gds_0524793_epner_v8 1 2005 iqlm conference iqlm network: meeting goals –meeting needs michael a...

GDS_0524793_Epner_v8 1

2005 IQLM Conference2005 IQLM Conference

IQLM Network:Meeting Goals –Meeting

Needs

Michael A Noble MD FRCPC

Networks Committee

April 29, 2005


Presentation ObjectivesPresentation 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

• 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


Defining Network Objectives (2003)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

• 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


Meeting the ObjectivesMeeting 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.

• 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.


Developing the Pilot ProjectDeveloping the Pilot Project

• A CLMA study with assistance and support of the IQLM Networks Committee.

Define the subjectDevelop the survey questionnaire designPre-test and validate the questionnaire with two independent subgroupsAdvertise the questionnaireLet the questionnaire Capture and analyze the dataPrepare for presentation

• A CLMA study with assistance and support of the IQLM Networks Committee.

Define the subjectDevelop the survey questionnaire designPre-test and validate the questionnaire with two independent subgroupsAdvertise the questionnaireLet the questionnaire Capture and analyze the dataPrepare for presentation


Survey ObjectivesSurvey 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

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


Survey Respondents 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

• 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


Survey ResponseSurvey Response

• Distribution pool 2,301

• Response pool 572 – 25%

• Distribution pool 2,301

• Response pool 572 – 25%


Respondent DemographicsRespondent Demographics

Distribution By Title

1%

3%

12%

35%

43%

1%

2%

13%

33%

45%

0% 10% 20% 30% 40% 50%

Medical Director

Qualitiy Specialist

Supervisor

Lab Manager

Admin/Director

CLMA Membership Responders

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Respondent DemographicsRespondent Demographics

Distribution By Facility

3%

7%

5%

20%

65%

2%

10%

10%

21%

57%

0% 10% 20% 30% 40% 50% 60% 70%

Other

Govt

University

Integrated Delivery Network

Independent Hospitals


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Respondent DemographicsRespondent DemographicsGeographic Distribution

13%

16%

33%

13%

25%

14%

19%

33%

12%

22%

0% 5% 10% 15% 20% 25% 30% 35%

Southwest

Northwest

Midwest

Southeast

Northeast


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Survey ResponseSurvey 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.

• 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.

PartnershipInformation Gathering Instrument

Snap-shot of Quality Activities

We consider this survey a success.

PartnershipInformation Gathering Instrument

Snap-shot of Quality Activities

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A Snap-shot View of Quality Management in America’s Hospital Clinical Laboratories

A Snap-shot View of Quality Management in America’s Hospital Clinical Laboratories

Julie Gayken, MT (ASCP) Administrative Director of Laboratory

ServicesRegions Hospital – St. Paul, MinnesotaChair – CLMA Quality Advisory CouncilMember – IQLM Networks Work Group

CLMA Quality Management Pilot

Survey

November 2004

CLMA Quality Management Pilot

Survey

November 2004

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Presentation ObjectivesPresentation Objectives

• Quality pilot survey objectives

• Summary of pilot survey results

• Conclusion from pilot survey results

• Quality pilot survey objectives

• Summary of pilot survey results

• Conclusion from pilot survey results

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Quality Pilot Survey ObjectivesQuality 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

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

Collect Information on Quality

Management Activities

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What Parts of Quality Management are Largely Implemented?What Parts of Quality Management are Largely Implemented?

99.7

97.7

96.5

91.1

86.7

85.8

84.8

77.4

76.2

75

74.8

73.6

65

61.5

61.2

54.2

51.9

50.3

45.1

45

44.1

35.7

14.2

9.8

4.9

0 10 20 30 40 50 60 70 80 90 100

Proficiency testing program

External assessments

Instrument and reagent QC program

Validation for test procedures

Laboratory records and information

Staff competencies

Written quality policy

Staff Training

CQI process

Program for procedural non-conformances

Customer Satisfaction Program

Review of quality management system

Quality planning process

Quality manager

Document control system for formal process

Environmental control program

Referral lab selection

Quality audit program and scheduled audits

Preventive action process

Pro-active preventive process

Quality indicators

Suppliers selection and evaluation

Guidelines for physicians for testing

Institutional rules for routine tests

Rules that limit esoteric tests

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99.7

97.7

96.5

91.1

86.7

85.8

84.8

77.4

76.2

75

74.8

73.6

65

61.5

61.2

54.2

51.9

50.3

45.1

45

44.1

35.7

14.2

9.8

4.9

0 10 20 30 40 50 60 70 80 90 100






Staff competencies


Staff Training

CQI process





Quality manager







Quality indicators





What Parts of Quality Management are Largely Implemented? (Top 5)What Parts of Quality Management are Largely Implemented? (Top 5)

99.7

98

97

91

87

80 85 90 95 100 105






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99.7

97.7

96.5

91.1

86.7

85.8

84.8

77.4

76.2

75

74.8

73.6

65

61.5

61.2

54.2

51.9

50.3

45.1

45

44.1

35.7

14

10

5

0 10 20 30 40 50 60 70 80 90 100






Staff competencies


Staff Training

CQI process





Quality manager







Quality indicators





What Parts of Quality Management are Largely Implemented? (Last 5)What Parts of Quality Management are Largely Implemented? (Last 5)

Suppliers of essential products and services

44

36

14

10

5

0 10 20 30 40 50

Quality indicators


Institutional rules for routine test

Rules that limit esoteric test

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Quality Management ActivitiesKey FindingsQuality Management ActivitiesKey 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

• 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

Quality Management Assessments

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Which Components of Quality Assessment Do You Conduct?Which Components of Quality Assessment Do You Conduct?

Component Percent

Structured review of incident reportsStructured review of incident reports 9393

Structured review of adverse events Structured review of adverse events (harm to patients related to medical care)(harm to patients related to medical care) 8383

Patient satisfaction surveyPatient satisfaction survey 8282

Employee satisfaction surveyEmployee satisfaction survey 7575

Physician/clinician satisfaction surveyPhysician/clinician satisfaction survey 7474

Structured review of management reports/metricsStructured review of management reports/metrics 7272

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Analysis of Quality Assessment ComponentsAnalysis of Quality Assessment Components

Components Frequency % Code/Trend % Intervention Guidelines

Adverse eventsAdverse events As neededAs needed 8484 6565

Management Management reportsreports MonthlyMonthly 8989 5959

Incident reportsIncident reports As neededAs needed 8585 5454

Employee Employee satisfactionsatisfaction AnnualAnnual 9090 5151

Patient satisfactionPatient satisfaction MonthlyMonthly 9292 4141

Nursing surveysNursing surveys As neededAs needed 7171 3030

Physician/clinician Physician/clinician satisfactionsatisfaction AnnualAnnual 7474 2323

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Quality Assessment Key FindingsQuality 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

• >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

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?Which Laboratory Events Lead to Full (In-depth) Investigations?

80

90

100

Adverse Event Incident Report PhysicianComplaint

PatientComplaint

EmployeeReport

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How are Full Adverse EventInvestigations Performed?How are Full Adverse EventInvestigations 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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Information used


Risk management director – 53%

Quality manager/specialist – 20%

Laboratory administrator/ manager – 19%

Tools used


action

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Information used


Tools used

Root cause analysis – 92%

Process improvement (eg: PDSA) – 66%

Failure mode and effects analysis – 59%


action

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Information used


Tools used


actionYes – 86%

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Adverse Events – In-Depth InvestigationsKey Findings

Adverse Events – In-Depth InvestigationsKey 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

• 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?Which Laboratory Events Lead to Full (In-depth) Investigations?

80

90

100

Adverse Event Incident Report PhysicianComplaint

PatientComplaint

EmployeeReport

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What Steps are Used in Investigations? What Steps are Used in Investigations?

0%

20%

40%

60%

80%

100%

ManagementReview

(situation)

Data Review Root CauseAnalysis

ManagementReview

(findings)

Corrective andor Preventive

Action

Other (ServiceRecovery

Action)

Incident Report Physician Complaint Patient Complaint Employee Report

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In-depth Investigations Key FindingsIn-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

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

Determine Indicators Being Used Today and Rank Usage

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Indicators TrackedIndicators Tracked

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Most Common Indicators TrackedMost Common Indicators Tracked

40

60

80

100

1 Proficiencytesting/

performanceevaluation

2 Qualitycontrol

3 Competencyof testingpersonnel

4 Resultavailability/ turn

around time

5 Patientidentif ication

and itsaccuracy

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Least CommonIndicators TrackedLeast CommonIndicators Tracked

0

10

20

30

40

50

1 Testutilization forbest patient

care

2 Cost /benefit

assessments

3 Patientconsent/shared

decisionmaking

4 Clinical andpreventive

action

5 Resultinterpretationby clinician/

patient

GDS_0524793_Epner_v8 42

Indicators TrackedKey FindingsIndicators TrackedKey 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

• 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

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?What Features Would You Like in a New Patient Identification System?

Features Percent

Handheld device reads bar codeHandheld device reads bar code 9090

Bar coded ID bandsBar coded ID bands 8484

System for + ID and blood administrationSystem for + ID and blood administration 8080

Automatic updates to handheld devices – Automatic updates to handheld devices – wirelesswireless 7979

Labels printed collection site – tests and Labels printed collection site – tests and containercontainer 6666

System to collect/track date + time and personSystem to collect/track date + time and person 6363

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Patient Identification Systems Key FindingsPatient 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

• 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

Gather List of Safety/Quality

Initiatives that Have Resulted in Error

Reduction

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Open Ended QuestionOpen 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

• 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 InitiativesMost Significant Initiatives

Patient/ Specimen

Identification

Information Systems/ Laboratory Information Systems

Quality Improvement/ Management

System

Other

18%

50%

13%

12%

7%

Process/ System

Redesign

GDS_0524793_Epner_v8 49

Significant Initiatives Key FindingsSignificant 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

• 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

Determine Topics for Future Surveys

and Benchmarks

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What Topics Would You Like To See in Future Surveys and Benchmarks?What Topics Would You Like To See in Future Surveys and Benchmarks?

Total Responses = 831 % of Total

How to do QI and benchmarks/best practices 17

Personnel issues(Productivity, recruitment, retention, assessment, enhancement)

16

Patient and specimen identification 13

Appropriate clinical ordering/ utilization 12

Turnaround times – ED and generalTurnaround times – ED and general 88

Cost analysis/financial justificationCost analysis/financial justification 44

Information systems and technology/LISInformation systems and technology/LIS 44

Point of care testing/servicesPoint of care testing/services 33

Instrument/process automation technologyInstrument/process automation technology 33

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Gather List of Individuals for a Future

Targeted Network

Gather List of Individuals for a Future

Targeted Network

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472 or 83%

YESSaid

To Participation in anOngoing Quality Network

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Conclusion Quality Pilot Survey Objectives MetConclusion 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

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

GDS_0524793_Epner_v8 55

Next Steps Pilot StudyNext Steps Pilot Study

• Present survey data to CLMA members who responded

• Prepare information for publication

• Present survey data to CLMA members who responded

• Prepare information for publication

GDS_0524793_Epner_v8 56

Thank youThank 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

• 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 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

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”

“Working Together – Our Patients Will Be Safer”

Thank You

GDS_0524793_Epner_v8 59

ConclusionConclusion

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

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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AcknowledgementsAcknowledgements

CDC

• Joe Boone, PhD, MS

• James Handsfield, MPH

• Devery Howerton, PhD, MS

• Colleen Shaw, MPH

• Susan Snyder, PhD, MBA

• Robin Stombler

CDC

• Joe Boone, PhD, MS

• James Handsfield, MPH

• Devery Howerton, PhD, MS

• Colleen Shaw, MPH

• Susan Snyder, PhD, MBA

• Robin Stombler

GDS_0524793_Epner_v8 61

IQLM Network WorkgroupIQLM Network Workgroup

Co-Leaders:• Mike Noble, MD, FRCPC• Barbara Goldsmith, PhD,

FCAB

CDC Co-Liaisons:• Julie Taylor, PhD, MS• Steve Glenn, MS

Co-Leaders:• Mike Noble, MD, FRCPC• Barbara Goldsmith, PhD,

FCAB

CDC Co-Liaisons:• Julie Taylor, PhD, MS• Steve Glenn, MS

Team:• David Bruns, PhD• Nancy Elder, MD, MSPH• Julie Gayken, MT(ASCP)• Paul Epner, MBA• Jennifer McGeary, MT(ASCP),

MSHA• Charlie Fenstermaker• Barbara Mitchell, MS, MT (ASCP)• Margaret Piper, PhD, MPH• Rusty Senac• Shahram Shahangian, PhD, MS• David Sundwall, MD• Scott Young, MD

Team:• David Bruns, PhD• Nancy Elder, MD, MSPH• Julie Gayken, MT(ASCP)• Paul Epner, MBA• Jennifer McGeary, MT(ASCP),

MSHA• Charlie Fenstermaker• Barbara Mitchell, MS, MT (ASCP)• Margaret Piper, PhD, MPH• Rusty Senac• Shahram Shahangian, PhD, MS• David Sundwall, MD• Scott Young, MD

GDS_0524793_Epner_v8 62

Define network project priorities

Establish the ongoing process to foster further successful project partnerships

Establish the process for information sharing

DO

REVIEW SHARE

PLAN

Network Workgroup

gds_0524793_epner_v8 1 2005 iqlm conference iqlm network: meeting goals –meeting needs michael a...

Documents

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iqlm networks committee

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survey objectives