7/26/2019 MS ISO15189
1/6
Schedule
lssue date: 09
December 2015
Valid until:
29
October
2016
NO: SAMM
480
Lab 6
of 10
(lssue
2,
09
December
2015 replacement
of SAMM
480
dated
19 February
2014)
Page:
1
of 6
LABORATORY
LOCATTON: MEDTCAL
LABORATORIES
(PERMANENT
LABORATORY)
HEMATOLOGY & TRANSFUSION
MEDICINE
LABORATORY
HOSPTTAL
UNIVERSII
SAINS MALAYSIA
(HUSM)
JALAN RAJA PEREMPUAN
ZAINAB II
16150
KUBANG
KERIAN
KELANTAN, MALAYSIA
A
medical laboratory's
fulfillment of
the
requirements
of
ISO
15189:2012
means
the
laboratory
meets both the technical
competence requirements
and
the
management system
requirements
necessary
for it
to consistently
deliver technically
valid test
results.
The
management system
requirements
in ISO 15189
(Section
4) are
written
in a
language
relevant to
a medical
laboratory's operations
and meet the
principles
of
ISO
9001:2008
Quality
management systems
-
Requirement and
are
aligned
with
its pertinent requirements
(Joint
IAF-ILAC-ISO Communiqud
issued in 2015)
FIELD
OF MEDTCAL
TESTING:
HAEMATOLOGY
SCOPE OF
ACCREDITATION :
sKlM AKREDTTAST MAKMAL MALAYS|A
(SAMM)
LABORATORY ACCREDITATION
SCHEME OF
MALAYSIA
MS tSO 15189
Specimen
Tested
Type
of
Tests/
Properties Measured
Test Method, Specification/
EquipmenUTechniques
Used
Routine Haematology
EDTA Blood
Dried Blood
EDTA Blood
Routine
Haematology
EDTA Blood
FBC
ESR
GOPD Screening
Reticulocyte
Count
FBP
o
FBC
Manual
Sysmex
XE500O / DC
Detection Method as
Documented
in
HUSM/HEMA-UPT/STM-R1
Sysmex l
7/26/2019 MS ISO15189
2/6
Schedule
NO:
SAMM 480
Lab
6
of
10
(lssue
2,
09 December
2015 replacement
of SAMM 480
dated 19 February
2014)
FIELD
OF
MEDTCAL
TESTING:
HAEMATOLOGY
SCOPE OF ACCREDITATION:
lssue
date: 09 December
2015
Valid
unti :
29
October
2016
Page:
2
of 6
MS rSO
'15189
Specimen
Tested
Type
of Tests/
Properties
Measured
Test Method,
Specification/
EquipmenUTechniques
Used
Molecular
EDTA B|ood/
EDTA
Bone Marrow
Coagulation
Plasma
Molecular
APTT
PT
/ INR
Fibrinogen
Factor
Assay:
Factor
Vlll:C &
Factor lX
D-Dimer
Lupus
Anticoagulant
Polymerase
Chain
Reaction
(PCR).
BCR-ABL
Fusion
transcript
using
Multiplex
RT-PCR
as
documented in
HUSM/HEMA-UPT/STM-M1
HUSM/HEMA-UPT/STM-M2
Polymerase
Chain
Reaction
(PCR).
JAK
2
Mutation
V617F
as
documented
in
HUSM/HEMA-UPT/STM-M3
HUSM/HEMA.UPT/STM-M4
HUSM/HEMA-UPT/STM-M5
Coag
u
lometric
Test-Mechan
ical
Clot
Detection
Method
on
STA CompacUSTA-R
EVOLUTION
as Documented
in
HUSM/HEMA-UPT/STM-C1
MechanicalClot
Detection
Method
on STA
Compact
/STA-R
EVOLUTION
as
Documented
in
HUSM/HEMA-UPT/STM-C1
MechanicalClot
Detection
Method
on
STA
CompacU
STA-R
EVOLUTION
as
Documented
in HUSM/H
EMA-U PT/STM-C2
MechanicalClot
Detection
Method
on
STA
Compact as Documented
in
HUSM/HEMA-UPT/STM-C3
lmmunoassay
Tests
-
Mechanical
Clot
Detection
on
STA CompacV STA-R
EVOLUTION Method
as
Documented in
HUSM/HEMA-UPT/STM-C4
STA Compact
/
Mechanical clot detection
method
as
documented in
HUSM/HEMA-UPT/STM-C6
HUSM/HEMA-UPT/STM.C7
ST
art
4
/
Mechanical
clot detection
method
as
documented
in
H
USM/H EMA-U PT/STM-C8
7/26/2019 MS ISO15189
3/6
Schedule
NO:
SAMM 480
Lab 6
of
10
(lssue
2,
09 December 2015 replacement
of
SAMM
480
dated 19 February 2014)
FIELD
OF
MEDICAL
TESTING: HAEMATOLOGY
SCOPE OF
ACCREDITATION:
lssue
date: 09 December
2015
Valid
until:
29
October 2016
@
S tSO 15189
Page:
4
of
6
Specimen Tested Type
of
T.ests/
Properties
Measured
Test Method,
Specification/
EquipmenUTechniques
Used
Flow
Cytometry
EDTA Blood
Haemopoetic
Progenitor
Cell-
Apheresis
(HPC-A)
anticoagulated with
ACDA; Peripheralblood
stem
cell
in
EDTA
container
(2mll3ml).
Haemoglobin
Analysis
EDTA Blood
lmmunophenotyping
Quantitation of CD34
Positive
Cells
For Stem
Cell
Transplantation
Haemoglobin
Electrophoresis
Hb
Analysis
Flow
Cytometry
FACS
CANTO llas
documented
in
HUSM/H
EMA-U
PT/STM-F1
FACS
Calibur
Flowcytometer
Single Platform ISHAGE
Gating Strategy
using
Flowcytometry
as documented in
HUSM/HEMA-UPT/STM-F2
Agarose
Gel
/
System Electrophoresis
lnterlab G26
as
Documented in
HUSM/HEMA.U
PT/STM-SH2
HUSM/HEMA.U PT/STM-SH3
HPLC
/
Bio-Rad
Variant ll
as documented
in HUSM/HEMA-UPT/STM/SH-1
sKlM
AKREDTTAST
MAKMAL
MALAYSTA
(SAMM)
LABORATORY ACCREDITATION
SCHEME OF
MALAYSIA
7/26/2019 MS ISO15189
4/6
Schedule
NO: SAMM
480
Lab 6 of 10
(lssue
2, 09
December
2015 replacement
ofSAMM
480 dated
19 February
2014)
FIELD
OF
MEDICAL
TESTING:
HAEMATOLOGY
SCOPE
OF
ACCREDTTATION:
lssue date:
09 December
2015
Valid until:
29 October
2016
Page:
3 of6
MS tSO
15189
Specimen
Tested
Type of Tests/
Properties
Measured
Test
Method,
Specifi
cation/
EquipmenUTechniques
Used
lmmunohaematology
EDTA B|ood
Transfusion
Microbiology
Serum/Plasma
Bone
Marrow
Aspirated
Bone
Marrow
ABO/Rh
Grouping
Antibody
Screen
(lndirect
Coombs
Test)
Cross Match
Rhesus Genotyping
Direct
Antiglobulin Test
RBC Phenotyping
Antibody
ldentification
HlV,
HCV
and
HBsAg
Screening
for
Blood
Donor
Bone marrow
examination
and
cytochemical
staining
Tile/Tube
Method
/ Gel Card
(Techno
Twin
Station)
(Antibody-Antigen
Reaction)
as
documented
in
HUSM/HEMA-UPT/STM.T1
HUSM/HEMA-UPT/STM-T2
Gel
Card
(Antigen-Antibody
Reaction) as
documented
in
H
USM/H
EMA-U
PT/STM-T3
Gel
Card
(Antigen-Antibody
Reaction)
Tube
Method
(lmmediate
Spin)
as documented
in HUSM/HEMA-UPT/STM-T4
Gel Card/
Tube
Method
(Antibody-Antigen
Reaction) as
documented
in
HUSM/HEMA-UPT/STM-Ts
Gel
Card
(Antigen-Antibody Reaction) as
documented
in
H
USM/H EMA-U
PT/STM-T6
Gel
Card/
Tube
Method
(Antigen-Antibody
Reaction) as
documented
in
HUSM/HEMA-UPT/STM-T7
Gel
Card
(Antigen-Antibody
Reaction)
as
documentEd
iN
HUSM/HEMA-U
PT/STM-T8
Abbott
Architect
(Chemiluminescent
Microparticle
lmmunoassay
(CMIA)
as
documented
in
H
USM/H
EMA-U
PT/STM-SI
Manual
Smear
&
Staining
Method
as
documented
in
H
USM/H
EMA-U
PT/STM-BM
1
H USM/H
EMA-U
PT/STM-BM2
H
USM/H
EMA-U
PT/STM-BM3
HUSM/H
EMA-U
PT/STM-BM4
HUSM/HEMA.U
PT/STM-BM5
H
USM/H
EMA-U
PT/STM-BM6
HUSM/H
EMA-U
PT/STM-BM7
7/26/2019 MS ISO15189
5/6
Schedule
NO:
SAMM
480
Lab
6
of
10
(lssue
2,
09
December
2015
replacement
ofSAMM
480
dated
19
Febryary
2014)
Key
Personnel:
lssue
date:
09 December
2015
Valid
until:
29
October
20{6
ns
6-rsrag
Page:5
of6
No.
Name
Designation
1.
Assoc.
Prof.
Dr. Rapiaah
Mustaffa
Laboratory
Director
2.
Assoc.
Prof. Dr.
Wan
Zaidah
Abdullah
Deputy
Laboratory
Director
Haematology
3. Assoc.
Prof.
Dr.
Wan
Zaidah
Abdullah
Quality
Manager
4.
Mdm.
Norizah
Tumin
Deputy
Quality
Manager
5.
Mdm. Maseta lsmail
Technical
Manager
6.
Mdm.
Narishah
Sharif
Deputy
Technical
Manager
7.
Mdm. Norizah
Tumin
Document
Controller
8. Ms.
Wan
NorAziemah
Wan
Zainulddin
Deputy
Document
Controller
9
Mdm.
Roazliana
Ramli
Technical
Officer
Routine
Haematology
10.
Mr. Muhammad
Ashraf
Zulkarnain
Technical
Officer
Routine
Coagulation
11.
Mr.
Saharim
Osman
Technical
Officer
Routine
Flowcytometry
12.
Mdm.
Salwana
Ahmad
Technical
Officer
Routine
Molecular
13.
Mdm.
SuryatiAbdullah
Technical
Officer
Routine
-Hb Analysis
14.
Ms.
Ang
Cheng
Yong
Technical
Officer
Routine
Bone Marrow
Transfusion
Medicine
15.
Assoc.
Prof. Noor
Haslina
Mohd Noor
Quality
Manager
16.
Mdm
Khairiah
Yazid
Deputy
Quality
Manager
17.
Mdm.
Salamah
Ahmad
Sukri
Technical
Manager
18.
Mdm.
Rohana
Yusof
Deputy
Technical
Manager
19.
Mdm. Khairiah
Yazid
Document
Controller
20.
Mr.
Muhamad
FakhriMohd
Azmi
Deputy
Document
Controller
21.
Mdm.
Suzana Abu
Technical
Officer lmmunohematology
22. Mr.
Abu
Salam Mohamed
Nor
Technical
Officer
Transfusion
Microbiology
23.
Mr.
Ahmad
Zaki
ldris
Technical
Officer Stem Cell
24.
Mdm Wan
RosniWan
Yakob
Technical
Officer
Donor
Section
sKtM
AKREDTTAST MAKMAL MALAYSTA
(SAMM)
LABORATORY ACCREDITATION
SCHEME OF
MALAYSIA
7/26/2019 MS ISO15189
6/6
Schedule
ffiL
Y
MS rSO
15189
lssue
date:
09 December 2015
Valid
until:
29
October 2016
NO:
SAMM 480
Lab 6 of 10
(lssue
2,
09
December
2015
replacement
of SAMM 480
dated
19 February
2014)
Clinical
Personnel:
Page:
6
of
6
No. Name
Discipline
1
Assoc.
Prof.
Dr. Rapiaah
Mustaffa
Haematology/Transfusion
Med
icine/Molecu
lar
2
Prof.
Dr. Rosline Hassan
Haematology/Transfusion
Med
icine/Molecu
lar
3 Assoc.
Prof. Dr.
Wan
Zaidah Abdullah
Haematology/Transfusion
Medicine/Molecu
lar
4
Assoc.
Prof.
Dr.
Suhair Abbas
Ahmed
Al-Salih Haematology/Transfusion
Medicine
5
Dr.
Wan HaslindawaniWan
Mahmood
Haematologyff
ransfusion
Medicine
6
Dr. Shafini Mohamed
Yusoff
Haematology/Transfusion
Med
icine
7
Assoc.
Prof.
Dr.
Rosnah
Bahar
Haematologyff
ransfusion
Medicine
I Assoc.
Prof.
Dr.
Noor
Haslina Mohd.
Noor
Haematology/Transfusion
Med
icine
I
Dr.
MariniRamli
Haematology/Transfusion
Medicine
10
Dr. Mohd
Nazri Hassan
Haematology/Transfusion
Med
icine
11 Dr. Muhamad
Farid
Johan
Molecular
12 Dr
Salfarina
lberahim
Haematology/Transfusion
Med icine
13
Dr. Marne
Abdullah
Haematology/Transfusion
Medicine
sKtM
AKREDTTAST
MAKMAL MALAYSIA
(SAMM)
LABORATORY ACCREDITATION
SCHEME
OF MALAYSIA
Top Related