The document explains the Individualized Quality Control Plan (IQCP), its objectives, components, and benefits for laboratories. It details the processes to create an IQCP, including risk assessment and the use of computer programs for guidance. Implementing IQCP allows for customized quality control but poses risks if not managed properly.

1. Individualized Quality Control
Plan (IQCP)
By:
Dr.Hatim Mahmoud
Clinical Pathology Consultant
MBBS,MD Pathology
University Of Khartoum, Sudan.

2. Objectives:
What is IQCP
What are the component of IQCP.
How you can make IQCP
How to performed risk assessment
What are impacts and benefits of IQCP

3.  IQCP is an exceptions to
the rule of using daily
controls, it permits the
laboratory to customize
its QC plan according
to:
i. Test method
ii. Environment
iii. Personnel competency

4. To make an IQCP, you need to:
i. Examine each of the steps in the testing process
to determine the possible problems at each step.
ii. Determine the likelihood of these potential
problems occurring, the degree of risk to patient
care and determine if there is any way to prevent
these potential problems from occurring.
iii. Make a Quality Control Plan (QCP).
iv. Developed ongoing assessment for your (QCP)

5. How to make IQCP:
 The easy option is to buy
a computer program
that can make IQCP's.
 Report detailing your
risk. The computer
program will grade you
as a low, intermediate or
high risk of having
problems if you use IQCP.
 If the computer program
assesses a “low risk”, all
you have to do is print
out the IQCP Summary
Report detailing your
risk, signed by Lab
Director the statement
that the risk is acceptable
and file this at the back
of the procedure manual.

6.  Then reduce the
external QC to the
manufacturer's
minimum requirement
or to weekly or to once
every 30 days or on
opening a new lot,
whichever comes first,
etc.
 If the computer
program assesses you a
“moderate risk” or
“high risk” you should
look over the data
entered into the
program to make sure it
is correct and there are
no transcription errors.

7.  If the entered information
is correct and the
computer program
assesses you a “moderate
risk” or “high risk” this
would indicate you are not
doing things optimally in
your laboratory.
 Go down the list of
questions and determine
what can be optimized.
 Repeat the process until
such time as the
computer program
reports “low risk”.
 If you don't have access
to any computer
programs that can make
an IQCP, you can make
the IQCP yourself.

9. Re-call …

18. Work sheet

21. Work sheet
Work` sheet2

22. The impact of IQCP:
 If you are using IQCP, it
could take up to 30
days to find out if your
test goes out of control
and begins to fail
external controls.
 It would be possible to
turn out a large
number of erroneous
test results.

 You have to bring it
back into control
 You have to re-test any
remaining specimens
examined since the last
external QC thirty days
ago.

23. Benefits of IQCP:

24. References:
1) How to be a Lab Director by Philip A. Dauterman, MD with graphs by Steven Matthew R. Dauterman
2018 edition
2) Laboratory quality management system: handbook. World Health Organization 2011
3) A Step-by-Step Guide Developing an IQCP, U.S. Department of Health and Human Services
4) Individualized Quality Control Plan (IQCP) Frequently Asked Questions ;
CAP ;May 5, 2015 (last updated 09/16/2019)