ISO 15189 accreditation inspection The Leicester experience

Lara Cresswell
ACGS workshop May 16th 2014
 Our CPA/UKAS journey including timescales
 Key gaps identified
 Personal experiences
 Not an expert
 Describe the process we went through
 Currently awaiting decision following evidence
 Still have evidence to submit
The Leicester lab
Cytogenetic only laboratory, 16.8 WTE
Part of Leicester/Nottingham pathology JV Empath
CPA full assessment in 2009
Surveillance visit 2011
Full CPA assessment visit was due April –October 2013
Slipped timescales due to UKAS transition
UKAS application forms requested April 2013
– Including AC4 form
• August 2013
– date set for Feb 2014
– expecting a CPA visit with ISO as an add on
Slipped timescales....
A recurring theme
 Jan 2014
 New assessment manager assigned
 Agreed dates not possible
 Peer assessor confirmed and new dates set for March
 3 day visit March 3rd-5th
 Both assessors being observed as first 15189 visits
Pre visit documentation
 Big difference between CPA and UKAS/ISO
 AC4 form
 Difficult, very little guidance on completion
 Easier if have lists of tests
 AC4 form includes related SOPs to the tests listed on the
form, these must all be submitted (~40 SOPs)
 Gap analysis must be submitted
 Quality manual
 Latest AMR
 Documentation requested by Feb 1st 2014
Gap analysis
• Key preparation document for the visit
• Took a simple approach
• Spreadsheet with all the standards listed out
– Considered how we fulfilled each standard and documented
the evidence and described the gaps
– RAG rated each standard
– Used this as a working document and action plan assigning
timescale and responsibilities
• Completed gap analysis mid Dec 13
– Would have been better to do this earlier
– Knew wouldn’t be able to address all the gaps before the visit
AC4 form
 Key document for 15189 accreditation
 Forms schedule of accreditation
 Must list all tests you do and the related equipment
 Important to state if you do in house calibrations
 Ensures correct assessment team available
 Original form rejected early Feb 14 (not detailed enough)
 Had to resubmit following limited guidance!
 AC4 form accepted by UKAS late Feb
Pre-visit reading
 Documents on UKAS website giving details on the visit
 Technical policy statements
 Guidance documents in technical information section
 GEN3 (reporting UKAS assessments) very useful
 Includes details on timescales for submission of
Visit plan
• Assessment manager issued a visit plan
• Should be sent 4 weeks prior to visit
– Received with 1 working day to go!
• Visit plan lists what the AM and PA what to see
– Plan from there to try and make all processes available
• Everything on the AC4 form is witnessed
• Challenging to cover everything in 3 days
Visit plan with AM
interviews and document assessment
ISO 15189 management requirements, to include:
Introductory meeting
Management and organisation – roles and responsibilities, including TPS 51 multi-site requirements
Annual Management Review and other meetings
Interviews with senior management, as appropriate( to be confirmed)
Document control including documents from external sources
Service agreements
Referral of testing and approval of service providers
Purchasing services and supplies – including evaluation of suppliers and supplier list
Nonconforming work, corrective and preventive action
Record control
On-going evaluation including quality objectives and assessment of user feedback, quality indicators
and KPIs
Breadth of internal audit and depth of internal audit reports
HR policies and associated staff records and mandatory training
CPA C5 (H&S standard)
Visit plan with PA
witnessing and document assessment
ISO 15189 technical requirements, to include:
Staff competence – initial training and on-going
EQA/IQC – coverage, performance and suitability of test assurance package
Method validation and verification including conclusions on fitness for
purpose of methods
Method Content
General accommodation and environment
Technical records – clarity and traceability
User information, sample reception and handling including records and
evaluation of sample suitability
Equipment, reagents and consumables management
Reference materials and traceability
Uncertainty of measurement
Interpretation, reporting of results and advisory services
Day 1 witness plan with PA
Culturing processes (includes harvesting and slide making) Using the following items of equipment
Across a range of different sample types as appropriate to assess the different competences in required.
 Biological safety cabinets NC026, NC027
 Centrifuges NC018
 Incubators (SOP in progress)
 Hanabi metaphase spreader NC089
 Light microscopes NC083
 Inverted microscope NC090
 Dissection microscope NC091
Analysis by G banding NC038
 MMC stress testing NC098
 SCE staining NC115
 Light microscopes NC083
 Cytovision image analysis system NC085, NC087
 Analysis/reporting processes NC009, NC040, NC041, NC042, NC050, NC071, NC131, NC143, NC144
Day 2 and 3 covered
 FISH, Karyotyping, image analysis, array scanning and analysis and plasma cell selection
The visit
• Private room for the assessors including computer access and
availability of paper record
• Free access to system meant not always seeing all the evidence,
better when guided
• Provide lunch and refreshments
• Opening meeting
– Register of attendees
– Had senior Empath representation
• Time is very tight
– No time for tour of the lab
– Remember to point out models rules for visitors etc
– Generally followed the plan!
– Supportive approach from the assessors
Our approach to the visit..
 Regular staff meetings prior to visit
 Very useful if have visit plan 4 weeks before
 Encouraged an open and honest approach
 Acknowledged where evidence thin
 No time to go on an evidence ‘hunt’
 Assessors will know this anyway from the gap analysis
 This approach was appreciated by the assessment team
and conveyed to all staff
Improvement Actions
• Ongoing process throughout the visit
• Given the IA form after each day to populate how the
action will be cleared, this is agreed with the
assessment team
– NOT an advisory service
• Still get the IA even if fix the problem straight away
• 40 improvement actions in total
– All mandatory findings
Key IAs
• Audit timetable must be in line with 15189
– must ensure completion of the timetable
• No criteria for selection and monitoring of suppliers
• Insufficient change management documentation
• More detail for external documents, quality and process
• Insufficient validation data
– Historic processes
• Laboratory information management
– Insufficient documentation for all systems
• BUT... Nothing was identified that was not on the gap
Closing meeting
All staff present
Brief overview of the visit
Confirmation of identified actions
Recommendations for accreditation
– Retain CPA but not 15189 yet!
• Clarification of timescales to submit evidence
• Timescales for revisit
– 3 months from last submission date
• Statement of resource UKAS need to clear evidence
– 1 day each AM & PA
– Confirm when the assessment report should be available
Evidence submission
 CPA/ISO finding – 8 weeks from final date of
 To allow clearance within 12 weeks to retain CPA
 ISO only finding - 12 weeks
 No negotiation on these dates
 Audited by UKAS
 Evidence is submitted electronically
 Separate submission forms for AM & PA
Where we are...
 30 April submitted evidence for 33/40 findings
 Should hear within 10 working days
 28 May for final 7 findings
 Will be assessed for 15189 at follow up visit in August
Key gaps
 Selection and monitoring of suppliers
 Change management
 Equipment, reagents, external services, LIMS
 Laboratory information management
 Quality manual not in 15189 format
 Had cross referenced 15189 on CPA manual
 Unique identifiers on all internal and external documents
including trust policies
 Need Q-pulse (or similar)!
 Own a copy of the standards no copies!!
 BSI group access in pathology
Uncertainty of measurement
 Identified as a gap
 Most difficult aspect for a subjective discipline
 IA required submission of how we will evaluate
uncertainty and submit evidence for 2 processes
 Open to interpretation as no specific guidance
 Awaiting outcome on our approach
 Overview of the process
 Significant amount of work involved
 Recommend starting early!
 Identified key gaps
 Flavour of the improvement actions
 Required evidence needs to be more robust than for
 Fingers crossed for a positive outcome!!

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