ISO 15189 accreditation inspectionThe Leicester experience

Lara CresswellACGS workshop May 16th 2014

OverviewOur CPA/UKAS journey including timescalesKey gaps identifiedPersonal experiences

Not an expertDescribe the process we went throughCurrently awaiting decision following

evidence submissionStill 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 possiblePeer assessor confirmed and new dates set

for March 20143 day visit March 3rd-5th

Both assessors being observed as first 15189 visits

Pre visit documentationBig difference between CPA and UKAS/ISOAC4 form

Difficult, very little guidance on completion Easier if have lists of testsAC4 form includes related SOPs to the tests listed

on the form, these must all be submitted (~40 SOPs)Gap analysis must be submittedQuality manualLatest AMRDocumentation 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 formKey document for 15189 accreditationForms schedule of accreditationMust list all tests you do and the related

equipmentImportant to state if you do in house

calibrationsEnsures 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 readingDocuments on UKAS website giving details

on the visit formatTechnical policy statementsGuidance documents in technical information

sectionGEN3 (reporting UKAS assessments) very

usefulIncludes 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 AMinterviews 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 PAwitnessing 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 beforeEncouraged an open and honest approach

Acknowledged where evidence thinNo time to go on an evidence ‘hunt’Assessors will know this anyway from the gap

analysisThis 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• 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 submissionCPA/ISO finding – 8 weeks from final date of

assessmentTo allow clearance within 12 weeks to retain

CPAISO only finding - 12 weeksNo negotiation on these dates

Audited by UKASEvidence is submitted electronically

Separate submission forms for AM & PA

Where we are...30 April submitted evidence for 33/40

findingsShould hear within 10 working days

28 May for final 7 findingsWill be assessed for 15189 at follow up visit in

August

Key gapsSelection and monitoring of suppliersChange management

Equipment, reagents, external services, LIMSLaboratory information managementQuality manual not in 15189 format

Had cross referenced 15189 on CPA manualUnique identifiers on all internal and external

documents including trust policiesNeed Q-pulse (or similar)!Own a copy of the standards no copies!!

BSI group access in pathology

Uncertainty of measurementIdentified as a gapMost difficult aspect for a subjective

disciplineIA required submission of how we will

evaluate uncertainty and submit evidence for 2 processesOpen to interpretation as no specific guidance

Awaiting outcome on our approach

SummaryOverview of the processSignificant amount of work involved

Recommend starting early!Identified key gapsFlavour of the improvement actionsRequired evidence needs to be more robust

than for CPA

Fingers crossed for a positive outcome!!