Sigma Metric Analysis of ARCHITECT c16000 Clinical Chemistry
Westgard Global Goal Survey
Survey Findings Chart Pack
Collected from December 2014 to January 2015
More than 460 responses from 80 countries
Sten Westgard, MS
Westgard QC, Inc.
1
Countries That Responded (80)
Andorra
Armenia
Argentina
Austria
Australia
Belgium
Bulgaria
Bahrain
Brazil
Botswana
Belarus
Cambodia
Canada
Cote d’Ivoire
Chile
Cameroon
China
Costa Rica
Croatia
Denmark
Ecuador
Estonia
Egypt
Ethiopia
Federated States of
Micronesia
Finland
France
Greece
Hong Kong
Indonesia
Ireland
India
Iran
Italy
Jordan
Japan
Kazakhstan
Kenya
Kuwait
Lebanon
Lithuania
Macedonia
Malaysia
Mauritius
Mongolia
Mozambique
Mexico
Nepal
Netherlands
Nigeria
Norway
Oman
Philippines
Poland
Portugal
Qatar
Romania
Russia
Saudi Arabia
Serbia
Singapore
Slovenia
South Africa
Spain
Sudan
Sweden
Switzerland
Thailand
Turkey
Uganda
Ukraine
United Kingdom
United States
Uzbekistan
Vietnam
Zambia
2
Type of Institution
Type of institution answering survey (N=460)
Government of public health
laboratory
Hospital laboratory
9.8%
2.0%
9.4%
Independent Laboratory (reference
or referral)
6.1%
0.7%
Office laboratory or small laboratory
6.1%
Blood bank
10.9%
55.0%
Medical Technology / CLS /
Educational Institution
Manufacturer / Vendor / Service
Provider to laboratories
Other (please specify)
3
Size/Volume of Institution
Size / Volume of your Institution (N=460)
14.4%
101 to 250 beds Or between
10,000 and 50,000 tests
performed annually
10.3%
12.4%
13.1%
29.5%
20.3%
less than 100 beds Or less than
10,000 tests performed annually
251 to 500 beds Or between
50,000 and 100,000 tests
performed annually
501 to 1,000 beds Or between
100,000 and 500,000 tests
performed annually
More than 1,000 beds Or more
than 500,000 tests performed
annually
No beds Or No tests directly
performed - manufacturer or
vendor
4
Size/Volume of Institution
Size and Volume of Survey Respondents
35.00
29.50
30.00
% of Respondents
25.00
20.3
20.00
15.00
10.00
14.40
12.4
13.1
10.3
5.00
0.00
No beds / No tests <100 beds or <10,000 101 to 250 beds or
tests
10,000 to 50,000
tests
251 to 500 beds or 501 to 1,000 beds or
50,000 to 100,000 100,000 to 500,000
tests
tests
<1,000 beds or
>500,000 tests
5
Types of Goals used in the Lab
(N=409)
Allowable Total Error (analytical)
63.3
Biologic goal for allowable SD/CV
58.4
Manufacturer Claim for performance
47.4
Biologic goal for allowable Total Error
37.9
State of the Art / Peer Group Performance
34.5
Biologic goal for allowable bias
33.7
Clinical intended use specification
32
Target measurement uncertainty
14.9
Root Mean Standard Deviation (RMSD)
11.7
Clinical outcome model
None. Quality Specs not used
6.6
2.4
6
Where do Labs find their Goals?
(N=400)
PT/ EQA/ Peer specifications from surveys
53
Manufacturer claims
52.5
Biologic Variation goals ("Ricos Goals")
50.5
CLIA PT goals from US
49.7
Scientific guidelines/ Journal studies
31.1
Lab-Developed specifications (actually calculated)
28.5
Lab-Developed specifications (historical goals)
17.9
RCPA allowable limits of performance
16.7
German Rilibak specifications
Lab-Developed specifications (surveys of clinician use)
13.6
7.3
7
How do laboratories use their
analytical goals? (n=441)
Evaluate method performance
78.1
Monitor performance of PT/EQA
75.8
Compare Performance with Peer Group
62.9
Select/Design QC procedures
61.1
Select Methods
48.6
Monitor Measurement Uncertainty
39.9
Assess quality on Six Sigma scale
27.4
None of the above
2.3
0
10
20
30
40
50
60
70
80
90
8
What changes would Labs like to
see in analytical goals (n=377)
Eliminate use of Total Error
Focus PT/EQA goals on bias, not TE
Adopt Tighter Goals to Improve Test Quality
Adopt Wider Goals that are more Practical
Formalize biologic max CV as target measurement uncertainty
Expand and update CLIA goals
Expand physician surveys to determine quality
Establish more expert groups and guidelines
Harmonize PT/EQA goals across countries
Develop new models based on intended clinical use
5.9
13.7
24.9
27.3
31.9
36.7
37.5
42.1
46.9
47.7
9
What support would laboratories like
related to their analytical goals? (n=370)
More support in Application of Goals
70.2
Simplify Selection of Goals
57.9
Expand Goals to pre- and post-analytical processes
56.3
Improve the Databases of Goals
51.9
More support in Definition of Goals
51.1
0
10
20
30
40
50
60
70
80
10
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