Point of Care testing (POCT)

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• Point of Care testing (POCT)
• For
• Sexually Transmitted Infections (STI)
• Barbara Bewley
• Operations Manager
• Pathology Clinical Services

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Pathology Clinical Services
vaStatStrip Seminars 2010
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POCT for STIs

• What is POCT?
• Who oversees POCT?
• Governance
• Who performs POCT?
• Hands on staff
• Why POCT?
• Benefits
• Why POCT for STIs?
• Benefits
• What is available?

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POCT - Definition
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.
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POCT Guidelines and Standards

• Management and Use of IVD Point of Care Test
  Devices
• March 2003 DB2002(03)
• Pre POCT implementation - Lab involvement
• Clinical need
• Equipment choice
• Business Case
• Clinical Governance
• Pros and Cons

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POCT Guidelines and Standards

• DB2002(03)
• Management and Organisation
• Accountiblity
• SOPs, Training, Health and Safety
• QA (inc QC, EQA)
• Maintenance, Record Keeping
• IT
• Adverse Incidents

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POCT Guidelines and Standards

• DB2010(02) February 2010
• More expansive
• Locations
• Wider variety of hospital and community areas
• Range of test examples
• References Strategic Government Papers
• Use of Case studies
• Illustrates poor practice
• Specific key learning points

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POCT Guidelines and Standards

• Ultimate responsibility

The laboratory, or the parent organization of
which it is a part, shall ultimately be
responsible for ensuring that appropriate
measures, including internal quality control
and participation in EQA schemes, are in place to
monitor the accuracy and quality of POCT
conducted within the healthcare organization.
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POCT Management

• Team
• Senior Biomedical Scientist Band 7
• Biomedical Scientist Band 6
• Associate Practitioners x 3 Band 4
• Administrative Assistant
• Multidisciplinary
• Trust Policies
• Procurement control

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POCT - Locations and Staff Groups
AE
Off Site
Consultants
Nurses
Anaesthetists
Out patients
wards
SpR
Midwives
HCAs
Other Hospitals
ODPs
SHO HO
Student nurses
PAs
Resp Techs
Pharmacy
Medical students
GP surgery
Pharmacists
COPD nurses
Lab staff
Practice staff
Out Reach
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POCT Why?

• Turn Around Time (TAT) for results
• Analysis time
• Reporting time
• Transport
• Benefits
• Rapid changes to care and medication
• AE 4 hour target
• Prevent unnecessary cancellation of appointments
• Captures hard to reach clients

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Quality Point of Care Testing

• Right result for
• Right investigation on
• Right specimen from
• Right patient at
• Right time in
• Right place using
• Right reference data at
• Right cost (?)

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POCT for STIs

• USA (2010)
• 30 STI organisms in lead group of reportable
  diseases
• gt19 million new cases per year
• Cost of 9.3 15.5 million dollars
• Lab TAT 2 14 days
• Contributed to low pt return rates
• Re infection of presenting patients
• On going transmission of infection

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POCT for STIs

• Ideal POCT for STI
• Immediate diagnosis and treatment in a single
  visit
• Address some of STI control needs

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POCT for STIs

• Barriers
• Complexity
• Time
• multiple time driven steps
• Difficulty reading results
• Interruption of workflow
• Unreliability
• Invasiveness

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POCT for STIs

• The WHO Sexually Transmitted Diseases Diagnostic
  Initiative coined the term ASSURED to define the
  criteria for a POCT for STIs in a resource
  limited setting.

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ASSURED WHO Criteria

• Affordable
• Sensitive
• Specific
• User friendly
• Rapid Robust
• Equipment free
• Delivered
• An ASSURED test that is less sensitive than a lab
  test might result in more infected people
  receiving treatment

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POCT for STIs

• Applicable to other settings
• Access and confidentiality
• Community based services
• Improve low return rates for results
• Reduction in mental stress for returners
• Transient populations
• Hard to reach communities

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Current examples of POCT for STIs

• STIs-
• chlamydia,
• gonorrhea,
• syphilis,
• HIV

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Future POCT for STIs

• BioMEMS
• Microfluidics allowing miniaturisation of complex
  reaction processes
• PCR
• Smaller equipment sample size
• Faster processing

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POCT for STIs

• What is POCT?
• defined
• Who oversees POCT?
• POC team/appropriate lab
• Who performs POCT?
• Clinical staff
• Why POCT?
• TAT, quicker changes to care/ medication
• improved patient care
• Reduction in cancelled appointments

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POCT for STIs

• Why POCT for STIs?
• Effectively treat more people with STIs
• Single visit diagnosis and treatment initiation
• Infection control strategy risk reduction
• What is available?
• Increasing number of manufacturers
• Increasing range of products
• Remember the WHO ASSURED criteria
• Not lab quality but must meet minimum criteria

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• Thank you