked
• Does not require constant attendance if
• They are in a limited access area
• No evidence of abuse, misuse, or diversion

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Leadership

• Uniform performance
• Consistency of process for sedation / anesthesia
  procedures for comparable risk patients in
  different locations
• Assessment
• Monitoring
• Recovery discharge
• Department directors responsibilities

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Department Directors Responsibilities

• All clinical activities within the department
• Integrate and coordinate
• Policies and procedures
• Recommend staffing levels
• Determine qualifications competence of staff
• Surveillance of professional performance of
  L.I.P.s
• Involve department in performance improvement
• Maintain quality control programs
• Provide for orientation, continuing education
• Recommend space and other resources
• Participate in selecting outside vendors

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Improving Organization Performance

• Department vs. organization-wide requirements
• Required measurement analysis
• Significant adverse events associated with
  anesthesia use
• Outcomes of patients undergoing moderate and deep
  sedation
• Outcomes related to resuscitation
• Patient perceptions of pain management
• Confirmed transfusion reactions
• Significant adverse drug reactions
• Significant medication errors
• All sentinel events

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Information Management

• Required documentation in the medical record
• Informed consent, when reqd by the hospital
• Findings of patient assessments
• Clinical observations
• Response to care, including sedation / anesth.
• All medications administered
• Any adverse drug reactions
• Discharge from PACU
• Compliance with discharge criteria
• Responsible L.I.P.

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Human Resources Management

• Sufficient numbers of qualified personnel (in
  addition to the L.I.P. performing the procedure)
• To evaluate the patient prior to sedation /
  anesth.
• To provide the sedation / anesthesia
• To perform the procedure
• To monitor the patient
• To recover and discharge the patient
• Staffing plan
• Orientation training
• Competency assessment

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Medical Staff Credentialing

• Qualified individuals provide sedation /
  anesthesia
• Licensed independent practitioners (L.I.P.s)
• Competent to
• evaluate patients for sedation / anesthesia
• administer drugs to predictably achieve desired
  level of sedation / anesthesia
• monitor patients to maintain desired level
• rescue patients who have slipped into next level
  of sedation / anesthesia

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Survey Process

• Anesthetizing locations visits
• Operating room
• Same-day surgery
• Endoscopy suites
• Interventional radiology / special procedures
• Dental clinics . . .
• Scheduled visits
• Interact with direct care staff
• Evaluate compliance with relevant standards
• Observe patients in PACU
• Physical environment, equipment utilities mgmt.

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Survey Process

• Patient Care Interview
• Builds on earlier survey activities
• Brings together representatives of staff
  concerned with all aspects of patient care
• Assesses coordination of care
• Addresses unresolved issues
• Medical Staff Leadership Interview
• Includes department directors
• Assesses MS role in hospital activities relating
  to patient care and performance improvement

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New Pain Assessment and Management Standards

• Effective January 1, 2001

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What Do They Address?

• Right to have Pain assessed and managed
• Screening for and Assessment of Pain
• Care
• Education
• Continuum of Care
• Ongoing Organization Improvement

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How Are They Surveyed?

• Document Reviews
• Policy, Procedure, Practice Guidelines
• Minutes
• Open and Closed Patient Records
• Observation and Interviews
• Staff
• Patients and Families

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New Rights Standard

• All patients/individuals/residents/clients have
  a right to have their pain assessed and managed
  appropriately.
• Surveyors look for how you let recipients of
  care and services know . . .

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New Assessment Standard

• Standard and its Intent Surveyed
• All patients/individuals/residents/clients are
  assessed.
• All are Screened
• Those with Pain are Assessed and Re-assessed

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Fifth Vital Sign?

• Yes - for patients with pain found at time of
  initial screening and/or for those who are likely
  to have pain
• (e.g., surgery, sickle cell crisis)
• Joint Commission standards do not view pain
  assessments as fifth vital sign for all
  recipients of care or services

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Addition to Care Standards

• Introduction
• Added Symptom Management to Introduction
• Medication Use
• Added Patient-controlled Analgesia to
  medication administration standard as well as
  Epidural/Spinal and Other Interventions
  (complementary/alternative)

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Many Ways to Provide Pain Care

• Ambulatory, Home, Hospital, and Long Term Care
• Formal Pain Programs, Departments or Services
• Pain management included in Care Paths, Care
  Maps, Clinical Practice Guidelines (CPGs), formal
  Practice Parameters, Standards of Practice
• Enforced Standardized Protocols or Policy
• Behavioral Health Assessment Protocol or
  Policy, Referral for individuals w/physical pain
• Other Innovative Ways
• Not Applicable for Health Care Networks, PPOs

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New Education Standard

• Patients/Individuals/Residents/Clients and their
  families are educated about pain and managing
  pain as part of treatment, when appropriate
  (PF.3.4)
• Intent of PF.3.4
• Understanding pain and the importance of
  effective management
• Understanding cultural and belief system barriers

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New Continuum of Care Language

• Addition to Intent of Discharge Planning standard
  (CC.6.1)
• Discharge planning focuses on meeting patients
  health care needs after discharge.
• Discharge planning identifies patients
  continuing physical, emotional, symptom
  management (e.g., pain, nausea, or dyspnea),
  housekeeping, transportation, social, and other
  needs and arranges for services to meet them.

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PI.3.1 Collect Data

• To monitor the organizations performance
• Leaders prioritize data collection based on
  mission and scope of services provided
• Leaders consider for data collection . . . The
  appropriateness and effectiveness of pain
  management
• Leaders required to collect data about the needs,
  expectations, and satisfaction of individuals and
  organizations served

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Scoring PI.3 Data Collection

• Surveyors will expect to see Evidence of data
  collection on one or both topics
• Outcomes of pain management (on consider list)
• Results of Patient Perceptions related to
  management of pain (on mandatory list)

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In Summary . . .

• Patients Rights Issue
• Staff Competence Issue
• Screening, Assessment, Reassessment
• Appropriate Guidelines for Management
• Clinical Practice Guidelines
• Practice Parameters
• Leadership Support, Policy/Procedure
• Quality Monitoring for Improved Processes and
  Outcomes