Assessment:

Norms and
Accreditation

1
 Learning Objectives
At the end of this module,
participants will be able to:
 compare and contrast accreditation,
certification and licensure;
 describe the process involved in
development of standards;
 discuss the need for laboratory
norms and standards.

Assessment: Norms and Accreditation-Module 11 2

 Scenario
Your hospital administrator has
asked you, the laboratory manager,
to examine the possibility of having
the laboratory accredited.

 What does it mean to be accredited?

 Where can you get information?
 How would you get started?

Assessment: Norms and Accreditation-Module 11 3

 The Quality Management System

Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Documents Occurrence
Assessment
& Management
Records

Process Customer Facilities

Improvement Service &
Safety

Assessment: Norms and Accreditation-Module 11 4

 Laboratory Assessment – WHY?
 recognition as delivering accurate
and reproducible results
 recognition of compliance with the
quality standards and norms used for
the assessment

Awarded to
Quality Lab
2009

Assessment: Norms and Accreditation-Module 11 5

 Laboratory
implements
international or Director seeks information about
accreditation and
national standards certification processes

seeks information uses outcomes to

about appropriate provide better service
norms and standards

Responsibilities
Laboratorian Quality Manager
aware of requirements

contributes to meeting standards explains the process for

meeting standards to staff
aware of assessment processes
organizes the laboratory in
helps prepare for assessment preparation for assessments

Assessment: Norms and Accreditation-Module 11 6

 Definitions
 Normative document— provides rules,
guidelines or characteristics for activities or their
results
 Standard document—established by consensus
and approved by a recognized body, that
provides, for common and repeated use, rules,
guidelines or characteristics for activities or their
results, aimed at the achievement of the
optimum degree of order in a given context
 Regulation—any standard that is mandated by a
governmental agency or authoritative body

Assessment: Norms and Accreditation-Module 11 7

 Self-developed Standards
Many agencies, organizations, or regions develop
their own accreditation requirements rather than
using internationally recognized standards.
 Advantages:
 optimized for local use, recognized local strengths and
weaknesses
 can be developed in progressive steps
 can lead to full international recognition
 Weaknesses:
 may be narrow or biased
 may not be recognized by other organizations

Assessment: Norms and Accreditation-Module 11 8

 Standardization Bodies

International organizations include:

 ISO
 CLSI
 CEN
 WHO

Assessment: Norms and Accreditation-Module 11 9

 International Organization for
Standardization

 world's largest developer and publisher

of international standards
 standards are applicable to many kinds
of organizations including clinical and
public health laboratories

Assessment: Norms and Accreditation-Module 11 10

 Clinical and Laboratory Standards
Institute

 global, nonprofit, standards-developing

organization
 promotes the development and use of
voluntary consensus standards and guidelines
within the health care community
 documents are developed by experts working
on subcommittees or working groups

Assessment: Norms and Accreditation-Module 11 11

 European Committee for Standardization

 national standards bodies in the

European Economic Community and
associated countries
 general terms include openness and
transparency, consensus, and
integration

Assessment: Norms and Accreditation-Module 11 12

 Ethiopian Standard Agency

Member of ISO and establishes

different standards in Ethiopia

Assessment: Norms and Accreditation-Module 11 13

 World Health Organization

 has developed several standards for

disease-specific diagnostic laboratories,
such as polio, tuberculosis, influenza,
measles

Assessment: Norms and Accreditation-Module 11 14

 Ethiopian National Accreditation Office

Give accreditation services to laboratories

(test and calibration), certification bodies and
inspection bodies, both domestic and foreign,
that operate both within the borders of the
Ethiopia and outside country
www.enao-eth.org

Assessment: Norms and Accreditation-Module 11 15

 National Standards and Technical
Guidelines

 Country-specific standards
 based on international standards
 adapted to the culture and general
condition of the country
 Guidelines
 supplement ISO standards with technical
guidance for use in laboratories
 can address a specific kind of testing

Assessment: Norms and Accreditation-Module 11 16

 SLIPTA: A framework to encourage, support and recognize the
implementation of QMS in medical laboratories in a stepwise
manner the
limb
c 5
lab
a Star
e lps 4
t h
tha l Star
o o
ntt 3
e
vem n Star
ro o
mp dita 2
ti
i > 95 %
lab cre Star
re d ac
tu y fo1r
A
MT

c
tru ead 85-94
SL

s
is a get r Star %
A
T nd
M 75-84
SL ps a 0
ste Star % ↑ Score on
65-74 external evaluation
% using a checklist
55-64
%
Progression toward Accreditation Readiness
SLMTA
 Strengthening Laboratory Management Training
Towards Accreditation(SLMTA)

o A task-based training and mentoring tool

kit provided to the laboratory personnel in
multi-workshop implementation model.
o Participants will be assigned to work on
improvement projects to improve the quality
management system of the laboratory.

18
 Strengthening Laboratory Management Toward Lab Improvement and Accreditation

Recommended Program Map

Strengthen laboratory management Achieve immediate laboratory improvement Accelerate the process toward accreditation readiness
Month 0 Month 1 Month 4 Month 7 Month 12 Month 18
S L M T A
Pre-requisites to entry Attendees An 18-month program with a series of workshops for the same group of lab
managers
1. Lab strategic plan
and policy drafted
Getting ready
2. Lab director, with for final
decision-making Improvement Improvement Improvement inspection
power, in place Projects Projects Projects
Baseline End-of-
3. QA manager in Workshop Workshop Workshop Training Accreditation
Assessment #1 #2 #3
place Assessment
4. Participant (3 months) (3 months) (3 months)
Gap Analysis
committed to same
& Site Visits Site Visits Site Visits
job responsibilities
Action Plan
throughout the 18-
month program
(preferred) On-going support by partners and CDC in-country staff (on-site mentoring, monitoring of improvement projects)

Online
How To Be A Quality Skill-based
Virtual Leadership
Quality Control Successful SOP Writing BioSafety Management training
Development Program
QA Manager System (e.g., SMDP)
(e.g., MSH)

Additional Training/Technical Assistance Based on Gap Analysis Optional Complementary Training

(offered at ACILT or in-country by partners)

SLMTA
 SLMTA Implementation Model

Improvement Improvement Improvement

Projects Projects Projects Behavioral
Workshop Workshop Workshop Changes &
#1 #2 #3 Laboratory
Improvement
(3 months) (3 months) (3 months)

Site Site Site

Visits Visits Visits

Multi-workshop delivery facilitates learning transfer

and behavioral changes.
 Specific and National
Norms, Standards, Regulations

Assessment: Norms and Accreditation-Module 11 21

 Definitions
 Certification (ISO/IEC 17000)
 Procedure by which a third party gives written assurance that
a product, process or service conforms to specific
requirements.

 Accreditation (ISO 15189)

 Procedure by which an authoritative body gives formal
recognition that a body or person is competent to care out
specific tasks.

 Licensure (Wikipedia 2007)

 Granting of ability to practice provided most often by a local
governmental agency, usually based on demonstrated
knowledge, training and skills.

Assessment: Norms and Accreditation-Module 11 22

 Does the
laboratory need
accreditation?

Which How does

standards the
should the laboratory
laboratory regard
use? regulation
?

Assessment: Norms and Accreditation-Module 11 23

 Elements of an Accreditation Process

 Accreditation Body

 Standards

 Assessors

 User laboratory

Assessment: Norms and Accreditation-Module 11 24

 Approved Knowledgeable

Certification
and
Accreditation
Bodies Standards-
based
Competent
staff

Objective
Assessment: Norms and Accreditation-Module 11 25
 Examples: commonly used standards
 Certification standards
 ISO 9001:2000
 ISO 14000
 Accreditation standards
 ISO 17025
 ISO 15189
 WHO polio standards
 Regulations
 US CLIA Regulations
 French GBEA (Guide de Bonne Exécution des Analyses (French: Guide of Good
Running Analysis)

 UN Transport of Dangerous Goods Regulations

Assessment: Norms and Accreditation-Module 11 26

 Scope of ISO 17025

tests
calibrations
sampling
to confirm or
recognize
competence

Does not cover compliance with regulatory and safety

requirements for laboratory operations
Assessment: Norms and Accreditation-Module 11 27
 Scope of ISO 15189
Based on ISO
17025:2005
&
9001:2000

to confirm or
recognize
competence

Assessment: Norms and Accreditation-Module 11 28

 Where is your Laboratory?
Reference
Laboratory

SOP
s
Laboratory
ISO 15
ISO 9001 1
l WHO P 89
anua OLIO
u ality M
SOP Q
s

ISO 9001
Laboratory
Q uality
Manu
al Accreditation

day!
i ngt o Certification
e n
Op

Licensure

Assessment: Norms and Accreditation-Module 11 29

 Process for Accreditation

not one to be taken lightly

or without forethought

commitment planning

Requirements

knowledge resources

Assessment: Norms and Accreditation-Module 11 30

 Accreditation Terms
Consensus
 represents general agreement in the absence of
strong and compelling objection
Normative Statement
 required and essential part of the standard
 includes the word “shall”
Informative Statement
 information (often a ‘note’) that may be
explanatory, or cautionary, or provide an
example

Assessment: Norms and Accreditation-Module 11 31

 Accreditation Terms
Compliance
 meets both the text and the spirit of a
requirement
Non-conformity
 failure to fulfill the requirements of a specified
process, structure or service
 may be categorized as major (complete) or
minor (partial)
Verification of conformity
 confirmation by examination of evidence

Assessment: Norms and Accreditation-Module 11 32

 Accreditation does not guarantee success,
it is only one step along the quality journey

QUALITY
MANAGEMENT

ERROR CUSTOMER
REDUCTION SATISFACTION

CONTINUAL
IMPROVEMENT
ACCREDITATION

Assessment: Norms and Accreditation-Module 11 33

 Accreditation outcomes

 strength and integrity of the

quality system are measured
 continual monitoring of the quality
system
 recognition for efforts

Assessment: Norms and Accreditation-Module 11 34

 Accredited laboratories tend to:
 perform better on proficiency
testing
 are more likely to have a working
quality management system

Assessment: Norms and Accreditation-Module 11 35

 It is an accomplishment
to receive accreditation

2007

PRIMARY

Assessment: Norms and Accreditation-Module 11 36

 2010
2007

MAINTAINED
PRIMARY
2009

MAINTAINED

2008
It is an
ACHIEVEMENT
MAINTAINED to maintain
accreditation
Assessment: Norms and Accreditation-Module 11 37
 Summary
 Standards provide guidelines that form
the basis for quality practices. They are
developed by organizations.
 Accreditation and certification are
processes that recognize that a
laboratory is meeting the designated
standards.
 An active quality management program
can assure the laboratory is in a constant
state of “accreditation-readiness”.

Assessment: Norms and Accreditation-Module 11 38

 Key Messages

 Accreditation is an important step in

the continual improvement of the
quality management system.

 It is an accomplishment to be
accredited; it is an achievement to
maintain accreditation.

Assessment: Norms and Accreditation-Module 11 39

 Organization Personnel Equipment

Questions?
Purchasing Process Information
&

Comments?
Control Management
Inventory

Documents Occurrence
Assessment
& Management
Records

Process Customer Facilities

Improvement Service &
Safety

Assessment: Norms and Accreditation-Module 11 40