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

2. vaStatStrip® Seminars 2010vaStatStrip® Seminars 2010 Ops Manager POCTPhlebotomyEndocrinologyDiabetes Physicians Assistants Immunology Clinical Haematology

3. 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?

4. 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.”

5. 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

6. 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

7. 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

8. 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.”

9. 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

10. POCT - Locations and Staff Groups wards Out patients GP surgery A&E Off Site Pharmacy Other Hospitals Consultants SpR SHO HO Medical students Nurses Midwives HCAs ODPs PAs Lab staff Resp Techs Anaesthetist s COPD nurses Student nurses Pharmacists Practice staff Out Reach

11. 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

12. 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 (?)

13. 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

14. POCT for STIs Ideal POCT for STI –Immediate diagnosis and treatment in a single visit –Address some of STI control needs

15. POCT for STIs Barriers –Complexity –Time –multiple time driven steps –Difficulty reading results –Interruption of workflow –Unreliability –Invasiveness

16. 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.

17. 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

18. 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

19. STI’s- –chlamydia, –gonorrhea, –syphilis, –HIV Current examples of POCT for STIs

20. Future POCT for STIs BioMEMS –Microfluidics allowing miniaturisation of complex reaction processes PCR –Smaller equipment & sample size –Faster processing

21. 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

22. 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

23. Thank you