Guidebook For Cervical Cancer Screening

GUIDEBOOK
for
CERVICAL CANCER
SCREENING
Guidebook for Cervical Cancer Screening iii
FOREWORD
DR HAJAH FARIDAH BINTI ABU BAKAR
Director
Family Health Development Division
Ministry of Health Malaysia
In Malaysia, cervical cancer is the third most common cancer among women
and the seventh highest among the entire population (Malaysia National Cancer
Registry report (MNCRR), 2007 – 2011). There were a total of 4,352 cases
diagnosed in 2007 to 2011 with an incidence rate (ASR) of 7.6 per 100,000
population accounting for 3.8% of all female cancers. More than 76% were
diagnosed at stage II and above, where intensive and invasive treatment are
required more often, culminating in increased economic burden.
Cervical cancer screening in Malaysia via conventional Pap smear was initiated
in 1969 through a family service package. Decades later with relentless efforts
and political advocy, a nationwide, opportunistic, clinic-based screening, “The
National Pap Smear Screening Programme” was established in 1998, aimed
for early detection of cervical cancer and ensuring early treatment as well as
follow-up after positive test results. This programme is still ongoing with
further enhancement to ensure the processes involved are performed
efficiently.
The Ministry of Health (MOH) has introduced an alternative method to address

the shortcomings of the conventional Pap smear which is liquid-based cytology
(LBC) in several states in the country. It has been proven that this method has
higher sensitivity rate in detecting precancerous lesions. Research have shown
significantly reduced numbers of unsatisfactory smears using LBC compared
with the conventional Pap smear.
iv Guidebook for Cervical Cancer Screening
The contributors to this guide book has established algorithms for managing
women with abnormal Pap smear and HPV results as well as management of
biopsy confirmed pre-invasive lesions that can be used by all levels of
healthcare workers involved in the cervical cancer screening programme. It is
produced based on local experiences and references from practices of other
countries such as United Kingdom, United State, Singapore and Australia. The
aims of this guideline are to standardize the cervical screening programme,
the management of abnormal cervical smear and biopsy confirmed cervical
pre-invasive lesions.
The development of this comprehensive guideline as well as the transformation

of the current cervical cancer screening tool from Pap smear to HPV test is the
way forward towards enhancing early detecting of cervical cancer. It is hoped
that this revised guideline will improve the programme’s performance and
assist in reducing the incidence of cancer of the cervix, and ultimately ensure
the health and well-being of women in Malaysia.
I would like to congratulate and thank the editors and the contributors for their
efforts towards the development of this revised guideline as well as those
preceding it.
DR HAJAH FARIDAH BINTI ABU BAKAR

Director
Family Health Development Division
Ministry of Health Malaysia
Guidebook for Cervical Cancer Screening v
LIST OF CONTRIBUTORS
Dr. Zaridah bt. Shafie

Pakar Perunding Kanan Obstetrik &
Dr. Hajah Faridah bt. Abu Bakar
Pengarah
Bahagian Pembangunan Kesihatan Keluarga Ginekologi (Ginekologi-Onkologi)
Kementerian Kesihatan Malaysia Hospital Tunku Fauziah
Dr. Jamil bin Omar

Pakar O&G (Ginekologi-Onkologi)
Dr. Zaleha bt. Abdul Hamid
Pegawai Kesihatan Primer Negeri
Jabatan Kesihatan Wilayah Persekutuan Institut Kanser Negara
Kuala Lumpur dan Putrajaya
Dr. Badrulzaman bin Muda @ Abdullah
Pakar Ginekologi-Onkologi
Hospital Sultan Ismail
YBhg. Dato’ Dr. Mohd Rushdan Mohd Noor
Pakar Perunding Kanan Obstetrik &
Ginekologi dan Pengerusi,
Subcomittee Ginekologi-Onkologi, Dr. Yong Chee Meng
Jawatankuasa Pengurusan dan Pakar Perunding Kanan Obstetrik &
Perkembangan Obstetrik & Ginekologi Ginekologi
Kebangsaan Hospital Ampang
Datin Dr. Fauziah bt Kassim

Pakar Perunding Patologi
Dr. Mukarramah bt. Che Ayub
Pakar Perunding Kanan Patologi
Hospital Raja Perempuan Zainab II Hospital Kuala Lumpur
Dr. Fuziah bt. Paimin

Pakar Perunding Perubatan Keluarga
Dr. Noor Laili Mohd Mokhtar
Hospital Serdang Klinik Kesihatan Presint 9,
PKD Putrajaya
Dr. Azlina bt. Abdul Rahman
Pakar Perunding Patologi Dr. Maimunah bt. Mahmud
Hospital Tengku Ampuan Afzan Pakar Perunding Perubatan Keluarga
Klinik Kesihatan Sungai Buloh
Dr. Razmin bt. Ghazali PKD Gombak
Pakar Patologi
Hospital Kuala Lumpur Dr. Shahila bt.Tayib
Pakar Obstetrik & Ginekologi
(Ginekologi-Onkologi)
Hospital Pulau Pinang
Dr. Prof. Dr. Ahmad Zailani Hatta bin
Mohd Dali
Pakar Perunding Ginekologi-Onkologi
Pusat Perubatan Hospital Universiti
Kebangsaan Malaysia
vi Guidebook for Cervical Cancer Screening
Dr. Nor Saleha Bt. Ibrahim Tamim Jamal Nasir Bin Sohaimi
Pakar Perubatan Kesihatan Awam Ketua Penyelia Penolong Pegawai Perubatan
Bahagian Kawalan Penyakit Sektor Dewasa,
Kementerian Kesihatan Malaysia Cawangan Kesihatan Keluarga
Bahagian Pembangunan Kesihatan Keluarga
Dr. Zakiah Bt. Mohd Said Kementerian Kesihatan Malaysia
Pakar Perubatan Kesihatan Awam
Sektor Dewasa, Dr. Shazimah Abd Samad
Cawangan Kesihatan Keluarga Pakar Perubatan Kesihatan Awam
Bahagian Pembangunan Kesihatan Keluarga Sektor Dewasa,
Kementerian Kesihatan Malaysia Cawangan Kesihatan Keluarga
Bahagian Pembangunan Kesihatan Keluarga
Dr. Suryani Bt. Yusof Kementerian Kesihatan Malaysia
Hospital Tunku Jaafar Dr. Wan Mohd Shariffudin Bin Zainudin
Ketua Penolong Pengarah
Dr. Farveen Marican Bt. Abu Backer Sektor Dewasa,
Ketua Jabatan Patologi Cawangan Kesihatan Keluarga
Hospital Sultan Abdul Halim Bahagian Pembangunan Kesihatan Keluarga
Kementerian Kesihatan Malaysia
Matron Rajeswary A/P N. Marie
Ketua Penyelia Jururawat Kesihatan Matron Rohaidza @ Aniza Bt. Jahaya
Sektor Dewasa, Sektor Dewasa,
Cawangan Kesihatan Keluarga Cawangan Kesihatan Keluarga
Bahagian Pembangunan Kesihatan Keluarga Bahagian Pembangunan Kesihatan Keluarga
Kementerian Kesihatan Malaysia Kementerian Kesihatan Malaysia
CONTENTS
TITLE PAGE
Foreword iii
List of Contributors v
List of Figures x
List of Tables xi
List of Abbreviations xii
1. Introduction 1
2. Objectives 4
3. Screening policy 4
3.1 Target groups 4
3.2 Screening interval 4
3.3 Screening Personnel 4
3.4 Reporting Personnel 4
4. Screening Options 5
4.1. Cytology Based Screening 5
4.1.1 Conventional Pap smear 5
4.1.2 Liquid-based Cytology 5
4.2 Molecular based technique using HPV test 5
4.3. Others 5
5. Taking a Pap smear 6

5.1. Advice for the woman 6
5.2. Requirements for Taking Smears in Clinic 6
5.3. How to take a Pap smear 6
5.4 Reasons for unsatisfactory smear 7
viii Guidebook for Cervical Cancer Screening
6. Sample processing in the cytology laboratory 15

6.1. Equipment 15
6.2. Processing 15
6.2.1 Conventional 15
6.2.2 Liquid-based 16
6.2.3 HPV testing 16
7. Pap Smear Reporting 16

7.1 Specimen Type 16
7.2 Adequacy of specimen 16
7.2.1 Satisfactory for evaluation 16
7.2.2 Unsatisfactory for evaluation 16
7.3 Interpretation/ Result 17
7.3.1 Negative for intraepithelial lesion or malignancy (NILM) 17
7.3.2 Epithelial cells abnormalities encompassing 17
squamous cell lesions, glandular cell lesions
and other malignant neoplasms
8. Management of Abnormal Cervical Smears 19

8.1 Management of Unsatisfactory Smear 20
8.2 Management of Normal Smear 21
8.2.1 Management of Negative for Intraepithelial
Lesion or Malignancy (NILM) 22
8.3 Management of Abnormal Pap Smear: 23
8.3.1. Squamous Cell Abnormalities 24
8.3.2. Glandular Cell Abnormalities 25
8.3.3. Management of woman age ≥ 45 with 26
endometrial cells presence undergoing Pap smear
8.3.4. Management of HPV results following HPV DNA 27
testing (lab-based test)
8.4 Pap Smear Guidelines after Hysterectomy 28
8.5 Management of Abnormal Pap Smear and CIN in Pregnancy 29
8.6 Indications for colposcopy 30
Guidebook for Cervical Cancer Screening ix
9. Management Of Biopsy Confirmed Pre-Invasive Lesion 31

9.1 Grade 1 (CIN 1) 32
9.2 Grade 2/3 (CIN 2 / CIN 3) 33
9.3 Suspicious of Micro-Invasion on Punch Biopsy 34
9.4 Adenocarcinoma in-situ on punch biopsy 35
10. Colposcopy Management Guidelines 36

10.1 Introduction 36
10.2 Colposcopic Management of CIN 1 37
10.3 Colposcopic management of CIN 2/3 in patient >25 38
10.4 Colposcopic management of CIN 2/3 in patient <25 39
years old
10.5 Follow-up post treatment for CIN 40
References 42
Appendix 1: Definition of Terms 45

Appendix 2: HPV Test / Cytology Request Form 46
Appendix 3: Pap Smear/Liquid-based Cytology Report 47
Appendix 4: HPV Test Result Report 48
Appendix 5A: Notification Letter to Clients with Normal Smear / HPV 49
Negative (English)
Appendix 5B: Notification Letter to Clients with Normal Smear / HPV 50
Negative (Malay)
Appendix 5C: Notification Letter to Clients with Abnormal HPV / 51
Pap Smear / LBC (English)
Appendix 5D: Notification Letter to Clients with Abnormal HPV / 52
Pap Smear / LBC (Malay)
Appendix 6: Cervical Brush for Cervical Sampling 53
Appendix 7: A guide and reporting pro forma for colposcopic 54
biopsies performed for the diagnosis and treatment
of pre-invasive cervical neoplasia
Appendix 8: Examples of Pathology Report 60
x Guidebook for Cervical Cancer Screening
LIST OF FIGURES
Figure 1: Organizations Providing Cervical Cancer Screening 3

Services
Figure 2: Pap Smear Sampling Procedure 11
Figure 3: Labelling with 2 unique identifiers on the frosted end of 12
glass slide
Figure 4: Cervical Smear Using Cervical Sampler Broom 12
Figure 5: Smearing the sample using a cervical sample broom in 13
one direction
Figure 6: Fixation of smear by alcohol spray 13
Figure 7: Transferring of sample into the vial containing preservative 14
Figure 8: Position of transformation zone (TZ) 14
Figure 9: Management of Unsatisfactory Smear 19
Figure 10: Management of NILM 20
Figure 11: Management of Atypical Squamous Cells 21
Figure 12: Management of Low Grade Squamous Intraepithelial 22
Lesion (LSIL)
Figure 13: Management of High-grade Squamous Intraepithelial 23
Lesion and Squamous Cell Carcinoma
Figure 14: Management of Atypical Glandular Cells and 24
Adenocarcinoma
Figure15: Management of Atypical Glandular Cells/ Endocervical 25
Adenocarcinoma-Situ/Adenocarcinoma
Figure 16: Management of presence of endometrial cells in women 26
more than 45 years old
Figure 17: Management of HPV results following HPV DNA testing 27
Figure 18: Management of Biopsy Confirmed Pre-invasive Lesion 31
Figure 19: Management of CIN 2/CIN 3 33
Figure 20: Management of Suspicious of Micro-Invasion on biopsy 34
Figure 21: Management of Adenocarcinoma In-situ on punch biopsy 35
Figure 22: Transformation Zone Categories 36
Guidebook for Cervical Cancer Screening xi
Figure 23: Management of CIN1 Following Colposcopy 37

Figure 24: Management of CIN2/3 in patients aged 25 years 38
and above following colposcopy
Figure 25: Management of CIN2/3 in patients aged 25 years and 39
less following colposcopy
Figure 26: Options for Follow-up Post Treatment 40
LIST OF TABLES
Table 1: Guidelines for Pap Smear Following Hysterectomy 28

Table 2: Recommended Waiting Time for Colposcopy 41
Appointment Following Pap Smear Report
xii Guidebook for Cervical Cancer Screening
LIST OF ABBREVIATIONS
AC Adenocarcinoma
AGC-N Atypical Glandular Cells-Favour Neoplasia
AGC-NOS Atypical Glandular Cells-Not Otherwise Specified
AIS Adenocarcinoma In Situ
ALTS Triage Study For Cervical Cancer
ASC-H Atypical Squamous Cells-Cannot Exclude High-Grade
Squamous Intraepithelial Lesion
ASCUS Atypical Squamous Cells Of Undetermined Significance
CIN Cervical Intraepithelial Neoplasia
ECC Endocervical Curettage
HPV Human Papillomavirus
HR-HPV High-Risk HPV
HSIL High-Grade Squamous Intraepithelial Lesion
LEEP/ LLETZ Loop Electrosurgical Excision Procedure/Large
Loop Excision Of The Transformation Zone
LSIL Low-Grade Squamous Intraepithelial Lesion
Pap smear Papanicolaou Smear
SCC Squamous Cell Carcinoma
TZ Transformation Zone
Guidebook for Cervical Cancer Screening 1
1. INTRODUCTION
Cervical cancer is the fourth most common cancer worldwide, affecting

women after breast, colorectal, and lung cancers, and ranks the eighth
overall, with an estimated 570,000 new cases in 2018 (Bray et al., 2018).
It is also the fourth most common cause of cancer death with an
estimation of 311,365 deaths in 2018 worldwide (World Health
Organization, 2018).
In Malaysia, cervical cancer is the third most common cancer among

women and the seventh highest among the entire population (Azizah, Nor
Saleha, Noor Hashimah, Asmah, & Mastulu, 2016). Chinese women were
found to have the highest incidence of cervical cancer followed by Indian
and Malay. Unfortunately, majority of patients (76%) with cervical cancer
are often detected at stage 2 and above which affects their prognosis.
A total of 4,352 cervical cases were diagnosed between 2007 – 2011 (ASR
was 7.6 per 100,000 population) which accounted for 3.8% of all female
cancers (Azizah et al., 2016). Cervical cancer incidence rate increased
with age after 30 years and has its peak at ages 60-69 years (Malaysian
Health Technology Assessment Section (MaHTAS), 2011).
Therefore, it is imperative to ensure the implementation of screening in

assuring early detection of cervical cancer. The cornerstone of cervical
cancer screening worldwide has been the Papanicolaou test; also known
as the Pap test or the Pap smear, which was developed by Georgios
Papanikolaou in 1940s. This tool is deemed to be useful in identifying
morphological changes in the cervical epithelium. The slow evolvement
of this disease through a long latent period supports its early
detection. Thus, diagnosing cervical cancer at an early stage and
providing access to effective treatment can significantly improve the
likelihood of survival.
Screening of cervical cancer was introduced in 1969 in Malaysia, as part

of a family services package, through the Maternal and Child Health
Services, Ministry of Health Malaysia. Conventional Pap smear was the
screening method employed in the clinics. Cervical cancer gained further
2 Guidebook for Cervical Cancer Screening
leverage in 1995 when ’cancer’ was chosen to be the theme of the Healthy
Lifestyle Campaign.
The objectives of this cervical cancer screening programme are:

a. To ensure early detection of cervical cancer
b. To determine the magnitude and extent of cervical cancer
among the target group
c. To plan activities for management and follow-up of women with
abnormal Pap smears
The current national policy for Pap smear screening programme is to

screen all women aged 30 and 65 years for cervical cancer, once every
three years.
The programme is carried out as an opportunistic screening where women

who attend the clinics for health screenings will be offered to undergo Pap
smear screening. Other agencies that are providing this service include
the National Population and Family Development Board (NPFDB),
university hospitals, private hospitals and clinics, hospitals and health
facilities of Ministry of Defence and the non-governmental organizations
(NGO) for example Federation of Reproductive Health Association
Malaysia (FRHAM), National Cancer Society of Malaysia (NCSM) and
National Cancer Council (MAKNA).
Pap smear coverage in Malaysia was 26% in 1996 (Narimah, 1997) and
43.7% in 2006 (Institute for Public Health (IPH), 2008). Most of these Pap
smears are done on women who come for post-natal check-up (Nor Hayati
& Ayob, 1997). Despite this, primary cervical cancer screening by Pap
smear is considered as the most successful cancer screening programme
to date.
Another technique of Pap test is Liquid-based Cytology (LBC) which offers

an alternative of cervical cell sample preparation to address the
shortcomings of the traditional Pap test. It produces better quality slides
since unwanted materials such as blood clots or mucous are removed as
well as cells are more evenly distributed. Studies has demonstrated that
this technique is as effective as the traditional smear (Moseley & Paget,

2002; Strander, Andersson‐Ellström, Milsom, Rådberg, & Ryd, 2007).
Despite its success, cytology has limitations especially technical

limitations regarding sampling and laboratory errors in screening and
interpretation. Therefore in recent years, there has been interest for
producing new tests with acceptable sensitivity and specificity for
detecting clinically significant cervical cancer precursors. One method is
HPV testing based on the knowledge that it results from Human
Papillomavirus infection.
This test will be incorporated in the current cervical cancer screening

programme. In contrast to screening by cytology, HPV testing is based
on the detection of HPV DNA, HPV mRNA or other viral markers
(Chrysostomou, Stylianou, Constantinidou, & Kostrikis, 2018). This test
maybe done as a primary screening strategy every 5 years or combined
with Pap smear in women over 30 years of age at an interval of at least 3
to 5 years in women who are negative on both tests in the annual
screening (Malaysian Health Technology Assessment Section (MaHTAS),
2011).
Ministry of Health
(Clinics and hospitals)
Pap smear FRHAM

NPFDB
services
University Private clinics/

Hospitals NGOs
hospitals
Note:
NPFDB: National Population and Family Development Board (Ministry of Women,
Family and Community Development)
FRH AM : Federation of Reproductive Health Association of Malaysia
NGOs : Non -governmental organizations
Figure 1: Organizations Providing Cervical Cancer Screening Services

2. OBJECTIVES
2.1. As a guide and reference for health personnel

2.2. To standardize the cervical screening programme
2.3. To standardize the management of abnormal cervical smear
2.4. To standardize the management of biopsy confirmed cervical pre-
invasive lesion.
3. SCREENING POLICY
3.1. Target groups
The cervical smear services are offered to all sexually active women
between the ages of 30 and 65 years. However, those who are sexually
active but less than 30 years are encouraged to come for screening.
3.2 Screening interval
• The initial screening interval is yearly for two years. If the results
were normal, then a 3-yearly Pap smear screening is indicated.
• If cytology and HPV testing were done together and both results
were negative, then the cervical screening interval is 5-yearly.
3.3 Screening Personnel
Doctors and nurses trained in taking cervical smears.
3.4 Reporting Personnel
Pathologists and Cytotechnologists.

4. SCREENING OPTIONS
4.1. Cytology Based Screening
4.1.1 Conventional Pap smear

Sample from cervical scrape is obtained using cervical
brush/broom and smeared directly onto a glass slide,
immediately fixed with 95% alcohol and stained with
Papanicolaou method for microscopic examination.
4.1.2 Liquid-based Cytology

Sample from cervical scrape is obtained using cervical
brush/broom and suspended in a vial of preservative for
transport to the laboratory.
The sample is processed and placed onto a glass slide

and stained with Papanicolaou method for microscopic
examination. The choice of technology must be FDA
approved or equivalent.
4.2 Molecular based technique using HPV test
HPV test is a molecular technique using a sample of cervical cells, to

detect the presence of Human Papillomavirus (HPV). This test screens
for high risk HPV genotypes. HPV test has been validated as reflex testing
for ASC-US and Low- Grade Squamous Intraepithelial Lesion.
Many developed countries have adopted HPV testing as a primary

screening tool (Pan American Health Organization (PAHO), 2016).
Incorporation of HPV testing into cervical cancer screening programmes
has the possibility of increased disease detection and lengthening the
screening interval (Saslow et al., 2012).
4.3. Others
In low resource areas, other options of cervical screening can be adopted

such as Visual Inspection with acetic acid (VIA)/VILLI.
5. TAKING A PAP SMEAR
5.1. Advice for the woman
i. Do not douche or insert any form of medication (suppositories) into

the vagina 24 hours prior to the procedure.
ii. Avoid sexual intercourse within a period of 24 hours prior to the
procedure.
iii. Avoid taking Pap smear during menstruation.
iv. Pap smear can be done during pregnancy.
5.2. Requirements for Taking Smears in Clinic
i. Bivalve vaginal speculum (CUSCO) - all sizes preferably disposable.

ii. Swabs
iii. Normal saline
iv. Hand gloves
v. Sampling devicesor instruments (refer to appendix C)
vi. Request form - PS1/98 (Pindaan 2019)
vii. Adequate light source
viii. Couch and screen
5.2.1 Conventional Smear

i. Frosted end glass slide and 2B pencil or ordinary
glass slide and diamond pencil.
ii. Fixative – 95% ethyl alcohol in coplin jar or alcohol
spray
iii. Slide mailer
5.2.2 Liquid-based Cytology

Preservative vial
5.3. How to take a Pap smear
For further clarification, please refer to Figure 2.

1. Complete the cytology request form - PS 1/98 (Pindaan 2019) and

label the glass slide or vial (Figure 3).
2. Wash your hands and wear gloves.
3. Examine the woman in a dorsal position.
4. Swab the introitus with normal saline.
5. Wet the bivalve speculum using sterile water or normal saline

(Do not use lubricant).
6. Introduce the speculum into the vagina carefully avoiding contact

with the cervix (for conventional smear, bleeding from the cervix
will interfere with the evaluation of smear).
7. Expose the cervix clearly. If there is a discharge, take a swab for

microscopic examination and send for culture and sensitivity if
indicated. Remove excess discharge before taking the cervical
sample.
8. Take a sample from the cervix using the sampler device according
to the sample type:
i. Conventional:
Take sample from the cervix including transformation zone,
turn one complete circle 360 degrees. Smear the sample onto
the labelled glass slide in one direction (Figure 5).
Note:
i. Position of transformation zone (TZ) varies according to age.
Selection of sampling device should be in accordance to the location
of transformation zone. (Figure 8A and Figure 8B)
ii. Smear should be taken before performing bimanual examination
iii. During colposcopic examination, smear should be taken before
applying acetic acid
ii. Liquid-based:
Take sample from the cervix including transformation zone.
Follow the instruction as in user manual, example:
ThinPrep: 360 degrees rotation 3X.

SurePath: 360 degrees rotation 5X in clockwise manner.
9. Fixation:
i. Conventional
a) After taking smear, immediately dip the slide into coplin
jar containing 95% ethyl alcohol for 30 minutes. Once
completed, stand the slide on slide rack to drain excess
fluid.
b) For spray fixation, spray fixative should be placed 15-25cm
and sprayed at the right angle. (Refer Figure 6)
ii. Liquid-based
Follow instruction as in user manual, example
a) ThinPrep:
Rinse the brush vigorously inside the preservative vial by
swirling and pushing against the vial wall 10 times.
Discard the brush.
Note:
• The fixative (95% ethyl alcohol) must be placed in a covered
container to avoid evaporation.
• The fixative must be changed regularly
• Do not allow the smeared slide to dry before fixation
• Endobrush may be used in severely atrophic cervix
• Ensure correct labelling of slide and completion of form
• Details of previous smears (if relevant) must be stated in the request
form
b) SurePath:
Drop the detachable cytobrush head into the preservative
vial.
10. For conventional smear, place the slide/s in the slide mailer.
11. Send the slide or the sample vial with the request form to
the laboratory. Avoid delay in sending and keep the slide in dry
environment to prevent fungal contamination
5.4 Reasons for unsatisfactory smear
• Insufficient sample
• Inadequate fixation time (less than 30 minutes)
• Delay in dipping the slide in the fixative
• Blood-stained smear
• Thick smear
• Excessive discharge (on the slide)
• Broken slide
• Usage of lubricant before taking smear
• Dirty and contaminated slides
HOW TO TAKE A PAP SMEAR:
Complete cytology request form (PS1/98-

pindaan 2019) and label slide/vial
Wash your hands and wear gloves
Examine the woman in a dorsal position
Swab the introitus with normal saline
Wet the bivalve speculum using sterile water

/ normal saline
Introduce the speculum into the vagina

carefully
Expose the cervix clearly and identify the

transformation zone
YES Swab for microscopic

Presence of
examination and/ or
Discharge
C&S
NO
Remove excess mucous and clean the

cervix with saline
Take sample using appropriate sampling

device
A
Conventional Liquid-based
Take sample from the cervix Take sample from the cervix
including transformation zone, including transformation zone.
turn one complete circle 360 Follow instruction as in user
degrees. Smear sample on a manual.
labelled glass slide
Fixation: Transfer the sample into the

labelled vial containing
Dip the slide into jar containing
95% ethyl alcohol for 30 minutes preservative according to user
OR manual.
Spray the slide with alcohol

fixative.
Then, place the slide in the slide
mailer.
Send slide / sample vial with the

request form to the laboratory
Record
Figure 2: Pap Smear Sampling Procedure

Use 2B pencil
2B
Mrs XYZ
*Note: N= area for name and identification number (IC or MRN)
Figure 3: Labelling with 2 unique identifiers on the frosted end of glass slide
Figure 4: Cervical Smear Using Cervical Sampler Broom

Figure 5: Smearing the sample using a cervical sample broom in one

direction
Figure 6: Fixation of smear by alcohol spray

(A) (B)
Figure 7: Transferring of sample into the vial containing preservative
A B
Figure 8: Position of transformation zone (TZ). Figure 8 (A) is TZ for

reproductive age group in which cervical sampler broom is
recommended. Figure 8 (B) is TZ for post-menopausal women in
which both cervical sampler broom and endocervical brush can be
used.
6. SAMPLE PROCESSING IN THE CYTOLOGY LABORATORY
Cytology laboratory shall be equipped with adequate resources for example

equipment, dedicated, trained cytotechnologists and anatomical pathologists.
The laboratory shall participate in quality assurance program and comply with
the International Standard of Medical Laboratory Accreditation (ISO 15189).
6.1. Equipment
i. Slide staining rack

ii. Staining trough
iii. Pap stains manual or automated
iv. Sink with tap
v. Slide drying stand rack
vi. Mounting medium
vii. Cover slip
viii.Binocular light microscope –
lenses with objectives X10, X20, X40, X60 (optional)
ix. Slide labels
x. Slide filing cabinet
xi. Fume hood for mounting
xii. Liquid-based slide processor/s
6.2. Processing
6.2.1 Conventional
Glass slide will be stained with Papanicolaou method (manual/
automated) and examined microscopically for any
abnormality. Screening is done manually by a cytoscreener
with stringent quality assurance programme in place to
maintain quality result which includes 100% rescreening (by
2 another cytoscreener) and targeted screening for abnormal
clinical history.
6.2.2 Liquid-based
Sample vial will be processed using processor/s. This method
produces an evenly spread cells with cleaner background.
Screening is done manually by a cytoscreener as for
conventional smear. Automated screening system is an
available option as a primary screening method. However, it
is required to be validated manually by cytoscreener/
pathologist.
6.2.3 HPV testing

Various HPV DNA testing methods are available. Most are
suitable to be used with liquid-based sample. To maintain the
validity of this sample, the remaining sample vial should be
kept in an optimal condition.
7. PAP SMEAR REPORTING
Pap smears are reported using The Bethesda Reporting System 2014.
7.1 Specimen Type
Indicate conventional smear or liquid-based preparation
7.2 Adequacy of specimen
7.2.1 Satisfactory for evaluation

It is pertinent to describe presence or absence of
endocervical/ transformation zone component and any other
quality indicators e.g. obscuring blood, inflammation etc.)
7.2.2 Unsatisfactory for evaluation

The reasons for unsatisfactory evaluation must be specified
for example scanty squamous cells.
7.3 Interpretation/ Result
7.3.1 Negative for intraepithelial lesion or malignancy (NILM)

This is defined when there is no cellular evidence of neoplasia.
This is stated in the general categorization above and whether
or not there are presence of organism or other non-neoplastic
findings.
7.3.2 Epithelial cells abnormalities encompassing squamous cell

lesions, glandular cell lesions and other malignant
neoplasms.
7.3.2.1 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/CIN1
- High grade squamous intraepithelial lesion (HSIL)

encompassing moderate and severe dysplasia, CIS,
CIN2 and CIN3. With features suspicious
of invasion.
- Squamous cell carcinoma
7.3.2.2 Glandular cell
- Atypical
• Endocervical cells (NOS or specify in comments)
• Endometrial cells (NOS or specify in comments)
• Glandular cells (NOS or specify in comments)
- Atypical
• Endocervical cells, favor neoplastic
• Glandular cells, favor neoplastic
- Endocervical adenocarcinoma in situ (AIS)
- Adenocarcinoma
• Endocervical
• Endometrial
• Extrauterine
• Not otherwise specified (NOS)
7.3.2.3 Other malignant Neoplasms: specify.

8. MANAGEMENT OF ABNORMAL CERVICAL SMEARS
8.1 Management of Unsatisfactory Smear
PAP SMEAR
Unsatisfactory for evaluation
Repeat smear within 3 months
Negative for
Normal 2nd smear Intraepithelial Lesion
unsatisfactory
or Malignancy (NILM)
Follow routine Refer for Refer to Flowchart for

screening schedule colposcopy Management of NILM
Figure 9: Management of Unsatisfactory Smear

8.2 Management of Normal Smear
8.2.1. Management of Negative for Intraepithelial Lesion or

Malignancy (NILM)
PAP SMEAR
NILM
Normal Atrophic No Specific Inflammatory Endometrial

changes endocervical/ micro- changes cells seen in
women ≥ 45
(without Transformation organisms
years
inflammation) zone cells seen identifield
Changes Treat any
resolve infection or
Repeat Treat Correlate with
atrophy.
smear in appropriately clinical
Repeat smear
1 year as clinically findings,
indicated in 4 – 6 weeks
clients’ age,
hormonal and
nd menstrual
Repeat in 2 smear
status
4–6 weeks with similar
after changes
treatment
Refer Refer
Resolve Gynaecologist/ Gynaecologist
Infection FMS
Persist
Refer Routine
Gynaecologist/ screening
FMS schedule
Routine
screening
schedule
Note:
Women with clinically suspicious looking cervix or persistent symptom
(eg: post coital bleeding) irrespective of the Pap smear result must be
referred for colposcopy
Figure 10: Management of NILM

8.3 Management of Abnormal Pap Smear:
8.3.1. Squamous Cell Abnormalities
8.3.1.1. Atypical Squamous Cells
PAP SMEAR
Atypical Squamous Cells
ASC-H ASCUS
HPV testing not HPV testing

available available
Colposcopy
HPV HPV
negative positive
Repeat HPV testing in Colposcopy

Repeat smear in 6 12 months
months x2
Negative Positive
5 years Colposcopy
rescreening
Figure 11: Management of Atypical Squamous Cells

8.3.1.2. Low-grade Squamous Intraepithelial Lesion (LSIL)
PAP SMEAR
Low-Grade Squamous Intraepithelial

Lesion (LSIL)
Presence of at least one

criteria:
· Age ≥ 30 years
· Poor compliance Yes Assessment of No
· Immunocompromised women for risk
· Symptomatic factor
· History of pre-invasive
lesion
· Positive for high risk Yes / HPV negative HPV Test
HPV available?
Repeat HPV test in 1 No

year
Repeat smear in 6
Immediate months x2
colposcopy
Negative for
HPV positive
HPV NILM ≥ ASCUS*
Resume routine Refer for

Colposcopy Refer 8.2.1
screening schedule colposcopy
Note:
Alternative: Co-testing at 12 months
if HPV is available and woman aged ≥30
Refers to ASCUS, ASC-H, LSIL, HSIL
Figure 12: Management of Low-grade Squamous Intraepithelial Lesion

8.3.1.3. High-grade Squamous Intraepithelial Lesion (HSIL) and

Squamous Cell Carcinoma
PAP SMEAR
High-grade Squamous
Squamous Cell
Intraepithelial Lesion (HSIL)/
Carcinoma
Suspicious For Invasion
Refer for Refer to Gynaecological

Colposcopy Oncologist
Figure 13: Management of High-grade Squamous Intraepithelial Lesion and

Squamous Cell Carcinoma
8.3.2. Glandular Cell Abnormalities
8.3.2.1. Atypical Glandular Cells and Adenocarcinoma
PAP SMEAR
Atypical Glandular Atypical Glandular Cells Adenocarcinoma in-

favor neoplastic situ (AIS) Adenocarcinoma
Cells-NOS
Refer Gynaecologist /Gynaecological- Refer to Gynaecological-Oncologist for

Oncologist for · Colposcopy
· Colposcopy · Endocervical sampling
· Endocervical sampling · Endometrial sampling
Figure 14: Management of Atypical Glandular Cells and Adenocarcinoma

8.3.2.2. Subsequent Management for Atypical Glandular

Cells / Endocervical Adenocarcinoma-in-situ (AIS)/
Adenocarcinoma on Pap smear
Atypical Glandular Cells / Endocervical

Adenocarcinoma in situ / Adenocarcinoma
Colposcopy + ECC + Endometrial Sampling
Abnormal Unsatisfactory Normal
Carcinoma AIS / SIL Cone Biopsy Cone biopsy
Manage according Manage as per

to guidelines for guideline for pre-
cervical cancer invasive disease
Figure 15: Management of Atypical Glandular Cells/Endocervical

Adenocarcinoma in situ (AIS)/ Adenocarcinoma
8.3.3. Management of woman age ≥45 years with endometrial cells

presence undergoing Pap smear
PAP SMEAR
Endometrial cells seen*
No cervical epithelial abnormalities With cervical epithelial abnormalities
Endometrial biopsy Endometrial biopsy and manage

cervical epithelial abnormalities as per
guidelines
*(Based on an article by Colletti et al (Colletti, Tranesh, & Nassar, 2017))
Figure 16: Management of presence of endometrial cells in women more

than 45 years old
8.3.4. Management of HPV results following HPV DNA testing

(lab-based test)
HPV DNA testing with partial genotyping
HPV not detected Oncogenic HPV Oncogenic HPV Unsatisfactory

positive not 16/18 positive16/18 HPV Test
Repeat HPV test at Liquid Liquid Repeat HPV test

5 years Based Cytology Based Cytology within 12 weeks
Colposcopy
Unsatisfactory ASC/LGSIL/HSIL Suspicious of SCC and

Negative
for evaluation Glandular lesion
Repeat LBC in Repeat HPV in 1 Colposcopy Refer for colposcopy /

6-12 weeks year gynaecological oncologist
Figure 17: Management of HPV results following HPV DNA testing

8.4 Pap Smear Guidelines after Hysterectomy
Table 1: Guidelines for Pap Smear Following Hysterectomy
No. Status Action
8.4.1 Hysterectomy for In the absence of symptoms,

benign disease: may not require any further
- Normal Pap smear screening.
history.
- Histopathology of
cervix known and is
benign with no
dysplastic / neoplastic
changes
8.4.2 Subtotal hysterectomy Should continue to have Pap

smears according to normal
screening schedule.
8.4.3 Hysterectomy where Should have one baseline vault

histology is not known smear. If this is normal, further
screening should be based on
clinical indications.
8.4.4 Immunosuppressed Should continue to have vault

women smears at yearly intervals.
8.4.5 Women with past Follow-up should be at the

history of CIN 2 & 3: discretion of the gynaecologist.
- If excision margin was In general, vault smears should
involved or histological be taken at least yearly.
assessment inadequate
No. Status Action
- CIN 2 / 3 completely Vault smears yearly for 5 years

excised at hysterectomy followed by two yearly smears.
regardless of margin
8.4.6 Women previously treated Should be followed up by a

for invasive gynaecological gynaecologist, preferably a
malignancy Gynaecological Oncologist.
8.5 Management of Abnormal Pap Smear and CIN in Pregnancy
• Colposcopic examination should be undertaken to exclude

invasive disease by a Colposcopist.
• If a high grade lesion is suspected on colposcopy, a biopsy is

indicated to exclude possible invasive disease. Cervical biopsy is
safe in pregnancy.
• For histology confirmed CIN 2 or 3, colposcopic review should

be done in the second and third trimester to exclude any possible
progression to invasive disease.
• Treatment of CIN should be deferred till at least 6 weeks

postpartum, when the lesion should be reassessed.
8.6 Indications for colposcopy
The following conditions are indicated for colposcopy:
• Suspicious looking cervix
• Unexplained post-coital bleeding, blood-stained vaginal discharge

and postmenopausal bleeding
• Persistent unsatisfactory smear on 2 occasions, 3 months apart
• Persistent inflammatory smear on 2 occasions, 4 to 6 weeks after

treatment
• Persistent Atypical Squamous Cells of Undetermined Significance

(ASC-US) on 2 occasions
• Atypical Squamous Cells of Undetermined Significance (ASC-US),

positive for high risk HPV
• Atypical Squamous Cells–cannot exclude high grade lesion (ASC-H)
• Persistent Low Grade Squamous Intraepithelial Lesion (LSIL) on

2 occasions, 6 months apart
• Persistent Low Grade Squamous Intraepithelial Lesion (LSIL) with

high risk factors
• High Grade Squamous Intraepithelial Lesion (HSIL)
• Squamous Cell Carcinoma (SCC)
• Atypical Glandular Cells (AGC)
• Adenocarcinoma
• Positive for high risk HPV DNA

9. MANAGEMENT OF BIOPSY CONFIRMED PRE-INVASIVE LESION
9.1 Grade 1 (CIN 1)
Grade 1 (CIN 1)
Low risk group *High risk group for

treatment
Observation Treatment
Repeat Ablation or excision

Colposcopy& Pap method decided by
smear 6 monthly x2** colposcopists
Colposcopy & Pap

Normal Abnormal smear follow-up in 6
results results months x2**
Colposcopy Normal Abnormal
Manage as
Manage as per per guideline
guidelines
Repeat Return to 3 yearly

colposcopy Normal screening if 2
& smear 12 consecutive annual
months x2 smears are normal
Figure 18: Management of Biopsy Confirmed Pre-invasive Lesion

* High Risk Group:

• Immunocompromised patient
• Smokers
• Multiple sexual partners
• Positive to high risk HPV
• Family history of Gynaecological Cancer
• Poor compliance for follow-up
• Age ≥ 30 years
• Poor access to health care
• Substance abuse
** Alternative:
Co-testing in 12 months if HPV testing is available and woman age ≥30
9.2 Grade 2/3 (CIN 2 / CIN 3)
Grade 2/3 (CIN 2/3)
CIN 2 and Age - All CIN 3

< 25 years with - CIN 2 and age >25
no risk factors CIN 2 with high risk factors
Colposcopy and Persistent CIN 2

cytology six or progression to Treatment
monthly for CIN3
24 months
Excision Ablation - Cryotherapy
1. LEEP / LEETZ 1. The upper limit of the lesion is completely

2. Cold Knife Conisation visualised
2. The whole transformation zone is seen on
colposcopy
3. There is no discrepancy of more than one
grade between cytology, colposcopy or biopsy
4. There is no suspicion of microinvasive /
invasive disease on cytology, colposcopy or
Both colposcopy biopsy
and cytology 5. There is no suspicion of any glandular lesion
normal on cytology, colposcopy or biopsy
6. The patient will be compliant to follow-up
Colposcopy & Pap smear in 6/12
Pap smear and colposcopy at 12/12
Pap smear 6 monthly X 2
Yearly Pap smear
Figure 19: Management of CIN 2/CIN 3

Note
CIN 2/CIN 3:
i. Evidence suggests that regression of CIN 2 in women less than 25
years occurs at a rate similar to CIN 1.
ii. CIN 2 in women less than 25 years old should be observed
with colposcopy at 6-month intervals for up to 24 months before
treatment is considered.
iii. CIN 3 in women less than 25 years old should be treated.
9.3 Suspicious of Micro-Invasion on Punch Biopsy
Suspicious of micro-invasion on biopsy
Cold knife cone biopsy of cervix
Subsequent management according to histology of

cone biopsy
Figure 20: Management of Suspicious of Micro-Invasion on biopsy

9.4 Adenocarcinoma in-situ on punch biopsy
Adenocarcinoma
In-situ
Cone Biopsy &

Endocervical Curettage
(ECC)
Invasion present No Invasion
No Yes
Refer Gynaecological-
Fertility
Oncologist.
Manage according to desired
guidelines for cervical
cancer
Assess margin and

Hysterectomy
ECC
Margin positive / Margin negative /

ECC positive ECC negative
Assess by Continue follow -

Gynaecological up by
Oncologist to Gynaecological
consider Oncologist
reconization
Figure 21: Management of Adenocarcinoma In-situ on punch biopsy

10. COLPOSCOPY MANAGEMENT GUIDELINES
10.1 Introduction
Terminology
Terminology is based on the 2011 IFCPC nomenclature (Bornstein et

al., 2012). Satisfactory colposcopy is defined as adequate visualisation
of cervix and a SCJ being fully visible, i.e. a type 1 or 2 TZ.
Type of Transformation Zone (TZ)
Figure 22: Transformation Zone Categories

10.2 Colposcopic Management of CIN 1
CIN 1 following Biopsy or ECC
Satisfactory colposcopy Unsatisfactory colposcopy

CIN 1 after HSIL/AGC
(Type 1 or 2 TZ) (Type 3 TZ)
Observe with cytology at Observe with colposcopy Review cytology and

12 months (preferred) and cytology Q 6/12 x2 histology (if available)
Manage according to Colposcopy and If discrepancy remains

CIN persists or
cytology cytology negative consider excisional
progresses
procedure
Return to screening Treatment

protocol
* Algorithm is based on SOGC/ Canadian Colposcopists Committee Guidelines (Bentley, 2012)
Figure 23: Management of CIN1 Following Colposcopy

10.3 Colposcopic management of CIN 2/3 in patient >25 years
CIN 2/3 following

biopsy (>25 years)
CIN 2/3
Satisfactory Unsatisfactory
colposcopy colposcopy
(Type 1 or 2 TZ) (Type 3 TZ)
Treatment Diagnostic Excision

procedure (Type 3
excision of TZ)
Figure 24: Management of CIN2/3 in patients aged 25 years and above

following colposcopy
10.4 Colposcopic management of CIN 2/3 in patient <25 years old
CIN 2/3 on Biopsy in

woman <25 years1
CIN 2 CIN 3
Observe with colposcopy and Satisfactory Unsatisfactory

cytology every 6/12 for colposcopy colposcopy
2 years (Type 1 or 2 TZ (Type 3 TZ)
Diagnostic Excision
CIN resolves CIN persists or
Procedure
progresses
Negative
Treatment2
Return to
screening
protocol Note: 1Pathologist should be asked to clarify whether the lesion is
CIN 2 or 3
2LEEP or excision preferred for CIN 3
Figure 25: Management of CIN2/3 in patients aged 25 years and less

following colposcopy
10.5 Follow-up post treatment for CIN
Once treated for CIN or adenocarcinoma in-situ (AIS), a woman is at

risk of persistence or recurrence and at long-term risk of invasive
carcinoma (Melnikow, McGahan, Sawaya, Ehlen, & Coldman, 2009;
Soutter, Sasieni, & Panoskaltsis, 2006; Wright Jr et al., 2007). The
aim of the follow-up is to identify any recurrence or persistence
dysplasia (Bentley, 2012).
Follow-up at 6 or 12 Follow-up at 6 months

months with colposcopy OR with cytology and HR-
and cytology HPV testing 1
Negative CIN 1
Return to screening Treat per guideline,

protocol excision preferred of CIN
2/3
1
HPV testing for high risk HPV
* Algorithm is based on SOGC/ Canadian Colposcopists Committee Guidelines
Figure 26: Options for Follow-up Post Treatment

Table below displays the recommended waiting time for colposcopy

appointment:
Table 2: Recommended Waiting Time for Colposcopy Appointment Following

Pap Smear Report
Type of Recommended Evidence level

Smear Report Standard Waiting
Time For Colposcopy
Appointment
ASC-H or AGC 6 weeks Level 3
HSIL/ACIS 4 weeks Level 3
Suspicious of Within 2 weeks Level 3

carcinoma
First time referral Within 12 weeks Level 3

with other
abnormal results
REFERENCES
Azizah, A. M., Nor Saleha, I. T., Noor Hashimah, A., Asmah, Z. A., & Mastulu, W. (2016).
Malaysian National Cancer Registry Report 2007-2011. Putrajaya: Malaysian National
Cancer Institute.
Bentley, J. (2012). Colposcopic management of abnormal cervical cytology and

histology. J Obstet Gynaecol Can, 34(12), 1188-1202. doi:10.1016/s1701-
2163(16)35468-8
Bornstein, J., Bentley, J., Bosze, P., Girardi, F., Haefner, H., Menton, M., . . . Walker, P.
(2012). 2011 colposcopic terminology of the International Federation for Cervical
Pathology and Colposcopy. Obstet Gynecol, 120(1), 166-172.
doi:10.1097/AOG.0b013e318254f90c
Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R. L., Torre, L. A., & Jemal, A. (2018).
Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians, 68(6),
394-424.
Chrysostomou, A., Stylianou, D., Constantinidou, A., & Kostrikis, L. (2018). Cervical
cancer screening programs in Europe: The transition towards HPV vaccination and
population-based HPV testing. Viruses, 10(12), 729.
Colletti, S. M., Tranesh, G. A., & Nassar, A. (2017). Significance of finding benign
endometrial cells in women 40-45 versus 46 years or older on Papanicolaou tests and
histologic follow-up. CytoJournal, 14, 22-22.
doi:10.4103/cytojournal.cytojournal_16_17
Institute for Public Health (IPH). (2008). The Thid National Health and Morbidity Survey
(NHMS III) 2006, Executive Summary, MInistry of Health, Malaysia. Retrieved from
http://iku.moh.gov.my/images/IKU/Document/REPORT/2006/ExecutiveSummary.pdf
Malaysian Health Technology Assessment Section (MaHTAS), Ministry of Health.

(2011). Health Technology Assessment Report:HPV DNA-based screening test for
cervical cancer. Retrieved from Ministry of Health: http://www.moh.gov.my
Melnikow, J., McGahan, C., Sawaya, G. F., Ehlen, T., & Coldman, A. (2009). Cervical
intraepithelial neoplasia outcomes after treatment: long-term follow-up from the British
Columbia Cohort Study. JNCI: Journal of the National Cancer Institute, 101(10), 721-
728.
Moseley, R. P., & Paget, S. (2002). Liquid-based cytology: is this the way forward for
cervical screening? Cytopathology, 13(2), 71-82. doi:10.1046/j.1365-
2303.2002.00394.x
Narimah, A. (1997). Pap smear examination in Public Health Institute, Ministry of

Health. Report of The Second National Health and Morbidity Survey Conference (pp.
141-144). In Kuala Lumpur: Ministry of Health.
Nor Hayati, O., & Ayob, M. C. (1997). Pap smear study: The squeal. Is there a need to
change the sampling tool. The Malaysian journal of pathology, 19, 77.
Pan American Health Organization (PAHO), World Health Organization (WHO), Centers
for Disease Control and Prevention of the United States of America (CDC). (2016).
Integrating HPV Testing In Cervical Cancer Screening Program: A Manual For Program
Managers. Washington, D.C. : Pan American Health Organization (PAHO).
Saslow, D., Solomon, D., Lawson, H. W., Killackey, M., Kulasingam, S. L., Cain, J., . .
. Committee, A.-A.-A. C. C. G. (2012). American Cancer Society, American Society for
Colposcopy and Cervical Pathology, and American Society for Clinical Pathology
screening guidelines for the prevention and early detection of cervical cancer. CA: a
cancer journal for clinicians, 62(3), 147-172. doi:10.3322/caac.21139
Soutter, W. P., Sasieni, P., & Panoskaltsis, T. (2006). Long‐term risk of invasive cervical
cancer after treatment of squamous cervical intraepithelial neoplasia. International
journal of cancer, 118(8), 2048-2055.
Strander, B., Andersson‐Ellström, A., Milsom, I., Rådberg, T., & Ryd, W. (2007).
Liquid‐based cytology versus conventional Papanicolaou smear in an organized
screening program. Cancer cytopathology, 111(5), 285-291.
World Health Organization. (2018). Global Health Observatory. Globocan Database.

Retrieved 13 April 2019, from World Health Organization who.int/gho/database/en/
Wright Jr, T. C., Massad, L. S., Dunton, C. J., Spitzer, M., Wilkinson, E. J., & Solomon,
D. (2007). 2006 consensus guidelines for the management of women with abnormal
cervical cancer screening tests. American journal of obstetrics and gynecology, 197(4),
346-355.
APPENDIX 1
Definition of Terms
Terms Definition
Colposcopy Examination of the cervix, vagina, and, in some instances

the vulva, with the colposcope after the application of a
3-5% acetic acid solution coupled with obtaining
colposcopically-directed biopsies of all lesions suspected
of representing neoplasia.
Endocervical Obtaining a specimen for either histopathological

sampling evaluation using an endocervical curette or a cytobrush
or for cytological evaluation using a cytobrush.
Endometrial Obtaining a specimen for histopathological evaluation

sampling using an endometrial aspiration or biopsy device, a
“dilatation and curettage” or hysteroscopy.
Endocervical A process of evaluating the endocervical canal for the

assessment presence of neoplasia using either a colposcope or
endocervical sampling.
Diagnostic A process of obtaining a specimen from the

excisional transformation zone and endocervical canal for
procedure histopathological evaluation and includes laser conization,
cold-knife conization, loop electrosurgical excision
procedure (LEEP), and loop electrosurgical conization.
Adequate Indicates that the entire squamocolumnar junction and the

colposcopy margin of any visible lesion can be visualized with the
colposcope.
APPENDIX 2
HPV Test / Cytology Request Form

APPENDIX 3
Pap Smear/Liquid-based Cytology Report

APPENDIX 4
HPV Test Result Report

APPENDIX 5A
Notification Letter to Clients with Normal Smear / HPV Negative

(English)
_________________________________________________________________
Name : ………………………………………………..
Address :……………………………………………………………………………………
……………………………………………………………………………………
_________________________________________________________________
Date : ……………………
Mrs/Ms,
Your HPV / Pap smear / LBC has been reported as normal. You are advised to
undergo a repeat HPV / Pap smear / LBC on …………………………….
However, if you should experience any symptoms such as vaginal bleeding after
intercourse or vaginal discharge, please consult your doctor.
……………………………………..
Signature
Name : ……………………………….
Department chop : ……………………………….
* Kindly take note that a HPV / Pap smear / LBC test is a screening test. In a
small number of women this test can fail to detect abnormal cervical changes.
APPENDIX 5B
Notification Letter to Clients with Normal Smear / HPV Negative

(Malay)
_________________________________________________________________
Nama : ………………………………………………..
Alamat :……………………………………………………………………………………
……………………………………………………………………………………
_________________________________________________________________
Tarikh : …………………………….
Puan,
Ujian HPV / Pap smear / LBC anda telah dilaporkan sebagai normal. Anda
dinasihatkan untuk melakukan ujian HPV / Pap smear / LBC pada
………………………………………
Walaubagaimanapun, sekiranya puan mengalami sebarang tanda seperti discaj

vagina atau pendarahan vagina selepas persetubuhan, sila berjumpa doktor.
………………………………….
Tandatangan
Nama : …………………………………………
Cop Jabatan : ………………………………………....
* Sila ambil perhatian bahawa ujian HPV / Pap smear / LBC adalah satu ujian
saringan. Dalam sebilangan kecil wanita ujian ini gagal mengesan tanda-tanda
abnormal pada/dalam pangkal rahim.
APPENDIX 5C
Notification Letter to Clients with Abnormal HPV / Pap Smear / LBC

(English)
_________________________________________________________________
Name : ………………………………………………..
Address :……………………………………………………………………………………
……………………………………………………………………………………
_________________________________________________________________
Date : ………………………………..
Mrs/Ms,
Your HPV / Pap smear / LBC test result is ready. You are kindly requested to
come to the clinic for follow-up treatment as follows:
Date : ……………………………….
Time : ……………………………….
Clinic / Hospital :……………………………….
Thank you.
……………………………………………
Signature
Name : ……………………………………………….
Department chop : ……………………………………………….
APPENDIX 5D
Notification Letter to Clients with Abnormal HPV / Pap Smear / LBC

(Malay)
_________________________________________________________________
Nama : ………………………………………………..
Alamat :……………………………………………………………………………………
……………………………………………………………………………………
_________________________________________________________________
Tarikh : ...................................
Puan,
Keputusan ujian HPV / Pap smear / LBC puan telah siap. Puan dikehendaki
datang ke klinik untuk mendapatkan rawatan selanjutnya sebagaimana berikut:
Tarikh : ...........................................
Masa : ...........................................
Klinik/ Hospital : ............................................
Terima kasih.
....................................................
Tandatangan
Nama : ………………………………………..
Cop Jabatan : ………………………………………..
APPENDIX 6
Cervical Brush for Cervical Sampling

APPENDIX 7
A guide and reporting proforma for colposcopic biopsies performed

for the diagnosis and treatment of pre-invasive cervical neoplasia.
[For invasive carcinoma please refer to the Clinical Practice Guidelines on

management of Cervical Cancer (Second Edition) MOH/P/PAK/294.15(GU)]
1. CLINICAL INFORMATION
1.1 Procedure performed • Cervical biopsy

a. Cervical excision type
-Type 1 (at least 6mm up to
10mm length)
-Type 2 (10 to 15mm length) Note: both type of
-Type 3 (>15mm length) excision and modality
b. Cervical excision modality should be provided
-Electrosurgical excision eg (for audit purposes).
Loop excision such as
LLETZ, LEEP
-Cold-knife cone biopsy
-Laser cone biopsy
• Endocervical curettage
• Other, specify
1.2 Colposcopic findings
1.3 Location of any lesions
1.4 HPV results

• HPV 16 detected Other relevant
• HPV 18 detected information
• Oncogenic HPV (not 16/18) eg: date of testing
detected
• Oncogenic HPV not detected
• Other, specify
1.5 LBC results
1.6 Relevant
gynaecological
procedure or treatment
1.7Comments
2. MACROSCOPIC
•
2.1 Specimen labelled as
2.2 Type of procedure • Cervical biopsy

a. Cervical excision type
-Type 1 (at least 6mm up to
10mm length)
-Type 2 (10 to 15mm length) Note: both type of
-Type 3 (>15mm length) excision and modality
b. Cervical excision modality should be provided
-Electrosurgical excision eg (for audit purposes).
Loop excision such as
LLETZ, LEEP
-Cold-knife cone biopsy
-Laser cone biopsy
• Endocervical curettage
• Other, specify
2.3 Orientation markers Not present / Present, specify For excision

specimens
2.4 Specimen
measurement
Number of pieces – PLEASE Report if more than 1

INDICATE piece is received.
Maximum dimension Report for Small

Numeric: ___mm Diagnostic Biopsies
Note: repeat for each
piece received
Dimensions Report for non-conical

Numeric: __x__x__mm excision specimens
and the below
measurements are
not possible.
Note: repeat for each
piece received
Length of canal Report for conical

Numeric: ____mm excision specimens
Note: This is measured
from the external os to
the apex.
Length of specimen Report for conical

Numeric: ____mm excision specimens
Diameter of ectocervix Report for

Numeric: ____x ___mm disorientated, conical
Loop/Laser excisions
Diameter of ectocervix in 3-9 o’clock Report for orientated,

plane conical excision
Numeric: ____mm specimens
Diameter of ectocervix in 6- 12 Report for orientated,

o’clock plane conical excision
Numeric: ____mm specimens
Macroscopically visible lesions For excision

Present or Absent specimens
Other macroscopic comment
Sampling (blocks). Eg: Serially sliced and

submitted in entirety
as in the diagram
3. MICROSCOPIC FINDINGS
3.1 Tissues present • Endocervical mucosa

• Squamous mucosa
• Other, specify
3.2 Tissue artefact Absent • minimal – thin rim of

thermal artefact only
Thermal with no significant
• Minimal interference with
• Moderate histological
• Extensive, impacting margin assessment
assessment • moderate – thermal
• Extensive, impacting diagnostic artefact focal or
assessment partially hinders
• Extensive, impacting both margin histological
and diagnostic assessment. assessment
Non-thermal artefact present, • extensive – thermal
specify artefact significantly
interferes with
histological
assessment
Specify whether
thermal artefact
interferes with:
o margin assessment:
if known the
specific margin(s)
affected should be
documented.
Whilst caution is
advised in
interpretation in
tissue affected by
artefact, when there
is significant
thermal artefact at
a tissue margin,
p16 IHC may assist
in clarifying margin
assessment.
o diagnostic
assessment – for
example grading of
SIL, inability to
exclude invasion,
diagnostic certainty
of AIS.
3.3 Degree of epithelial • Minimal • minimal – there is no

loss • Moderate significant epithelial
• Extensive, impacting margin loss (<10%)
assessment • moderate – focal or
• Extensive, impacting diagnostic partial epithelial loss
assessment that may hinder
• Extensive, impacting both margin histological
and diagnostic assessment assessment (10-
30%)
• extensive –
significant epithelial
loss that is likely to
hinder histological
assessment (>30%)
Specify as to
whether epithelial
loss influences:
o margin assessment:
if known, specific
margin(s) affected
should be
documented
o diagnostic
assessment – if
there is a specific
known diagnostic
issue this should
be documented,
however generally
significant epithelial
loss results in the
possibility of a
missed diagnosis
that is unable to be
further qualified.
3.4 CIN LESION Present

Possible
Not identified
3.5 CIN LESION subtype CIN1 CIN1 (Applicable only

CIN2 if no HSIL/AIS or
CIN3 invasive carcinoma is
present)
3.6 CIN LESION EXTENT For excision

specimens
3.7 Endocervical Present

Adenocarcinoma in situ Possible
(AIS) Not identified
3.8 AIS Extent For excision

specimens
3.9 MARGIN STATUS

- Ectocervical - Involved Applicable to excision
- Endocervical - Not involved specimens
- Radial/deep stromal - Cannot be assessed
- Unspecified margin * Record only if CIN2/3
or AIS identified in the
specimen. Does not
apply to LSIL.
* Unspecified margins
(Applicable for
excision specimens
where it is not
possible to say
whether the margin
is ectocervical or
endocervical)
3.10 Distance of non- - Ectocervical ___mm

invasive lesion to - Endocervical ___mm
surgical margin - Radial/deep stromal ___mm
- Unspecified margin* ___mm
3.11 Other microscopic

comment or relevant
pathology
3.12 Ancillary tests P16 IHC, HPV test If performed, record

the findings.
4. DIAGNOSTIC SUMMARY
Type of specimen and diagnosis.

Margin status – if relevant
APPENDIX 8
Examples of Pathology Report
Example Report 1
CLINICAL INFORMATION PROVIDED

Procedure performed: Cervical biopsy
Colposcopic findings: LSIL
LBC results: LSIL
Relevant gynaecological procedure or
treatment: LLETZ in 2012
MACROSCOPIC
Specimen labelled as: Cervical biopsy 12 o’clock
Maximum dimension: 5mm
Specimen description: Pale tissue
MICROSCOPIC
Tissues present: Squamous mucosa; Endocervical mucosa
Tissue artefact: Absent
Degree of epithelial loss: Minimal
CIN2/3: Not identified
CIN1: Present
Endocervical Adenocarcinoma in situ (AIS): Not identified
Other microscopic comment:
Features of HPV effect
ANCILLARY TESTS: Not performed
CASE CATEGORISATION Low-grade Squamous Intraepithelial Lesion

Squamous component: (LSIL)
Normal
Endocervical component:
DIAGNOSTIC SUMMARY
Cervical biopsy – Low Grade Squamous Intraepithelial Lesion (LSIL)
Example Report 2

Procedure performed: LLETZ Cervical
Colposcopic findings: Normal
HPV results: HPV 16/18 detected
LBC results: ASC-H
MACROSCOPIC
Specimen labelled as: LLETZ
Orientation markers: Not present
Number of pieces: 2
SPECIMEN SIZE
Piece 1 dimensions: 12x9x4mm
Piece 2 dimensions: 11x8x4mm
Specimen description: Tan rubbery tissue with a small amount of
Macroscopically visible lesions: mucosa
Sampling: Absent
1.1–1.3 larger piece serially sectioned with
1.1 containing end pieces,
1.4-1.6 smaller piece serially sectioned with
1.4 containing end pieces
MICROSCOPIC
Tissue artefact: Thermal, extensive, impacting diagnostic
assessment
Degree of epithelial loss: Extensive, impacting diagnostic assessment
CIN1: Not identified
Endocervical Adenocarcinoma in situ (AIS): Not identified
ANCILLARY TESTS: Performed

Immunohistochemistry: P16 immunohistochemistry negative on
blocks 1.2 and 1.5
CASE CATEGORISATION Benign findings

Squamous component: Benign findings
Endocervical component: Severe thermal artefact hinders accurate
Comment: histological assessment
DIAGNOSTIC SUMMARY
Cervical biopsy – Low Grade Squamous Intraepithelial Lesion (LSIL)
Example Report 3

Procedure performed: Cervical punch biopsy
Colposcopic findings: ?HSIL ?metaplasia
Location of any lesions: 6 o’clock
HPV results: HPV 18 detected
LBC results: ASC-H
Relevant gynaecologicalprocedure or Colposcopy / biopsy
treatment:
MACROSCOPIC
Specimen labelled as: Cervical biopsy 6 o’clock 4mm
Maximum dimension: Pale tissue
Specimen description: Endocervical mucosa
MICROSCOPIC
Tissues present: Endocervical mucosa
CIN1: Not identified
Endocervical Adenocarcinoma in situ (AIS): Nil
Other relevant pathology: -
Other microscopic comment: The biopsy was examined at multiple (12)
levels, all showing benign endocervical
glandular mucosa only. No squamous
epithelium was seen in the multiple levels.
There are no features of cervical glandular

neoplasia.
Not performed
ANCILLARY TESTS:
CASE CATEGORISATION
Squamous component: Not identified
Endocervical component: Normal
Comment: The biopsy was benign, however no
squamous mucosa was identified.
DIAGNOSTIC SUMMARY
Cervical biopsy 6 o’clock – Benign endocervical mucosa
Example Report 4

Procedure performed: Cervical biopsy
Colposcopic findings: Favour LSIL
Location of any lesions: 12 o’clock
HPV results: HPV 16 detected
LBC results: HSIL
Relevant gynaecological procedure or -
treatment:
MACROSCOPIC
Specimen labelled as: Cervical biopsy 12 o’clock 5mm
Maximum dimension: Pale grey tissue
Specimen description: Block A: submitted entirely
MICROSCOPIC
Degree of epithelial loss: Minimal Present
CIN2/3: CIN2
Endocervical Adenocarcinoma in situ (AIS): Not identified.
ANCILLARY TESTS:
Performed
p16 positive (strong, block-like)
CASE CATEGORISATION
Squamous component: Cervical Intraepithelial Neoplasia 2 (CIN 2)
Endocervical component: Normal
Comment: On H&E sections there are prominent
features of HPV effect, and atypical
squamous epithelial cells extending mid-way
through the squamous mucosa. As p16
immunohistochemistry is positive, this is
classified as CIN 2.
DIAGNOSTIC SUMMARY
Cervical biopsy – Cervical Intraepithelial Neoplasia 2 (CIN 2)

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GUIDEBOOK

The Ministry of Health (MOH) has introduced an alternative method to address

The development of this comprehensive guideline as well as the transformation

DR HAJAH FARIDAH BINTI ABU BAKAR

Dr. Zaridah bt. Shafie

Dr. Jamil bin Omar

Datin Dr. Fauziah bt Kassim

Dr. Fuziah bt. Paimin

List of Abbreviations xii

5. Taking a Pap smear 6

6. Sample processing in the cytology laboratory 15

7. Pap Smear Reporting 16

8. Management of Abnormal Cervical Smears 19

9. Management Of Biopsy Confirmed Pre-Invasive Lesion 31

10. Colposcopy Management Guidelines 36

Appendix 1: Definition of Terms 45

Figure 1: Organizations Providing Cervical Cancer Screening 3

Figure 23: Management of CIN1 Following Colposcopy 37

Table 1: Guidelines for Pap Smear Following Hysterectomy 28

Cervical cancer is the fourth most common cancer worldwide, affecting

In Malaysia, cervical cancer is the third most common cancer among

Therefore, it is imperative to ensure the implementation of screening in

Screening of cervical cancer was introduced in 1969 in Malaysia, as part

The objectives of this cervical cancer screening programme are:

The current national policy for Pap smear screening programme is to

The programme is carried out as an opportunistic screening where women

Another technique of Pap test is Liquid-based Cytology (LBC) which offers

this technique is as effective as the traditional smear (Moseley & Paget,

Despite its success, cytology has limitations especially technical

This test will be incorporated in the current cervical cancer screening

Pap smear FRHAM

University Private clinics/

Figure 1: Organizations Providing Cervical Cancer Screening Services

2.1. As a guide and reference for health personnel

3.1. Target groups

3.2 Screening interval

3.3 Screening Personnel

Doctors and nurses trained in taking cervical smears.

3.4 Reporting Personnel

Pathologists and Cytotechnologists.

4.1. Cytology Based Screening

4.1.1 Conventional Pap smear

4.1.2 Liquid-based Cytology

The sample is processed and placed onto a glass slide

4.2 Molecular based technique using HPV test

HPV test is a molecular technique using a sample of cervical cells, to

Many developed countries have adopted HPV testing as a primary

In low resource areas, other options of cervical screening can be adopted

5. TAKING A PAP SMEAR

5.1. Advice for the woman

i. Do not douche or insert any form of medication (suppositories) into

5.2. Requirements for Taking Smears in Clinic

i. Bivalve vaginal speculum (CUSCO) - all sizes preferably disposable.

5.2.1 Conventional Smear

5.2.2 Liquid-based Cytology

5.3. How to take a Pap smear

For further clarification, please refer to Figure 2.

1. Complete the cytology request form - PS 1/98 (Pindaan 2019) and