Joint Commission on Accreditation of Healthcare Organizations 1 Medical Errors, Sentinel Events, and...

Joint Commissionon Accreditation of Healthcare Organizations

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Medical Errors,Sentinel Events, and

Accreditation

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 Commission’sSentinel 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 Human:Building a Safer Health System

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

Institute of Medicine Report, November 1999


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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:1. Limited to well-defined “serious adverse events,” if mandatory

2. Standardized definition of a reportable medical error or event

3. Requirement for in-depth analysis of each error/event

4. Federal protection from disclosure of the resulting information

5. Requirement for action plan with follow-up

6. Sharing of event-related information with oversight bodies


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Experience to Date

188 inpatient suicides126 events relating to medication errors119 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 fires167 “other”

Of 983 sentinel events reviewed by the Accreditation Committee:


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Total “Reviewed” Events by State

International3

PR: 13

3

56

29 8

68

2

5

6

9

2

6

4

31

7

5

14

31

9

10

13

9

8

14

55

32

11 30

9

20

8 17 22

62

16

24

258

34

62

7

15543

105

59

6

8

2

9


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Sources of Sentinel Event Information


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Settings of the Sentinel Events

0 200 400 600 800 1000 1200

Health care network

Clinical laboratory

Ambulatory care setting

Home care service

Emergency department

Long term care facility

Out-pt behavioral health

Psychiatric unit

Psychiatric hospital

General hospital

Total 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

0 10 20 30 40 50 60 70

Storage/access

Staffing levels

Equipment factors

Competency/credentialing

Information availability

Physical environment

Pt. Assessment process

Communication

Orientation/training

(All categories)

Percent of events

HR.4

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

LD.3.2 / IM.5


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Root Causes of Medication Errors

0 10 20 30 40 50 60 70

Distraction

Labeling

Supervision

Competency/credentialing

Information availability

Storage/access

Communication

Orientation/training HR.4

TX.3.3/3.5

IM.5

HR.5/MS.5

MS.2.5

TX.3.5

EC.4.1

LD.3.2 / IM.5

Percent of events


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Root Causes of Wrong Site Surgery

0 10 20 30 40 50 60 70 80

Competency / credentialing

Distraction

Info not available in OR

No verification process

No communication with pt

OR hierarchy

Verification Policy not followed

Incomplete pt assessment

OR team miscommunication 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

0 10 20 30 40 50 60 70 80

Mark operative site

Require verbal team verification in OR

Develop verification checklist

Require surgeon to get informed consent

Require pre-op site verification by patient

Software enhancements

Revise competency assessment process

Monitor high-risk policy compliance

Revise equipment set-up procedures Percent of events


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Suggestions from the Joint Commission to Reduce the Risk of Wrong-Site Surgery:

1. Involve patient and surgeon in pre-op identification and marking of operative site

2. 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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New PublicationWe are pleased to introduce the first issue of Sentinel Event Alert, a periodic publication dedicated to providing important information relating to the occurrence and management of sentinel events in Joint Commission-accredited health care organizations. Sentinel Event Alert, to be published when appropriate as suggested by trend data, will provide ongoing communication regarding the Joint Commission's Sentinel Event Policy and Procedures, and most importantly, information about sentinel event prevention. It is our expectation and belief that in sharing information about the occurrence of sentinel events, we can ultimately reduce the frequency of medical errors and other adverse events.

Medication Error Prevention -- Potassium ChlorideIn the two years since the Joint Commission enacted its Sentinel Event Policy, the Accreditation Committee of the Board of Commissioners has reviewed more than 200 sentinel events. The most common category of sentinel events was medication errors, and of those, the most frequently implicated drug was potassium chloride (KCl). The Joint Commission has reviewed 10 incidents of patient death resulting from misadministration of

SENTINEL EVENT ALERTA publication of the Joint Commission onAccreditation of Healthcare Organizations

Jo in t C om m issionon A ccred ita tion o f H ea lthcare O rgan iza tions

One Renaissance BoulevardOakbrook Terrace, IL 60181Phone: (630) 792-5800

Issue One2-27-98

"The w ay to p reven t trag ic dea ths from acc iden ta l in travenous in jection o f concen tra ted K C l is excruc ia ting ly s im p le - -o rgan iza tions m ust take it o ff the floo r s tock o f a ll un its . It is one o f the best exam ples I know o f a 'fo rc ing function ' -- a p rocedure tha t m akes a certa in type o f e rro r im possib le ." Luc ian L . Leape, M .D .


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Sentinel Event Trends:All Reviewed Events

0

100

200

300

400

500

1995 1996 1997 1998 1999 2000


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Sentinel Event Trends:Potassium Chloride Events

0

2

4

6

8

10

1995 1996 1997 1998 1999 2000

S. E. Alert # 1

February 1998


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Sentinel Event Trends:Suicide Events (Percent of Total)

0

5

10

15

20

25

30

1995 1996 1997 1998 1999 2000

S. E. Alert # 7

November 1998


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Sentinel Event Trends:Restraint Deaths (Percent of Total)

0

2

4

6

8

10

1995 1996 1997 1998 1999 2000

S. E. Alert # 8

November 1998


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Sentinel Event Trends:Wrong-site Surgery (Percent of Total)

0

2

4

6

8

10

12

14

16

1995 1996 1997 1998 1999 2000

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” effectThe 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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Government’s Responseto the IOM Report

The President’s response

The QuIC Report

HCFA’s 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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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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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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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

1. Minimal sedation Cognitive function & coordination affected Respond normally to verbal commands CP function unaffected

2. 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

3. 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

4. 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 patient’s 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

1. They are in a limited access area

2. 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 req’d 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 organization’s 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 . . .

Patient’s 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

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Joint Commission on Accreditation of Healthcare Organizations 1 Medical Errors, Sentinel Events, and...

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