External Quality Assessment

External Quality Assessment
Assessment: EQA - Module EQA 12 - Module 10
Learning Objectives
At the end of this module, participants will be able to: Discuss the importance of an EQA program in improving the quality of laboratory test results. Describe at least three EQA methods and the advantages and disadvantages of each. Outline a method to investigate an unacceptable test result from an EQA sample.
Assessment: EQA - Module 10 2
Scenario
A newly appointed laboratory supervisor has begun reviewing past EQA results, and observes poor Gram stain performance. How should the laboratory investigate this problem?
The Quality Management System

Organization Personnel Equipment
Purchasing & Inventory
Process Control
Information Management
Documents & Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities & Safety
Assessment: EQA - Module 10

A system for objectively checking the laboratorys performance using an external agency or facility
EQA Methods
Proficiency Testing
Rechecking Retesting
On-site Evaluation
External Quality Assessment (EQA)

comparison among different test sites early warning for systemic problems objective evidence of testing quality areas that need improvement training needs
EQA Benefits
Laboratory oriented objectives Public Health oriented objectives
Confidential Recognition / Education
Free / not free
EQA
Mono / multi Regional/ National/ International
Obligatory / voluntary
EQA
important for improvement a measure of laboratory performance
10
Definition
Proficiency Testing
ISO/IEC Guide 43-1:1997
Proficiency testing schemes (PTS) are interlaboratory comparisons that are organized regularly to assess the performance of analytical laboratories and the competence of the analytical
personnel.
Definition
Proficiency Testing
CLSI GP27-A2 27:8
A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratorys results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others.
PT Process
PT organization /provider
Laboratory
Analyze
PT samples sent regularly Evaluation
Return results
Receive PT report
PT performance report
Corrective Actions
13
PT: Roles of Laboratory

ISO 15189
PT Patient sample sample Analyze same manner with same personnel Final PT report received
Laboratory 1
Laboratory 2
No discussion between labs

Improvement
14
Information received from PT participation must be directed toward improvement in the laboratory to receive the full value.
PT Results
15
PT Limitations
PT results are affected by variables not related to patient samples PT will not detect all problems in the laboratory PT may not detect problems with pre- and postexamination procedures
16
Other EQA Methods
Rechecking/Retesting
Peripheral laboratory
Reference laboratory Rechecking
17
Retesting

tested by reference laboratory performed on dried blood spots or serum not blinded statistically significant primarily used to assess HIV rapid testing
18
Rechecking

samples must be collected randomly avoid systematic sampling bias statistically significant resolve discrepancies effective feedback primarily AFB
19
Comparison of rechecking non-blinded and random blinded smears for acid-fast bacilli
Performance characteristics measured Non-blinded sample (1998) Random blinded sample (2002)
State A-sensitivity State B-sensitivity State A-specificity State B-specificity
99.7% 98.9% 99.8% 99.9%
86.7% 84.7% 99.1% 99.7%
Martinez A, et al. Int J Tuberc Lung Dis 2005;9(3):301-5.

On-site Evaluation
to obtain a realistic picture of laboratory practices
to provide assistance with problem areas
Periodic visits
Laboratory External group or Organizer

AFB Microscopy Comparison of performance before and after on-site monitoring

BEFORE (%) AFTER(%)
No sand bucket No decontamination of sputum cups
96 60
27 23
No disinfectant
No biohazard waste bin (covered) No lab coats Technologists do not wash hands Shortage of lab reagents Improper sputum collection Improper filling of laboratory register Improper labeling slides/containers
31
48 48 17 75 60 29 31
4
8 46 4 27 31 4 13
22
Aziz, M. and G. Bretzel, Int J Tuberc Lung Dis 2002:6(4):340-349.
Proficiency Testing and Rechecking

Characteristics
Interlaboratory comparison Simulated samples
Real samples Time and resources needed Analytes evaluated PT RC
Yes
Yes Yes/No Less Many
Yes
No Yes More Few
23
EQA Participation
Recommended for all laboratories Required by ISO
ISO 15189
24
Management Process
handle and analyze EQA samples treat EQA samples same as patient monitor and maintain records investigate deficiencies manage corrective action efforts communicate outcomes
EQA results
Corrective actions
25
EQA performance problems

CHALLENGE Sample Management
Preexamination
Examination
PT PROVIDER
Report
Postexamination
EQA Should Lead to Actions

EQA
Take Corrective Action
Identify problems
27
Summary
EQA is a system for objectively checking the laboratorys performance using an external agency or facility All laboratories should participate in EQA Several methods of EQA in use EQA samples must be treated the same as patient samples
28
Key Messages
EQA uses valuable resources, make best possible use EQA should not be punitive EQA should be viewed as educational EQA can help direct improvement efforts
EQA is a critical element of a quality management system

29
Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
Information Management
Comments?
Questions?
Documents & Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities & Safety
30

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External Quality Assessment

External Quality Assessment

Assessment: EQA - Module EQA 12 - Module 10

The Quality Management System

Purchasing & Inventory

Documents & Records

Facilities & Safety

Assessment: EQA - Module 10

External Quality Assessment

Assessment: EQA - Module 10

Assessment: EQA - Module 10

External Quality Assessment (EQA)

Assessment: EQA - Module 10

Assessment: EQA - Module 10

Confidential Recognition / Education

Free / not free

Assessment: EQA - Module 10

ISO/IEC Guide 43-1:1997

CLSI GP27-A2 27:8

PT samples sent regularly Evaluation

PT: Roles of Laboratory

No discussion between labs

Assessment: EQA - Module 10

Assessment: EQA - Module 10

Other EQA Methods

Assessment: EQA - Module 10

Assessment: EQA - Module 10

Assessment: EQA - Module 10

State A-sensitivity State B-sensitivity State A-specificity State B-specificity

99.7% 98.9% 99.8% 99.9%

86.7% 84.7% 99.1% 99.7%

Martinez A, et al. Int J Tuberc Lung Dis 2005;9(3):301-5.

to provide assistance with problem areas

Laboratory External group or Organizer

AFB Microscopy Comparison of performance before and after on-site monitoring

No sand bucket No decontamination of sputum cups

Aziz, M. and G. Bretzel, Int J Tuberc Lung Dis 2002:6(4):340-349.

Proficiency Testing and Rechecking

Assessment: EQA - Module 10

Recommended for all laboratories Required by ISO

Assessment: EQA - Module 10

EQA performance problems

EQA Should Lead to Actions

Take Corrective Action

Assessment: EQA - Module 10

Assessment: EQA - Module 10

EQA is a critical element of a quality management system

Assessment: EQA - Module 10

Purchasing & Inventory

Documents & Records

Facilities & Safety

Assessment: EQA - Module 10

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