How To Achieve POCT How To Achieve POCT AccreditationAccreditation

Tony Cambridge POCT Co-Ordinator Plymouth Hospitals NHS Trust

A Bit of BackgroundA Bit of Background2000- POCT section was part of the Chemistry Special Investigations section2000- POCT section was part of the Chemistry Special Investigations section

2006- POCT section created with a section lead (BMS3), deputy (BMS2), BMS 2006- POCT section created with a section lead (BMS3), deputy (BMS2), BMS and ATO staff with rotation of BMS staff through the laboratory and ATO staff with rotation of BMS staff through the laboratory

2008- Rotation of staff through the POCT team removed2008- Rotation of staff through the POCT team removed

2009- Workforce redesign. Reduction of state registered staff in favour of 2009- Workforce redesign. Reduction of state registered staff in favour of associate practitionersassociate practitioners

2011- Further changes to the team including addition of an ATO2011- Further changes to the team including addition of an ATO

2012- (January) CPA Pre-Assessment visit2012- (January) CPA Pre-Assessment visit (July) CPA 2 day Assessment (3 assessors)(July) CPA 2 day Assessment (3 assessors)

2012- (November) Received 3 certificates of accreditation2012- (November) Received 3 certificates of accreditation

The TeamThe Team

CPA AssessmentCPA Assessment-Pre Assessment £750, one day-Pre Assessment £750, one day-regional assessor-regional assessor-gap analysis-gap analysis-action plan-action plan-Full assessment booked (2 days, 3 assessors)-Full assessment booked (2 days, 3 assessors)

Overall Cost around £3000Overall Cost around £3000

What are CPA looking for?What are CPA looking for?► A safe, quality service with an appropriate A safe, quality service with an appropriate

governance structure governance structure ► Suitable resources for the size of the serviceSuitable resources for the size of the service► A multi-discipline approachA multi-discipline approach► User satisfactionUser satisfaction► Evidence to support an application for Evidence to support an application for

accreditationaccreditation► Positive impact on patient carePositive impact on patient care

Achieving ComplianceAchieving ComplianceEssential elements that must be in Essential elements that must be in

place-place-►An Effective Governance Group An Effective Governance Group ►QMSQMS►Governance StructureGovernance Structure►Controlled DocumentationControlled Documentation

Achieving ComplianceAchieving Compliance►Training and Competency AssessmentTraining and Competency Assessment►Evaluation/Validation of Equipment Evaluation/Validation of Equipment

and Results against Laband Results against Lab►Continuous AuditContinuous Audit►Management of Non-Conformance: Management of Non-Conformance:

Address any trendsAddress any trends►Quality AssuranceQuality Assurance

Evidence BasedEvidence BasedAnecdotal evidence does not countAnecdotal evidence does not count► Agendas and Minutes of meetingsAgendas and Minutes of meetings► A record of non-conformance resolutionA record of non-conformance resolution► Record IQC/EQA and monitorRecord IQC/EQA and monitor►Document Audit Findings (set up a calendar) Document Audit Findings (set up a calendar)

and corrective actionand corrective action

Evidence BasedEvidence Based

► Regularly review documentation and Regularly review documentation and processesprocesses

► Record assets and maintenanceRecord assets and maintenance► Periodic review of the service and AMR Periodic review of the service and AMR ►Database for training and competencyDatabase for training and competency

Evidence BasedEvidence BasedEffectiveness of the service must be Effectiveness of the service must be

gauged:gauged:► -clinical need-clinical need► -clinical effectiveness-clinical effectiveness► -cost effectiveness of the service-cost effectiveness of the service► -has the service delivered its objectives-has the service delivered its objectives

Report this in the AMR and review objectives Report this in the AMR and review objectives periodicallyperiodically

How To Deliver ThisHow To Deliver This

► POCT TeamPOCT Team► Resources, BudgetResources, Budget► POCT NetworkPOCT Network►Managerial and Managerial and

Clinical supportClinical support►Named ContactsNamed Contacts►MDLPMDLP

► Cascade TrainersCascade Trainers► Supplier Supplier

Trainers/AuditorsTrainers/Auditors►Medical TeamsMedical Teams►Nursing TeamsNursing Teams► Self Audit ToolsSelf Audit Tools► POCT ACB mail basePOCT ACB mail base

Think about the resources available in your hospitalThink about the resources available in your hospital

Do you need full Do you need full connectivity?connectivity?

► In my experience, No, In my experience, No, but it is preferredbut it is preferred

Connected:Connected:Blood GasBlood GasSome GlucoseSome GlucoseHaemoglobinHaemoglobin

Non-connected:Non-connected:Most glucoseMost glucoseBlood ketoneBlood ketoneUrinalysisUrinalysisUrine PregnancyUrine PregnancyINRINRESRESR(fFn)(fFn)

How did we meet the How did we meet the standards?standards?

►What does connectivity provide?What does connectivity provide?►Do results need to be backed up in a Do results need to be backed up in a

HIS/LIS?HIS/LIS?►Does it change the care the patient Does it change the care the patient

receives?receives?►Can you record data in a similar way Can you record data in a similar way

without software?without software?►Do you have time to monitor software?Do you have time to monitor software?

How did we meet the How did we meet the standards?standards?

Anticipate the questions you will be Anticipate the questions you will be asked about elements of your service.asked about elements of your service.

►Explain why you are doing it the way Explain why you are doing it the way you are!you are!

►Argue your caseArgue your case►Get your lab quality manager on your Get your lab quality manager on your

sideside►Stick to your gunsStick to your guns

PreparePrepareI wrote many documents prior to the I wrote many documents prior to the main visit:main visit:I anticipated being asked why we were doing things I anticipated being asked why we were doing things that way!that way!

POCT Quality Manual (separate to the lab QM)POCT Quality Manual (separate to the lab QM)POCT Control of Reagents and ConsumablesPOCT Control of Reagents and ConsumablesPOCT Sample HandlingPOCT Sample HandlingPOCT Quality Control PolicyPOCT Quality Control PolicyPOCT Patient Result ReportingPOCT Patient Result ReportingPOCT ConnectivityPOCT ConnectivityPOCT Test Lot Verification ProcedurePOCT Test Lot Verification Procedure

OutcomeOutcome►We had 19 non-conformances, all minor, We had 19 non-conformances, all minor,

across 3 sections:across 3 sections: Hospital Based WardsHospital Based Wards Hospital Based ClinicsHospital Based Clinics External ClinicsExternal ClinicsIf you have the same non-conformance in each section it counts If you have the same non-conformance in each section it counts

as 3!as 3!

90 days from inspection to clear non-conformances. 90 days from inspection to clear non-conformances. They were cleared in 6-7 weeks.They were cleared in 6-7 weeks.We aim to get 0 non-conformances next time! Haha…We aim to get 0 non-conformances next time! Haha…

Thanks for listeningThanks for listening►Questions?Questions?