Point of Care

Testing
Quality Assurance, Accreditation
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3 MAY 2012
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Ng Wai Yoong, PhD CSci
Snr Principal Scientific Officer
Pathology
outline
background
quality indicators
accreditation
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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-may3 3
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 Hospital
facts 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 Hospital
pathologys 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
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Quality indicators
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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
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Quality indicators
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IQCs? regular testing for quality assurance
right QC material? with vendors 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 vendors
recommendations
expect to be the same as
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expect to be the same as
central laboratorys performance?
POCT may less stringent;
take into account, users 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
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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
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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
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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 indicators
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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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costs involved
Look at industry standards
Look for achievable standards
Look at whats 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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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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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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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
Accreditation
monitor 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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Accreditation
monitor 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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Accreditation
monitor to improve
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Accreditation
monitor 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 Testing
http://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
Resource
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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) testing
in 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
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governance
compliance
buy-in
policy
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testing cycle testing 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.