EQALM SYMPOSIUM 2009

Quality requirements and quality goals

Kaiserin-Friedrich-Haus, 1.-2. July in Berlin, Germany

Introduction

Summary

Medical loops

Error management
NEXUS
Post(-post)-analytical
recommendations
Post-analytical factors Conclusions

and their influence

on analytical quality
specifications
Henk MJ Goldschmidt
Wednesday 01 July 2009
Post-analytical factors
and their influence
on analytical quality specifications
Post-(post-)analytical factors:
Introduction
1. Reporting
2. Interpretation Summary

3. Overall error management Medical loops

4. Throughput times
Error management
5. Context fit NEXUS
6. Critical difference (1/4 BVii, zero error)
Post(-post)-analytical
7. Follow up recommendations
Conclusions

Their influence on analytical quality specifications:

1. Define graphics
2. Clinical outcome indicators
3. Define redundancy
4. Define logistical checks
5. Check and double check
6. Define patients context
7. Provide consultation routinely
UPDATE, overview

Introduction
• It started with time dependencies Summary

(first within the lab, than outside, att.f.) Medical loops

Error management
• Lundberg: loop PA-A-PA NEXUS

• Goldschmidt and Lent: Post(-post)-analytical

recommendations

Data + Context
Information (CFV) Conclusions

• Goldschmidt: loop PPA-PA-A-PA-PPA

• Weggeman: K = I * ESA
• Error budget calculation
• NEXUS model
 The brain-to-brain information loop

Introduction

Patient Summary
Physician’s Action
medical history Medical loops
brain
15% Error management
NEXUS
Ordering Interpretation Post(-post)-analytical
75% recommendations
Conclusions
Test request Test results
Collection
Laboratory Report
Identification box
Transport
Preparation Analysis 10%

G.D. Lundberg: JAMA 1981, 245: 1762

relative error rate
types of errors: sporadic, systematic and analytical
 The brain-to-brain information loop

Introduction

Patient Summary
Physician’s Action
medical history Medical loops
brain
1 15% 9 Error management
NEXUS
Ordering Interpretation Post(-post)-analytical
75% recommendations
2
8 Conclusions
Test request Test results
Collection 3
Laboratory Report
Identification box
Transport 7
4 Preparation
Analysis 10%
5 6 G.D. Lundberg: JAMA 1981, 245: 1762
relative error rate
types of errors: sporadic, systematic and analytical
 The brain-to-brain information loop

Introduction

Patient Summary
Physician’s Action
medical history Medical loops
brain
1 15% 9 Error management
NEXUS
Ordering Interpretation Post(-post)-analytical
75% recommendations
2
8 Conclusions
Test request Test results
Collection 3
Laboratory Report
Identification box
Transport 7
4 Preparation
Analysis 10%
5 6 G.D. Lundberg: JAMA 1981, 245: 1762
relative error rate
types of errors: sporadic, systematic and analytical
Complete Diagnostic / Therapeutic Loop

Introduction

Summary
PRE PRE DOCTOR Medical loops
Analytical Phase
POST POST Error management
Analytical Phase NEXUS

PRE Post(-post)-analytical
Analytical recommendations
EPR
Phase Conclusions

Analytical POST
Phase Analytical
Phase Laboratory Box
Quality of the product (medical
treatment not the isolated lab test)

Introduction

Summary

Medical loops

Error management
NEXUS

Post(-post)-analytical
recommendations
Conclusions

Ref: Travers, Clinical Laboratory Management, p. 769, ISBN 0-683-08376-7, 1997

 The medical laboratory in the
medical process
Physician’s brain
Goldschmidt HMJ
EPR Postanalytical
factors and their
influence on
analytical quality
specifications.
Scand J Clin Lab
Invest 1999; 59: 551-
General knowledge
base 554

K(knowledge) = I(information) * E(experiences) . S(skills) . A(attitudes)

 Linking the concepts of biological
variation and medical allowable error

Table: Calculated and studied error rates Introduction

Summary
Phase frequency of occurrence justification source
Medical loops
Pre-pre-analytical phase 1:8 12.0 % own enquiry1 Error management
Pre-analytical phase 1:49 2.0 % literature NEXUS
Analytical phase 1:625 0.2 % results lab author 12
Post(-post)-analytical
Post-analytical phase 1:45 2.2 % literature
recommendations
Post-post-analytical phase 1:19 5.0 % own enquiry3
Conclusions

Overall error rate 20.0 % see paper for calculation

Error budget that can be afforded 26.9 % see paper for estimation

1 Interviewing clinicians,
checking for errors in e.g. thinking wrong hypothesis
2 Internal, not external, quality control figure
3 Interviewing clinicians, checking for e.g. misinterpretation of results
 NEXUS approach: linking all concepts
Goldschmidt HMJ Clin Chem Lab Med 2004 42(7) 868-873

Error Error
Budget Budget
spent allowed
Introduction
? 0%
1 Patient's request
Summary
based upon an event
Medical loops
Lundbergs' Pre-pre analytical 12.0% 0%
2 Physician's request
brain-to- (feed forward) Error management
brain loop
NEXUS
Trauchauds'
Pre analytical 2.0 % 0% Post(-post)-analytical
quality loop 3 data generation and
registration recommendations
metrological 0.2 % ¼ BVii
Analytical Conclusions
traceability, GUM
2.2 % 0%
Post analytical
Weggemans' 4 Physician's answer
knowledge
model
5 context check,
information generation
Post-post
and check on general
analytical
medical knowledge (feed backward)

6 decision (action) 5.0 % 0%

7 Patient's answer
? 0%
Linking the concepts of biological
variation and medical allowable error

In a way the two approaches are: Introduction

Summary
what is right now practically Medical loops

achievable and what is, from a Error management

NEXUS

theoretical point of view, possible. Post(-post)-analytical

recommendations
Conclusions

So the potential of laboratory

medicine is given by the
biological variance concept.
Post and post-post analytical steps
possible errors linked to potential solutions

Introduction
7
Summary

Medical loops

Error management
NEXUS

Post(-post)-analytical
8 recommendations
Conclusions

9
 Quality of laboratory information

The Stockholm statements: Introduction

1999 quality of laboratory results Summary

Medical loops
The Antwerp statements: Error management
NEXUS
2003 quality of laboratory information Post(-post)-analytical
recommendations
Conclusions

Jean-Claude Libeer formulated the following

questions:
Is our information useful for patient care?
Do we know what clinicians want?
Do clinicians know what we can offer?
The patient in the lead: all involved

Introduction

Summary

Medical loops

Error management
NEXUS

Post(-post)-analytical
recommendations
Conclusions
 The patient in the lead: all involved

Introduction
Consults by
hospitals or Summary
home doctor
specialized
Medical loops
care
Error management
NEXUS

Post(-post)-analytical
recommendations
Conclusions
Health care Patient Family
inspection friends

Government Health care

Politics insurance
RECOMMANDATIONS

1. Use graphics to report Introduction

Summary
2. Use clinical outcome indicators
Medical loops

3. Use redundancy Error management

NEXUS
4. Use logistical checks Post(-post)-analytical
recommendations
5. Check and double check Conclusions

6. Define the patients context

7. Provide consultation routinely
RECOMMANDATIONS

1. Use graphics to report Introduction

Summary
2. Use clinical outcome indicators
Medical loops

3. Use redundancy Error management

NEXUS
4. Use logistical checks Post(-post)-analytical
recommendations
5. Check and double check Conclusions

6. Define the patients context

7. Provide consultation routinely
The guessing experiment

Histogram of 611 Z-scores of clinical test

results of 3 outpatient clinics and 4
physicians. The Z-scores are the context fits
a particular clinical chemical test result.

In:
Chemometrics and Intelligent Laboratory
Systems 28 (1995) 181-192 From data to
information: how to define the context?
H.M.J. Goldschmidt and R.W. Lent.
Chemistry / Hematology

http://www.ifrance.com/valab/
Coagulation
 Context geared

Goldschmidt, H.M.J. and Lent R.W.,

Chemometrics and Intelligent Laboratory Systems 28 (1995) 181 - 192
 Define personalized
analytical specifications
• It’s time to recognize the physician as Introduction

well as the patient Summary

Medical loops
• Use comprehensive models Error management
NEXUS
• Use time dependencies Post(-post)-analytical

• Use autovalidation and recommendations

Conclusions

autoverification
• Bring the quality upto the new level:
– systematic errors: zero
– random errors: ¼ BVii
Post-analytical factors and their influence
on analytical quality specifications

Post-(post-)analytical factors:
1. Reporting
2. Interpretation Summary

3. Overall error management

4. Throughput times
5. Context fit
6. Critical difference (1/4 BVii, zero error)
7. Follow up

Their influence on analytical quality specifications:

1. Define graphics
2. Clinical outcome indicators
3. Define redundancy
4. Define logistical checks
5. Check and double check
6. Define patients context
7. Provide consultation routinely
The patient in the lead