1. Point of Care Testing - CLSI

2. Quality practices for better health. Our Vision Free Wind 2014 / Shutterstock.com

3. Develop clinical and laboratory practices and promote their use worldwide. Our Mission

4. 4 Global Activities — WHO CLSI is the only designated collaborating center for clinical laboratory standards development.

5. 5 ISO TC212 International Organization for Standardization (ISO) CLSI is the ANSI appointed secretariat for ISO Technical Committee 212, “Clinical laboratory testing and in vitro diagnostic test systems” and its working groups: CLSI is administrator of the ANSI-Accredited US Technical Advisory Group (TAG) to ISO/TC 212. WG 1: Quality and competence in the medical laboratory. WG 2: Reference systems WG 3: In vitro diagnostic products WG 4: Antimicrobial susceptibility testing WG 5: Laboratory Biorisk Management

6. 6 Relationship of CLSI and ISO Standards Broad, standard requirements Detailed help and practical guidance Complimentary, not conflicting, roles

7. “Laboratory testing performed outside of clinical laboratory” OR “Clinical laboratory testing conducted close to the site of the patient care” POCT Definition

8. Emergency diagnosis Treatment/monitoring Clinics Doctors’ office testing (POL) Self or home testing Bed side Operating theatres Applications of POCT

9. Faster TAT Small sample size Reduced pre-examination errors Eliminate or minimize preparation steps Improved patient satisfaction Faster decision making and follow-up with patient Better management of therapy Convenience Advantages of POCT

10. Cost Training/competency Concerns about inaccuracy, imprecision, performance Education/experience level of testing personnel Competing priorities of testing personnel Compliance to requirements Documentation of requirements Quality assurance more challenging Disadvantages of POCT

11. Expectations of the program Clinical justification Who has oversight Who will perform the testing Training and competency evaluation Proficiency testing Considerations for Developing and Maintaining a POCT Program

12. Organizational Structure Review of quality control Quality assurance Infrastructure Cost to the patient Result reporting Documentation Considerations for Developing and Maintaining a POCT Program

13. POCT is rapidly growing Components of successful program include proper organizational structure, POC device selection and implementation, training, competency, QC, QA Connectivity integral for documentation and oversight Proper quality and compliance critical for patient care and patient safety In Conclusion

14. Questions?