Medical Errors, Sentinel Events, and Accreditation
Association of Anesthesia Program Directors October 28, 2000
Joint Commission
on Accreditation of Healthcare Organizations
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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
Joint Commission
on Accreditation of Healthcare Organizations
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Accreditation is, at its core, a risk reduction activity.
Joint Commission
on Accreditation of Healthcare Organizations
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The Joint Commission’s Sentinel 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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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To Err Is Human: Building 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
Joint Commission
on Accreditation of Healthcare Organizations
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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. 2. 3. 4. 5. 6. 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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on Accreditation of Healthcare Organizations
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Experience to Date
Of 983 sentinel events reviewed by the Accreditation Committee:
188 126 119 88 51 49 42 41 32 22 22 18 18 167 inpatient suicides events relating to medication errors operative/post op complications events of surgery at the wrong site deaths related to delay in treatment patient falls (13 multi-story) assault/rape/homicide deaths of patients in restraints deaths following elopement transfusion-related events Perinatal death/injury infant abductions/wrong discharges fires “other”
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on Accreditation of Healthcare Organizations
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Total “Reviewed” Events by State
8 9 4 6 6 3 5 56 29 7 2 31 5 14 68 3 2 PR: 13
Joint Commission
on Accreditation of Healthcare Organizations
6 2 1 10 55 11 13 9 8 8 62 17 22 9 20 9 14 32 30 8 25 24 16 34 62
7 59 5 43 5 15 9 10
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International 3
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Sources of Sentinel Event Information
Self-report 350 300 250 200 150 100 50 0 1995 1996 1997 1998 1999 2000 Media Other
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on Accreditation of Healthcare Organizations
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Settings of the Sentinel Events
Total events General hospital Psychiatric hospital Psychiatric unit Out-pt behavioral health Long term care facility Emergency department Home care service Ambulatory care setting Clinical laboratory Health care network
0
200
400
600
800
1000
1200
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Joint Commission
on Accreditation of Healthcare Organizations
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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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Root Causes of Sentinel Events
(All categories)
Orientation/training Communication Pt. Assessment process Physical environment Information availability Competency/credentialing Equipment factors Staffing levels Storage/access 0 10 20
IM.5 HR.5/MS.5 EC.2.7/EC.2.13 EC HR.4 LD.3.2 / IM.5 PE.1
HR.2 TX.3.5/TX.4.3/EC.4.1
30
40
50
60
70
Percent of events
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on Accreditation of Healthcare Organizations
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Root Causes of Medication Errors
Orientation/training Communication Storage/access Information availability Competency/credentialing Supervision Labeling Distraction 0 10
IM.5 HR.5/MS.5 MS.2.5 TX.3.5 LD.3.2 / IM.5 TX.3.3/3.5 HR.4
EC.4.1
20
30
40
50
60
70
15
Percent of events
Joint Commission
on Accreditation of Healthcare Organizations
Root Causes of Wrong Site Surgery
OR team miscommunication Incomplete pt assessment Verification Policy not followed OR hierarchy No communication with pt No verification process Info not available in OR Distraction Competency / credentialing
IM.5 EC.4.1 HR.5 / MS.5 ? ? IM.5 PE.1.8
TX.5.2/PF.1.10 ?
0
10
20
30
40
50
60
70
80
Percent of events
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on Accreditation of Healthcare Organizations
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Strategies for Reducing the Risk of Wrong Site Surgery
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
0
10
20
30
40
50
60
70
80
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Joint Commission
on Accreditation of Healthcare Organizations
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 highrisk procedures (e.g., site verification procedure) Software enhancements to ensure consistent site identification and information availability
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on Accreditation of Healthcare Organizations
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SENTINEL EVENT ALERT
A publication of the Joint Commission on Accreditation of Healthcare Organizations Issue One 2-27-98
Joint Commission
on Accreditation of Healthcare Organizations
One Renaissance Boulevard Oakbrook Terrace, IL 60181 Phone: (630) 792-5800
New Publication
"The way to prevent tragic deaths from accidental intravenous injection of concentrated KCl is excruciatingly simple - -organizations must take it off the floor stock of all units. It is one of the best examples I know of a 'forcing function' -- a procedure that makes a certain type of error impossible." Lucian L. Leape, M.D. We 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.
M edication Error Prevention -- Potassium Chloride
In 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
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on Accreditation of Healthcare Organizations
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Sentinel Event Trends: All Reviewed Events
500 400 300 200 100 0 1995 1996 1997 1998 1999 2000
20
Joint Commission
on Accreditation of Healthcare Organizations
Sentinel Event Trends: Potassium Chloride Events
10 8 6 4 2 0 1995 1996 1997 1998 1999 2000
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S. E. Alert # 1
February 1998
Joint Commission
on Accreditation of Healthcare Organizations
Sentinel Event Trends: Suicide Events (Percent of Total)
30 25 20 15 10 5 0 1995 1996 1997 1998 1999 2000
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S. E. Alert # 7
November 1998
Joint Commission
on Accreditation of Healthcare Organizations
Sentinel Event Trends: Restraint Deaths (Percent of Total)
10 8 6 4 2 0 1995 1996 1997 1998 1999 2000
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S. E. Alert # 8
November 1998
Joint Commission
on Accreditation of Healthcare Organizations
Sentinel Event Trends:
Wrong-site Surgery (Percent of Total)
16
S. E. Alert # 6
14 12 10 8 6 4 2 0 1995 1996 1997
August 1998
1998
1999
2000
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Joint Commission
on Accreditation of Healthcare Organizations
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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on Accreditation of Healthcare Organizations
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IOM Recommendation for Establishment 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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on Accreditation of Healthcare Organizations
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Government’s Response to 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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on Accreditation of Healthcare Organizations
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Standards Relating to Sentinel Events
LD.4.3.4 Role of Leadership
PI.2
PI.3.1.1
Design of new processes
Data collection
PI.4.3 PI.4.4
Root cause analysis Action plan
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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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Proposed Standards Revisions for 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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on Accreditation of Healthcare Organizations
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Proposed Standards Revisions for 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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on Accreditation of Healthcare Organizations
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Proposed Standards Revisions for Error Reduction Programs
Information Management standards to strengthen
Aggregation of safety-related information Use of knowledge-based information on safetyrelated issues Effective communication among participants in health care processes
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on Accreditation of Healthcare Organizations
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Proposed Standards Revisions for 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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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Standards Relevant to Anesthesia Services
Patient rights Revised to apply to Moderate Patient assessment and Deep Sedation and Anesthesia care Anesthesia Medication use Effective January 2001 Leadership Performance improvement Human resources management Information management Medical staff
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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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New Pain Assessment and Management Standards
Effective January 1, 2001
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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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 Reassessed
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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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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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on Accreditation of Healthcare Organizations
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