Quality management systems in the

European screening laboratories in blood

establishments: a view on current
approaches and trends
Paulo Pereira

IPFA/PEI 22nd International Workshop, NRL European Workshop on Quality

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
Introduction
The screening laboratory has a critical role in the post-transfusion safety.
The success of its goals and efficiency depends on the quality system used.
The European Union Directive 2002/98/EC requires a quality management
system in blood establishments considering technical requirements in
screening tests.

© Paulo Pereira 2/36

What is happening in European blood
establishments?
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
2012 EDQM Survey - Answers in 186 Blood Establishment in 33
Countries
Quality Management System - Implementation

A QMS is implement 138; 84.7%

A QMS is partially or no
25; 15.3%
implemented

0 20 40 60 80 100 120 140 160

© Paulo Pereira 4/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
2012 EDQM Survey
Quality Management Systems - Implemented Approaches
National standards/guidelines 132; 81,5%
46; 28.4%
PIC/S Guide for Blood Establishments
EU GMP for Blood Derived Products… 51; 31.5%
EU GMP Medicinal Products for… 33; 20.4%
WHO GMP for Blood Establishments 43; 26.5%
Council of Europe Guide to the… 134; 12.4%
ISO 15189 45; 27.8%
ISO 17025 38; 23.5%
ISO 9001 84; 51.9%
EU Directive 2005/62/EC 119; 73.5%
EU Directive 2005/61/EC 114; 70.4%
EU Directive 2004/33/EC 119; 73.5%
EU Directive 2002/98/EC 121; 74.7%
0 20 40 60 80 100 120 140 160

© Paulo Pereira 5/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
2012 EDQM Survey
Quality Management Systems - Mandatory Approaches
National standards/guidelines 120; 75.5%
PIC/S Guide for Blood Establishments 21; 13.2%
EU GMP for Blood Derived… 38; 23.9%
EU GMP Medicinal Products for… 22; 13.8%
WHO GMP for Blood Establishments 19; 11.9%
Council of Europe Guide to the… 64; 40.3%
ISO 15189 20; 12.6%
ISO 17025 14; 8.8%
ISO 9001 36; 22.6%
EU Directive 2005/62/EC 106; 66.7%
EU Directive 2005/61/EC 103; 64.8%
EU Directive 2004/33/EC 102; 64.2%
EU Directive 2002/98/EC 112; 70.4%
0 20 40 60 80 100 120 140

© Paulo Pereira 6/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
• Most of blood establishments have a QMS implemented
• Most of blood establishments has mandatory requirements (national law)
assuring the fulfillment of the blood establishments’ EU directives
• Around half of blood establishments fulfill ISO 9001 requirements for
quality management systems
• Around one fourth of blood establishments has at least one test
accredited under ISO 15189 focusing on quality and competence of
medical laboratory tests
• Around one fourth of blood establishments has at least one test
accredited under ISO/IEC 17025 focusing on the competence of testing
and calibration laboratories

© Paulo Pereira 7/36

So what are major concerns?
 Quality management in the European screening laboratories in
“All laboratory testing
blood establishments: a view on current
procedures shall be” approaches and trends
• Commission Directive 2005/62/EC of 30 September 2005

“Quality assurance” “Laboratory testing”

“Validation” “Validation” Ensure that

the quality
“Re-validation” “Proficiency testing” system is in
place in all
blood
“All procedures, premises, and establishments
equipment that have an influence “The quality of the laboratory complies with
on the quality and safety of blood testing shall be regularly Directive
and blood components shall be” assessed”
“Processing and validation”

“All equipment and technical

devices shall be”
© Paulo Pereira 9/36
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
The questions:

a) What are the recommended approaches? Currently there is not a

standardization of procedures.

b) Are these requirements enough to assure post-transfusion safety of

screening tests? Absolutely not: review evidence-based laboratory
medicine cases, review published articles, review Clinical and Laboratory
Standards Institute guidelines for medical laboratories (CLSI EP12, etc.).

It is often assumed in medical laboratories that the high level of automated

technology assures quality, but many manufacturers and screening
laboratories focus on minimum requirements for compliance with regulatory
and inspection requirements.
© Paulo Pereira 10/36
Selection of test is required by 61.9% of pre-examination,
Quality lawmanagementin the European screening laboratories inand post-
examination
blood examination
establishments: a view on current approaches errors (Carraro &
and trends
Plebani, 2007)
Testing processing flow with interactions according to NEXUS vision (worst case scenario)

Pre-pre- Pre-analytical 23.1% of pre-examination,

analytical error error
examination and post-
examination errors (Carraro &
15% of pre-examination,
Incorrect
Incorrect
Plebani, 2007)
requirement of
conditions
test
examination and post-
examination errors (Carraro &
Death or
Plebani, 2007) injury

Abnormal
Reported Incorrect The clinical decision is
abnormal clinical
result
result decision incorrect due to false
results/major risk of post-
transfusion infection
Analytical Post-analytical Post-post-
© Paulo Pereira 11/36
error error analytical error
Good management practices (GMP):
ISO/DIS 9001:2015“Quality
management systems - requirements”
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends

• It is applicable to the blood establishment, not uniquely applicable to a

screening laboratory

• The practical approach to meet ISO 9001 requirements must be designed

at each blood establishment, and there is not any “one approach” to be
used

• Screening laboratory activities should be represented in a process - input:

samples and data, output: reported results

• Its goal is continual customers’ satisfaction

© Paulo Pereira 13/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
Continual improvement

Plan Do

Plan Do Act Check

Act Check

Continual costumer satisfaction/sustainability* of blood establishment

*It is not required on ISO 9001 © Paulo Pereira 14/36
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
• ISO 9001 is undergoing a “major revision”
• “Quality management principles” will be part of ISO 9001 (Annex B):
Customer-focus, leadership, engagement of people, process approach,
improvement, evidence based decision making, and relationship
management.
• “Products and services” instead of “product”
• New requirements:
a) Determine the context of the organization
b) Identify relevant needs and expectations of relevant interested parties
c) “Organizational knowledge”
d) Beefed-up requirements on leadership and commitment
Adapted from Nigel Croft, ISO 9001:2015 – what will change, and why? TCA Global, June 2014

© Paulo Pereira 15/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends

• More emphasis on “risk-based thinking” - risk is defined as the “effect of

uncertainty on an expected results”
• Elimination of the term “preventive action” - Concept still remains, and is
actually reinforced (by addressing “risk”)
• “External provision of products and services” instead of “purchasing” -
includes outsourced processes
• Elimination of specific requirements for Quality Manual and management
representative

Adapted from Nigel Croft, ISO 9001:2015 – what will change, and why? TCA Global, June 2014

© Paulo Pereira 16/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends

• All organizations are strongly encouraged to start the transition since the
DIS publication (July 2014)

• Scheduled publication date September 2015

• ISO/TC176, ISO/CASCO and IAF have approved a 3-year transition

period

Adapted from Nigel Croft, ISO 9001:2015 – what will change, and why? TCA Global, June 2014

© Paulo Pereira 17/36

Good laboratory practices (GLP):
ISO 15189:2012 “Medical
laboratories - Requirements for
quality and competence”
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
• ISO 15189 is the global accreditation standard for medical laboratory
tests and methods, focused principally in GLP - it is an advanced
approach to assure best practices in screening laboratories – important to
the decrease and control of residual risk

• It is mandatory in Australia, Latvia and in France after November 1, 2016

• Outside of ISO’s global guidelines, there are a few national GLP

programs: CLIA (US), the NATA (Australia), CCKL (The Netherlands), and
RiliBÄK (Germany)

© Paulo Pereira 19/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
New test
A flowchat for test selection,
verification, validation,
measurement uncertainty and Selection Rejected
IQC/EQA
Accepted

Verification Rejected Rejected test

Accepted

Validation Rejected

Accepted

Rejected
Expanded Measurement
Accepted
uncertainty uncertainty

Accepted

Rejected result/
IQC/EQA
CAPA

Clinical decision
Reported result
intervals © Paulo Pereira 20/36
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
Continual improvement of the QMS according to ISO 15189 in a blood establishment
laboratory
Costumers Organization and Costumers
(e.g., patients, management (e.g., patients,
blood donors) Quality blood donors)
management
system

Evaluation and
Resource Costumer
continual
management satisfaction
improvement
Requirements
(including
technical Process approach
requirements Pre- Post- Result Reported
Input Examin. Output
according to examin. examin. report results
results
intended use)

Support processes © Paulo Pereira 21/36

Pros and cons of the approaches
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
ISO 9001 Pros

• Useful for an implementation of a recognized global QMS approach

• Provides continuous assessment and improvement

• Compatible with the EU Directives requirements of QMS

• Successfully applied in blood establishments

• It will require to consider the risk in all decisions

© Paulo Pereira 23/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
ISO 9001 Cons

• It does not include any technical requirements for quality and

competency: By itself, ISO 9001 does not guarantee that reported result
is the output of a technical evidence-based test

• Lower sensitivity to detect nonconformities caused by technical failures

• It does not have efficiency/sustainability requirements

• A nonconformity in ISO15189 might not be in ISO 9001

© Paulo Pereira 24/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
ISO 15189 Pros

• It requires a detailed set of technical requirements

• Its implementation complements most of the regulatory requirements in

different countries

• The laboratory must select a set of protocols for the examination process
(published in recognized textbooks, peer-reviewed journal articles,
international or national consensus texts or laws)

• Higher sensitivity to detect nonconformities caused by technical failures,

such as a better capacity to have successful corrective and preventive
actions
© Paulo Pereira 25/36
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
ISO 15189 Cons

• More complex approach when compared to ISO 9001

• The technical requirements fulfillment vary according to the chosen

source: non standardization of technical practices

• The maximum permissible error is also non standardize → non

standardization of residual risk of infection caused by test failure

• Usually not mandatory in most of European countries

• Unsuccessfully implementation in most European countries

© Paulo Pereira 26/36

Concluding
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends

Technical Good Good Quality

requirements laboratory management management
fulfillment practices practices requirements
fulfillment

Other
requirements

Law, EU
directives, © Paulo Pereira 28/36
etc.
Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends
The screening laboratory should use the Clinical Laboratory Standard Institute guidelines as
best source for the fulfillment of technical requirements (http://clsi.org):

© Paulo Pereira 29/36

Quality management in the European screening laboratories in
blood establishments: a view on current approaches and trends

• Complementary approaches are needed to implement a quality

management system also focused on screening laboratories technical
requirements laboratories complying with ISO 15189 requirements

• The lack of standardization of screening laboratories practices is not only

a problem in blood establishments but is common to all European medical
laboratories

• Realistic recommendation: ISO 15189 accreditation of tests

• Long term recommendation: regulatory Directives to medical laboratories

including technical/quality control/maximum permissible error
requirements
© Paulo Pereira 30/36
 http://www.ipst.pt/
paulo.pereira@ipst.min-saude.pt

This presentation is intended to be used on this conference only.

The use outside this conference can only occur with the consent of the author.