Point of Care testing (POCT) For Sexually Transmitted Infections (STI) Barbara Bewley Operations...
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Point of Care testing (POCT)For
Sexually Transmitted Infections (STI)
Barbara BewleyOperations ManagerPathology Clinical Services
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Pathology Clinical Services
ClinicalHaematology
Immunology
PhysiciansAssistants Diabetes
Endocrinology
Phlebotomy
POCT
OpsManager
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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 bya healthcare professional outside theconventional laboratory.”
“…testing that is performed near or at the siteof the patient with the result leading to possiblechange 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– Pro’s and Con’s
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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 parentorganization of which it is a part,shall ultimately be responsible forensuring that appropriate measures,including internal quality control andparticipation in EQA schemes, arein place to monitor the accuracy andquality of POCT conducted withinthe 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
wardsOut
patients
GPsurgery
A&EOff Site
Pharmacy
OtherHospitals
Consultants
SpR
SHOHO
Medicalstudents
Nurses
Midwives HCAsODPs
PAs
Lab staff
RespTechs
Anaesthetists
COPDnurses
Studentnurses
Pharmacists
PracticestaffOut
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– A&E 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– >19 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• DeliveredAn 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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• STI’s-– chlamydia, – gonorrhea, – syphilis, – HIV
Current examples of POCT for STIsCurrent examples of POCT for STIs
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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