F-06/06

ACCREDITATION Issue Date: 02/05/12

Rev. No: 00
DOCUMENT
ML 001

Accreditation No: ML 001

Awarded to

Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan.

The scope of accreditation is in accordance with the standard specifications outlined in the
following page(s) of this document. The accredited scope shall be visible and legible in areas
such as customer service, sample-receiving section etc and shall not mislead its users.

The accreditation was first time granted on 28-03-2012 by Pakistan National Accreditation
Council.

The laboratory complies with the requirements of ISO 15189:2012.

The accreditation requires regular surveillance, and is valid until 11-06-2018.

The decision of accreditation made by Pakistan National Accreditation Council implies that the
organization has been found to fulfill the requirements for accreditation within the scope.

The organization however, itself is responsible for the results of performed measurements/tests.

PAKISTAN NATIONAL ACCREDITATION COUNCIL

_____________ ____________________________
Date Director General

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 F-06/06
ACCREDITATION Issue Date: 02/05/12
Rev. No: 00
DOCUMENT
ML 001

Medical Laboratory.

Accreditation Scope of Armed Forces Institute of Pathology (AFIP),

Rawalpindi, Pakistan.

Permanent laboratory premises X

Field of Medical Testing Laboratory:

Standard
Types of test/ Range of Minimum Uncertainty of specification/
Sample Type/
Properties measurement detection Measurement Techniques/
Matrix
measured limit (where applicable) equipment used
MU (±)
Chemical
Pathology

1. Plasma Glucose 0.11- 41.6 0.11 5.0% Hexokinase/

Glucose mmol/l mmol/l Modular P
800

2. Serum Urea 1.8-53.6 1.8 5.0% Urease with

Urea mmol/l mmol/l GLDG /Advia
1800

3. Serum
Creatinine Creatinine 8.8-2210 8.8 µmol/l 5.0% Jaffe Kinetic /
µmol/l Advia 1800

4. Serum
Enz Kinetic /
Alanine ALT 0.5 - 1100 U/l 0.5 U/L 5.0%
Advia 1800
Aminotransf
erase

5. Serum Total 2-598 µmol/l 2 µmol/l 5.0% Vanadate

Total Bilirubin oxidation /
Bilirubin Advia 1800

Date Director
 F-06/06
ACCREDITATION Issue Date: 02/05/12
Rev. No: 00
DOCUMENT
ML 001

6. Serum Albumin 10 - 70 g/l 2 g/l 5.0% Bromocresol

Albumin Green / Advia
1800

7. Serum ALP 1-1200 U/l 0.67 µ 5.0% AMP/ Advia

Alkaline Kat/l 1800
Phosphatase

Biuret
8. Serum Total Protein 2 - 150 g/l 2 g/l 4.7% Reaction/
Total Modular P
Protein 800

Arzenao III /
9. Serum Calcium 0.05 – 5.0 0.05 4.7% Modular P800
Calcium mmol/l mmol/l
Total

Modular P
10. Serum LDH 6 – 1200 6 U/L 9.2% 800
Lactate mmol/l
Dehydrogena
se
gamma glut-
11. Serum Gamma 3–1200 U/L 3 U/L 9.2% 3-carb-4
Gamma Glutamyl nitraonilide /
Glutamyl Transferase Advia 1800
Transferase

ISE/ Cobass
12.serum sodium 20 - 250 20 1.4mmol/L 221
sodium mmol/l

ISE/ Cobass
13.serum Potassium 0.2 - 20 0.2 0.1mmol/L 221
potassium mmol/l

Oxidase/
14.serum Cholesterol 0.08-20.7 0.08 2.8% Modular P
cholesterol mmol/l 800

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15.Serum HDL 0.08-3.10 0.08 2.8% Direct HDL

HDL mmol/l mmol/l Roch 3rd gen
cholesterol / Advia 1800

16.Serum magnesium 0.16-2.06 0.03 2.8% Xylidyl Blue/

magnesium mmol/l mmol/l Advia 1800

17.serum Phosphate 0.1 – 6.46 0.1 2.8% Phosphomoly

phosphate mmol/l mmol/l date UV/
Advia 1800

18.Serum Triglycerides 0.05-11.3 0.05 5.6% Lipase/GPO-

triglycerides mmol/l µmol/l PAP/ Modular
P 800

19.Serum Uric acid 11.9-148.7 11.9 5.6% Uricase

uric acid µmol/l µmol/l perox/ Advia
1800
20.Serum Aspartate
aspartate Amino 4-800 U/L 4 U/L 5.6% Tris buffer no
aminotransf Transferase P5P,IFCC/
erase Modular P
800
21.serum Creatine
creatine Kinase 7-2000 U/L 7 U/l 5.6% CK-NAC/
kinase Advia 1800

22.Serum HbA1C 2.9-15.4% 2.9% 5.6%

Glycosylate Immunoturbid
d ity / Advia
Haemoglobi 1800
n

Endocrinology
FT4 T4 1.3 – 155 1.3 ±3.22%
pmol/L pmol/L Chemilumine
scent
techonology
T3 Triidothyroni 0.15 -12.3 0.15nmol/ ±0.68% Advia
ne nmol/L L Centaur

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ACCREDITATION Issue Date: 02/05/12
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DOCUMENT
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TSH Chemilumine
Thyroid 0.008-150 0.008mIU ±1.92% scent
stimulating mIU/L /L techonology
hormone Advia
FSH Centaur
Follicular 0.3-200 0.3mIU/m ±3.5%
stimulating mIU/ml l Chemilumine
homone scent
LH techonology
Lueitiizing 0.07-200 0.07mIU/ ±3.3% Advia
homone mIU/ml ml Centaur

Prolactin Chemilumine
Prolactin 6.4-4240 mI 6.4mIU/L ±7.42% scent
U/L techonology
Advia
Progesteron Centaur
e Progesterone 0.67-190.8 0.67nmol/ ±3.7%
nmol/L L Chemilumine
scent
techonology
Testosteron Advia
e Testosterone 0.35-52.1 0.35nmol/ ±1.32% Centaur
nmol/L L
Chemilumine
Estradiol scent
Estradiol 36.7-3670 36.7- ±15.48% techonology
pmol/L 3670mol/ Advia
L Centaur
Ferritin
Ferritin 0.5-1650 0.5ng/ml ±10.22% Chemilumine
ng/ml scent
techonology
Cortisol Advia
Cortisol 5.5-2069 5.5nmol/l ±9.24% Centaur
Growth nmol/l
Hormone Growth 0.01-40ng/ml 0.01 ng/ml ±92.24 Chemilumine
Hormone scent
techonology
Advia
PTH Centaur
PTH 3-2500 pg/ml 3 pg/ml ±3.19
Chemilumine
scent
Date Director
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Tumor techonology
marker Advia
Centaur
Serum AFP
AFP 1.08 -830 1.08 ± 6.2% Chemilumine
IU /ml mIU/ml scent
BhCG techonology
BhCG 2 .0 - 1000 2 nmol/l ± 12.5% Advia
mIU/ml Centaur
Folic acid
Folic acid 0.79 -54 0.79 ± 4.3% Immulite
nmol/l IU/ml 2000

CA 125 CA 125 2.0 - 600 2 ng/ml ± 4.3%

IU/ml

CEA CEA 0.5 -100 0.5 ng/ml ± 3.2%

ng/ml Immulite
2000

PSA PSA 0.01-100 0.01nmol/ ± 1.1%

ng/ml L Advia
Centaur

Vitamin D Vitamin D 10-375 10 nmol/l ± 9.9%

Total Total nmol/L

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ML 001

Toxicology 1.Valproic 10-200 ug/ml 2.0 ug/ml ± 6% Immulite

& TDM Acid 1000
Serum
2.Carbamaz 1.25-20 ug/ml 0.2 ug/ml ± 8.5 % Solid phase
epine competitive
2.5-40 ug/ml 0.5 ug/ml ± 6.2 % chemilumines
3.Phenytoin cent enzyme
0.5-8 ng/ml 0.1 ng/ml ± 8.6% immunoassay
4.Digoxin (Valproic
Acid,
Carbamazepin
e, Phenytoin
& Digoxin)

IMMUNOLOGY 1. Anti nuclear Negative→Po Not Not applicable Indirect

Serum antibodies sitive applicable immunofluore
scence
2. Anti double
stranded DNA Negative→Po Not Not applicable Indirect
antibodies sitive applicable immunofluore
scence

RA factor Positive/Nega Ref range: 8 IU/ml Not applicable Latex

(serum) tive Less than 8 agglutination
IU/ml
(Negative)

CRP Less than 6 Ref range: 6 mg/l - Not applicable 1.Latex

mg/l Less than 6 agglutination
(serum) mg/l 2.
Chemilumine
scence

Date Director
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ACCREDITATION Issue Date: 02/05/12
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ML 001

Anti Positive/Nega Positive/Nega Compared Not applicable Indirect

glomerular tive tive to positive immunofluore
basement Cut off control scence
membrane According to According
(GBM) ELISA kit in to ELISA ELISA
antibodies use kit in use

Monoclonal Present/Absen Not Not Not applicable Immunfixatio

paraprotein t applicable applicable n
Immunoelectr
ophoresis

Histopathology
H&E Not Not Not applicable 1- Trimming
Tissue Staining applicable applicable Path Hood
biopsy (Bio Optica)
material
2- Tissue Tek
VIP-5
Periodic Acid - Not Not Not applicable Processor -1
Schiff (PAS) applicable applicable
stain 3- Tissue Tek
VIP-5
Processor -2

4- Tissue Tek
Embedding
Console
System-1

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ML 001

MICROBIOLO Protein Trace to 0.2 mg/dl Not applicable Cyberow

GY
1. Urine 10g/L Reader 720
“ “
Glucose 5.5-55 5.5 Not applicable
Mmol/L mmol/L ““

Urobilinogen 16-131 16umol/L Not applicable ““

umol/L
““

Bilirubin + to + + + “ “

““
PH 5-9 5 Not applicable
“ “
Nitrite Neg to Pos NA Not applicable
Lab kit
Ketones
0.5-10 0.5mmol/ Not applicable OMEGA
2. Serum mmol/L L
RPR NA NA Gram stain
3. Serum TPHA NA
NA
Gram Stain Pos/Neg Bacteriuri
4. Bacterial
cultures NA Strip

C/S NA ICFU Lab kit

5. Urine
Pregnancy 200-900 IU/L 200 IU/L

Stool Occult blood NA NA NA STANBIO

LABS USA
Parasite/ova
/cyst detection NA NA NA NA

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Serum H. pylori NA NA NA OMEGA

Antibody

Bacterial Throat culture NA

cultures NA NA Disk
Diffusion

Genital
culture NA NA NA
NA

Fungal KOH slides NA NA NA NA

Culture

VIROLOG
Y HBAs Ag +ve/-ve +ve/-ve Not applicable Standard
1. Serum Company kit
Sample used
Not applicable
Standard
Anti HCV +ve/-ve +ve/-ve Company kit
2. Serum used
Sample
Not applicable

+ve/-ve +ve/-ve Standard

3. Serum Anti HIV Company kit
Sample used

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ACCREDITATION Issue Date: 02/05/12
Rev. No: 00
DOCUMENT
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Haematolo
gy System Kx21
Hb 1-25g/dl 1g/dl ± 1%
EDTA Photometric
Hct
Blood 10-60% 10% ± 3.5% measurement
of Hb by
RBC count 0.3-7. 0.30x109/ 0.30x109/1 Sodium
X1012/1 1 lowrile
sulphate
WBC count 9
1-99x10 /1 ±0.2x109/1 (SLS)
9
1.0x10 /1 method.
Platelet 9
10-999x10 /1 ±10x109/1 (Stromatolyze
Count 9 r WH)
10x10 /1
Impediecne
method;
(Direct
Current)
DC method.
Tri sodium PT 12 – 14 s 10 s + 5% Stago
citrate blood Equipment/
APTT 28 – 34 s 25 s + 5% Manual

Tests based
on PT &
APTT:
Factors assays %
Mixing
studies >50%
correction
EDT Hb studies Cellulose
A Blood HbA 1-100% acetate
HbF 1-100% 1% 5-10% electophoresis
HbA2 1-8%

Date Director