SOP CYTO Updated

Star Imaging & Path Lab Private Limited
()
Title: SOP Cytopathology

Classification: Document No:
Effective Date: Revision:
CYTOPATHOLOGY SOPs-SIPL/CYTO
Name of copy holder:
Copy No. :
Issue No. :
Issue Date :
For private circulation only. No part of this document shall be copied or disclosed
without the prior permission of Star Imaging & Path Lab.
INDEX
Star Imaging & Path Lab (P) Ltd.
(Medical Device Testing Lab)
Doc. No: SUPPORTING PROCEDURES
SIPL/QM/01
Issue No.:05 Issue Date: Amend. No. Amend. Date: Page 1
15/02/2015 of 39
Prepared by QM Approved by HOD Issued by

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S. No. PARAMETER SOP No. PAGE
1. FNAC SIPL/CYTO/01 5-6

2. Guided FNAC SIPL/CYTO/02 7-9
(USG/CT)
3. Conventional Pap SIPL/CYTO/03 10-15
smear
4. Liquid based SIPL/CYTO/04 16-23
cytology
5. Fluids SIPL/CYTO/05 24-28

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DOCUMENT REVIEW
Star Imaging & Path Lab (P) Ltd. Standard Operating Procedure
Cytopathology
Name of Department: Cytopathology

Name of Document: SOP/CYTO
Document ID No ____________
Adopted Date Sign of Tech Sign of HOD

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AMENDMENT SHEET
S. Page No. Section/ Clause Date Nature of Authorization
No. Amendment
1. P-7,8,9 Guided FNAC 05/10/2018 Addition of new SOP
SOP
2. P-10 Sampling of 07/10/2018 Addition of sampling
conventional method
smear
3. P-15,21 Reference 10/10/2018 Change in reference
style
4. P-22 Interpretation 15/10/2018 Addition of

differentiating points
between conventional
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& LBC.
5 P-24 Biochemistry 18/10/2018 Addition of reference
6. P-27 Interpretation 22/10/2018 Change in protein
interpretation
7. P-28 Synovial fluid 22/10/2018 Addition of Group IV
SOP# SIPL/CYTO/01
FNAC
Intended Use: Fine needle aspiration cytology of any lesion/lump in the body.
Principle of Test: Cell/Fluid is aspirated by applying negative pressure

technique. Smears prepared are stained and screened under the microscope.
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Person Authorized to perform Test: Pathologist (authorized signatory)
Sample [Type of sample, storage & stability]: Fluid or cells. Slides are
stored for 5 years.
Turn Around Time: Sample is collected from 9a.m. to 5p.m. Report is given
after 10-12hours of collecting the sample.
Equipment: Microscope
Slides
Syringe
Needle (21-22G, 24G)
Reagents:
 MGG Stain
 Pap stain
 AFB stain
Technique:
The part on which the FNAC is to be performed should be clearly visible
under suitable light and then by applying a negative pressure technique
sample is collected using 10ml syringe and needle. The sample is collected
and put on the slide the slide is stained and examined under the microscope.

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Staining Procedure :
1) Stain the fixed smear for 1 minute in May-Grunwald stain for 1 minute.
2) Put the smears without washing for 15 minutes into Giemsa stain diluted
with 9 volume of distilled water.
3) Wash the smears in distilled water and let them dry.
4) Observe the stained cells in light microscope.
Calculation: Not applicable.
Biological Test Interval: Not applicable.
Quality Control : - EQAS (PGI Chandigarh, once a year)

- Interpersonal comparison.
Linearity: Not applicable.
Interference & Limitations: Not applicable.
Interpretation: Depending upon the site and clinical findings interpretation is

done. In case of discrepancies found between cytology reports and biopsy
reports the following protocol is followed :-
 The cytology smears are reviewed in-house by at least two

Pathologists.

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 ILC is done for both cytology and histopathology slides.

 Results are conveyed to the patient and the discrepant results are
documented.
Safety and precautions:-
1. Gloves should be worn at the time of FNAC

2. Suitable lighting should be there.
Reference: Orell and Sterrett’s Fine needle aspiration cytology (Vth edition)
SOP# SIPL/CYTO/02
GUIDED FNAC (USG/CT)
Intended Use: Fine needle aspiration cytology under USG/CT guidance of

any lesion/lump in the body.
Principle of Test: Cell/Fluid is aspirated under USG/CT guidance with the

help of Radiologist by applying negative pressure technique. Smears
prepared are stained and screened under the microscope.
Person Authorized to perform Test :- Pathologist & Radiologist
Sample [Type of sample, storage & stability]: Fluid or cells. Slides are
stored for 5 years.
Turn Around Time: Sample is collected from 9a.m. to 5p.m. Report is given
after 10-12 hours of collecting the sample.

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Equipment: Microscope
Slides
Syringe
Needle (21-22G).
Lumber puncture needle (21-22G).
Reagents:
 MGG Stain
 Pap stain
 AFB stain
Technique:
FNAC is performed under USG/CT guidance(by Radiologist) of the part
under adequate illumination and proper asepsis ,then by applying a
negative pressure technique or non aspiration technique (if vascular lesion)
sample is collected using 10ml syringe and LP needle. The sample is
collected and put on the slide the slide is stained and examined under the
microscope.
Staining Procedure :
5) Stain the fixed smear for 1 minute in May-Grunwald stain for 1 minute.

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6) Put the smears without washing for 15 minutes into Giemsa stain diluted
with 9 volume of distilled water.
7) Wash the smears in distilled water and let them dry.

8) Observe the stained cells in light microscope.
Biological Test Interval: Not applicable.
Quality Control: - EQAS (PGI Chandigarh, once a year)

- Interpersonal comparison.
Interference & Limitations: Not applicable.
Interpretation: Depending upon the site and clinical findings interpretation is

done. In case of discrepancies found between cytology reports and biopsy
reports the following protocol is followed :-
 The cytology smears are reviewed in-house by at least two

Pathologists.
 ILC is done for both cytology and histopathology slides.
 Results are conveyed to the patient and the discrepant results are
documented.

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Safety and precautions:-
1. Gloves should be worn at the time of FNAC

2. Suitable lighting should be there.
3. Proper asepsis to be maintained.
Reference: Orell and Sterrett’s Fine needle aspiration cytology (Vth edition)

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SOP# SIPL/CYTO/03
CONVENTIONAL PAP SMEAR
Intended Use:- To study the cytology of the ectocervix and endocervix.
Principle of Test : - Sample is collected from the cervical canal, stained and
cellular features seen under microscope.
Person authorized to perform test : - Doctor, Technician

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Person authorized to do reporting :- Pathologist (authorized signatory)
Special Instructions on Specimen Collection and Handling :-
Patient Preparation: Proper patient preparation encompasses the following:

 The patient should not douche for 24 hours before the genital smears are
obtained.
 During the childbearing age, smears should be obtained at mid-cycle.
 Smears obtained during menstrual bleeding may be difficult to interpret
because of contamination with blood, endometrium, debris, and
macrophages (histiocytes). Thus, discourage sampling during menses.
Sampling for Conventional Smear

 The cervical smear must be obtained under direct vision after introduction
of the unlubricated speculum.
 If there are difficulties in introducing the speculum, a few drops of normal
saline solution may be used to moisten it.
 Spread material obtained onto a labelled glass slide.
 Fix slides immediately in 95% ethyl alcohol fixative in coplin jar, making
sure the smear is adequately coated with fixative.
 Ectocervical scrape: With spatula thoroughly scrape the entire ectocervix

with emphasis on the squamo-columnar junction. Spread material onto a
labelled glass slide and fix immediately.
 Vaginal smear: Obtain specimen by lightly scraping the posterior vaginal
fornix with spatula. Spread the material evenly onto a labelled glass slide
and fix immediately.
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 Write patient’s name and ID with pencil on the frosted end of the glass
slide. Any unlabeled slide will be rejected and discarded. The clinic will be
informed before rejection of specimen.
 Fixation: If more than one slide is immersed in fixation solution (95%
ethyl alcohol), attach a paper clip to each slide (on the frosted end of the
slide) to separate slides and allow for circulation of the fixative.
 For adequate study of the female genital tract for malignancy, we suggest
a well-collected and prepared smear be taken from the ectocervix and the
endocervix.
 It is also important to label all slides with the patient's name and the site(s)
of specimen collection.
Sample [Type of sample, storage and stability]: Cervical canal brushings are
taken. Slides are stored for 5 years at room temperature.
Turn Around Time :- Samples are collected from 9a.m to 5p.m. Report is given
after 24 hours of collecting the sample.
Equipment :-
• Instrument(s) to obtain smear

• Spatula
• Clean microscopic glass slides
• Fixative
• Microscope

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Reagents :-
Rapid Papanicolau Stain
Staining : -
1.Smears are prepared from the samples and wet fix in equal amount of alcohol
and ether for 1 hour.
2. 10 dips of the slides are given in 80% then 50% and distilled water.
3. Slides are kept in haematoxylin for 10 mins.
4. Slides are put under tap water for 10 mins.
5. Differentiate the slide in 1% HCL.
6. Bluing is done in 1% ammonia solution.
7. Keep the slide in running water for 5 mins.
8. 10 Dips each of the slide in distilled water flowed by 70% alcohol and absolute
alcohol.
9. Stain in OG-6 and EA-6 for 10 mins.
10. Differentiate in absolute alcohol with 1 dip.
11. Clear in Xyline and mount with DPX.
12. View the slide under microscope.
INTERPRETATION /RESULT NEGATIVE FOR INTRAEPITHELIAL LESION

OR MALIGNANCY
SPECIMEN TYPE:
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Indicate conventional smear (Pap smear) vs. liquid-based preparation vs. other
SPECIMEN ADEQUACY
• Satisfactory for evaluation ( describe presence or absence of endocervical/
transformation zone component and any other quality indicators, e.g., partially
obscuring blood, inflammation, etc. )
• Unsatisfactory for evaluation . . . ( specify reason )
– Specimen rejected/not processed (specify reason )
– Specimen processed and examined, but unsatisfactory for evaluation of
epithelial abnormality because of ( specify reason )
GENERAL CATEGORIZATION (optional )

• Negative for Intraepithelial Lesion or Malignancy
• Other: See Interpretation/Result ( e.g., endometrial cells in a woman ≥45 years
of age )
• Epithelial Cell Abnormality: See Interpretation/Result ( specify ‘squamous’ or
‘glandular’ as appropriate )
INTERPRETATION/RESULT
NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY
(W hen there is no cellular evidence of neoplasia, state this in the General

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Categorization above and/or in the Interpretation/Result section of the report --

whether or not there are organisms or other non-neoplastic fi ndings )
NON-NEOPLASTIC FINDINGS ( optional to report optional to report; list not
inclusive )
• Non-neoplastic cellular variations
– Squamous metaplasia
– Keratotic changes
– Tubal metaplasia
– Atrophy
– Pregnancy-associated changes
Reactive cellular changes associated with:
– Inflammation (includes typical repair)
• Lymphocytic (follicular) cervicitis
– Radiation
– Intrauterine contraceptive device (IUD)
• Glandular cells status post hysterectomy
ORGANISMS
• Trichomonas vaginalis
• Fungal organisms morphologically consistent with Candida spp.

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• Shift in flora suggestive of bacterial vaginosis

• Bacteria morphologically consistent with Actinomyces spp.
• Cellular changes consistent with herpes simplex virus
• Cellular changes consistent with cytomegalovirus
OTHER
• Endometrial cells ( in a woman ≥45 years of age )
( Specify if “negative for squamous intraepithelial lesion” )
EPITHELIAL CELL ABNORMALITIES
SQUAMOUS CELL
• Atypical squamous cells
– of undetermined significance (ASC-US)
– cannot exclude HSIL (ASC-H)
• Low-grade squamous intraepithelial lesion (LSIL)
( encompassing: HPV/mild dysplasia/CIN 1 )
• High-grade squamous intraepithelial lesion (HSIL)
( encompassing: moderate and severe dysplasia, CIS; CIN 2 and CIN 3 )
– with features suspicious for invasion (i f invasion is suspected )
• Squamous cell carcinoma
GLANDULAR CELL
• Atypical

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– endocervical cells (NOS o r specify in comments )

– endometrial cells (NOS o r specify in comments )
– glandular cells (NOS o r specify in comments )
• Atypical
– endocervical cells, favor neoplastic
– glandular cells, favor neoplastic
Endocervical adenocarcinoma in situ
• Adenocarcinoma
– endocervical
– endometrial
– extrauterine
– not otherwise specifi ed (NOS)
OTHER MALIGNANT NEOPLASMS: (specify)
ADJUNCTIVE TESTING
Provide a brief description of the test method(s) and report the result so that it is
easily understood by the clinician.
COMPUTER-ASSISTED INTERPRETATION OF CERVICAL CYTOLOGY
If case examined by an automated device, specify device and result.
EDUCATIONAL NOTES AND COMMENTS APPENDED TO CYTOLOGY
REPORTS ( optional )

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Suggestions should be concise and consistent with clinical follow-up guidelines

published by professional organizations (references to relevant publications may
be included).
Reference: The 2014 Bethesda system for reporting cervical cytology
SOP# SIPL/CYTO/04
LIQUID BASED CYTOLOGY (LBC)

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Intended Use:- To study the cytology of the ectocervix and endocervix. To

reduce the screening area of tedious conventional Pap smear and
obscurance by blood and inflammation.
Procedure:-
1. Obtain an adequate sampling from the cervix using a broom-like device.

2. Insert the central bristles of the broom into the endocervical canal deep
enough to allow the shorter bristles to fully contact the ectocervix.
3. Push gently, and rotate the broom in a clockwise direction five times.
4. Rinse the broom as quickly as possible into the PreservCyt solution vial by
pushing the broom into the bottom of the vial 10 times, forcing the bristles
apart.
5. As a final step, swirl the broom vigorously to further release material into the
solution.
6. Using the thumb and forefinger of gloved hand, disconnect the head of the
device in to the preservative solution.
7. Tighten the cap so that the torque line on the cap passes the torque line on the
vial.
8. Write the patient’s name and ID on the sticky label on the vial.
9. Write any relevant clinical information and medical history on the request form.
10. Any unlabeled vial will be rejected and discarded. A call will be made to the
clinic before specimen is rejected.

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Principle : The Prep Stain System converts a liquid suspension of a cervical

cell sample in to a discretely stained, homogenous thin-layer of cells while
maintaining diagnostic cell clusters. The process includes cell preservation,
randomization, enrichment of diagnostic material, pipetting, sedimentation,
staining and cover slipping to create a slide for use in routine cytology
screening and categorization as defined by Bethesda System. The sure
path slide presents a well-preserved population of stained cells present within
a 13mm diameter circle. The number of white blood cells is significantly
reduced, allowing for easier visualization of epithelial cells, diagnostically
relevant cells and infectious organisms.
Person authorized to perform test:- Doctor/ Technician
Person authorized to do reporting: -Pathologist
Sample [ storage and stability]:-. Preservative fluid without cytologic

samples at room temperature (15 to 30ºC) in vials provided. Preservative fluid
preserves cells for up to 4 weeks at room temperature
(15 to 30ºC).

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Turn Around Time-: Samples are collected from 9 a.m. to 5p.m. Report is
given after 24 hours of collecting the sample.
Equipment:-
Prep Mate BD Sure Path
Reagent:-
Rapid Papanicolaou Stain
Staining : -
1.Smears are prepared as per procedure described.

2.10 dips each in three changes of buffer solution.
3 .Stain in Harris Haematoxilin for 75 seconds.
4. Differentiate in Blind Ringer reagent 10 dips each in three changes.
5. Stain in Combo reagent for 85 seconds.
6. 10 dips each in three changes of Blind Ringer reagent.
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7. Dip in Xylene in three changes.

8.Mount with DPX.
9. View slide under microscope for staining..
INTERPRETATION /RESULT NEGATIVE FOR INTRAEPITHELIAL LESION

OR MALIGNANCY
SPECIMEN TYPE:
Indicate conventional smear (Pap smear) vs. liquid-based preparation vs. other
SPECIMEN ADEQUACY
• Satisfactory for evaluation ( describe presence or absence of endocervical/
transformation zone component and any other quality indicators, e.g., partially
obscuring blood, inflammation, etc. )
• Unsatisfactory for evaluation . . . ( specify reason )
– Specimen rejected/not processed (specify reason )
– Specimen processed and examined, but unsatisfactory for evaluation of
epithelial abnormality because of ( specify reason )
GENERAL CATEGORIZATION (optional )

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• Negative for Intraepithelial Lesion or Malignancy

• Other: See Interpretation/Result ( e.g., endometrial cells in a woman ≥45 years
of age )
• Epithelial Cell Abnormality: See Interpretation/Result ( specify ‘squamous’ or
‘glandular’ as appropriate )
INTERPRETATION/RESULT
NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY

(W hen there is no cellular evidence of neoplasia, state this in the General
Categorization above and/or in the Interpretation/Result section of the report --
whether or not there are organisms or other non-neoplastic fi ndings )
NON-NEOPLASTIC FINDINGS ( optional to report optional to report; list not
inclusive )
• Non-neoplastic cellular variations
– Squamous metaplasia
– Keratotic changes
– Tubal metaplasia
– Atrophy
– Pregnancy-associated changes

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Reactive cellular changes associated with:

– Inflammation (includes typical repair)
• Lymphocytic (follicular) cervicitis
– Radiation
– Intrauterine contraceptive device (IUD)
• Glandular cells status post hysterectomy
ORGANISMS
• Trichomonas vaginalis
• Fungal organisms morphologically consistent with Candida spp.
• Shift in flora suggestive of bacterial vaginosis
• Bacteria morphologically consistent with Actinomyces spp.
• Cellular changes consistent with herpes simplex virus
• Cellular changes consistent with cytomegalovirus
OTHER
• Endometrial cells ( in a woman ≥45 years of age )
( Specify if “negative for squamous intraepithelial lesion” )
EPITHELIAL CELL ABNORMALITIES
SQUAMOUS CELL
• Atypical squamous cells

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– of undetermined significance (ASC-US)

– cannot exclude HSIL (ASC-H)
• Low-grade squamous intraepithelial lesion (LSIL)
( encompassing: HPV/mild dysplasia/CIN 1 )
• High-grade squamous intraepithelial lesion (HSIL)
( encompassing: moderate and severe dysplasia, CIS; CIN 2 and CIN 3 )
– with features suspicious for invasion (i f invasion is suspected )
• Squamous cell carcinoma
GLANDULAR CELL
• Atypical
– endocervical cells (NOS o r specify in comments )
– endometrial cells (NOS o r specify in comments )
– glandular cells (NOS o r specify in comments )
• Atypical
– endocervical cells, favor neoplastic
– glandular cells, favor neoplastic
Endocervical adenocarcinoma in situ
• Adenocarcinoma
– endocervical
– endometrial

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– extrauterine
– not otherwise specifi ed (NOS)
OTHER MALIGNANT NEOPLASMS: (specify)
ADJUNCTIVE TESTING
Provide a brief description of the test method(s) and report the result so that it is
easily understood by the clinician.
COMPUTER-ASSISTED INTERPRETATION OF CERVICAL CYTOLOGY
If case examined by an automated device, specify device and result.
EDUCATIONAL NOTES AND COMMENTS APPENDED TO CYTOLOGY
REPORTS ( optional )
Suggestions should be concise and consistent with clinical follow-up guidelines
published by professional organizations (references to relevant publications may
be included).
Reference: The 2014 Bethesda system for reporting cervical cytology

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Conventional Pap Smear LBC
• In a conventional pap smear, cells • Whereas the liquid based pap

are scraped from the cervix and test is an addition to the
smeared directly on the slide and conventional pap, producing
the collection device is discarded a thin layer cell preparation
along with the remaining cervical process intended for the use
cell sample. in the screening and
detection of cervical cancer ,
pre-cancerous lesions,
atypical cells .The head of the
collection device is detached
and placed into the liquid
medium which can be
preserved for a period of 4
weeks and can be sent
further for HPV detection.
 More screening time  Less screening time

 More background obscuration  Cleaner background
 Uneven spread of cellular elements.  Better spread of cellular
elements.

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Quality Control:-
Internal :- Log is maintained to check the quality of Pap stain

Inter person comparison.
External :- EQAS ( PGI Chandigarh, once a year)
Interference: Not applicable.
Safety & Precautions:
Gloves should be worn at the time of collecting the sample.

Good laboratory practices should be followed and all the procedures for use of
the Prep Stain system should be strictly observed.
Reference: Sure Path Collection product insert.

The 2014 Bethesda system for reporting cervical cytology.

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SOP# SIPL/CYTO/05
FLUIDS
Intended Use: To determine the cytological and biochemical parameters of

different fluids to determine the abnormality/cause of the effusion.
Principle of Test: Received Fluid is diluted in Turk’s fluid (WBC fluid) in 1:20
dilution which is charged into the neubauer’s chamber. Four large corner squares
are counted for cells (WBCs).

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Calculation formula : - N (number of cells counted) X 50
In case of CSF un-diluted fluid is charged into neubaur’s chamber and all 9 large
squares are counted which gives the total WBC count.
*N = Number of cells.
Biochemistry-Includes Glucose, protein and chloride. ( refer SOP #SIPL/BIO/01, SOP

#SIPL/BIO/10, SOP #SIPL/BIO/24)
Person Authorized to perform test: Pathologist, Technician
Sample [Type of sample, Storage and stability]: CSF, Peritoneal, pleural,

synovial, any other body fluids. Sample can be stored at 2-8 oC for 24 hours.
Turnover Time: Sample is collected from 8a.m. to 7pm. Report is given after 10-
12hrs of collecting the sample. In case of emergency report is provided within
2hrs of collecting the sample.
Equipment
Cytology
Neubauer’s Chamber
Slides
Microscope
Biochemistry Vitros 5600 (fully automated analyzer)
Technique:
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1. Physical Appearance
Volume
Colour
Transparency/ Turbidity
Clot formation/coagulum
Presence or absence of blood.
2. Cytology
TLC-Done on Neubauer Chamber
Cytospin Smear Preparation:-
100 microlitre of fluid is poured in cytofuge well, filter paper is fixed in the slide
frame, slides are adjusted, Slides frame is put in cytofuge along with balance.
Cytofuge lid is closed and rotated for 10 minutes. Slide is taken out, dried and
stained.
Staining Procedure :-
MGG stain is poured over the slide and kept for 1 minute, then Geimsa stain
(1:9 dilution) is prepared and poured over the slide and kept for 10 – 15
minutes.
Slide is washed in running tap water, dried and mounted.
3. Biochemistry
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Glucose/Protein/Chloride done by automated method. (On Vitros 5600)
Calculation and Result: Not Applicable.
Quality Control :- EQAS

Interpersonal comparison.
Linearity:- Not Applicable.
Interference and limitation of procedure

Same as that for the TLC, Protein, Sugar, Chloride.
Biological Test Intervals:-
Fluid Ref. Rang of TLC Ref. Rang of Ref. Rang Ref. Rang of
Types Protien of Glucose Chloride/U acid
CSF Adult – 0-5/ cumm 15 – 45 mg/dL 50 – 80 115 – 130 mEq/L
1-15 yrs. 0-10/ cumm mg/dL
< 1yr. 0 - 30/ cumm
Ascitic < 100/cumm < 3.0 g/dL 70 – 100

mg/dL
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Pleural < 100/cumm 1 – 2 g/dL 70 – 100

mg/dL
Synovial 0 – 150 /cumm 1 – 3 g/dL 70 – 110 U Acid: 2 – 8 mg/dL

Neutrophils < 25% mg/dL*
Note: * Blood Glucose/ Synovial fluid difference is 0 – 10mg/dL.
Interpretation :-
CSF Bacterial Viral Meningitis Tubercular

Meningitis Meningitis
TLC > 1000/cumm <100/ cumm Variable

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Protein Mild to Marked Normal to mild Increased

increase increase
Glucose ≤40 mg/dL Normal <45 mg/dL
SAAG ( Serum to Ascitic Albumin Gradient = Serum Albumin – Ascitic Albumin

g/dL).
Ascitic
High Albumin Gradient Ascitis Low Albumin Gradient Ascitis

( ≥ 1.1) (≤ 1.1)
Causes : Cirrhosis Causes : Tubercular Peritonitis

Congestive heart failure Nephrotic Syndrome
Spontaneous bacterial peritonitis
Protein less than 3.0 g/dL-Transduate

Protein more than 3.0 g/dL-Exudate.
Glucose less than 50 mg/dL may be seen in TB and peritoneal carcinomatosis.

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Pleural Fluid
1. The Fluid is considered as exudate if ratio of Pleural fluid to serum protein

is ≥ 0.5.
2. Pleural Fluid /Serum LDH is ≥ 0.6.
3. Pleural Fluid/ Serum LDH > 2/3 of upper limit of normal serum LDH value.
Synovial Fluid
Group I Group II Group III Group IV

Non Inflammatory Inflammatory Infectious Hemmorhagic
WBC/cumm <3000 3000- 75000 50,000 – 2,00, 000 50-10,000
Polymorphs <30 >50 >90 <50
Blood 0 - 10 0 - 40 20 – 100 0-20

Glucose
/Synovial Fluid
Difference (in
mg/dL)

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Reference:- Henry’sClinical Diagnosis and Management by laboratory methods

21st edition (page 426-449)
STAR IMAGING & PATH LAB (P) LTD.

4B/4 TILAK NAGAR,
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NEW DELHI 110018
Tel.: 011-45602200 (100 lines)

Website : www.starimaging.in

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SOP CYTO Updated

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Star Imaging & Path Lab Private Limited

Title: SOP Cytopathology

Effective Date: Revision:

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Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

S. No. PARAMETER SOP No. PAGE

1. FNAC SIPL/CYTO/01 5-6

Star Imaging & Path Lab (P) Ltd.

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

Name of Department: Cytopathology

Adopted Date Sign of Tech Sign of HOD

Star Imaging & Path Lab (P) Ltd.

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

4. P-22 Interpretation 15/10/2018 Addition of

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

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Principle of Test: Cell/Fluid is aspirated by applying negative pressure

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

Person Authorized to perform Test: Pathologist (authorized signatory)

Star Imaging & Path Lab (P) Ltd.

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

Calculation: Not applicable.

Biological Test Interval: Not applicable.

Quality Control : - EQAS (PGI Chandigarh, once a year)

Linearity: Not applicable.

Interference & Limitations: Not applicable.

Interpretation: Depending upon the site and clinical findings interpretation is

 The cytology smears are reviewed in-house by at least two

Star Imaging & Path Lab (P) Ltd.

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

 ILC is done for both cytology and histopathology slides.

Safety and precautions:-

1. Gloves should be worn at the time of FNAC

Intended Use: Fine needle aspiration cytology under USG/CT guidance of

Principle of Test: Cell/Fluid is aspirated under USG/CT guidance with the

Person Authorized to perform Test :- Pathologist & Radiologist

Star Imaging & Path Lab (P) Ltd.

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

Star Imaging & Path Lab (P) Ltd.

Prepared by QM Approved by HOD Issued by

Title: SOP Cytopathology

Effective Date: Revision:

7) Wash the smears in distilled water and let them dry.

Calculation: Not applicable.

Biological Test Interval: Not applicable.

Quality Control: - EQAS (PGI Chandigarh, once a year)

Linearity: Not applicable.

Interference & Limitations: Not applicable.