Transcript Slide 1

Accreditation of Point of Care TestingNHS Lanarkshire action plan
Jacqueline McGuire
Consultant Clinical Scientist
Elaine Kennedy
POCT co-ordinator
Alison Campbell
Quality Manager
• Overview of NHS Lanarkshire POCT
service
• Update you on the CPA POCT
standards
• Describe our action plan
• Company solutions
3 acute hospitals
1607 beds
POCT in NHSL - a challenge!
• POCT has developed on each site
independently. Supported by the laboratory
in the majority of cases. Unfunded.
• POCT Policy - draft stage, awaiting
approval
• Many clinical services are unaware of the
consequences of POCT and try to initiate
new tests without the support or guidance
of the laboratory
Shift to community centred Health Care
• Devolution of control to primary care
– greater emphasis on the prediction and
prevention of disease
– people are requiring further control over their
own healthcare.
• More alternatives to centralised testing
– automation and portable technologies have
increasingly made diverse tests available at
the point of care.
– Exponential increase in the number of POC
tests conducted, the array of analytes and
available locations for testing in coming
years
POCT Tests in NHSL
(acute & primary care)
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Glucose meters
Blood Gases
Pregnancy testing
Urinalysis (including analysers)
Cholesterol testing
INR testing
HIV testing
Not all with the support of the laboratory
Total cost 2009-10 £309,179 (lab supported)
Staffing (Biochemistry)
• Lead by a Consultant Clinical Scientist
• BMS2 POCT co-ordinator.
Role: Organising training, reporting,
troubleshooting, EQA, IQA, SOPs, liaising
with users, quality co-ordinator etc
• BMS1/2 performing routine POCT functions
on each site eg maintenance, troubleshooting
• Increasing pressure on all labs to support
POCT.
Quality Management – 2009/10
• Subject to the same document control
system as the laboratory
• Record CAPAs, Datix etc
• Perform regular audits
• Staff training & initial competence testing
recorded, limited competence testing
thereafter.
• Participate in the laboratory annual review.
• Have quality objectives and plans set
annually.
Blood Gas analysers
• 8 Siemens 1200 series POCT
analysers, 6 laboratory analysers
• AE, ICU, SCBU, Labour ward
• Linked to LIMS via RapidComm 3
• Significant time resource required for
maintenance and troubleshooting
• 33,000 samples
• 770 users
Glucose
• Acute
– 194 Abbott Xceed Pro connected meters
– 3007 trained operators (797 retired
operators)
– 380,752 patient tests
– WEQAS EQA (bi-monthly)
• Primary Care
– 550 Bayer hand held meters
– Risen by 100 meters in last year
– 779 staff have been trained
– Frimley Park EQA (monthly)
Urinalysis
Siemens CLINITEK Status
• Pregnancy tests – 5 locations
• Laboratory = 11,386
• POCT =
7,000
– Numbers increasing 10% per yr
– eg Dermatology, Day surgery, AE
• Urinalysis – 5 locations
RSV Testing
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4611 tests
Winter period
Paediatric wards
Staff re-trained every year
Additional standards for POCT
facilities – CPA (UK) Ltd, V1.01
• Required to register your intent to have POCT
accredited by 31ST Dec
• Based on ISO 22870:2006 (POCTRequirements for quality and competence).
– Require to purchase these standards
• Should also meet the CPA’s standards for the
Medical Laboratory (incorporates ISO
15189:2007)
Definition of POCT
“… any analytical test performed for a
patient by a healthcare professional
outside the conventional laboratory.”
“…testing that is performed near or
at the site of the patient with the
result leading to possible change in
the care of the patient.”
Definition of POCT
• Department of Health, 2009
“… any diagnostic test performed on a person
by a competent individual, where a result that
can be interpreted is provided before the
person leaves.”
NHSL POCT accreditation
• Intention to register Acute site only – from 1
base with 2 satellite services
• Glucose
• Blood Gases
• Pregnancy testing
• RSV
• Urinalysis – meters only
• Will not be applying for community Glucose
accreditation – initially
• ?? INR
Ultimate responsibility
“The governing body of the organization
shall be ultimately responsible for
ensuring appropriate measures are in
place to monitor the accuracy and
quality of POCT conducted within the
healthcare organization”
Practical management
Laboratory
A Organisation & Quality Management System
A1 Organisation & Management
• A 1.6 (POCT)
Laboratory management shall ensure that POCT is
organized and operates in conformity with these
Additional Standards and the CPA (UK) Ltd “Standards
for the Medical Laboratory”
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• A 1.7 (POCT)
Top management of the organisation within which POCT
is provided, shall ensure that there are procedures in
place to monitor the quality of the service.
A1 Organisation & Management
A 1.8 (POCT)
The organisation within which POCT is provided, shall
ensure that there is a healthcare professional grouping
(e.g. a governance group) responsible to its top
management for defining the scope of POCT. The
scope of POCT shall take into account:
a) the clinical need
b) its financial implications
c) technical feasibility and
d) the resources available.
NHSL Acute Clinical Governance Committee
A1 Organisation & Management
• A 1.9 (POCT) The laboratory director or designee, in
conjunction with organisation management, shall appoint
a multidisciplinary POCT management group to advise
on the management and provision of POCT. The group
shall ensure that:
a) the responsibilities, authority and interrelationships of
all personnel involved in POCT are specified and
communicated within the organization
• Responsibilities and relationships details in POCT policy
and service level agreements (new).
• Job descriptions for Clinical director and Clinical Lead
already have POCT included.
NHSL POCT
Organisational
Structure
Lab Clinical
Director
Convenor
Acute
Clinical
Governance
Committee
POCT Committee
POCT Committee
Lab Quality
Manager
Wards
POCT Co-ordinator
& Quality Coordinator
ICU, AE
Clinics
NHSL POCT Committee
Terms of Reference
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The composition shall include stakeholder representatives
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from the supporting laboratory services (POCT /
Quality co-ordinators)
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and from the key clinical users (Diabetes, A&E,
Anaesthetics/ ITU, Obstetrics, Neonatology,
Theatres).
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Key link personnel will be co-opted as required from
Pharmacy, Infection Control, Procurement and
Information Technology.
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Where deemed necessary, the POCT committee will
establish sub-groups to deal with policy development and
monitoring of specific POCT processes (eg blood glucose
monitoring) working with other groups as appropriate.
A1 Organisation & Management
b) staff performing POCT receive appropriate
training, supervision and competence
testing.
• Training
• Supervision – built into POCT policy, SOPs
and service level agreements.
• Competence testing
A1 Organisation & Management
c) all proposals to introduce any product, device, or system for
POCT are evaluated for their clinical effectiveness and cost
efficiency the selection of POCT devices and systems
includes their practicability and the comparability of their
results with those obtained in the laboratory.
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Business Case:
– capital cost of the equipment
– the revenue costs of consumables
– the cost of Quality Assessment material and scheme
registration
– repair and maintenance costs
– details of staff costs to perform the test and the
availability of laboratory and other staff to support the
facility on site or the cost of provision of additional staff
to provide this support.
May include published evaluation reports or evaluation
performed locally
A1 Organisation & Management
d) the selection of POCT devices and systems
includes their practicability and the
comparability of their results with those
obtained in the laboratory.
Comparability:
• Gases & Pregnancy Tests – all analysers
evaluated prior to install
• Glucose – capillary v plasma
• Urinalysis - Not run in the lab
Selection of equipment
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Diagnostic capability
Rule in or rule out
Technical Validation
Underpinning performance
Concordance with laboratory
Location of equipment
Power
Water
Drainage
Space
IT infrastructure
A1 Organisation & Management
e) the reports of the POCT quality
assurance programme(s) are reviewed by
the group and advice on improvement is
provided and implemented.
• Registered all POCT with an EQA scheme.
Results will be reviewed by the Committee
and local QA meetings. CAPA’s logged.
• The Committee has the power to stop any
POCT service if required.
A2 Needs and Requirements of
Users
• A 2.5 (POCT) Where the laboratory
provides POCT to another healthcare
organization, (a separate (legal) entity), and
uses resources, including staff, provided by
that organisation, the ultimate responsibility
for the examination results/reports shall be
defined in a formal agreement (see A 2.4).
• Not applicable
A4 Quality management system
• A 4.4 (POCT) Laboratory management shall establish a
quality management system for POCT.
• Included POCT in the Quality Policy and added the
quality co-ordinator to the Quality Manual.
• Already included POCT under lab document control
procedures.
• Added it to the laboratory annual review documentation.
• Require to increase auditing of the service
A7 Quality manager
• A 7.4 (POCT) Laboratory management
shall appoint an individual with defined
responsibility for ensuring that the POCT
quality management system is implemented
and maintained.
Already in the Quality Managers job
description
A8 Document control
• A 8.4 (POCT)
Manuals and instructions for use of POCT shall
be subject to document control and readily
available to users.
• Documentation on QP5
• Available to users on local intranet.
• Limited instructions printed for Glucose
Analysers
• Full instructions printed for other services
• Watermark ‘Uncontrolled when printed’
A11 Management review
A 11.4 (POCT)
Laboratory management shall conduct
an annual review of POCT. The review
shall include:
a) the clinical need for POCT
b) the clinical effectiveness of POCT
c) the cost effectiveness of POCT
• Included in Annual Review Documentation
• Identify areas for improvement (Quality Improvement &
Plans)
B PERSONNEL
B1 Laboratory Director
• B 1.6 (POCT) The laboratory director or designee shall
appoint a multidisciplinary POCT management group
(A 1.9)
• B 1.7 (POCT) The laboratory director or designee shall
implement a periodic management review that
includes an ongoing evaluation of the clinical
effectiveness and cost efficiency of POCT activities
provided and identifies opportunities for improvement.
• POCT already in Laboratory Director and Clinical Lead
job descriptions
B2 Staffing
• B 2.4 (POCT) The POCT management group
shall ensure that there are appropriate numbers
of staff to implement the POCT Quality
Management system and provide training to
personnel performing POCT.
• Staffing – will require significantly more time for
lab staff to be involved in POCT
• Ensure all staff trained in Quality Management /
audit (include MLAs)
• Ensure training programmes in place for POCT
B6 Staff records
• B 6.3 (POCT) The POCT management
group shall designate staff performing
POCT and maintain a record of their
competency.
• Maintaining Competency – DIFFICULT!
B9 Staff training and education
• B 9.7 (POCT) The POCT training programme shall,
as appropriate, include the following:
a) the context and clinical utility of POCT
b) the theoretical aspects of the measuring system
c) sample collection and handling
d) reagent storage
e) quality control
f) infection control
g) limitations of the measuring systems
h) response to results outside predefined limits
i) documentation and reporting of results
POCT training programme
• Checked all SOPs, COSHH, training logs
and company provided training materials to
ensure all areas covered.
• May require to add to company provided
training.
• Regular training already provided. Training
schedules on the intranet site.
• Use the company provided training as much
as possible!
B9 Staff training and education
• B 9.8 (POCT) Competency to perform POCT tasks
shall be assessed following training and periodically
thereafter. Retraining and reassessment shall occur
when necessary. Records of competency
assessments shall be kept (B6).
• All initial training includes a competence
assessment
• Thereafter - partial compliance
• Risk assessed each POCT service to identify level
of competence assessment required
Blood Glucose – competence & audit
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Require ‘good low and high IQC’ once every 12 months
(post training) and users sent for re-training if their
registration expires.
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Have sent staff for retraining resulting from
– CAPA incidents
– EQA assessment
– Results of audits
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Auditing – assess glucose meters stations – annually (MLA)
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Now require:
– random examination audits (1 per hospital per year)
– Vertical (1 per year)
– Horizontal (1 per year for POCT service– additional stds
only)
Blood Gases – competence & audit
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No electronic way of re-assessing competence.
Automatic IQA and lab staff performing EQA
CAPA incidents - could send staff for re-training
Now require
– 1 examination audit to be performed for each
analyser per yr (8 audits). Bolt on 3 hours of
competence assessments.
– Remove staff from server who have not tested for >
1year.
– 1 vertical audit
Pregnancy test – competence & audit
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No electronic way of re-assessing competence.
Automatic IQC on cassettes
Can send staff for retraining resulting from
– CAPA incidents
– EQA assessment
– Results of audits
Now require
– examination audit to be performed for each analyser per
yr (5 audits) plus 3 hrs of competence assessments
– 1 vertical audit
– Connectivity - could remove users who have not used
the device >1yr
E-learning /Competence Assessment
• However:
– Integration with hospital system
– Time allowed to complete
– Need to integrate results into the data
management system
• IL GEM Blood Gas analysers
• Nova Statstrip Glucose meters
C PREMISES AND ENVIRONMENT
C 1.5 (POCT) The healthcare organization
shall ensure the premises within which the
POCT is performed, provide a working
environment in which staff can undertake
required functions in accordance with
national legislation and guidelines.
• Generally comply but can be difficult to
control eg storage facilities, if reagents are
stored at ambient temperature is this
monitored
D EQUIPMENT, INFORMATION
SYSTEMS AND MATERIALS
• Make sure all POCT equipment in the
equipment inventory
• Record all maintenance, engineer visits etc
as you would for a lab equipment – raise a
CAPA
• Ensure back-up of connected data systems
• Inventory management (difficult for glucose
meters)
E PRE EXAMINATION PROCESS
• E3 Specimen collection and handling
• E 3.4 (POCT) Where a POCT sample may
be unsuitable for analysis there shall be
procedures to report this to the POCT user
and records shall be maintained.
• SAN notices (actions recorded)
• Communication: Letters to users via
contacts, newsheets etc
• Change to SOP
F EXAMINATION PROCESS
• F3 Ensuring the quality of
examinations
F 3.6 (POCT)
Where results are obtained by POCT
and the laboratory, the comparability
between the methods used shall be
determined and made available to
users upon request
G THE POST EXAMINATION PHASE
G2 The report
• G 2.6 (POCT) Results of POCT shall
be recorded in the patient’s medical
record and be distinguishable from
results provided by the laboratory. A
record shall be kept of the person
performing the POCT.
G2 The report
• Issues:
– Manual Tests – provide log books for
reagent logs etc and instruct staff to
transcribe results into notes
– Often operator information is missing
– Thermal Paper
– Patient identification
Connected glucose meters &
blood Gases
• All information available on server.
• Test results, IQC, EQA results, operator ID, time/date,
reagent lot numbers.
• Can extract IQC for analysis
• Glucose – record competence
• Nurses transcribe glucose results to notes and print
out of gas results entered into patient notes.
• Stock control!
• Future – results to PMS, identified as POCT glucose
and POCT user recorded.
Pregnancy & Urinalysis Testing
• Currently unconnected but user access via
barcode.
• IQC lot of hCG cassettes through pharmacy
• Manual log book
– Stock Control – new!
– IQC results (urinalysis)
– test results
– Records user
– Lot numbers
– Date / time
• Future : To connect all Clinitek Status
analysers to RapidComm.
H EVALUATION AND QUALITY
ASSURANCE
H5 External quality assessment
H 5.5 (POCT)
There shall be participation in external quality
assessment schemes. Where such a scheme
is not available an alternative internal quality
assessment scheme shall be implemented *
• *This may involve circulation of a sample to
multiple POCT analysers and comparison of
results.
Problems!!!
• User identification – using others barcodes
• Patient identification
– ‘emergency barcodes’ overuse
– Using there own barcode
– Wrong patients
• Transcription errors- unknown!
• Reagent storage and stock control
• Personnel Management – will they ask
nursing staff if they have had an AJR??
Competence assessments
• Do we have the man power to
comply?
• Will a random selection assessment
be adequate?
• Medical staff and competence!!!
Solutions
• Connected POCT – where ever
possible!
• On-line competence testing.
• Barcode users ID and patient ID
• Buy in from Board Level, Patient
Safety and Nursing Education and
Training
• Treat POCT as you would a lab test
Guidance and Stds for POCT – some examples
1996 Near Patient Testing - A Statement of Best
Practice for Scotland. Scottish Office, Department
of Health; National Advisory Committee for Scientific
Services .
2002 Medicines and Healthcare products Regulatory
Agency (MHRA). Management and use of in vitro
diagnostic devices for point of care testing
2006 ISO 22870:2006 Point-of-care testing (POCT)
Requirements for quality and competence
2007
Safe, Accurate and Effective: An Action Plan for
Healthcare Science in NHS Scotland. The Scottish
Government
CLINITEK Status Connect System
Solution 2010:
CLINITEK Status Connect System
• Timing
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• Mis-reading of the strip
• Permanent record of the result
• Patient ID (lab no) - barcode
entry
• No transcription errors – direct
to LIMS through RAPIDComm
Addition benefits
• Increased patient results storage (950
compared with 200 on Clinitek Status
Classic)
• Operator ID storage / lockout (700)
• QC compliance - ability to set
reminders / lockouts
• Urinalysis - Strip integrity & sample
interference alerts, QC compliance
(reminder/ lockout)
Additional benefits of Status +
connected system
• Operator ID
– lock out untrained users (Send from
RAPIDComm)
– Re-validation
– Audit trail
• Reagent traceability
– Lot and expiry date entry for hCG
cassettes
• QC result storage
– QC testing (rather than running QC as a
patient) and storage of 200 QC results