LIKUNI MISSION HOSPITAL LMHL-HEMA-002

LABORATORY BC3000plus OPERATING PROCEDURE

V 1.0
EFECTIVE DATE: APRIL 2017

Effective Date: Revision 0 Supersedes; None

April 2017

Prepared/Revised by Signature Date

Reviewed by Signature Date

Approved by Signature Date

Distributed to Number of copies

Master file 1

Lab 1

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LMHL-HEMA-BC3000plus Operating Procedure-002
 LIKUNI MISSION HOSPITAL LMHL-HEMA-002
LABORATORY BC3000plus OPERATING PROCEDURE
V 1.0
EFECTIVE DATE: APRIL 2017

Document History

Revision Effective Date Changes

Staff Signatures
Signing below indicates that you have read this SOP and understand the material contained in it
Name Signature Date

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LMHL-HEMA-BC3000plus Operating Procedure-002
 LIKUNI MISSION HOSPITAL LMHL-HEMA-002
LABORATORY BC3000plus OPERATING PROCEDURE
V 1.0
EFECTIVE DATE: APRIL 2017

1. RESPONSIBLE PERSON: All trained and authorized Laboratory staff.

2. PURPOSE
The purpose of this standard operating procedure is to guide the user to properly, effectively,
and safely run a Full Blood Count (FBC) on clinical samples using the BC-3000plus hematology
analyzer for diagnostic purposes in vitro.

3. PRINCIPLE
The BC-3000plus Auto Hematology Analyzer uses electrical impedance method in counting cells.
This method is based on the measurement of changes in electrical resistance produced by a
particle, which in this case is a blood cell, suspended in a conductive diluent as it passes through
an aperture of known dimension. An electrode is submerged in the liquid on both sides of the
aperture to create an electrical pathway. As each particle passes through the aperture, a
transitory change in the resistance between the electrodes is produced. This change produces a
measurable electrical pulse. The number of pulses generated indicates the number of particles
that passed through the aperture. The amplitude of each pulse is proportional to the volume of
each particle. Each pulse is amplified and compared to the internal reference voltage channels,
which only accepts the pulses of a certain amplitude. Each blood cell has a threshold which will
be referred to and will be counted according to the threshold it falls in.

4. SPECIMEN
EDTA anti-coagulated blood.

5. SAFETY AND ENVIRONMENT

The sample probe is sharp and may contain biohazard material, so avoid contact with the probe
when working around it.
Wear personal protective equipment and follow safe laboratory procedures when handling
samples in the laboratory.

6. MAINTAINANCE
6.1 Daily
Check if there are enough reagents.
Check if the reagents are cloudy and degenerative
Check the tubing’s if there any bends and leakages
Empty the waste container

6.2 Weekly
Do probe cleanser cleaning. On how to do it see Operators manual 10.3.6 Probe Cleanser
Cleaning Page 10-10

6.3 Monthly
Do probe wipe cleaning. On how to do it refer Operators Manual 10.3.12 wipe block
cleaning Page 10-20

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LMHL-HEMA-BC3000plus Operating Procedure-002
 LIKUNI MISSION HOSPITAL LMHL-HEMA-002
LABORATORY BC3000plus OPERATING PROCEDURE
V 1.0
EFECTIVE DATE: APRIL 2017

7. CALIBRATION
You should run calibration programs if it is the first time the analyzer has been used, certain
major component (s) of the analyzer has been changed and if the quality control results indicate
there may be a problem.
To use the calibration program, refer to Operators manual chapter 9 page 9-1.

8. QUALITY CONTROL
Quality control should be run on a daily basis, after running record on the Quality Control Log
(LMHL-HEMA-BC3000plus Quality Control Log-003). To run the controls, select whole blood
mode then follow as stated below:
Press MENU → Select Quality Control → L-J Analysis → L-J Count. Then select File 1 for Low level
control, File 2 for Medium level control and File 3 for High level Control.
After running each level press Print to print the Quality Control Results.

9. OPERATION
9.1 Preparation Before Turning on the Instrument
Check if there enough reagents
Check if the reagents are cloudy and degenerative
Check if tubing has any bends
Empty waste container

9.2 Turning on the Instrument

Press the power switch located at the back of the analyzer to turn on the analyzer. The
analyzer will automatically flush the fluidic lines check the background and enter the
“Count” screen.

9.3 Background Check

When the “Count” screen appears, background results will be displayed on the screen. The
background result shall be:
WBC≤0.3x109/L RBC≤0.03x1012/L HGB≤0.1g/dL PLT≤10x109/L

9.4 Whole Blood Count

a. Press MENU and select “Sample Mode” to enter the Sample Mode screen. Select
“Whole Blood”.
b. Press ID to enter sample/patient details then press ok to confirm.
c. Mix the EDTA anticoagulated blood well and present the sample tube to the probe so
that the probe tip is well into the sample.
d. Press the aspirate key to start the count.

9.5 Predilute Count

a. Press MENU and select “Sample Mode” to enter the Sample Mode screen. Select
“Prediluted”

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LMHL-HEMA-BC3000plus Operating Procedure-002
 LIKUNI MISSION HOSPITAL LMHL-HEMA-002
LABORATORY BC3000plus OPERATING PROCEDURE
V 1.0
EFECTIVE DATE: APRIL 2017

b. Press DILUENT and then press the aspirate key to dispense 0.7ml diluent into a test
tube.
c. Rapidly add the collected 20µL of capillary blood sample into the test tube holding 0.7ml
of diluent to make the prediluted sample.
d. Thoroughly mix the prediluted sample (do not use excessive force for shaking, otherwise
bubbles may be produced and the analysis may not be reliable)
e. Keep the prediluted sample still for three minutes and mix it again.
f. Press ID to enter the sample details then Present the sample to the probe and press the
aspirate key to start the count.

9.6 Shutdown
Press MENU and the select “Shutdown”
Use E-Z cleanser to execute “Shutdown” program every day before turning off the
instrument. After the screen prompts “You can turn off the analyzer now” turn off the
analyzer by switching of the switch at the back panel of the analyzer.

10. RELATED DOCUMENTS AND FORMS

LMHL-HEMA-BC3000plus Maintenance Log-001
LMHL-HEMA-BC3000plus Quality Control Log-003
LMHL-HEMA-BC3000plus Reagent Log-004

11. REFERENCES
Mindray, BC3000plus Auto Hematology Analyzer, Operators Manual.
LMHL-MA-SOP for Writing SOP-001

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LMHL-HEMA-BC3000plus Operating Procedure-002