This document discusses the journey of laboratory testing from bedside testing to centralized laboratories to point-of-care testing. It provides a brief history of early diagnostic tests and outlines the benefits of point-of-care testing such as simpler sample collection and faster turnaround time. It discusses quality requirements for point-of-care testing devices and the roles of the manufacturer, laboratory, and point-of-care coordinator in ensuring quality. It also addresses challenges of point-of-care testing and the importance of oversight committees.

1. Dr. Jayesh Warade
MBBS MD FACB

3.  History
 Quality Requirement
 Responsibility
 Manufacturer Role
 Laboratory Role
 POCT Coordinator

4. JOURNEY
OF LAB
TESTING
Bed side testing
Central Laboratory
Point of Care Testing

5. Hippocrates suggested that women who had missed their
period should drink a solution of honey in water at
bedtime. If they had abdominal distention and cramps,
this would indicate the presence of a pregnancy.
Another archaic example of a rapid diagnostic test was
the practice of tasting a patient’s urine to detect the
presence of glycosuria, which indicates diabetes mellitus.
If it tasted sweet, they knew that the patient had
diabetes mellitus.

6. Simpler
sample
collection
1
Simpler
preanalyti
cal
process
2
Faster TAT
leading to
more timely
treatment
3
Removes
pathology
access
barriers
4
Increased
patient
satisfactio
n
5

7. “With Great Power Comes Great Responsibility”

8. Clinical Laboratory Improvement Amendment (CLIA) criteria
Waived Test
 Non-critical tests
 approved by the FDA for home use
 employ methodologies that are so simple and accurate
 erroneous results negligible,
 or pose no reasonable risk of harm to the patient if performed
incorrectly.

9. Moderately Complex Testing:
• require minimal scientific and
technical knowledge and training to
perform accurately,
• operational steps are either
automatically executed or easily
controlled, and
• minimal interpretation and judgment
are required.
Highly Complex Testing:
• require specialized scientific and
technical knowledge, training and
experience to perform accurately,
• operational steps require close
monitoring or control,
• and extensive independent
interpretation and judgment are
required.

10. ISO22870 ISO15189

11. QUALITY
REQUIREMENT
FOR POCT -
DEVICE
CLSI document POCT09-
A :- Selection Criteria
for Point-of Care
Testing Devices;
Approved Guideline. .

12. DEVICE
SELECTION
 System performance
 Data from preliminary
evaluation
 Ease of Use
 Subjective assessments from
operators
 System Calibration and QC
 Software/ firmware features
 Lockouts, connectivity
 Reagents / consumables
 Storage; shelf-life; preparation
 Vendor support
 Cost

13. Is POCT fit for intended clinical purpose?
How much of the testing will move from lab to POC?
What is the intended population?
Why would POC be a benefit?
Is the Intended Use of the POCT appropriate to the
targeted application/ patient population/ sample type?
What are the limitations of the procedure?
Are accuracy and precision claims sufficient for targeted
use?

14. IVD
approved
US – FDA
CLSI –
Compliance
CAP -
Compliance

15. Validation – Before the instrument put in the
market
Verification – after installing the instrument
at facility

16. Often can use data collected
during preliminary evaluation
to support validation of
system
 Accuracy - “true” -
reproducibility
 Precision - Repeatability
 Reportable range -
 Reference interval
verification
 Method comparison studies

17. Accuracy - “true” - reproducibility
Precision - Repeatability
Reportable range -
Reference interval verification
Method comparison studies

19. POCT
CHALLENGES
 Management
 Responsibility
 Location
 Staff training and competency
maintenance
 Reliability of POCT results
 Quality Control
 POCT Challenges for End Users
 Data Management
 Noncompliance with procedures
(specimen labeling, QC,
proficiency testing etc.)
 Infection Control
 Billing

20. POCT Management - Controlling in an uncontrolled
premises

22. test
performed
outside the
laboratory
the operator?
the laboratory?
the manufacturer?

23. MANUFACTURER - VENDOR
Providing Quality Instrument and
Initial Performance Verification
Operating and Trouble shooting Training
Performing planned-unplanned maintenance and
Calibration on routine basis.
Limitations of the device
Conventional

25.  Organization of POCT unit
 Designing of processes in POCT
 Planning for Quality Control
 Training of trainer/operator
 Performance Verification
 Regulatory Compliance
 Optimization of space
 Documentation

27.  Evaluating each new piece of instrument & each new lot of reagent,
 maintaining a performance record
 carrying out co-relation studies.
 Quality Assurance (Internal & External)
 Storage & Preparation of QC material
 Quality Control Plan
 Operator Training
 Designing processes related to sample testing
 Preparation of Standard Operating Procedure
 Basic Trouble shooting
 Pre analytical factors

28. POCT
COORDINATOR
An experienced medical
professional should be
appointed as POCT
coordinator
responsible for both
generating results and
the correct use of the
POC devices

29. THE ROLE OF
POCT
COORDINATOR
 Identifying suitable POCT
equipment for evaluation
 Performing an evaluation
 Installing POCT equipment
 Writing procedures
 Training staff
 Preparing worksheets, log
books, etc.
 Maintenance schedules
 QC programs
 Troubleshooting
 Monitoring and reviewing
procedures
 Competency reviews

30. Multidisciplinary
POCT Committee to
oversee POCT
Representation from
all the stakeholders
should be included
in POCT Committee

31. Determining if POCT is justified at a particular location -
increased clinical effectiveness
Continuing audit and assessment of POCT
Ensuring that no POCT device is used unless it has been
looked at by the POCT committee
Setting up a quality hierarchy
Establishing the presence of a link nurse or other
healthcare professional at the point of service delivery
Including representatives from primary care and the
community where necessary
Ensuring documented training for users
Ensuring that IQC and EQA schemes

33. Email: jdyajdo@gmail.com
9028219916
9028219916
http://clinlabworld.blogspot.in/