Point of Care Testing

Quality Assurance, Accreditation

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3 MAY 2012

4.3cm x 5.5cm

Ng Wai Yoong, PhD CSciSnr Principal Scientific Officer

Pathology

outline

background quality indicatorsaccreditation

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Point-of-care testing (POCT)as we know today

this is modern terminology

but as early as in ancient Egypt, urine testing practised

Bedside testing

Near-patient testing

2012-may33

practices in the hospital are under

strict regulatory requirements;

different from self-testing environment

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Challenges of POCT in the healthcare institution

Dispersed test sites; large campus

Large operators/users base

Compliance issues

Monitoring effectiveness

Diverse job scopes – nurses, pharmacists, therapists, doctors

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need affirmative action – particularly in accreditation exercises

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Singapore General Hospitalfacts and figures

Oldest, largest tertiary acute hospital in Singapore

42 hectares of campus grounds

34 wards serving 29 clinical departments

18 medical specialist centres

18 specialist outpatient clinics

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figures from annual report -2010

1590-beds

in 2010 – 74,779 inpatient admissions

698,689 outpatient attendances

144,973 A&E attendances

80,797 surgical operations

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Singapore General Hospitalpathology’s induction

Pathology Department

already CAP-accredited (College of American Pathologists)

recognition of highest standards in clinical laboratory analysis

given role to provide oversight of all POCT activities

needed to ensure JCI standards are met

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needed to ensure JCI standards are met

background work sought

survey present situation

committee met to deliberate action plans

(nursing, pathology)

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at the Hospital

blood glucose in wards, outpatient clinics, specialist centres

blood gases in surgical, medical, neonatal ICUs

in emergency

urinalysis in wards

survey data showed..

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urinalysis in wards

urine preg.tests in specialist wards, emergency

h.pylori test in specialist centre

fast troponin test in specialist wards, emergency

fetal blood pH in labour ward

activated.clotting in specialist centres

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quality indicators

quality

quality

Quality indicatorsiqc eqa

Quality Assurance

is about activities or processes that are undertaken to ensure

test results obtained are reliable and comparable to that

determined in the central laboratory

Hence, expectations of standards would mirror laboratory

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Hence, expectations of standards would mirror laboratory

standards

QC practices should take the cue from the laboratory

quality

Quality indicatorsiqc eqa

IQCs? regular testing for quality assurance

right QC material? with vendor’s recommendation

frequency? daily or weekly

EQAs? what needs to be included

frequency? annual or more frequent needed

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User training and competency

Regular equipment service and maintenance

Implementation issues who should do it

record keeping

corrective action log

Implementation issues no two devices the same IQCs – liquid QCs,

‘dry’ electronic QCs, no QCs available?

starting principles – ask for vendor’s

recommendations

expect to be the same as

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Quality indicatorsiqc eqa

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expect to be the same as

central laboratory’s performance?

POCT may less stringent;

take into account, user’s technical level

look at industry standards

may need to tailor measures to local conditions

POCT devices…

simple to implement and control

little to troubleshoot with simple devices

typically classified as ‘waived’ test by US FDA indicates that device is

quality

Quality indicatorsiqc eqa

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typically classified as ‘waived’ test by US FDA indicates that device is

unlikely to ‘fail’ when tested by non-laboratory persons

eg. glucose, urine dipsticks

‘moderate complexity’ means more stringent QC requirements are required

eg. blood gas instruments, clotting time instruments

POCT devices…

US FDA complexity criteria (CLIA ‘88) : quality specifications

. knowledge

. training and experience

. reagents and materials preparation

quality

Quality indicatorsiqc eqa

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. reagents and materials preparation

. operation steps

. calibration, quality control and PT materials

. test system troubleshooting and equipment maintenance

. interpretation and judgement

POCT devices…

Situations requiring QC checks apart from regular ones

. Change of reagent lot#, consumables lot#

. New delivery lot#

. User requires it as additional check

quality

Quality indicatorsiqc eqa

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. User requires it as additional check

. User feels POCT result does not fit clinical picture

. Substantial service/maintenance done

. Device had suffered a knock, some mishandling

. Calibration just carried out

if EQA is needed…

for the user

peer comparison

reminder of quality compliance

assurance of oversight

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Quality indicatorsiqc eqa

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for the POCT coordinator

overview of performance

communication ties with users

presence of oversight compliance

consistent with industry standards/guidelines

if EQA is needed…

However there are also other considerations..

many instruments

logistics in implementation

criteria of acceptable limits to be decided if in-house/local EQA

costs involved

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Quality indicatorsiqc eqa

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costs involved

Look at industry standards

Look for achievable standards

Look at what’s necessary

Blood glucose weekly QC minimum daily (good)

EQA needed

Blood gases daily QC every 8hr (good)

EQA needed

Urine dipsticks weekly QC

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Quality indicatorsiqc eqa

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Urine dipsticks weekly QC

EQA good

Pregnancy screen typically factory specs

EQA good

additional points to note

Do not use expired reagents, kits, cartridges

Keep QC records for at least 2 years, including corrective actions

QC records should be signed by user and reviewed by supervisor

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Quality indicatorsiqc eqa

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SOPs must be reviewed annually or set period as stipulated

Date opened or in-use for reagents, kits, cartridges

Typically for blood glucose QC controls, both open and expiry dates

are written on the bottle

Service / PM records

final decisions made

minimum IQC - as manufacturer recommendations

- guided by industry standard

- guided by local governance

- guided by improving performance in later stages

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Quality indicatorsiqc eqa

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EQA - select important POCT that needs EQA

- guided by industry standards

- logistics issues

at the Hospital

further work required

need POCT policy to be drawn up / approval for circulation

implement audits

recommend document control, QC records to date

implement regular instrument maintenance schedule

implement external quality assessment

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implement external quality assessment

(blood glucose/gases)

ready for external audit/inspection

accreditation

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What do inspections look for?

Compliance to SOPs

Compliance of oversight

At management level: policy, SOPs, formation of key people

Accreditationmonitor to improve

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At test site level: IQCs, SOPs, training records, patient safety measures

At POCT oversight level: evidence of oversight, training checklist

operations eg. EQA, audits

Meeting the inspectors

. Records audits

. Data EQA performance, Inventory checks

. Review Improvements made

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Accreditationmonitor to improve

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. Cross-checks are typically verified at ward level

. User competency list; checklist

. User interviews on practices, policy

. Annual competency records

. Evidence of services done

. PM stickers / records audit

. Expiry dates of reagents, kits, cartridges

. Storage conditions

blood glucose performance – split-sampling

feedback to users

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Accreditationmonitor to improve

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Accreditationmonitor to improve

“When used appropriately, POCT can improve patient outcome by providing a faster result and a shorter time frame to therapeutic intervention”.*

“When over utilized or incorrectly performed, POCT presents a patient risk”.*

POCT should benefit the patient through the provision of results

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POCT should benefit the patient through the provision of results that have the same quality and fitness-for-purpose as those coming from the central laboratory

*National Academy of Clinical Biochemistry(NACB) —Laboratory Medicine Practice Guideline on Evidence-based Practice for Point-of-

Care Testinghttp://www.arc.org/AACC/members/nacb/LMPG/OnlineGuide/PublishedGuidelines/poct/poctpdf.htm

ISO 22870:2006

Point-of-care testing (POCT) Requirements for quality

and competence

Resourceaccre

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CLSI Guidelines

POCT01-A2

Point-of-care connectivity

Framework for design, interface, communications, data sharing and lab

information systems

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Resource

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CLSI Guidelines

POCT02-A

Implementation guide of POCT01 for healthcare

providers

POCT04-A2

Point-of-care In Vitro Diagnostic (IVD) testingin preparation..

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Resource

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Point-of-care In Vitro Diagnostic (IVD) testing

POCT05-A

Performance metrics for continuous interstitial glucose

monitoring

in preparation..

POCT06-P method comparison

POCT07-P approach to reduce errors

POCT08-P noninstrumented testing

POCT09-P selection criteria

connectiv

ity

governance

compliance

buy-in

policy

Patient

Pre-Analytics

Analytics

Post-Analyticstesting cycletesting cycle

quality

practices

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connectivity

instruments

Acknowledgements

Emergency / Nursing Administration

Magdalene Chow RN, BHSN

Ng Siew Keng RN, BSc< single image >

4.3cm x 5.5cm

This presentation contains information which is confidential and/or legally privileged. No part of this presentation may be disseminated, distributed, copied, reproduced or relied upon without the expressed authorisation of SingHealth.

Ng Siew Keng RN, BSc

Dr Png Hong Hock RN, PhD

Pathology

Jayme Wong BSc, MSc, MACB

Dr Edward Jacob PhD, FRACP

Dr Yeo Chin Pin, MBBS, FAMS

Thank you

< single image >

4.3cm x 5.5cm

This presentation contains information which is confidential and/or legally privileged. No part of this presentation may be disseminated, distributed, copied, reproduced or relied upon without the expressed authorisation of SingHealth.