PointofCare Testing POCT Role in patient care Dr

Point-of-Care Testing (POCT): Role in patient care Dr. Imran Siddiqui Associate Professor Department of Pathology & Microbiology The Aga Khan University 1

OUTLINE q POCT Defined q POCT: Views q POCT: Current Changes q POCT vs. Laboratory Testing q The Laboratory Role q POCT Program Management q Conclusion q Resources 2

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) 3

POCT: Views Ø Supplementary to Central Laboratory testing Ø Second tier testing Ø Unmanageable Ø Potentially disruptive competitor to Central Lab services Ø An added responsibility http: //www. cap. org 4

POCT: Current Changes Ø Attitude of POCT as an inferior testing changing Ø One of the fastest growing Ø 10 -12% per year vs. 6 -7 % for central lab tests http: //www. mtic. dk/files/Pdf/Market_Perspectives_Diagnostics_Industry_Arhus_20 JAN 10_Redac. pdf 5

POCT: Current Changes Ø POCT: part of the clinical laboratory services Ø Comparability with Central Laboratory testing is mandated Ø Efficacy must be always evaluated 6

POCT vs. Laboratory Testing 1. Turn-Around-Time (TAT) Critical need for information & Monitoring vs. Accuracy & Initial Diagnosis 2. Cost Higher cost per test vs. Overall cost 3. Errors Non Lab Personal as Increased pre-analytical factors 4. Clinical Outcome & Efficacy 7

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Laboratory Role in POCT: The Dilemma End User – Non Lab Personnel Ø Who performs the test? End-user Ø Who performs the QC? End-user Ø Who maintains the instrument? End-user Ø Who performs the PT? End-user Ø Who is Fundamentally Responsible for POCT program? LABORATORY !!! 11

Laboratory Role in POCT Ø 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 12

POCT Management 13

POCT Management Tips Ø Lab lead Multi-Disciplinary Team o Lab, Nursing, Physicians, IT, Biomed, others Ø Assign a POCT coordinator o A team leader, oversees QA of the program, Program Control Ø Identify current practice o Who has what and who uses what? ! Ø Practice Control o Enforcement 14

POCT System Considerations q Accuracy & Precession q Control q Consolidation q Integration & Connectivity q Data Management q User friendly q Durability q Cost & Support q Efficacy 15

Necessary Tools q Policies and Procedures q QC Program q Quality Management Plan q Training and Compliance Documentation q PT q Accreditation & Regulatory Compliance 16

Practice Control 17

Questionnaire to be Completed by the POCT Requestor QUESTION ANSWER 1 What new POC test/device is proposed? 2 Is the test available in the laboratory? If Yes, Why should the testing be done on the 3 ward/unit rather than sending samples to the laboratory? 4 Which group of patients needs the test? 5 How many samples will be analyzed per month / year? 6 What device is most suitable for your purpose? 7 Where will the devices be located? 8 Who will be performing the tests? 18

NO YES NO NO NO 19

Is POCT Manageable? 20

Multi-disciplinary 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 q Regulations for the frequency of running QC q Continuous educational activities for best practices of QC q Continuous communication and update with end-users 22

Conclusion Ø POCT is to decrease TAT & improve clinical outcome Ø Clinical needs must be identified before POCT is implemented Ø POCT is not to be used as a diagnostic tool, but in conjunction with main lab Ø Ø POCT is mostly considered waived but it is still regulated Multi-disciplinary but lead and monitored by Clinical Laboratory 23

Conclusion Ø Proper selection of POCT system is a key to success Ø Costly, inefficient and ineffective, if not well managed Ø Manageable with good communication and leadership Ø Proper management of POCT guarantees quality service and improved patient out-come 24

Resources for Information About POCT 1. http: //www. cap. org 2. http: //www. clsi. org 3. http: //www. pointofcare. net 4. http: //www. aacc. org 25

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