CPA is a UKAS

company

Overview of CPA / UKAS

Wales Region ACB National Training Course 2014
Jan Chatfield
Senior Assessment Manager UKAS / CPA
 Introduction
CPA is a UKAS
company

• Accreditation and the relationship between

CPA & UKAS
• UKAS and the ISO Standards
• Understanding the transition to ISO
Standards and the impact on Laboratories
 CPA, UKAS &
Accreditation CPA is a UKAS
company

Accreditation: Assessment

• The recognition of • CPA/UKAS assesses for

competence of conformity against criteria
organisations to perform of competence (CPA /
specific tasks international standards)
 Accreditation CPA is a UKAS
company

• ISO/IEC 17000: 2004

Third-party attestation related to a
conformity assessment body conveying
formal demonstration of its competence
to carry out specific conformity
assessment tasks
 In simple terms….. CPA is a UKAS
company

• Providing confidence that a body can

provide reliable, reproducible outcomes
that are fit for purpose
• Expectation that one will get the ‘right’
result and a reliable outcome
 Purpose of Assessment CPA is a UKAS
company

• Can you demonstrate your competence?

• Has competence been maintained since the last
assessment
– Records, minutes, feedback, complaints
• Are you still competent now?
– Witnessing, interviewing, questioning
• How will you maintain competence in the future?
– Effective & compliant Quality Management System
 Relationship between
CPA & UKAS CPA is a UKAS
company

• UKAS is the appointed National

Accreditation Body
• CPA is part of UKAS, although currently
two legal entities
• Moving towards common
staff / procedures
 Relationship between
CPA & UKAS CPA is a UKAS
company

• Clinical Pathology Accreditation (UK)

Private company, wholly owned by
UKAS
• CPA is a non-profit distributing
organisation that acts in the public
interest.
 Relationship between
CPA & UKAS CPA is a UKAS
company

CPA UKAS

Chief Executive

Technical Director Business Development Director Finance Director

UKAS CPA Accreditation UKAS CPA Transition

Manager Project Manager

UKAS/CPA Assessment
Managers
 UKAS – who we are CPA is a UKAS
company

• The national accreditation body

• Established in 1995 by Ministers as
a private company limited by
guarantee
• UKAS appointed as national
accreditation body by The
Accreditation Regulations 2009
 UKAS – mandate CPA is a UKAS
company

• EU Regulation 765/2008 provides legal

framework for accreditation
• Operates under an MoU with BIS
• Accreditation recognised as a public
authority activity
• Duty to act in the public interest:
commercially aware, but not commercially
driven
 Standards
CPA is a UKAS
company

• BS EN ISO 15189:2012
Medical laboratories – Requirements for quality and
competence

• BS EN ISO/IEC17025:2005
General requirements for the competence of testing and
calibration laboratories

• BS EN ISO 22870:2006
Point of Care Testing (POCT) - Requirements for quality
and competence
The Transition Project CPA is a UKAS
company

• Delia Geary appointed as Project

Manager for the transition project
• Purpose: To manage and progress
the transition of all CPA accredited
laboratories to UKAS accreditation
for ISO 15189:2012
Key Milestones CPA is a UKAS
company

• Successful completion of the pilot assessments (Sept

2013)
• Assessment of the laboratories involved in the first wave
of ISO 15189 assessments (Oct 2013 onwards)
• Identification of the laboratories involved in the second
and third wave of assessments (Oct 2013 onwards)
• Website integration (Apr 2014)
Further information CPA is a UKAS
company
Further information CPA is a UKAS
company
Key Milestones CPA is a UKAS
company

• EA evaluation (March 2014)

• First grants of accreditation (July 2014)
• First surveillance visits (January 2015)
• Withdrawal of CPA accreditation and standards
(anticipated March 2018)
Long term impact on laboratories CPA is a UKAS
company

• Pathology laboratories complying with ISO 15189

• Point of care testing complying with ISO 22870
• Testing Laboratories complying with ISO 17025
• Withdrawal of CPA Standards by 2018
 Transition to ISO Laboratory
Standards (UKAS) CPA is a UKAS
company

• ISO15189 pilot completed

• All CPA MVs will now include 15189
assessment
• All new Lab Applications for 15189
(not CPA Standards)
• Surveillance visits continue as CPA
only
Basic principles of assessment CPA is a UKAS
company

• Unchanged
• Multiple ways of meeting requirements
• As before, not an audit, but an assessment
• Holistic approach to add value
• Assessment Team looking for conformity
Identifying the differences CPA is a UKAS
company

• Project Steering Groups: Gap analysis performed between

CPA Standards and ISO 15189
• Reviewed the differences as well as the implementation
and application of respective Standards
• Additional requirements of ISO 15189
• Approach to the assessment and expectations
• Differences in focus
• Possible areas of inconsistency
• May be assessed now but certainly under ISO 15189
Early assessments – key findings CPA is a UKAS
company

• Initial application documentation was not sufficiently

detailed
• Steering group gap analysis was confirmed – high
numbers of findings around verification, traceability,
uncertainty
• Unable to offer accreditation to 20% of labs
• Some labs clearly under prepared for assessment
 Evaluation &
CPA is a UKAS
Information Risk management Equipment company

management records

Staff Service
suggestions New agreements

Staff Modified
EQA/IQC
competence

Validation/
Uncertainty Traceability
Verification

Laboratory director Purchasing

& clinical staff
competence
Key Documentation CPA is a UKAS
company

UKAS Application Form

UKAS Agreement and supplement
AC4
Accreditation Schedule
ISO 15189 compliant quality manual
Gap analysis - The laboratory is responsible for
identifying and addressing gaps between the ISO 15189
standard and their own quality management system
 AC4
CPA is a UKAS
company

The AC4 document governs what is assessed and consequently what

is accredited.

The AC4 needs to include

• Types of Examination / Technical Fields/ Activities

• Types of Materials or Products tested
• A description of the equipment used, the measurement principle and
key SOP reference
 AC 4 Form CPA is a UKAS
company

• Scope of activity – repertoire, equipment and location

TYPES OF *LOCATION
EXAMINATION/TECHNICAL DESCRIPTION OF EQUIPMENT
MEDICAL MATERIALS OR PRODUCTS
FIELDS/ACTIVITIES (PLEASE GIVE USED AND MEASUREMENT
LABORATORY FIELDS TESTED
GENERAL HEADER FOLLOWED BY LISTING PRINCIPLE
OF ALL ANALYTES ETC)

EXAMPLE EXAMPLE EXAMPLE EXAMPLE EXAMPLE

Microbiology Therapeutic drug monitoring – Blood ‘Manufacturers’ Analyser and Remote

antibiotics Enzyme-multiplied ‘spoke’ at
- Gentamicin immunoassay Medtown

*Blood Sciences Blood ‘Manufacturers’ Analyser and GP (two

POCT –Haemoglobin photometry sites) and
Theatres
at main
hospital
 AC 4 Form CPA is a UKAS
company

• Identification of other activities that support the functioning of

the laboratory and where these activities are conducted e.g.
facilities management, HR, Procurement etc
• Identification of activities outside of the scope of ISO 15189
• Details of in-house calibration activities
• Details of locations
Schedule of Accreditation
CPA is a UKAS
company

Materials/Products Type of test/Properties Standard specifications/

tested measured/Range of measurement Equipment/Techniques used

Venous blood; plasma Biochemistry

Hormone Assays and tumour on ORTHO VITROS 5600- chemi
markers iluminescence
•Troponins
Key SOP(s)-PH-LAB-CHEM-13
•AFP
•beta HCG
•CA 125

•Sodium, On ORTHO VITROS 5600- dry slide

•Potassium, technique detected by potentiometric
electrometry.
Key SOP(s)-PH-LAB-CHEM-13

Venous whole blood: Haematology • Sysmex analyser 2000i

EDTA Key SOP PH-LAB-HAEM-17
•FBC
Light Absorbance
o Haemoglobin Electric impedance, hydro dynamic
focusing
estimation
Calculated by height of pulse Flow
Electric impedance, hydro dynamic
o Red cell and focusing
platelet counts

o Haematocrit

o Differential white
cell count and
reticulocytes

Venous whole blood: • Film and marrow staining Hematek

EDTA May-Grunwald staining on methanol fixed
And Bone Marrow blood smears.
Key SOP PH-LAB-HAEM-12

• Microscopy and WBC Diff Microscopy

PH-LAB-HAEM-11
 Evaluation &
CPA is a UKAS
Information Risk management Equipment company

management records

Staff Service
suggestions New agreements

Staff Modified
EQA/IQC
competence

Validation/
Uncertainty Traceability
Verification

Laboratory director Purchasing

& clinical staff
competence
Clinical staff competence CPA is a UKAS
company

• Clause: 5.1
• On-going competency assessment programme
• Acceptance criteria for performance
• Records of qualifications, experience and training
• Evidence of incorporation into management system
• Coverage by internal audit
• Links to: 4.7; 4.12; 4.14; 5.6
 Clinical staff competence CPA is a UKAS
company

MRCPath status in isolation does not confer competency. Equally,

the absence of such status does not automatically mean lack of
competence. UKAS will assess the laboratory’s justification as to
how it feels it meets requirements and seek evidence to support
this. This will include assessment of:

• Qualification records, experience, knowledge and training

• EQA records
• Suitability of acceptance criteria
• Appraisal records
• Mechanisms to monitor on-going competency and associated
records
• CPD
• Review of test reports
Validation and verification CPA is a UKAS
company

• ISO 15189 definitions:

• Verification – confirmation, through provision of

objective evidence, that specified requirements have
been fulfilled

• Validation – confirmation, through provision of

objective evidence, that the requirements for a
specific intended use or application have been fulfilled
Verification CPA is a UKAS
company

• Clause: 5.5.1.2 but mentioned in 13 clauses

• Documented procedure to verify competence
• Can manufacturer's specifications be met?
• Use of kit limited to manufacturer’s specified scope or
requirement to validate?
• Have representative staff been involved?
• Authorisation by competent personnel

• Links to: 4.12; 4.14; 5.6

Validation CPA is a UKAS
company

• Clause: 5.5.1.3
• Defined acceptance criteria
• Documented procedure – as detailed as required?
• Critical evaluation of manufacturer’s validation, including
traceability
• Suitable for use within the lab for user demographic
• Validation supplemented where necessary?
• Changes to methods captured for impact on validation
• Suitable authorisation
• Links to: 4.12; 4.14; 5.6
Traceability CPA is a UKAS
company

• Clause: 5.3.1.4
• When equipment directly or indirectly affects results
• Verification at defined intervals
• Records of metrological traceability of calibration
standards
• Manufacturer data may or may not be sufficient
• Provenance of reference materials
• Where traceability not possible/relevant, other means of
providing confidence in the results required
• Links to: 4.14; 5.5; 5.6
Measurement Uncertainty CPA is a UKAS
company

• Clause: 5.5.1.4
• Performance requirements for each measurement
procedure to be defined
• Regularly reviewed
• Uncertainty estimates to be readily available
• Requirements cover examinations reporting measured
quantity values and those that include a measurement
step
• Links to: 4.14; 5.1; 5.6
Evidence requirements CPA is a UKAS
company

• Where does it say what you do?

• Why is it done that way?
• Do staff know what should be done and why?
• Where is this implemented?
• Where is the evidence that this is implemented?
• Is the evidence objective?
• What does the evidence tell you?
• Does it work?
Rationale CPA is a UKAS
company

• Individual components of Standard are not assessed in

isolation
• Elements link together and will be assessed as such:
• Staff competence, test assurance, uncertainty, validation
• Purchasing, equipment, test assurance, responsibilities
• Holistic assessment
• Designed to facilitate continual improvement
• Not a new concept
Summary CPA is a UKAS
company

• Changes are in specific areas but impact on the whole

Standard
• Different types of changes
• New
• Revised expectations
• Performance should be evaluated at management review,
including review of suppliers
• Health and Safety assessment - much reduced
• Objective evidence critical
 For information updates CPA is a UKAS
company

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 CPA is a UKAS
company

Overview of CPA / UKAS

Wales Region ACB National Training Course 2014
Jan Chatfield
Senior Assessment Manager UKAS / CPA