Transcript Document 7654714

2005 IQLM Conference
IQLM Network:
Meeting Goals –Meeting Needs
Michael A Noble MD FRCPC
Networks Committee
April 29, 2005
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Presentation Objectives
• Stating the goals of the network committee
• Characterizing the IQLM-Network project
• A Snap-shot View of Quality Management
in America’s Hospital Clinical Laboratories
• Conclusions
• Acknowledgements
• IQLM Network –Next Steps
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Defining Network Objectives (2003)
•
Identify a partner
•
Develop laboratory networks
•
Complete pilot study to determine potential of web based formatted
survey
•
Collect information on laboratory quality practice and services
•
Determine respondents willing to participate in ongoing survey
•
Track trends in a volunteer group of laboratories
•
Develop process to obtain information on quality
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Meeting the Objectives
• In the first meeting of the Networks Committee (Atlanta
2003), three organizations offered to consider developing a
project.
• Following discussion, it was agreed that the Clinical
Laboratory Management Association was in the best position
to develop the initial pilot project.
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Developing the Pilot Project
• A CLMA study with assistance and support of the IQLM
Networks Committee.
Define the subject
Develop the survey questionnaire design
Pre-test and validate the questionnaire with two independent
subgroups
Advertise the questionnaire
Let the questionnaire
Capture and analyze the data
Prepare for presentation
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Survey Objectives
To collect information on quality management activities in
clinical laboratories
Note that survey information was the product of
two data formats:
•
Pre-defined specific answers
•
Invited open format comment
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Survey Respondents
• Targeted to U.S. hospital-based laboratories, including integrated
delivery systems, university hospitals, government hospitals and
independent labs owned by hospitals.
• One respondent per institution – Most senior manager invited to
participate; given option to delegate to most appropriate person
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Survey Response
• Distribution pool
• Response pool
2,301
572 – 25%
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Respondent Demographics
Distribution By Title
45%
43%
Admin/Director
33%
35%
Lab Manager
13%
12%
Supervisor
2%
3%
Qualitiy Specialist
1%
1%
Medical Director
0%
10%
20%
CLMA Membership
30%
40%
50%
Responders
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Respondent Demographics
Distribution By Facility
57%
Independent Hospitals
65%
21%
20%
Integrated Delivery Network
10%
University
5%
10%
Govt
7%
2%
3%
Other
0%
10%
20%
30%
CLMA Membership
40%
50%
60%
70%
Responders
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Respondent Demographics
Geographic Distribution
22%
Northeast
25%
12%
13%
Southeast
33%
33%
Midwest
19%
Northwest
16%
14%
13%
Southwest
0%
5%
10%
15%
CLMA Membership
20%
25%
30%
Responders
35%
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Survey Response
• Over 25% of eligible CLMA members responded to the
survey.
• The respondents represent a nationwide sample and
distribution of laboratories that correlate closely with
the distribution of CLMA member laboratories.
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We consider this survey a success.
Partnership


Snap-shot of Quality Activities 
Information Gathering Instrument
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A Snap-shot View of
Quality Management
in America’s Hospital
Clinical Laboratories
CLMA Quality
Management Pilot Survey
November 2004
Julie Gayken, MT (ASCP)
Administrative Director of Laboratory Services
Regions Hospital – St. Paul, Minnesota
Chair – CLMA Quality Advisory Council
Member – IQLM Networks Work Group
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Presentation Objectives
• Quality pilot survey objectives
• Summary of pilot survey results
• Conclusion from pilot survey results
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Quality Pilot Survey
Objectives
1. Collect information on quality management activities
2. Identify types of events that lead to investigations
and process used
3. Determine indicators being used today and rank usage
(poster)
4. Determine steps used in patient ID process as example
for benchmarking (poster)
5. Gather list of safety/quality initiatives that have resulted
in error reduction (poster)
6. Determine topics for future surveys and benchmarking
(poster)
7. Gather list of individuals for a future targeted network
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Collect Information
on Quality
Management
Activities
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What Parts of Quality Management
are Largely Implemented?
0
10
20 30 40
50 60 70 80
90 100
Proficiency testing program
99.7
External assessments
97.7
Instrument and reagent QC program
96.5
Validation for test procedures
91.1
Laboratory records and information
86.7
Staff competencies
85.8
Written quality policy
84.8
Staff Training
77.4
CQI process
76.2
Program for procedural non-conformances
75
Customer Satisfaction Program
74.8
Review of quality management system
73.6
Quality planning process
65
Quality manager
61.5
Document control system for formal process
61.2
Environmental control program
54.2
Referral lab selection
51.9
Quality audit program and scheduled audits
50.3
Preventive action process
45.1
Pro-active preventive process
45
Quality indicators
44.1
Suppliers selection and evaluation
35.7
Guidelines for physicians for testing
Institutional rules for routine tests
Rules that limit esoteric tests
14.2
9.8
4.9
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What Parts of Quality Management
are Largely Implemented? (Top 5)
0
80
85
90
95
20 30 40
50 60 70 80
90 100
Proficiency testing program
100
Proficiency testing program
10
105
99.7
External assessments
97.7
Instrument and reagent QC program
96.5
99.7
Validation for test procedures
91.1
Laboratory records and information
External assessments
98
97
Instrument and reagent QC program
86.7
Staff competencies
85.8
Written quality policy
84.8
Staff Training
77.4
CQI process
76.2
Program for procedural non-conformances
Validation for test procedures
Laboratory records and information
91
87
75
Customer Satisfaction Program
74.8
Review of quality management system
73.6
Quality planning process
65
Quality manager
61.5
Document control system for formal process
61.2
Environmental control program
54.2
Referral lab selection
51.9
Quality audit program and scheduled audits
50.3
Preventive action process
45.1
Pro-active preventive process
45
Quality indicators
44.1
Suppliers selection and evaluation
35.7
Guidelines for physicians for testing
Institutional rules for routine tests
Rules that limit esoteric tests
14.2
9.8
4.9
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What Parts of Quality Management
are Largely Implemented? (Last 5)
0
10
20 30 40
50 60 70 80
90 100
Proficiency testing program
99.7
External assessments
97.7
Instrument and reagent QC program
96.5
Validation for test procedures
91.1
Laboratory records and information
86.7
Staff competencies
85.8
Written quality policy
84.8
Staff Training
0
10
20
30
40
50
77.4
CQI process
76.2
Program for procedural non-conformances
Quality indicators
Customer Satisfaction Program
74.8
Review of quality management system
73.6
44
36
Suppliers of essential products and services
75
Quality planning process
65
Quality manager
61.5
Document control system for formal process
14
Guidelines for physicians for testing
Institutional rules for routine test
10
61.2
Environmental control program
54.2
Referral lab selection
51.9
Quality audit program and scheduled audits
50.3
Preventive action process
45.1
Pro-active preventive process
Rules that limit esoteric test
5
45
Quality indicators
44.1
Suppliers selection and evaluation
35.7
Guidelines for physicians for testing
14
Institutional rules for routine tests
Rules that limit esoteric tests
10
5
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Quality Management Activities
Key Findings
• Most components recommended by
guidelines are implemented to some degree
• Lowest implementation percentage
for test utilization components:
– Develop clinical guidelines for physician
use on appropriate testing
– Institutional rules for frequency of tests
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Quality Management
Assessments
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Which Components of Quality
Assessment Do You Conduct?
Component
Percent
Structured review of incident reports
93
Structured review of adverse events
(harm to patients related to medical care)
83
Patient satisfaction survey
82
Employee satisfaction survey
75
Physician/clinician satisfaction survey
74
Structured review of management reports/metrics
72
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Analysis of Quality
Assessment Components
Components
Frequency
% Code/Trend
% Intervention
Guidelines
Adverse events
As needed
84
65
Monthly
89
59
As needed
85
54
Employee satisfaction
Annual
90
51
Patient satisfaction
Monthly
92
41
As needed
71
30
Annual
74
23
Management reports
Incident reports
Nursing surveys
Physician/clinician
satisfaction
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Analysis of Quality
Assessment Components
Components
Frequency
% Code/Trend
% Intervention
Guidelines
Adverse events
As needed
84
65
Monthly
89
59
As needed
85
54
Employee satisfaction
Annual
90
51
Patient satisfaction
Monthly
92
41
As needed
71
30
Annual
74
23
Management reports
Incident reports
Nursing surveys
Physician/clinician
satisfaction
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Analysis of Quality
Assessment Components
Components
Frequency
% Code/Trend
% Intervention
Guidelines
Adverse events
As needed
84
65
Monthly
89
59
As needed
85
54
Employee satisfaction
Annual
90
51
Patient satisfaction
Monthly
92
41
As needed
71
30
Annual
74
23
Management reports
Incident reports
Nursing surveys
Physician/clinician
satisfaction
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Quality Assessment
Key Findings
• >70% conduct, code and trend quality
reports and surveys
• <65% have guidelines that dictate when
intervention (i.e. contact or change) is needed
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Identify Types
of Events that Lead
to In-Depth
Investigations and
Processes Used
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Which Laboratory Events Lead
to Full (In-depth) Investigations?
100
90
80
Adverse Event Incident Report
Physician
Complaint
Patient
Complaint
Employee
Report
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How are Full Adverse Event
Investigations Performed?
Information used
Lab records – 99%
Medical record – 93%
Nursing interviews – 90%
Physician interviews – 89%
Who chairs or leads
investigation
Tools used
Structured process for review
and corrective action
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How are Full Adverse Event
Investigations Performed?
Information used
Who chairs or leads
investigation
Risk management director – 53%
Quality manager/specialist – 20%
Laboratory administrator/ manager – 19%
Tools used
Structured process for review
and corrective action
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How are Full Adverse Event
Investigations Performed?
Information used
Who chairs or leads
investigation
Root cause analysis – 92%
Tools used
Process improvement (eg: PDSA) – 66%
Failure mode and effects analysis – 59%
Structured process for review
and corrective action
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How are Full Adverse Event
Investigations Performed?
Information used
Who chairs or leads
investigation
Tools used
Structured process for review
and corrective action
Yes – 86%
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Adverse Events –
In-Depth Investigations
Key Findings
• 53% state risk management director
leads review
• Reviews conducted on lab, patient, nursing,
physician information
• 92% use root cause analysis process
• 14% do not use a structured process
for review and corrective action
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Which Laboratory Events Lead
to Full (In-depth) Investigations?
100
90
80
Adverse Event Incident Report
Physician
Complaint
Patient
Complaint
Employee
Report
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What Steps are Used in Investigations?
Incident Report
Physician Complaint
Patient Complaint
Employee Report
100%
80%
60%
40%
20%
0%
Management
Review
(situation)
Data Review
Root Cause
Analysis
Management
Review
(findings)
Corrective and
or Preventive
Action
Other (Service
Recovery
Action)
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In-depth Investigations
Key Findings
Incident Reports, Physician Complaints,
Patient Complaints, Employee Reports
• Laboratories utilize the same processes for
investigating various quality reports and complaints
• <60% of labs use root cause analysis for investigation
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Determine Indicators
Being Used Today
and Rank Usage
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Indicators Tracked
31.0%
25.3%
28.5%
Ordered test appropriate for patient care
Patient consent/Shared decision making
Test utilization by clinician/patient for best patient care
Physician/Clinician written order vs. order received by the lab
Cost/benefit assessment
Patient identification and its accuracy
Patient preparation for specimen collection
Timing of specimen collection
Phlebotomy success
Specimen integrity/quantity
Specimen preparation for analysis
Specimen transportation
Accuracy of specimen identification
Condition for specimen storage
Quality control
Proficiency testing/performance evaluation
Result availability and turnaround time
Result reporting accuracy
Adequacy of information for interpretation of lab results
Report delivery turnaround
Consistency of critical values reporting
Result interpretation by clinician/patient
Clinical and preventive action
Blood and/or Urine culture contamination
Laboratory safety
Competency of testing personnel
Patient's satisfaction with laboratory services
Patient's satisfaction with phlebotomy services
Physician/Clinician's satisfaction with laboratory services
Vacancy of technical staff
51.6%
25.5%
89.5%
43.9%
62.4%
56.8%
82.0%
42.1%
51.2%
83.9%
45.8%
96.5%
98.3%
94.4%
79.4%
33.6%
56.6%
87.1%
8.0%
11.9%
76.7%
83.6%
94.6%
62.9%
75.5%
73.3%
52.1%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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Most Common
Indicators Tracked
10 0
80
60
40
1 Proficiency
testing/
performance
evaluation
2 Quality
control
3 Competency
4 Result
5 Patient
of testing
availability/ turn identification
personnel
around time
and its
accuracy
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Least Common
Indicators Tracked
50
40
30
20
10
0
1 Test
utilization for
best patient
care
2 Cost /
benefit
assessments
3 Patient
consent/
shared
decision
making
4 Clinical and
preventive
action
5 Result
interpretation
by clinician/
patient
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Indicators Tracked
Key Findings
• All 30 total testing process indicators
are being tracked to some degree
• The top 5 indicators most commonly tracked
are required by regulation or patient safety goals
• The 5 indicators least tracked are in the areas
of appropriateness of testing for best care
• Pre-analytic and post-analytic indicators monitored less
than analytic
– Less than 35% monitor order and use of testing for best care
– Less than 10% monitor result interpretation by clinician or
patient
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Determine Steps Used
in Patient Identification
Process as Example
for Benchmarking
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What Features Would You Like in a
New Patient Identification System?
Features
Percent
Handheld device reads bar code
90
Bar coded ID bands
84
System for + ID and blood administration
80
Automatic updates to handheld devices – wireless
79
Labels printed collection site – tests and container
66
System to collect/track date + time and person
63
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Patient Identification Systems
Key Findings
• Most labs use two unique identifiers – patient name
and medical record number
• 50% of labs currently have the ability to print labels
at the site of collection
• >80% would like future ID systems to include
hand held devices that
– Read bar coded ID bands
– Could be used for blood administration
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Gather List of
Safety/Quality
Initiatives that Have
Resulted in Error
Reduction
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Open Ended Question
• What is the most significant initiative your laboratory
implemented in the last three (3) years that effectively
reduced laboratory errors or improved patient safety?
Total # of Responses – 557
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Most Significant Initiatives
Other
Process/
System
Redesign
18%
7%
50%
Patient/
Specimen
Identification
12%
Quality
Improvement/
13%
Management
System
Information
Systems/ Laboratory
Information Systems
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Significant Initiatives
Key Findings
• 50% of initiatives emphasize accurate
patient and specimen identification
• The use of technology at 13% is either an untapped safety
tool or many hospital laboratories have already implemented
necessary technology for safety improvement
• The response of 12% indicating that their most significant
event was implementing new or improved quality
management systems demonstrates an evolving quality
management environment
• Process/system design at 7% demonstrates that hospital
laboratories are starting to look for error reduction by
addressing process and system issues
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Determine Topics
for Future Surveys
and Benchmarks
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What Topics Would You Like To See
in Future Surveys and Benchmarks?
Total Responses = 831
How to do QI and benchmarks/best practices
Personnel issues
% of Total
17
(Productivity, recruitment, retention, assessment,
enhancement)
16
Patient and specimen identification
13
Appropriate clinical ordering/ utilization
12
Turnaround times – ED and general
8
Cost analysis/financial justification
4
Information systems and technology/LIS
4
Point of care testing/services
3
Instrument/process automation technology
3
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Gather List
of Individuals
for a Future
Targeted Network
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472 or 83%
Said
YES
To Participation in an
Ongoing Quality Network
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Conclusion Quality Pilot Survey Objectives Met
1. Collected information on quality management activities
2. Identified types of events that lead to investigations
and process used
3. Determined indicators being used today and rank usage
4. Determined steps used in patient ID process as example
for benchmarking
5. Gathered list of safety/quality initiatives that have resulted
in error reduction
6. Determined topics for future surveys and benchmarking
7. Gathered list of individuals for a future targeted network
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Next Steps Pilot Study
• Present survey data to CLMA members who responded
• Prepare information for publication
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Thank you
• CDC – Julie Taylor, PhD, MS and Staff
• Mike Noble, MD, FRCPC and IQLM Network Workgroup
• Paul Epner, MBA, Abbott Diagnostics
• CLMA
– Charlie Fenstermaker, Staff Liaison
–
–
–
–
Survey respondents
Those who have agreed to be in the ongoing network
Board of Directors
Quality Advisory Council
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CLMA Quality Advisory Council
Chair - Julie Gayken
CLMA Board Liaison – Anne Daley
Staff Liaison – Charlie Fenstermaker
Members •
Peggy Ahlin, Senior Vice President, Quality & Compliance, ARUP Laboratories
•
Lucia Berte, Quality Systems Consultant
•
Paul Epner, Director, Global Business Research, Abbott Diagnostics
•
Claudine Panick, Regional Director, Adventist Health Systems
Special Advisors -
•
Joanne Born, Executive Director, JCAHO, Laboratory Accreditation Program
•
Cecelia Kimberlin, Ph.D., V.P. Quality Assurance, Regulatory Affairs & Compliance,
Abbott Diagnostics
•
Barbara Mitchell, Proficiency Testing Manager, American Academy of Family Physicians
•
Anne Pontius, President, Laboratory Compliance Consultants, Inc.
•
Steve Raymond, Administrative Laboratory Director,
Phoenix Indian Medical Center
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“Working Together –
Our Patients
Will Be Safer”
Thank You
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Conclusion







Identify a partner
Develop laboratory networks, pilot completed
Pilot study to determine potential of web based formatted survey
Collect information on laboratory quality practice and services
Determine respondents willing to participate in ongoing survey
Track trends in a volunteer group of laboratories
Develop process to obtain information on quality
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Acknowledgements
CDC
• Joe Boone, PhD, MS
• James Handsfield, MPH
• Devery Howerton, PhD, MS
• Colleen Shaw, MPH
• Susan Snyder, PhD, MBA
• Robin Stombler
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IQLM Network Workgroup
Co-Leaders:
Team:
• Mike Noble, MD, FRCPC
• David Bruns, PhD
• Barbara Goldsmith, PhD, FCAB • Nancy Elder, MD, MSPH
• Julie Gayken, MT(ASCP)
CDC Co-Liaisons:
• Paul Epner, MBA
• Julie Taylor, PhD, MS
• Jennifer McGeary, MT(ASCP), MSHA
• Steve Glenn, MS
• Charlie Fenstermaker
• Barbara Mitchell, MS, MT (ASCP)
• Margaret Piper, PhD, MPH
• Rusty Senac
• Shahram Shahangian, PhD, MS
• David Sundwall, MD
• Scott Young, MD
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Network Workgroup
Define network project priorities
Establish the ongoing process to
foster further successful
project partnerships
Establish the process for
information sharing
PLAN
DO
SHARE
REVIEW
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