ISO 15189 accreditation inspection The Leicester experience
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Transcript ISO 15189 accreditation inspection The Leicester experience
Lara Cresswell
ACGS workshop May 16th 2014
Overview
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
submission
Still have evidence to submit
The Leicester lab
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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
2014
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
format
Technical policy statements
Guidance documents in technical information section
GEN3 (reporting UKAS assessments) very useful
Includes details on timescales for submission of
evidence
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
Complaints
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
LIMS
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
Using
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
records
• Insufficient validation data
– Historic processes
• Laboratory information management
– Insufficient documentation for all systems
• BUT... Nothing was identified that was not on the gap
analysis
Closing meeting
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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
assessment
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
Summary
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
CPA
Fingers crossed for a positive outcome!!