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Point-of-Care Testing (POCT): Role in patient care. Dr. Imran Siddiqui Associate Professor Department of Pathology & Microbiology The Aga Khan University. OUTLINE. POCT Defined POCT: Views POCT: Current Changes POCT vs. Laboratory Testing The Laboratory Role POCT Program Management
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Point-of-Care Testing (POCT):Role in patient care Dr. Imran Siddiqui Associate Professor Department of Pathology & Microbiology The Aga Khan University
OUTLINE • POCT Defined • POCT: Views • POCT: Current Changes • POCT vs. Laboratory Testing • The Laboratory Role • POCT Program Management • Conclusion • Resources
POCT Defined “Point-of-Care Testing (POCT) is defined as “Laboratory Tests”designed to be used at or near the site where the patient is located, that do not require permanent dedicated space, and that are performed outside the physical facilities of the Clinical Laboratories.” Collage of American Pathologists (CAP)
POCT: Views • Supplementary to Central Laboratory testing • Second tier testing • Unmanageable • Potentially disruptive competitor to Central Lab services • An added responsibility http://www.cap.org
POCT: Current Changes • Attitude of POCT as an inferior testing changing • One of the fastest growing • 10 -12% per year vs. 6 -7 % for central lab tests http://www.mtic.dk/files/Pdf/Market_Perspectives_Diagnostics_Industry_Arhus_20JAN10_Redac.pdf
POCT: Current Changes • POCT: part of the clinical laboratory services • Comparability with Central Laboratory testing is mandated • Efficacy must be always evaluated
POCT vs. Laboratory Testing • Turn-Around-Time (TAT) Critical need for information & Monitoring vs. Accuracy & Initial Diagnosis • Cost Higher cost per test vs. Overall cost • Errors Non Lab Personal as Increased pre-analytical factors • Clinical Outcome & Efficacy
Laboratory Role in POCT: The Dilemma End User – Non Lab Personnel • Who performs the test? End-user • Who performs the QC? End-user • Who maintains the instrument? End-user • Who performs the PT? End-user • Who is Fundamentally Responsible for POCT program? LABORATORY !!!
Laboratory Role in POCT • The Clinical Laboratory responsibility lies in: • Method and Instrument Selection, Validation, and Installation • End-user initial training • User Competency • QC monitoring • PT monitoring • Accreditation and Regulatory compliance http://www.cap.org
POCT Management Tips • Lab lead Multi-Disciplinary Team • Lab, Nursing, Physicians, IT, Biomed, others • Assign a POCT coordinator • A team leader, oversees QA of the program, Program Control • Identify current practice • Who has what and who uses what?! • Practice Control • Enforcement
POCT System Considerations • Accuracy & Precession • Control • Consolidation • Integration & Connectivity • Data Management • User friendly • Durability • Cost & Support • Efficacy
Necessary Tools • Policies and Procedures • QC Program • Quality Management Plan • Training and Compliance Documentation • PT • Accreditation & Regulatory Compliance
NO YES NO NO YES NO NO NO
Multi-disciplinary Team Team Leader: Head of POCT Program Project Coordinator: POCT Coordinator Team Members: Nursing Biomedical Engineer IT Representative QA Coordinator POCT program specialist (Vendor)
Implemented Actions & Success • Regulations for the frequency of running QC • Continuous educational activities for best practices of QC • Continuous communication and update with end-users
Conclusion • POCT is to decrease TAT & improve clinical outcome • Clinical needs must be identified before POCT is implemented • POCT is not to be used as a diagnostic tool, but in conjunction with main lab • POCT is mostly considered waived but it is still regulated • Multi-disciplinary but lead and monitored by Clinical Laboratory
Conclusion • Proper selection of POCT system is a key to success • Costly, inefficient and ineffective, if not well managed • Manageable with good communication and leadership • Proper management of POCT guarantees quality service and improved patient out-come
Resources for Information About POCT • http://www.cap.org • http://www.clsi.org • http://www.pointofcare.net • http://www.aacc.org