Proposed Outline for Cervical Cancer Service Delivery ...
Malawi Ministry of Health
National Service Delivery Guidelines for Cervical Cancer Prevention
April 2005
Malawi Ministry of Health
National Service Delivery Guidelines for Cervical Cancer Prevention
April 2005
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( Ministry of Health 2005
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This publication was made possible through support provided by the U.S. Agency for International Development, under the terms of Award No. 690-A-00-04-00085-00. The authors’ views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the United States Government.
Acknowledgements
The Ministry of Health would like to extend its sincere thanks and gratitude to the following individuals who contributed a considerable amount of time and effort to the development of these guidelines:
Mrs. J. Banda (Malawi College of Health Sciences, Zomba Campus)
Mrs. J. Chimenya (Mulanje District Hospital)
Mr. P. Chirambo (Malawi College of Health Sciences, Lilongwe Campus)
Dr. C. Dzamalala (Department of Pathology, College of Medicine and National Cancer Registry)
Ms. L. van der Hoeven (Ministry of Health/Reproductive Health Unit)
Dr. G. Kafulafula (Department of Obs/Gynae, College of Medicine)
Mrs. L. Kamwendo (Kamuzu College of Nursing, Blantyre Campus)
Mrs. H. Kapyepye (Nurses and Midwives Council of Malawi)
Ms. A. Kleine (JHPIEGO)
Ms. M. Lacoste (JHPIEGO)
Mrs. E. Makhula (Queen Elizabeth Central Hospital)
Dr. S. Makin (Mulanje Mission Hospital)
Dr. A. Malata (Kamuzu College of Nursing, Blantyre Campus)
Mr. J. Malewezi (Ministry of Health/Reproductive Health Unit)
Dr. A. Metaferia (Department of Obs/Gynae, College of Medicine)
Mr. K.M. Mkandawire (Medical Council of Malawi)
Dr. R. Mpazanje (Ministry of Health)
Mrs. J. Namasasu (Ministry of Health/Reproductive Health Unit)
Mr. G. Nkhoma (JHPIEGO)
Dr. B. Reich (Kamuzu Central Hospital)
Dr. Y. Rijken (Queen Elizabeth Central Hospital)
Dr. F. Sungani (Queen Elizabeth Central Hospital)
Mr. G. Vilili (JHPIEGO)
Mrs. R. Wasili (Christian Health Association of Malawi)
Finally, the Ministry of Health would like to express its gratitude to the United States Agency for International Development and JHPIEGO for the support rendered in the development, revision, and printing of these guidelines.
TABLE OF CONTENTS
ACKNOWLEDGEMENTS IV
FOREWORD v
ABBREVIATIONS AND ACRONYMS vi
1. INTRODUCTION 1
2. DEFINITION OF CERVICAL CANCER 1
3. CAUSE OF CERVICAL CANCER 1
4. RISK FACTORS FOR CERVICAL CANCER 2
5. PREVENTING CERVICAL CANCER 2
5.1 Prevention strategies 2
6. NATURAL HISTORY OF CERVICAL CANCER 3
7. CERVICAL CANCER SCREENING 4
7.1 The Single Visit Approach (SVA) 4
7.2 Target screening group 4
7.3 Screening frequency 4
7.4 Visual inspection of the cervix using acetic acid (VIA) 4
7.5 Who can perform VIA 5
7.6 Where VIA services can be provided 5
7.7 Training of Providers 5
7.8 Flow Chart 6
8. GENERAL COUNSELLING AND GROUP EDUCATION 7
9. PROVISION OF CERVICAL CANCER SCREENING SERVICES 8
9.1 Responsibilities by Level 8
9.2 Instruments and Supplies 8
9.3 Client assessment 10
9.4 Group and Individual Counselling before VIA 10
9.5 VIA Procedure 11
10. PROVISION OF CRYOTHERAPY SERVICES 15
10.1 Who is eligible for cryotherapy 15
10.2 Who can perform cryotherapy 15
10.3 Where cryotherapy services can be provided 15
10.4 Counselling prior to cryotherapy 15
10.5 Performing Cryotherapy Procedure 16
11. REFERRAL 21
11.1 What cases to refer 21
12. BIOPSY PROCEDURE 22
12.1 Who can perform: 22
12.2 Who is eligible for biopsy: 22
12.3 Where biopsy can be performed: 22
12.4 Supplies required: 23
12.5 Biopsy Procedure 23
13. LARGE LOOP EXCISION FROM THE TRANSFORMATION ZONE (LLETZ) 23
13.1 Who is allowed to perform LLETZ 23
13.2 What is LLETZ? 23
13.3 Indications for LLETZ 24
13.4 LLETZ Procedure 24
14. HISTOPATHOLOGY SPECIMEN PREPARATION 27
15. INFECTION PREVENTION FOR VIA/CRYOTHERAPY INSTRUMENTS 28
15.1 PROCESSING VIA EQUIPMENT 28
15.2 PROCESSING CRYOTHERAPY EQUIPMENT 29
16. CLINICAL DOCUMENTATION 30
17. MONITORING AND EVALUATION 30
17.1 Client Identification Number 32
17.2 Indicators 32
17.3 Target Population Calculation 34
17.4 Reporting 35
18. Conclusion 36
REFERENCES 38
Appendix A: Standard Equipment for a Cervical Cancer Screening and Treatment Site 40
Appendix b: Histopathology Sample Page 42
Appendix C: Health Passport Sample Page 43
Appendix D: MALAWI CERVICAL CANCER PREVENTION PROGRAMME
LOGBOOK Sample Pages 44
Appendix E: CERVICAL CANCER PREVENTION PROGRAMME MONTHLY
LOGBOOK SUMMARY Sample Page 46
Appendix F: CERVICAL CANCER PREVENTION PROGRAMME Quarterly/ANNUAL Report Sample Page 49
FOREWORD
THE MINISTRY OF HEALTH SUPPORTS THE CONCEPT OF COMPREHENSIVE REPRODUCTIVE HEALTH AS DEFINED DURING THE 1994 INTERNATIONAL CONFERENCE ON POPULATION AND DEVELOPMENT IN CAIRO AND SUBSEQUENTLY ENDORSED AT THE 1995 FOURTH WORLD CONFERENCE ON WOMEN IN BEIJING:
“Reproductive health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity in all matters relating to the reproductive health system, its functions and processes. Reproductive health includes:
• Meeting the needs of individuals and couples for a variety of safe and effective and affordable methods of fertility regulation from which they can make an informed choice;
• Reduction of pregnancy-related morbidity and mortality as well as reduction of newborn deaths and disabilities;
• Prevention and management of reproductive tract infections, including HIV/AIDS and other sexually transmitted diseases; and
• The provision of services for the early detection and management of cancers and other conditions of the reproductive tract.
With regard to the latter point on management of reproductive tract cancers, although these services are referenced in the national reproductive health policy, efforts to address this area have been minimal to date. Looking at the ever-increasing rates of cervical cancer, and the demand generated by small pilot projects, the Ministry of Health decided in 2004 to embark on development and implementation of a national cervical cancer prevention programme.
The Malawi Ministry of Health National Service Delivery Guidelines for Cervical Cancer Prevention, in concert with the Malawi Ministry of Health National Cervical Cancer Programme Strategy (August 2004), provides the most current up-to-date knowledge and direction on cervical cancer screening, treatment and management and forms a solid foundation from which service providers at all health facilities in both the public and private sectors, as well as non-governmental organisations, can provide high quality and standardised cervical cancer prevention services. The Ministry of Health also encourages the use of these guidelines by managers, policymakers and training institutions.
These Guidelines will be periodically reviewed based on stakeholder and provider observations and feedback, international experience and guidance and scientific/research development on intervention and delivery approaches.
The Malawi Government believes that individuals and couples have the right to have access to comprehensive, high quality reproductive healthcare and services, including cervical cancer prevention, and that the use of these services is a critical factor in the socio-economic development and well-being of every Malawian, especially women.
Screening for cervical cancer can save a woman’s life if the signs are discovered early and treated quickly. I urge all health workers to promote this service so as to save many of our women from needless suffering and death.
ABBREVIATIONS AND ACRONYMS
ACCP Alliance for Cervical Cancer Prevention
CBDAs Community-Based Distribution Agents
CHWs Community Health Workers
CIN Cervical Intraepithelial Neoplasia
CIS Carcinoma in Situ
HGSIL High-grade Squamous Intraepithelial Lesion
HIV Human Immunodeficiency Virus
HLD High Level Disinfection
HMIS Health Management Information System
HPV Human Papillomavirus
HSAs Health Surveillance Assistants
IEC Information, Education and Communication
LGSIL Low-grade Squamous Intraepithelial Lesion
LLETZ Large Loop Excision from the Transformation Zone
LMP Last Menstrual Period
MoH Ministry of Health
RH Reproductive Health
RHU Reproductive Health Unit
SCJ Squamocolumnar Junction
STIs Sexually Transmitted Infections
SVA Single Visit Approach
VIA Visual Inspection with Acetic Acid
INTRODUCTION
According to Malawi cancer statistics, cervical cancer accounted for 32.3% of all female cancers in the Blantyre urban and rural populations, and 26.8% of all female cancers nationally in 2000–2002. The incidence of invasive disease reaches a maximum at about age 40 (Dzamalala C, C Mdokwe, and N Chimwemwe 2004). In addition, at least 80% of these cancer admissions present in inoperable stages II–IV, and nearly all of them will die.
In these cases, the only treatment option available to them is palliative care, which is generally inadequate in Malawi.
To initiate cervical cancer prevention services, Project HOPE piloted a cervical cancer prevention programme from 1999 to 2002, concentrated in selected health facilities in Blantyre and Mulanje districts. An evaluation of the project revealed that it was accepted by women, providers, and policymakers and was relatively successful, screening 5,446 women, 9.4% of whom were assessed as VIA-positive. The Reproductive Health (RH) policy, formulated in 2001, included cervical cancer so that the policy would be in place in order to later initiate a national cervical cancer prevention programme.
Considering the demand created by Project HOPE and recognized needs for screening and treatment, the Ministry of Health (MoH) subsequently decided to start a national programme using a phased approach and beginning on a limited scale. This programme aims to screen 80% of all Malawian women aged 30 to 45 over a five year period (approximately 668,668 women by 2010). Although the national RH service delivery guidelines included a component on cervical cancer, it was decided that this section needed to be elaborated in order to properly guide service providers in delivery of cervical cancer screening and treatment services. These guidelines have therefore been developed for use by service providers in the delivery of cervical cancer screening and treatment services using VIA and cryotherapy.
DEFINITION OF CERVICAL CANCER
Cervical cancer is a malignant change of the cervical epithelium, which usually starts at the squamocolumnar junction (SCJ). In almost all cases, precancerous lesions develop before invasion occurs; thus, screening makes it possible to detect treatable precancerous and some cancerous lesions.
CAUSE OF CERVICAL CANCER
Research has concluded that the Human Papillomavirus (HPV), a sexually transmitted infection, is the necessary, but not solely sufficient, cause of cervical cancer. There are
15 types of high-risk oncogenic types of HPV that have been linked to cervical cancer. Data show that 95% are linked to eight types and 60% are linked to two types of HPV (ACCP 2004). The majority of women with an oncogenic HPV types never develop cervical cancer, meaning that additional factors must be present that act in conjunction with the HPV infection. These factors are as yet unknown.
RISK FACTORS FOR CERVICAL CANCER
Known risk factors for developing cervical cancer are:
• Early sexual activity (debut during teenage years)
• High parity
• Multiple sexual partners (woman or her partner)
• Exposure to sexually transmitted infections (STIs)
• Mother or sister with cervical cancer
• Previous abnormal test finding (Pap smear or VIA)
• Smoking
• Immunosuppression (HIV/AIDS, chronic corticosteroid use, etc…)
PREVENTING CERVICAL CANCER
Cervical cancer is one of the most preventable cancers. The progression of cancer may take as long as 20 years from the time of HPV infection before developing into invasive cancer—thus, it is possible to detect and treat precancerous lesions well before invasive cancer presents.
5.1 Prevention strategies
Primary prevention
• Vaccine to prevent HPV infection (in development)
• Reduce high risk sexual behaviours:
• Delay age of sexual debut
• Encourage abstinence
• Limit number of sexual partners
• Correct and consistent use of condoms
• Avoid smoking (to prevent progression from HPV infection to cervical cancer)
Secondary prevention
• Identification and treatment of precancerous lesions before they develop into cervical cancer through screening. Screening has been shown to reduce cervical cancer by 70–80% in previously unscreened populations (Franco and Monsonego 1997)
NATURAL HISTORY OF CERVICAL CANCER
When programmes to prevent or control cervical cancer were first developed, it was assumed that cervical cancer developed from precancerous lesions (broadly known as dysplasia), progressing steadily from mild to moderate to severe dysplasia (CIS) before invasive cancer develops. In fact, it now appears that the direct precursor to invasive cervical cancer is high-grade dysplasia (HGSIL / CIN II or III), which can progress to cervical cancer over a period of up to 10 years or more (Figure 1). Most low-grade dysplasia (LGSIL / CIN I), resulting from HPV-related changes of the cervix, disappears without treatment or does not progress, particularly those changes seen in younger women. Most of the HPV-related changes regress within 2–3 years and never result in dysplasia. Prevalent cases of dysplasia, however, where disease has been present for a longer period of time, are less likely to regress. This is the situation that exists when cervical cancer testing is first being started in a country or region.
Figure 1. Natural History of Cervical Cancer—Current Understanding
[pic]
Source: PATH 1997.
The natural history of cervical cancer suggests that screening should initially focus on women at greatest risk for high-grade dysplasia—women in their 30s and 40s. Although cervical cancer most often develops in women after age 40, high-grade dysplasia (CIN II or III) generally is detectable up to 10 years or more before cancer develops, with a peak dysplasia rate at about age 35. Although unscreened women over 50 remain at relatively high risk of cervical cancer, women in this group who have had one or more negative tests in their 30s or 40s, are at much lower risk.
Data from some countries suggest that age-specific rates for CIN, CIS and cervical cancer have shifted downward by about 5 years due, in part, to increasing STI and HIV/AIDS rates. If true, screening recommendations in these countries may need to be adjusted accordingly. The observation of more cases in younger women, however, may just be a reflection of changes in the age structure of the population or of cervical cancer screening patterns, rather than a shift in age-specific rates.
CERVICAL CANCER SCREENING
7.1 The Single Visit Approach (SVA)
The single visit approach to cervical cancer prevention with VIA and cryotherapy implies that both screening and initial management of a client can occur in the same visit. In this case, a client assessed as VIA-positive is offered the option of treatment with cryotherapy, or referral for other services, on the same day the screening is done. The objective of the single visit approach is to inform a client of her screening test result and next steps before she leaves the facility. It may not be possible to perform cryotherapy, if indicated, in the same visit because women may wish to seek partner consent.
The single visit approach to cervical cancer prevention using VIA and cryotherapy is endorsed by the MoH as the screening modality and treatment option of choice for Malawi. Therefore, these guidelines focus on provision of the single visit approach using VIA and cryotherapy.
7.2 Target screening group
• Women aged 30–45 years
• STI clients with abnormal vaginal discharge or lower abdominal pain (even if outside age group). In STI clinics where VIA is conducted, speculum exams should be done.
• Non-pregnant women (Although it should not be routine practice, pregnant women can safely be screened, but should not be treated with cryotherapy. VIA should not be included in antenatal clinic.)
• Women attending STI or FP clinics that specifically request cervical cancer screening.
7.3 Screening frequency
If women are VIA-negative, they should be screened every 5 years, at a minimum. Women with VIA-positive findings and subsequent treatment should return for re-screening after one year.
7.4 Visual inspection of the cervix using acetic acid (VIA)
Visual inspection of the cervix using acetic acid means looking at the cervix with a naked unaided eye to detect abnormalities after application of dilute (3–5%) acetic acid or vinegar. The area that is abnormal turns acetowhite, which shows that it may have precancerous lesions.
VIA is recommended practice for low-resource settings compared to other screening tests (Table 1) because:
• It is safe, inexpensive and easy to perform;
• The test performance is similar to other tests used for cervical cancer screening;
• It can be learned and provided by almost all health professionals at all levels of the health care system;
• It provides immediate results on which decisions about management (treatment or referral) are based;
• Most equipment and supplies for this service are locally available;
• Instant treatment through cryotherapy is linked to the screening; and
• It is non-invasive and effectively identifies many precancerous lesions.
Table 1. Comparison of VIA with other screening tests
|Type of test |Safety |Practical |Affordable |Effective |Available |
|Pap Smear |YES |NO |NO |YES |NO |
|HPV/DNA Test |YES |NO |NO |YES |NO |
|Cervicography |YES |NO |NO |YES |NO |
Source: Ministry of Health and Population; Reproductive Health Unit. 2001. Malawi National Reproductive Health Service Delivery Guidelines. Ministry of Health and Population: Lilongwe, Malawi.
7.5 Who can perform VIA
• Nurse/midwives (both enrolled and state registered)
• Clinical officers
• Medical officers
• Obstetrician/gynaecologists
7.6 Where VIA services can be provided
• Family planning clinics
• STI clinics
• Gynaecology clinics
7.7 Training of Providers
Providers of VIA and cryotherapy will be selected according to programme needs, and the following criteria:
• Experience in provision of family planning
• Experience with counselling and group education
• Experience performing pelvic examination
• Eyesight adequate to visualize the cervix
Providers will participate in a competency-based training containing the following modules:
• Anatomy of the cervix
• Cervical cancer etiology, causes, and prevention
• Cervical cancer prevention policies and guidelines
• Individual counselling and group education
• Performing VIA and cryotherapy
• Infection prevention practices
• Handling, maintenance, cleaning, and storage of equipment
• Data collection and recording
• Reporting requirements
Specific guidelines can be found in a separate document, Training and Supervision Guidelines for Cervical Cancer Prevention Services.
7.8 Flow Chart
The Cervical Cancer Screening Program follows the flow chart, shown in Figure 2. This flow chart outlines specific steps that should be followed at each stage of the process, depending on the individual client’s results.
Figure 2. Flow Diagram for Cervical Cancer Prevention—Malawi
[pic]
GENERAL COUNSELLING AND GROUP EDUCATION
Women coming for cervical cancer screening will need accurate and up-to-date information about the disease, screening option(s) on offer and the treatment procedure. All women should be counselled properly for them to make informed decision with all their reproductive health rights respected (i.e., the right to choice, privacy, confidentiality, dignity, safety, opinion, information etc.).
Some sample messages include:
• Cervical cancer develops slowly.
• Screening can detect treatable, precancerous lesions before they progress to cancer.
• Women aged 35 and older are more likely to develop cervical cancer than younger women.
• Women in their 30s and 40s should be screened at least once.
• The screening procedure is relatively simple and quick.
• Screening generally is not painful.
• The small number of women who need treatment after screening often receive a simple outpatient procedure to treat the lesion.
(Source: ACCP 2002)
PROVISION OF CERVICAL CANCER SCREENING SERVICES
9.1 Responsibilities by Level
Table 2 shows the roles played by various groups within the cervical cancer prevention programme, from the community level through the tertiary care facility.
Table 2. Provision of Cervical Cancer Prevention Services (by Level of Healthcare Facility
and Staff)
|LEVEL |STAFF MAY INCLUDE |SERVICES |REQUIREMENTS |
|Community |Community leaders |Recognition of importance of |Community mobilization |
| |Women’s groups |cervical cancer |Information, Education and |
| |Health Surveillance Assistants |Referral to facilities where |Communication (IEC) (awareness): |
| |(HSAs), Community-Based |screening is available |radio messages, pamphlets and other|
| |Distribution Agents (CBDAs), other |Palliative (supportive) care |public information |
| |Community Health Workers (CHWs) | |Training and access to necessary |
| | | |supplies |
|Primary Level |Nurses, midwives or clinicians |Above activities, plus: |As Above, PLUS |
|(Primary Health Centres,| |Counselling (sexual and cancer |Pelvic exam |
|Family Planning Clinics)| |risk) |Infection prevention |
| | |VIA |Basic equipment, CO2 and supplies |
| | |Treatment with cryotherapy or | |
| | |referral | |
|First Referral Level |Above plus: |Above activities (VIA, cryotherapy)|As Above, PLUS |
|(District Hospital) |Nurse midwives |plus: |Limited specialty hospital |
| |Clinicians |Visual Inspection of the cervix |LLETZ machine and thin wire loops |
| |(Ob/Gyn specialists) |using acetic acid |General anaesthesia |
| | |LLETZ or cone biopsy (where there | |
| | |is Ob/Gyn) | |
| | |Simple hysterectomy (where there is| |
| | |Ob/Gyn) | |
|Secondary and |Above plus: |Above activities, plus: |As Above, PLUS |
|Tertiary Level |Ob/Gyn specialists |Full diagnostics (colposcopy, |Full specialty hospital |
|(Regional or |(Ob/Gyn oncologists) |biopsy, HPV) |[Radiotherapy services] |
|Referral Hospital) |(Radiotherapist) |Radical surgery |[Chemotherapy] |
| | |Radiotherapy | |
9.2 Instruments and Supplies
VIA can be performed in any clinic having the following items:
• Examination table and stool
• Light source adequate to reliably illuminate the vagina and cervix
• Graves bivalved speculum
• Instrument tray or container
The examination table should allow the examiner to insert the speculum and see the cervix.
Light from a window is usually not sufficient to see the cervix, so use a reliable light source, such as a lamp or torch, if available. The light source, such as a 60-watt angle poised lamp or a torch, must be strong enough for the examiner to see the upper end of the vagina where the cervix is located. Inspection cannot be performed if there is not enough light to see the entire cervix. It is also important that the light source not be too hot. A lamp that is too hot will be uncomfortable for both the woman and provider. A high quality torch provides adequate light without too much heat. In addition, the torch does not require a source of electricity, is portable and can be placed in whatever position allows the best view of the cervix.
Bivalved specula (Cusco or Graves) are preferred because they can be set and left open while the cervix is being examined. They leave the provider’s hands free to swab the cervix, adjust the light source and manipulate the cervix and speculum in order to see it fully.
There are few supplies needed for performing VIA. They should all be available locally:
• Cotton swabs or sponge holding forceps with cotton wool
• New disposable examination gloves
• New wooden spatula and/or condom
• Dilute (3–5%) acetic acid solution (white vinegar is acceptable),
• 0.5% chlorine solution for decontaminating instruments and gloves
• Sanitary pads
Cotton swabs are used to remove mucus and discharge from the cervix and to apply acetic acid to the cervix. These swabs should be generously covered with clean cotton so that they will be able to wash the cervix thoroughly with acetic acid and not scratch or injure the cervix. The cotton swabs do not have to be sterile.
Examination gloves should be new. Use a new pair of gloves for every woman.
The wooden spatula is used to push away the lateral walls of the vagina if they protrude through the speculum blades. Use a new spatula for every woman. Alternatively, a condom with a cut tip can be rolled over the speculum blades to prevent the walls of the vagina from pushing into the space and preventing an adequate view of the cervix.
Acetic acid is the main ingredient of vinegar. A dilute (3–5%) solution is recommended. In some countries, vinegar is not available. Often what is sold in the market is a “vinegar-substitute”, or “imitation vinegar” that in fact is acetic acid. If neither vinegar nor an acetic acid substitute is available, a pharmacist/chemist or local chemical supplier can make the dilute acetic acid.
Chlorine solution (0.5%) is used to decontaminate the speculum and gloves after each use. After decontamination, the speculum, instrument tray or container and gloves should be washed with soap and water, thoroughly rinsed and then high-level disinfected or sterilized.
See Appendix A for a full list of equipment and supplies.
9.3 Client assessment
A brief reproductive health history should be taken, including the following components:
• Parity
• LMP (if pregnant give gestational age in weeks)
• Age at first sexual intercourse
• Use of contraceptive methods
• Number of sexual partners
• Any history of STIs (including HIV)
• Smoking
• Previous abnormal pap smears or positive VIA
• Mother or sister with cervical cancer
• Use of steroids
Notes can be recorded in the Health Passport.
9.4 Group and Individual Counselling before VIA
Prior to performing the procedure, women should be grouped together for a group education and counselling session whenever possible. Before accepting VIA, women may wish to go home and discuss the procedure with their husbands, so they can be prepared to accept cryotherapy if they have a positive test result and treatment is indicated. During this 10- to 15-minute presentation, the following topics should be addressed:
• Clear all misconceptions and rumours about VIA and cryotherapy
• Nature of cervical cancer as a disease
• Risk factors for the disease
• Importance of early screening and treatment
• Consequences of not being screened
• Review treatment options if VIA is abnormal
• Role of male partner in screening and treatment decisions
• Importance of a single visit approach thus preparing women to have cryotherapy on the same day they had an abnormal VIA
• Meaning of a positive or negative VIA test
• Importance of washing genital area prior to coming for a VIA test
9.5 VIA Procedure
9.5.1 Client Assessment and Getting Ready
Step 1 Before performing the VIA test, discuss the procedure with the woman. Explain why the test is recommended and exactly what will take place during the examination. Also discuss with her the nature of the most likely findings as well as what followup or treatment might be required. Ensure she is not pregnant.
Step 2 Make sure that all necessary instruments and supplies are available, including a high-level disinfected or sterile speculum, cotton swabs in a clean container, a bottle of dilute acetic acid and adequate light source. Test the light source to be sure it is working.
Bring the woman into the examination area. Ask her to empty her bladder if she has not already done so. Ask her to remove only enough clothing (including undergarments) so that the pelvic examination and VIA test may be performed.
Step 3 Assist the woman to position herself on the examination table and drape her for the pelvic examination.
Step 4 Wash hands thoroughly with soap and water and dry with a clean, dry cloth or air dry. Palpate the abdomen. Wash hands again.
Step 5 Put one pair of new examination gloves on both hands. If available, put a second glove on left hand so that when you are ready to use the light source, you can remove the outer glove and move the light source with a clean glove.
Step 6 Arrange the instruments and supplies on a high-level disinfected tray or container, if not already done.
9.5.2 VIA Test
Step 1 Inspect the external genitalia and check the urethral opening for discharge. Palpate the Skene’s and Bartholin’s glands. Tell the woman that the speculum is about to be inserted and that she may feel some pressure.
Step 2 Gently insert the speculum fully or until resistance is felt and slowly open the blades to reveal the cervix. Adjust the speculum so that the entire cervix can be seen. This may be difficult in cases where the cervix is large or extremely anterior or posterior. It may be necessary to use a spatula or other instrument to gently push the cervix down or up into view.
|Note: If the walls of the vagina are very lax, a wooden spatula or other instrument to push away any tissue protruding between the |
|blades of the speculum. Alternatively, prior to inserting the speculum, a condom can be rolled over the blades and the tip of the |
|condom cut off. When the speculum is inserted and the blades are opened, the condom will prevent the walls of the vagina from pushing|
|into the space between the blades. |
Step 3 When the cervix can be seen in its entirety, fix the blades of the speculum in the open position so that it will remain in place with the cervix in view. Doing this enables the provider to have at least one hand free.
|Note: Throughout the procedure, it may be necessary to repeatedly adjust either the angle from which the cervix is viewed or the |
|light source in order to achieve the best view of the cervix. |
Step 3a If using an outer glove, immerse this hand in 0.5% chlorine solution and remove the glove by turning it inside out. To dispose of the glove, place it in a leakproof container or plastic bag.
Step 4 Move the light source so that you can see the cervix clearly.
Step 5 Using the light source, look at the cervix and check for evidence of infection (cervicitis) such as whitish purulent discharge (mucopus); ectopy (ectropion); grossly apparent tumours or Nabothian cysts, ulcers or “strawberry” lesions (Trichomonas infection).
Step 6 Using the sponge forceps and a clean cotton ball, remove any discharge, blood or mucus from the cervix. Dispose of the cotton ball by placing in a leakproof container or plastic bag.
Step 7 Identify the cervical os and SCJ and the area around it.
Step 8 Soak three clean cotton balls in dilute acetic acid solution and place them in the left hand. Use these cotton balls to apply the solution to the cervix. If necessary, use clean cotton balls to repeat applications of acetic acid until the cervix has been thoroughly washed with acid. Dispose of used cotton in leakproof container.
Step 9 Once the cervix has been washed with the acetic acid solution, wait 1 minute for it to be absorbed and any acetowhite reaction to appear. Observe the cervix with the light source during this minute.
Step 10 Inspect the SCJ carefully. Check to see if the cervix bleeds easily. Look for any raised and thickened white plaques or acetowhite epithelium.
|Note: The SCJ should be completely seen to determine if the cervix is normal or abnormal. |
Step 11 As needed, reapply acetic acid or swab the cervix with a clean cotton ball to remove any mucus, blood or debris that develops during the inspection and may obscure the view. Dispose of used cotton.
Step 12 When visual inspection of the cervix has been completed, use a fresh cotton ball to remove any remaining acetic acid from the cervix and vagina. Dispose of used cotton.
Step 13 Gently remove the speculum. Place the speculum in 0.5% chlorine solution for 10 minutes for decontamination.
Step 14 Perform a bimanual examination and rectovaginal examination (if indicated). Check for cervical motion tenderness; size, shape and position of the uterus; pregnancy or any uterine abnormality and enlargement or tenderness of adnexa.
9.5.3 After the VIA Test
Step 1 Wipe the light source with 0.5% chlorine solution or alcohol to avoid cross-contamination between patients. This is done if the light source has been adjusted with a contaminated hand during the procedure.
Step 2 Immerse both gloved hands in 0.5% chlorine solution. Remove the gloves by turning them inside out and place them in a leakproof container or plastic bag. If a rectovaginal examination was performed, gloves must be disposed of. Submerge them in 0.5% chlorine solution for 10 minutes for decontamination before disposing.
Step 3 Ask the woman to move toward the head of the table and help her sit up. Ask her to get dressed.
Step 4 Wash hands thoroughly with soap and water and dry them with a clean, dry cloth or air dry.
Step 5 Record the VIA test results and other findings such as evidence of infection (cervicitis); ectropion; grossly apparent tumours; or Nabothian cysts, ulcers or “strawberry cervix.” If acetowhite change, which is characteristic of a diseased cervix, is present, record the cervical examination as positive. Draw a “map” of the cervix and the diseased area on the cervical map in the Health Passport. Table 3 shows VIA classifications according to clinical criteria.
Step 6 Discuss the results of the VIA test and pelvic examination with the woman. If the VIA test is negative, tell her when to return for repeat VIA testing.
Step 7 If the VIA test is positive or cancer is suspected, tell the woman what the recommended next steps are. If treatment is immediately available, discuss this possibility with her. If referral is required for further testing or treatment, make arrangements for the referral and provide the woman with the necessary forms and instructions before she leaves the clinic. If it is possible to make an appointment now, this is the best time.
Step 8 If the area where VIA was performed is contaminated or soiled, it should be cleaned according to the infection prevention guidelines before the next client sits on the examination bed.
Table 3. VIA Classification Categories
|VIA CLASSIFICATION |CLINICAL CRITERIA |
|Test negative |Smooth, pink, uniform, featureless, ectropion, cervicitis, Nabothian cysts, |
| |and insignificant acetowhite lesions |
|Test positive |White plaques (acetowhite epithelium is distinctly visible) with raised, |
| |clear margins connected to or extending from the squamocolumnar junction |
|Suspected cancer |Cauliflower-like growth or ulcer, fungating mass |
Source: Ministry of Health and Population; Reproductive Health Unit. 2001. Malawi National Reproductive Health Service Delivery Guidelines. Ministry of Health and Population: Lilongwe, Malawi.
For more details about clinical criteria for the three VIA classifications, and corresponding photos, refer to the job aid “Atlas of Visual Inspection of Cervix with Acetic Acid.”
9.5.4 Counselling after the VIA procedure
• If VIA is negative tell the client to come for review in 5 years, and remind her about risk factors.
• If test is positive explain the meaning of a test positive and the importance of treatment and follow up, and discuss recommended next steps.
• If ready for cryotherapy counsel for the procedure to be done preferably the same day or any other day if the client so wishes.
• If there is need for referral, complete the necessary paperwork and arrangements. Refer to Table 4 for recommended referral actions.
Table 4. Recommended Referral Actions
|VIA FINDING |REFERRAL ACTION |
|Women suspected of having cervical cancer |Refer immediately to a facility that can adequately provide treatment |
| |for invasive cancer. |
|Test-positive women whose lesions occupy greater than 75% of|Refer for assessment and treatment at the nearest facility offering |
|the cervix, extend into the vaginal wall or extend more than|LLETZ or cone biopsy. If travel to the other facility is not possible or|
|2 mm beyond the cryotherapy probe including the tip of the |judged not likely to happen, then counsel about the greater likelihood |
|probe |of persistence of the lesion at 12 months and the need for re-treatment.|
|Test-positive women who fulfil criteria for immediate |Counsel about advantages and disadvantages of all treatment methods. |
|treatment but who request to be treated using a procedure |Refer to closest facility offering treatment of their choice. |
|other than cryotherapy | |
|Test-positive women who request further (more diagnostic) |Refer to closest tertiary care facility offering a gynaecology clinic |
|testing, not offered at the site |(as indicated). |
|Test-positive women declining any treatment |Counsel about the likelihood of disease progression and prognosis. |
| |Recommend a return visit within a year for a repeat VIA test to reassess|
| |disease status. |
PROVISION OF CRYOTHERAPY SERVICES
Cryotherapy involves freezing the cervix, using either compressed carbon dioxide or nitrous oxide gas as the coolant. Treatment consists of applying the coolant continuously for a 3-minute freeze, followed by a 5-minute thaw and then another 3 minute freeze.
10.1 Who is eligible for cryotherapy
Women with:
• Acetowhite lesions covering less than 75% of the cervix (if more than 75% of the cervix is covered, cryotherapy should be done only by the gynaecologist)
• No suspected cancer
• Lesion that does not extend to the vaginal walls
• Lesion that extends less than 2mm beyond diameter of the cryotherapy probe
Cryotherapy is not an appropriate treatment method if:
• Acetowhite lesion greater than 75% of face of cervix
• Acetowhite lesions extending into the vaginal wall or extending more than 2mm beyond the outer or inner (in the canal) edge of the cryotherapy probe
• Acetowhite lesion where client requests alternate treatment to cryotherapy or requests additional diagnostic tests
• Cancer is suspected
• During bimanual examination, an ovarian mass or fibroid is suspected
10.2 Who can perform cryotherapy
All providers trained to perform VIA, namely:
• Nurse/midwives (both enrolled and state registered)
• Clinical officers
• Medical officers
• Obstetrician/gynaecologists
10.3 Where cryotherapy services can be provided
Cryotherapy should be available at all sites providing VIA.
10.4 Counselling prior to cryotherapy
Informed verbal consent must be obtained before performing the procedure.
• Explain in detail the cryotherapy as a procedure, its risks, benefits, success rates and alternatives
• Encourage the client to ask questions and give her opinions
• Ask the woman if she has understood the procedure and is willing to have cryotherapy.
• Give additional information about STIs and how to prevent them.
10.5 Performing Cryotherapy Procedure
10.5.1 Instruments and Equipment
Refer to Appendix A.
The cryotherapy unit enables high-pressure compressed gas to travel from the gas cylinder into the expansion/freezing chamber of the cryoprobe. The unit consists of:
• Regulator with pressure gauge and cryogun holder;
• Flexible hose to connect the regulator to the cryogun;
• Cryogun with handle and freeze/defrost triggers;
• Insulated probe; and
• Metal cryotip designed to fit up against the cervix and completely cover the areas surrounding the SCJ and diseased areas.
The cryotherapy unit is designed to connect to a compressed gas cylinder. In Malawi, dry carbon dioxide gas will be used for cryotherapy.
Supplies
Refer to Appendix A for a full list of supplies.
10.5.2 Client Assessment/Getting Ready for Cryotherapy
Step 1 Prior to performing cryotherapy, discuss the procedure with the patient. Explain why the treatment is necessary, what the alternatives to cryotherapy treatment are and why abstinence (or use of condoms) is important following the procedure. Tell her about the steps of the procedure, the loud sound emitted by the equipment, any discomfort she may feel and the side effects she will encounter after the procedure. Ensure she is not pregnant.
Step 2 Make sure that all necessary instruments and supplies are available. This includes a high-level disinfected speculum, cotton swabs in a clean container, a bottle of dilute acetic acid, a wooden spatula and adequate light source (test the light source to be sure it is working). The gas should be turned on at the master cylinder valve and the pressure should read at least 40–70 kg/cm2. Finally, the timer should be set to zero.
Step 3 Insert a high-level disinfected cryotip into the clear plastic protective sleeve. Align the small plastic tabs on the sleeve with the slots beneath the nipple of the cryotip and firmly secure them in position.
Step 4 Remove the protective cover from the end of the probe.
Step 5 Before bringing the patient into the examination/procedure area, be sure she has emptied her bladder if it has been more than 30 minutes since the VIA test. Ask her to undress only from the waist down. Following this, help her onto the examining table and drape her for the procedure.
Step 6 Wash hands thoroughly with soap and water and dry with a clean, dry cloth or air dry. Then, put one pair of new examination gloves on both hands. If available, put a second glove on the left hand so that when you are ready to use the light source, you can remove the outer glove and move the light source with a clean glove.
Step 7 Arrange the instruments and supplies on a high-level disinfected tray or container, if not already done.
10.5.3 Cryotherapy Procedure
Step 1 Tell the woman that the speculum is about to be inserted and that she may feel some pressure.
Step 2 Gently insert the speculum fully or until resistance is felt and slowly open the blades to see the cervix. Adjust the speculum so that the entire cervix can be seen. This may be difficult in cases where the cervix is large, parous, patulous or extremely anterior or posterior. It may be necessary to use a clean cotton swab, spatula or forceps to gently push the cervix down or up into view.
Step 3 When the cervix can be seen in its entirety, fix the blades of the speculum in the open position so that it will remain in place with the cervix in view. This enables the provider to have at least one hand free.
Step 3a If using an outer glove, immerse this hand in 0.5% chlorine solution and remove the glove by turning it inside out. To dispose of the glove, place it in a leakproof container or plastic bag.
Step 4 Move the light source so that you can see the cervix clearly.
Step 5 Use a clean cotton ball to remove any discharge, blood or mucus from the cervix. Identify the cervical os, the SCJ, and the site and size of the lesion. If necessary, apply acetic acid so that the lesion can be seen. Dispose of the cotton by placing in a leakproof container or plastic bag.
Step 6 Point the probe at the ceiling. Press the freeze button for 1 second and then the defrost button for 1 second to blow gas out through the thin metal tube. Note: Tell the patient that she will hear the sound of the cryotherapy unit.
Step 7 Screw the cryotip with sleeve onto the end of the probe. Tighten it with your hands only. Do not use any tools to tighten the cryotip onto the probe. Note: If the cryotip will not attach to the probe correctly, check that the sleeve tabs are properly inserted into the slots on the cryotip.
Step 8 Apply the cryotip to the cervix, ensuring that the nipple is cantered and placed squarely onto the os. It is not necessary to grasp the cervix with a tenaculum or forceps. Be sure that the lateral vaginal walls are not in contact with the cryotip. Remind the woman that the unit will make noise during the procedure.
|Note: It may be necessary to use a wooden spatula to push away any tissue protruding from between the blades of the speculum. |
|Alternatively, before inserting the speculum, a condom can be rolled over the blades and the tip of the condom cut off. When the |
|speculum is inserted and the blades are opened, the condom will prevent the walls of the vagina from pushing into the space between |
|the blades. |
Step 9 Hold the cryogun perpendicular to the plane of the cervix and apply pressure to the cervix with the cryogun. Press the freeze button to start the freezing process, and keep the pressure applied to the cervix. This is critical to an adequate freeze. Set the timer for 3 minutes. Watch as the ice ball develops at the cryotip.
Step 10 After 15 seconds, press the defrost button for no longer than 1 second. Immediately press the freeze button again. Press the defrost button every 15 seconds during the 3 minutes of freezing. Note: If possible, have an assistant say “clear” every 15 seconds.
|Note: When CO2 is used as the coolant, it is important to use this “freeze-clear-freeze technique” during the entire freeze time. If |
|it is done correctly, this technique will not adversely affect the freezing of cervical tissue, but will prevent the cryotherapy unit|
|from becoming clogged with ice during the procedure. If a provider waits for more than 15 seconds to press the defrost button, the |
|unit may become clogged later during the procedure. Puffs of white gas or small pieces of ice may come out of the exhaust port; this |
|means that the unit is removing ice from the hose. If the unit becomes clogged, follow steps for clearing the ice. |
Step 11 After 3 minutes of freezing, the cryotip will be attached to the cervix by the ice ball. Do not pull the cryotip off. Wait for it to defrost and detach itself from the cervix. (This usually takes less than 30 seconds.) Use the “defrost” button on the cryogen to hasten the process of defrosting, allowing the probe to be safely removed.
Step 12 Wait 5 minutes and repeat the freezing procedure using the freeze-clear-freeze technique. It may be necessary to increase the freeze time up to 5 minutes if the ice ball is not 4 mm beyond the lateral edges of the probe. If no “freezeball” is apparent, repeat steps 9 and 10 at least once, putting more pressure on the cervix as the freezing process is initiated.
|Note: During the cryotherapy procedure, the cylinder will become cold, moisture may form on the outside of the cylinder and hose. In |
|addition, the pressure gauge will show a drop in pressure. All of these changes are normal. If the pressure gauge, however, shows |
|that the pressure is below 50 kg/cm2, stop performing cryotherapy. Wait until the cylinder returns to room temperature and the gas |
|pressure rises above 50 kg/cm2. Also, white grains of ice may come out of the exhaust port. This is normal and will not interfere |
|with the operation of the cryotherapy unit. |
Step 13 After the procedure, close the master cylinder valve.
Step 14 Inspect the cervix for any bleeding. If there is bleeding, apply pressure to the area using a clean cotton ball. Dispose of cotton in a leakproof container.
Step 15 Remove the speculum and place in a 0.5% chlorine solution for 10 minutes for decontamination.
10.5.4 Postcryotherapy Tasks
Step 1 Wipe the light source with 0.5% chlorine solution or alcohol to avoid cross-contamination between patients.
Step 2 Immerse both gloved hands in 0.5% chlorine solution. Remove gloves by turning inside out. To dispose of gloves, place in leakproof container or plastic bag.
Step 3 Wash hands thoroughly with soap and water and dry with clean, dry cloth or air dry.
Step 4 Check that the woman is not having excessive cramping before she sits up, gets off the examining table and gets dressed. If severe cramping persists beyond 5–10 minutes, give her an oral analgesic (acetaminophen or ibuprofen).
Step 5 Advise the woman regarding post-treatment care, warning signs and followup schedule. Give her written instructions for post-cryotherapy care.
Step 6 Record her results of the treatment woman’s Health Passport.
Step 7 Observe the woman for at least 15 minutes. Ask her how she feels before sending her home.
Step 8 Clean the cryotherapy unit according to protocol (See Section 15.2).
10.5.5 Post-cryotherapy counselling
Give the woman details of self-care while at home. Until the vaginal discharge is done (at least 4 weeks), the woman should be advised to AVOID:
• Douching
• Inserting herbs in the vagina
• Using vaginal tampons
• Having sexual intercourse
|Note: Women are asked to avoid inserting objects into the vagina for 4 weeks after cryotherapy in order to prevent infection. Explain|
|that after cryotherapy, the cervix has a sore on it that needs time to heal. Emphasize that home care should be carefully followed, |
|and that the woman should make every effort to abstain from sexual intercourse. If the woman will not be able to abstain from sexual |
|intercourse, tell her to use condoms with every act of intercourse. Provide her with condoms. |
Advise the woman of warning signs that require her to return to the facility for care, as follows:
• Fever for more than 2 days.
• Severe abdominal pains especially if in conjunction with a fever.
• Bleeding for more than 2 days that is heavier than the woman’s heavy menstrual periods.
• Bleeding with clots
Advise the woman to return for an assessment in three months, and for another VIA test in one year. Record the appointments in her Health Passport.
10.5.6 Follow-up after cryotherapy
The woman should return for an assessment in three months. The purpose of this visit is to ensure that the woman has not experienced any problems post-cryotherapy. The provider can assess the cervix to see how it has healed, but should NOT perform a VIA test. This
3 months review is not clinically necessary, but it is important in order to remind the woman that she must return for a VIA test one year after her treatment. At the one year follow up visit, after obtaining a history of any problems, the VIA test should be done and any abnormalities noted in the Health Passport. Because the SCJ may not be visible, the cervix should be carefully checked to assess how it has healed and whether any lesion persists.
If the woman has a positive VIA test after 1 year, she should be referred to a clinician for further evaluation and management.
If the woman returns for a problem visit, her side effects should be managed as outlined in Table 5.
Table 5. Management of Side Effects
|SIDE EFFECT |MANAGEMENT |
|Cramping |Counsel patient before procedure to expect some cramping during and after procedure |
| |Reduce cramping by pressing lightly on the cervix with cryotherapy probe |
| |If cramping is severe give paracetamol or aspirin |
|Vaginal discharge (profuse water) |Counsel patient to expect discharge lasting approximately 4 weeks |
| |Counsel patient to expect discharge colour change from pink to tint to clear white or yellow tint |
| |Counsel client to return if discharge changes to foul smelling, itchy or pus coloured (and treat |
| |according to standard STI guidelines) |
| |Strongly advise on abstinence for four weeks |
| |If unable to abstain, advise on use of condoms for at least 4 weeks |
|Spotting/light bleeding |Counsel patient to expect light bleeding or spotting for one to two weeks |
| |Counsel patient to return for evaluation if there is heavy bleeding |
Source: Ministry of Health and Population; Reproductive Health Unit. 2001. Malawi National Reproductive Health Service Delivery Guidelines. Ministry of Health and Population: Lilongwe, Malawi.
REFERRAL
11.1 What cases to refer
Nurse providers should refer women who present with the following conditions to the next level of care:
• Acetowhite lesions greater than 75% of surface of cervix
• Acetowhite lesions extending into the vaginal wall or extending more than 2mm beyond the outer or inner edge of the cryotherapy probe
• Acetowhite lesion where client requests alternate treatment to cryotherapy or requests additional diagnostic tests
• Suspect cancer
• Other gynaecological conditions (e.g., ovarian mass, fibroid, polyp)
The clinician (i.e., clinical officer, medical officer, physician) can take Punch biopsies, and review large lesions and if suspicious for cancer, refer immediately to Ob/Gyn. The clinician will further refer to the Ob/Gyn who will perform Cone biopsies, LLETZ, hysterectomies, or palliative care where indicated. Referral responsibilities are as outlined in Table 6, and a referral algorithm is detailed in Figure 3.
Table 6. Referral responsibilities
|Activity |Responsible cadre |Time frame |
|Refer large, suspicious or cancerous lesions |Nurse |Immediately |
| |Clinician | |
|Take biopsy |Ob/Gyn |In same visit as VIA if Clinician is|
| |Clinician |on site |
|Perform LLETZ |Ob/Gyn |By appointment as soon as possible |
|Process specimen for histopathology findings |Pathologist |Within 4 weeks |
|Follow up results |Clinician who referred client |After 4 weeks |
Figure 3. Referral algorithm
BIOPSY PROCEDURE
12.1 Who can perform:
• Gynaecologists
12.2 Who is eligible for biopsy:
• Women with large lesions who are ineligible for cryotherapy
• Women with suspected cancer
12.3 Where biopsy can be performed:
• Sites where trained gynaecologists are present
12.4 Supplies required:
• VIA supplies (refer to Section 9)
• Punch Biopsy (Baby Tischler)
• Monsel’s solution
• Other: sanitary pads, biopsy containers and labels, formalin, histopathology forms
12.5 Biopsy Procedure
To perform a cervical biopsy, the provider utilizes a cervical punch biopsy instrument to obtain a tissue sample from the cervix for histological diagnostic information. The biopsy will follow VIA or colposcopy when an abnormal or suspected precancerous lesion or cancerous lesion is identified and the lesion does not meet the criteria for immediate cryotherapy.
Step by step instructions:
Step 1 Prior to the procedure counsel the patient she will feel a short pinching pain and may have bleeding or spotting after the procedure and should not have intercourse for 2 days.
Step 2 Insert speculum, visualize cervix.
Step 3 Stain cervix with 3-5 % acetic acid or Lugol solution to identify the lesion.
Step 4 If patient requests, 1% lidocaine can be injected locally in the cervix for pain relief.
Step 5 Apply the “hook” of the biopsy instrument to the area to be biopsied. Obtain biopsy by closing the punch instrument.
Step 6 Stop bleeding with cotton swab or Monsel’s solution.
Step 7 Place biopsy in formaline bottle, label the bottle and send for histological examination with the appropriate forms.
Step 8 Counsel patient again about the expected effects from the biopsy and when she needs to return to discuss the results.
LARGE LOOP EXCISION FROM THE TRANSFORMATION ZONE (LLETZ)
13.1 Who is allowed to perform LLETZ
• Gynaecologists trained in the LLETZ procedure
13.2 What is LLETZ?
LLETZ is a low voltage, high frequency alternating current to a thin wire electrode can be used to cut through tissue and excise a cervical lesion. It can be used as an electrosurgical conization (as an alternative to surgical cold knife cervical conization).
The LLETZ Procedure:
• Can be diagnostic and/or therapeutic;
• May replace cold knife cone;
• Is intended for treatment of precancerous lesions; and
• Can diagnose pre-cancer or cancer.
If cervical cancer is suspected by VIA, referral/evaluation and biopsy are first needed, not a LLETZ procedure.
13.3 Indications for LLETZ
• No evidence or suspicion of invasive cervical cancer or
• Acetowhite lesion upon VIA, and not a candidate for cryosurgery
• Lesion covers >75% of the surface of the cervix
• Lesion extends >2mm beyond the cryoprobe tip
Anaesthesia requirements for LLETZ:
• Intra-cervical local anaesthesia, lidocaine with or without epinephrine
• Intravenous conscious sedation occasionally necessary
Absolute contraindications to LLETZ:
• Suspected or proven cervical cancer;
• Pregnancy up to 6 weeks postpartum; and/or
• Active pelvic inflammatory disease.
If acetowhite lesion extends into the endocervical canal, a “top hat” or “cowboy hat” loop electrosurgical excision can be done with excision of part of the endocervical canal as a second step.
13.4 LLETZ Procedure
13.4.1 General Description
The provider utilizes a wire electrode to excise 1) the transformation zone with a VIA positive acetowhite lesion and 2) part of the cervical stroma, endocervical glands and endocervical canal. The depth and the width of the excision depends on the size of the TF zone, the location of the squamocolumnar junction and the extent and location of the precancerous / acetowhite or non Lugol staining lesion. This may result in one or more excised specimens. Prior to the procedure the lesion(s) are identified by application of Lugol solution or acetic acid.
13.4.2 Step by step instructions
Step 1 Counselling pre-LLETZ: Explain the procedure and obtain consent for it to be performed. Prior to the procedure, discuss the procedure with the patient. Explain why treatment is necessary, what to expect to feel, hear, and see during the procedure. Explain what she may expect after the procedure.
Step 2 Inspect all necessary equipment and supplies:
• Lugol’s iodine solution
• Grounding pad and wire
• Monsel solution
• Coated vaginal speculum
• 10cc syringe
• Coated lateral wall retractor
• 1% lidocaine
• Pencil holder for electrode
• Spinal needle
• Footswitch
• Cotton swabs
• Ring forceps
• Wire loops
• Smoke evacuation tubing and Connections
• Ball electrode
• Tenaculum
Step 3 Inspect electrosurgical unit and smoke evacuation. Make sure they are attached and operating. Connect grounding pad to the patient, connect wire to pencil holder or footswitch. Set electrosurgical unit to blend waveform (30–40).
Step 4 Insert coated vaginal speculum, identify and center cervix. Widen speculum as far as possible. Assure clear passageway for wire loop electrode to the cervix.
Step 5 Insert coated lateral vaginal wall retractor and widen as far as possible. Assure a clear passageway for wire loop electrode to cervix.
Step 6 Apply Lugol solution with cotton swab to cervix, identify lesion, squamocolumnar junction, and select wire electrode with the size for desired excision(s). Imagine the direction and size of the excision and its depth.
Step 7 Inject intracervically 1% lidocaine circumferentially submucosal injection. Allow 3–4 minutes for effect and assemble wire electrode in pencil.
Step 8 Wipe away blood, reapply Lugol solution.
Step 9 Again visualize the excision direction, depth, and width. Start the smoke evacuation unit. Check if wire loop is safe and functional (machine will indicate “pass” if patient is properly grounded and electric current flows).
Step 10 Apply electrode to cervix. Generate power and in a continuous motion perform the excision. Remove tissue with ring forceps.
Step 11 If a 2 or 3 step procedure was planned, repeat step 10.
(Do not ever interrupt power during the excisional movement, wire loop may get stuck and bleeding may persist.
Step 12 If separate endocervical excision is planned, select a different wire loop for endocervical excision as in step 10 and 11.
Step 13 After excision, change wire loop electrode to ball electrode. Change setting on electrosurgical unit to “coagulation” (30-40) and cauterize wound bed and wound edges.
Step 14 After adequate hemostasis is obtained, apply Monsel’s solution to wound bed with cotton swabs.
Step 15 Remove vaginal speculum and lateral wall retractor, place in 0.5% chlorine solution for 10 minutes.
Step 16 Remove grounding pad.
Step 17 Give patient a pad to wear.
Step 18 Observe patient for at least 15 minutes.
Step 19 Clean and disinfect all instruments that will be reused according to local infection prevention practices.
Step 20 Counselling post-LLETZ:
Provide information about home care:
• No cleaning or insertion of herbs or drugs inside the vagina
• No sex for 4 weeks. Provide condoms in case abstinence cannot be negotiated.
Inform about danger signs which require them to come back immediately
• Severe bleeding (heavier than a heavy period over 1-2 hours)
• Severe lower abdominal pains with fever and smelly discharge.
Give appointment after 4–6 weeks or before if any problem and emphasize the importance of the returning for follow up visits as per schedule or as problems arise.
HISTOPATHOLOGY SPECIMEN PREPARATION
Who can extract specimens for histopathology
• Gynaecologists
• Trained Clinicians
Histopathology Specimen Collection
• Choose a representative sample for biopsy
• Specimen should be drawn from the margin between normal and abnormal tissue.
Histopathology Specimen Preservation and Storage
• Specimen must be fixed in formaldehyde (formalin), diluted to 10%, immediately after collection
• Specimen must be placed in an appropriate size container (avoid bottle-necked containers)
• Ratio of volume of specimen to that of formaldehyde should be at least 1:10
• Specimen must be fully immersed in formalin, because formalin is absorbed by the tissue
• Containers must be appropriately labelled
• Label should identify name of patient, date, facility
• Container must have tightly closed or sealed lids to avoid leakage or evaporation of formaldehyde (formalin) during transportation.
• Fill out a histopathology request form, including the following details:
• Client information: ID, full name, age, sex, and address
• Brief clinical history
• Site of specimen extraction
• Preferred contact mode for receiving results (i.e., Email, fax, or phone)
• Name and signature of the responsible clinician
A sample histopathology request form is provided in Appendix B.
Histopathology Specimen Transport
• The specimen may be transported to the laboratory at College of Medicine in Blantyre by whatever means
• Each institution should liaise with transportation officer to develop a protocol for timely delivery of specimens. For example:
− Some specimens may be hand delivered to the laboratory by clients or health officers, but clients should not be forced to deliver the specimen
− Others are sent by post office, local bus, express bus, coach parcel (Note: if sent by post or coach, lab must be notified for pick up)
− Pony express and DHL have also been utilized by some individuals and institutions
• The specimen must be accompanied by the histopathology request form
Histopathology Results
• Results will be communicated to the clinician from the laboratory via Email, fax, or phone (indicated on request form), followed by a printed written report.
• Results should be recorded in a register kept in the Histopathology laboratory provided for the Cervical Cancer Prevention Programme.
• When client returns for results at the appointed time (depending on amount of time needed to process biopsy), clinician will record results in the Health Passport.
• Clinician will manage the client per appropriate protocol, depending on results.
INFECTION PREVENTION FOR VIA/CRYOTHERAPY INSTRUMENTS
There are several ways in which disease transmission can be prevented:
Wash Hands
• Routine hand washing for 10 to 15 seconds with soap and water removes most of the organisms (90%). This should be done before and after patient contact.
• Where there is no water, an alcohol hand rub can be used. A simple alcohol hand rub can be made by adding either glycerine or Sorbitol to alcohol (2 mLs glycerine or Sorbitol in 100 mLs of 60–90% ethyl or isopropyl alcohol). Use 3–5 ml for each application and continue rubbing the solution over hands until they are dry (usually about 2–5 minutes), using a total of 6–10 ml per scrub.
Wear Gloves
• Several types of gloves are used to prevent disease transmission. The type of gloves depends on the task. For example, inexpensive, disposable exam gloves are used for performing pelvic examinations and doing VIA testing, and thick utility gloves are used for washing instruments, cleaning spills, and disposing of medical waste. Gloves should be changed after each client or patient contact to prevent cross-contamination. After performing a VIA test or cryotherapy, staff should remove their gloves and wash their hands before writing up notes. Gloves should not be reused.
Wear protective clothing
• Protective clothing such as gloves and goggles and aprons also protect against disease transmission. For example, goggles or face masks should be worn while washing instruments, to prevent splashing from contaminating the eyes and face. Plastic aprons are effective because they do not allow any fluids to pass through.
15.1 PROCESSING VIA EQUIPMENT
• After conducting VIA, remove the speculum and submerge it completely with all other metallic equipments (sponge forceps and gallipots) used in 0.5% chlorine solutions for 10 minutes to decontaminate.
• Note: By the time the client encounter is complete, 10 minutes pass and speculum can be transferred to soapy water before the next client is examined
• Immerse gloved hands in 0.5 % chlorine solution and dispose of them in a leak proof container.
• Wash hands with soap and air dry or dry with a clean individual hand towel.
• After 10 minutes remove the instruments from the solution, wash them in soapy water, Air-dry them in readiness for HLD or sterilization.
15.2 PROCESSING CRYOTHERAPY EQUIPMENT
15.2.1 Decontamination and Cleaning
• After completing the procedure and before beginning the cleaning process put utility gloves on both hands to protect yourself.
• Decontaminate the cryotherapy unit, hose and regulator by wiping them with alcohol and letting them air dry.
• Remove the cryotip from the probe. Place the protective cover over the thin metal tube on the end of the probe. Put the cryotherapy unit in the holder on the regulator.
• Remove the plastic sleeve from the cryotip. Insert the small, cone-shaped rubber stopper firmly into open hole in the bottom of the cryotip.
• Wash the cryotip and the plastic sleeves with soap and water until visibly clean. Do not allow the stopper to fall out during washing. Rinse the cryotherapy tip and the plastic sleeves thoroughly with clean water.
• Allow the cryotip and the plastic sleeves to air dry.
• After washing, high level disinfect or sterilize the cryotip before reuse.
15.2.2 High Level Disinfection (HLD) or Sterilization
Do not boil, steam, or soak the cryotherapy unit handle and probe. To high-level disinfect the cryotip and plastic sleeve:
• Soak a chemical disinfectant, such as 0.1% chlorine solution made with boiled water, Cidex (2–4% glutaraldehyde), or 8% formaldehyde for 20 minutes then rinse with boiled water.
• Note: After activation, Cidex solution expires after 30 days. All 5 litres must be activated at once. If full amount cannot be used in one month, the solution can be shared between sites.
15.2.3 Sterilization
The metal cryotip can be sterilized by high-pressure steam sterilization (autoclave) or dry heat sterilization (dry heat oven), if available. Do not place the plastic sleeve or the cryotherapy unit handle and probe in the autoclave or dry heat oven while sterilizing the cryotip.
15.2.4 Storage
After high-level disinfection (or sterilization), the dry cryotip and plastic sleeve can be reassembled and reattached to the cryoprobe on the cryotherapy unit. The cryotherapy unit should then be placed in the holder on the regulator.
15.2.5 Processing of Biopsy Forceps
• The process is the same as for decontamination of the cryotips. Soak a chemical disinfectant, such as 0.1% chlorine solution made with boiled water, Cidex (2–4% glutaraldehyde), or 8% formaldehyde for 20 minutes then rinse with boiled water.
• Wash with soapy water making sure all debris of tissues are removed with a brush and air dry.
15.2.6 Waste disposal and decontamination
• After completing VIA or cryotherapy, while still wearing gloves, dispose of contaminated objects (swabs and other waste items) in a properly marked leak proof container or plastic bag.
• Immerse both hands in the bucket containing 0.5% chlorine solution and them carefully remove gloves by turning them inside out and dispose them in a leak proof container or plastic bag.
• All surfaces contaminated with blood or any fluids should be wiped with chlorine solution.
15.2.7 High-Level Disinfection
• HLD by boiling, steaming, or using chemicals is acceptable for final processing of instruments and surgical gloves used for VIA and cryotherapy. Metal instruments should be steamed or boiled for 20 minutes and allowed to dry. Instruments can be soaked for 20 minutes in 0.1% chlorine solution prepared with boiled water, 2–4% glutaraldehyde, or 8% formaldehyde, thoroughly rinsed in boiled water, and air dried. Instruments should be used immediately or stored for up to 1 week in a dry, HLD container with a tight-fitting lid or cover.
CLINICAL DOCUMENTATION
Individual details about each client will be recorded in the Health Passport (sample form found in Appendix C) for the purpose of establishing a record of services and referrals. When clients are seen by a specialist for histopathology, those details are recorded on the Histopathology Form (Appendix B, also referenced on page 27).
MONITORING AND EVALUATION
To calculate process and outcome indicators for the cervical cancer prevention programme, to monitor the quality of services, and plan appropriately for resources and scale-up, data will be collected on 21 data elements, listed below and labeled A–U in the logbook. The data collection tool is the logbook, which will be located in each clinic where VIA is offered (see Appendix D). The instructions below indicate how clinicians should complete the logbook data elements, by section.
Intake
Client Information
|Data Element |Description |
|A |Date |Fill in the visit date |
|B |Client ID |Fill in the unique client identification numbers assigned by the cervical cancer prevention programme. See |
| | |section 16.1 below on how to create this number for each client. |
|C |Client Name |Fill in client’s first and last name. |
|D |Address |Fill in client’s current home address, to be used to locate the client in the case of needed follow-up. Add|
| | |phone numbers here if available. |
|E |Age |Enter the client’s current age. |
Visit Type
|Data Element |Description |
|F |Initial VIA |Insert a tick ( in this box if this is an initial VIA visit. |
|G |Postponed Cryo |Insert a tick ( in this box if this is a postponed cryotherapy visit. |
|H |Unscheduled Visit |Insert a tick ( in this box if this is an unscheduled problem visit. |
|I |3-Month Review |Insert a tick ( in this box if this is a 3-month review visit. |
|J |One-Year Follow Up |Insert a tick ( in this box if this is one-year follow-up visit where VIA is performed. |
Testing and Results
VIA Results
|Data Element |Description |
|K |+ |Insert a tick ( in this box if VIA was performed on this visit and was positive. |
|L |( |Insert a tick ( in this box if VIA was performed on this visit and was negative. |
|M |Suspect Cancer |Insert a tick ( in this box if the result of the examination is suspect cancer. |
|N |Provider Name |Fill in the VIA provider’s name. |
Detection and Referral
|Data Element |Description |
|O |Large Lesions |Insert a tick ( in this box if the clinician found large lesions during the VIA or pelvic exam, and is|
| | |referring the client for further diagnostic examination. |
|P |Suspect Cancer |Insert a tick ( in this box if the clinician found suspect cancer during the VIA or pelvic exam, and |
| | |is referring the client for further diagnostic examination. |
|Q |Other Gyn |Insert a tick ( in this box if the clinician found other gynaecological problems during the VIA or |
| | |pelvic exam, and is referring the client for further diagnostic examination. |
Cryotherapy
|Data Element |Description |
|R |Done Today |Insert a tick ( in this box if VIA and immediate cryotherapy were performed today. |
|S |Postponed |Insert a tick ( in this box if VIA was performed today, and the client was VIA+ and eligible, but the|
| | |client chooses to postpone cryotherapy. |
|T |Postponed Cryo Done Today|Insert a tick ( in this box if client returned from a previous visit and the postponed cryotherapy |
| | |was performed today. |
|U |Provider Name |Fill in the cryotherapy provider’s name. |
17.1 Client Identification Number
Until national identification numbers are instituted in Malawi, unique client identification numbers will be assigned for the cervical cancer prevention programme. This will help providers track clients and follow up with referrals. The identification number is composed of four parts:
• Serial number
• Year
• Facility code
• Clinic code
An example is: 0056-04-1234-1
• The four-digit serial number is assigned in numeric order at each clinic (0-9999) on an annual basis.
• This is followed by the two-digit year (04 in 2004, 05 in 2005, etc.)
• Next is the facility code used by the HMIS (most are four digits, some are two- or three-digits).
• Finally, in some facilities there is more than one clinic in which VIA will be performed. So, the following codes should be used: 1=Family Planning Clinic; 2=STI Clinic; 3=Gynaecology Clinic.
17.2 Indicators
Indicators related to provision of VIA and cryotherapy services will be tracked for monthly and quarterly reporting. Additional indicators, related to histopathology and treatment provided at tertiary care facilities, will be tracked separately, using existing data collection mechanisms. Indicator reports are important to inform policymakers and programme implementers about how well the programme is doing. They can also help the MoH to determine where and how to expand services. All of these indicators can be calculated using the logbook. Each column in the logbook is labelled with a letter (A, B, C, etc...). Table 7 below shows how to calculate each indicator listed in the reporting form. Instructions show both the title and letter of the column used in each calculation. Instructions are also provided with the logbooks.
Table 7. Malawi Cervical Cancer Prevention Programme Logbook Indicator Equations
|Indicator |Calculation |EQUATION |
|Number of Initial VIA Visits |Add number of records where “Initial VIA” Visit Type (F) is ticked |F |
|Number of Postponed Cryotherapy |Add number of records where “Postponed Cryotherapy” Visit Type (G) is |G |
|Visits |ticked | |
|Number of Unscheduled Visits |Add number of records where ”Unscheduled Visit” Visit Type (H) is |H |
| |ticked | |
| Number of 3-Month Review Visits |Add number of records where “3-Month Review” Visit Type (I) is ticked |I |
|Number of 1-Year Follow Up Visits |Add number of records where “1-Year Follow Up” Visit Type (J) is |J |
| |ticked | |
|Initial VIAs that were Positive |NUMBER: Add number of records where both “Initial VIA” (F) and “+” (K)|F and K |
| |are ticked | |
| |PERCENTAGE: Number of positive Initial VIAs (F and K)/ Total Initial |[pic] |
| |VIAs (F) | |
|One Year Follow Up VIAs that were |NUMBER: Add number of records where both “1-Year Follow Up” (J) and |J and K |
|Positive |“+” (K) are ticked | |
| |PERCENTAGE: Number of positive OYFU VIAs (J and K)/ Total OYFU VIAs |[pic] |
| |(J) | |
|Initial VIAs that were Negative |NUMBER: Add number of records where both “Initial VIA” (F) and “-” (L)|F and L |
| |are ticked | |
| |PERCENTAGE: Number of negative Initial VIAs (F and L)/ Total Initial |[pic] |
| |VIAs (F) | |
|One Year Follow Up VIAs that were |NUMBER: Add number of records where both “1-Year Follow Up” (J) and |J and L |
|Negative |“-” (L) are ticked | |
| |PERCENTAGE: Number of negative OYFU VIAs (J and L)/ Total OYFU VIAs |[pic] |
| |(J) | |
|Initial VIA Clients with Suspect |NUMBER: Add number of records where both “Initial VIA” (F) and |F and M |
|Cancer |“Suspect Cancer” (M) are ticked | |
| |PERCENTAGE: Number Suspect Cancer (M) / Total Initial VIA Tests (F) |[pic] |
|Initial VIA+ Clients referred for |NUMBER: Add number of records where “Initial VIA” (F), “+” (K) and |F, K, and O |
|Large Lesions |“Large Lesions” (O) are ticked | |
| |PERCENTAGE: Number Large Lesions / Total Initial VIA+ |[pic] |
|Initial VIA Clients referred for |NUMBER: Add number of records where both “Initial VIA” (F) and |F and P |
|Suspect Cancer |“Suspect Cancer” (P) are ticked | |
| |PERCENTAGE: Number Suspect Cancer Referrals (P) / Total Initial VIA |[pic] |
| |Tests (F) | |
|Initial VIA Clients referred for |NUMBER: Add number of records where both “Initial VIA” (F) and “Other |F and Q |
|Other Gynaecological Reasons |Gyn” (Q) are ticked | |
| |PERCENTAGE: Number Other Gynaecological Reasons (Q) / Total Initial |[pic] |
| |VIA Tests (F) | |
Table 7. Malawi Cervical Cancer Prevention Programme Logbook Indicator Equations (continued)
|Indicator |Calculation |EQUATION |
|Initial VIA+ Clients with Immediate |NUMBER: Add number of records where “Initial VIA“ (F), “+” (K) and |F, K, and R |
|Cryotherapy |“Done Today” (R) are ticked | |
| |PERCENTAGE: Number of Immediate Cryotherapy (F, K and R) / Total |[pic] |
| |Initial VIA+ (F and K) | |
|Initial VIA+ Clients with Postponed |NUMBER: Add number of records where both “Initial VIA” (F) and |F and S |
|Cryotherapy |“Postponed” (S) are ticked | |
| |PERCENTAGE: Number Postponed Cryotherapy (S) / Total Initial VIA+ (F |[pic] |
| |and K) | |
|Number of Postponed Cryotherapy |NUMBER: Add number of records where “Postponed Cryotherapy” (S) is |S |
|Performed |ticked | |
|Percentage of Target Population |Cumulative total of initial VIA tests performed / Total Target |[pic] |
|Screened |Population | |
Additional Indicators to be collected, with expected data source:
|INDICATOR |DATA SOURCE |
|Number of biopsies performed |Gynaecology Clinic Logs |
|Number of biopsy results in each of the following categories: |Histopathology Laboratory Logbooks/ Reports |
|Normal, Chronic Inflammation, Carcinoma In Situ, and Invasive | |
|Carcinoma | |
|Number of LEEP procedures performed |Gynaecology Clinic Logs (KCH, QECH, Mulanje Mission) |
|Number of cone biopsies or cold knife cone procedures performed |Gynaecology Clinic Logs |
|Number of hysterectomies performed as treatment for invasive |Gynaecology Clinic Logs |
|cervical cancer | |
17.3 Target Population Calculation
Indicator 2 above requires the target population for each healthcare facility for the denominator. The MoH Health Management Information System (HMIS) Unit has already estimated the catchment area population for each healthcare facility in Malawi, and the Malawi Cervical Cancer Programme has used those estimates within the following methodology to estimate the target population for each cervical cancer screening site. The method is described below for your reference, but you may get the current target population for your facility from the Programme.
Method for Calculating Cervical Cancer Screening Target Population, by Facility
1. Obtain total population for facility catchment area.
2. For the total number of women aged 30–45, multiply total population x 0.0674.
3. For 80% of the total number of women aged 30–45, multiply the result of step 2 by 0.8.
4. For the number of women who need to be screened in one year, divide the result of step 3 by 5.
5. For the number of women who need to be screened in one month, divide the result of step 4 by 12.
|2004 MIDYEAR POPULATION |
|(US Census International Database) |
| |Both Sexes |
|Total Population |11,906,855 |
| | |
|AGE |Female Population |
|30-34 |338,786 |
|35-39 |244,900 |
|40-44 |187,206 |
|45 |32,170 |
|30-45 |803,062 |
|Women 30-45 | |
|% of Total Pop |6.74% |
Example: 2004 Estimates for Bangwe Health Center Catchment Area, Blantyre District
| |2003 |
|Total Population* |110,403 |
|30-45** |7,441 |
|TARGET OF 80% OF WOMEN 30-45 OVER 5 YEARS |
|7,441 x 80% |5,953 total to screen in five years |
|5,953/5 years |1,191 per year |
|1,191/12 months |99 per month |
|99/20 days |5 per day if offering services 5 days per week |
|99/12 days |8 per day if offering services 3 days per week |
|99/8 days |12 per day if offering services 2 days per week |
|* National Census Projection |
|** 6.74% of Total Population, based on 2004 population data |
17.4 Reporting
Each month, a summary form should be completed in order to track indicators within the facility. A sample monthly summary report can be found in Appendix E. On-site supervisors or administrators should request these from facility clinical staff to track program progress, and to use in providing feedback. Every quarter (once every three months), the quarterly totals on the quarterly/annual report form must be completed and sent to programme managers at JHPIEGO and the MoH. A staff member will either collect the reports or an envelope will be provided for delivery by post. One individual at the facility should be designated as responsible for completing, submitting, and filing these reports. A sample reporting form can be found in Appendix F.
Once data from all facilities are compiled and analyzed, results showing aggregated data will be returned to all facilities so that providers can compare their performance with other service delivery sites.
Conclusion
The focus of these guidelines is prevention of cervical cancer in low-resource settings; as such, the document describes guiding principles and standards of Visual Inspection Using Acetic acid (VIA) and Cryotherapy.
These guidelines are for use by nurses, clinical officers, doctors and other health workers, programme managers and policymakers responsible for national cervical cancer screening services in Malawi. Training institutions will also find this document very useful as they incorporate cervical cancer information into their preservice curricula.
These guidelines should be used at all levels of clinical service delivery in Malawi that have providers who have been certified in cervical cancer screening services. Certification is granted to providers by the Reproductive Health Unit (RHU), Ministry of Health, after they complete a standardized 2-week training session and are deemed competent in VIA and cryotherapy skills by an approved supervisor.
A training package complements these national guidelines. The package consists of the following materials: Guidelines for Cervical Cancer Prevention in Low-Resource Settings, Cervical Cancer Prevention Course Notebook for Trainers, Cervical Cancer Prevention Course Notebook for Participants, and Visual Inspection for Cervical Cancer Prevention: An Interactive Training Tool (CD-ROM). The training materials can be obtained from the RHU and are for use only by trained facilitators.
These guidelines will be periodically reviewed based on stakeholder and provider observations and feedback, international experience and guidance and scientific/research development on intervention and delivery approaches.
To report any inconsistencies or request clarification, users are encouraged to consult the Secretary for Health, Ministry of Health, P.O.Box 30377, Lilongwe 3; Tel. 265 (0) 1 789 400; Attention: Director of Clinical Services.
REFERENCES
Alliance for Cervical Cancer Prevention (ACCP). 2004. Fact Sheet: Risk Factors for Cervical Cancer: Evidence to Date.
Alliance for Cervical Cancer Prevention (ACCP). 2002. Fact Sheet: Key Steps for Meeting Women’s Needs.
Dzamalala C, C Mdokwe, and N Chimwemwe. 2004. Malawi Cancer Registry 2000–2002. Ministry of Health Malawi: Blantyre, Malawi
Franco E and J Monsonego (eds). 1997. Spontaneous screening: benefits and limitations, in New Development in Cervical Cancer Screening and Prevention. Blackwell Science: Oxford, UK, pg 226.
McIntosh N, PD Blumenthal, and A Blouse (eds). Cervical Cancer Prevention Guidelines for Low-Resource Settings. 2001. JHPIEGO: Baltimore, MD.
Ministry of Health and Population; Reproductive Health Unit. 2001. Malawi National Reproductive Health Service Delivery Guidelines. Ministry of Health and Population: Lilongwe, Malawi.
Ministry of Health and Population; Reproductive Health Unit. 2002. Reproductive Health Policy. Ministry of Health and Population: Lilongwe, Malawi.
Program for Appropriate Technology in Health. 1997. Planning Appropriate Cervical Cancer Prevention Programs, First Edition. PATH: Seattle, WA
Appendix A
Standard Equipment for a Cervical Cancer Screening and Treatment Site
(PROVISIONS ARE MADE FOR A MAXIMUM OF 24 CLIENTS PER DAY)
|Item |Quantity |
|Instrument table |1 |
|Instrument tray with lid |1 |
|Examination table |1 |
|Light source (angle pause 60 watts) |1 |
|Bivalved speculum |24 (20 medium and 4 large) |
|Drapes for table |12 |
|Chucks |12 |
|Tray covers |5 |
|Trolley covers |5 |
|Rolling stool |1 |
|Torch |1 |
|Sponge holding forceps |24 |
|Stainless Gallipots |24 |
|Cryotherapy unit** |1 |
|Cryotherapy tips |2 (1 for backup) |
|Rubber stoppers for cryo units |1 per unit |
|C02 tank |2 (1 for backup) |
|C02 tank carrier with wheels |1 |
|Wretch /spanner |1 |
|Washers for cryo machine |5 (as needed) |
|Plastic buckets for decontamination |2, one for soapy water, one for instruments in Jik |
|Plastic bins |1 for each examination room |
|Utility gloves |2 pairs |
|Antibiotics for STIs* |Initial supply of 50 packets |
|Dry cell batteries for the torch* |2 pairs / month |
|Latex disposables gloves* |700 (14 boxes of 50/box) |
|Acetic acid * |12 bottles of 750 ml / month |
|Cotton wool* |5 rolls / month |
|Cotton tip 8” long swabs or wooden spatula |1 box of 50 – as needed |
|Chlorine decontaminant (Jik) * |12 litres / month |
|Cidex (2–4% glutaraldehyde) |5 litres / month |
|Biohazard plastic bags * |60/month |
|Powdered soap* |1 large or 2 small boxes |
|Gauze swabs* |100 / month |
|Sanitary pads/cotton for post-cryo |20 / month |
|Condoms |200 / month |
|Toothbrushes* (for cleaning) |1 |
|Cloth face masks (for IP) |2 |
|VIA Atlas |2 |
|Repair and Maintenance Manual |1 |
|Service Delivery Guidelines |1 |
|Timer |1 |
|VIA Examination Guide |2 |
|Stamp for Health Passport |1 |
|Ink for stamp |1 |
* These supplies may be required on a monthly basis
** Backup cryotherapy unit should be available at zonal office or other central location
Appendix B
Histopathology Sample Page
HISTOPATHOLOGY FORM
Cervical Cancer Prevention Programme
Facility:__________________________________ Date of Visit: //
Name of Clinician Taking Biopsy:
Preferred Contact: E-mail Phone
Fax
Client Name:_______________________________________ Client Age: ___________
Client ID: Client Sex: F
Client Address:
Brief Clinical History:
Histopathology Form
Cervical Cancer Prevention Programme
Facility:__________________________________ Date of Visit: //
Name of Clinician Taking Biopsy:
Preferred Contact: E-mail Phone
Fax
Client Name:_______________________________________ Client Age: ___________
Client ID: Client Sex: F
Client Address:
Brief Clinical History:
Appendix c
Health Passport Sample Page
CERVICAL CANCER PREVENTION PROGRAMME
Client ID: - - -
VIA Date: / /
Facility: Provider Name:
Cervical Map
VIA Result
Negative Positive Suspect cancer
Cryotherapy
Performed Today Postponed Date performed:
Referral Refer to:
Suspect cancer Lesion size
Other gynae problem (specify):
Other non-gynae problem (specify):
Biopsy
Date: Clinician Name:
Biopsy Result Normal Chronic Inflammation
Carcinoma In Situ Invasive Carcinoma Other _____________
Appendix d
MALAWI CERVICAL CANCER PREVENTION PROGRAMME LOGBOOK Sample Pages
|MONTH ___________ |YEAR __________ | | | | |
|INTAKE |
|CLIENT INFORMATION |VISIT TYPE |
|DATE (A) |
|VIA RESULT |Detection and REFERRAL |CRYOTHERAPY |
|+ |– |Suspect Cancer |Provider Name (N) |Large Lesions |
|(K) |(L) |(M) | |(O) |
| | | | |# |% |
|Number of Postponed |Add number of records where |G | | |NA |
|Cryotherapy Visits |“Postponed Cryotherapy” Visit Type | | | | |
| |(G) is ticked | | | | |
|Number of Unscheduled |Add number of records where |H | | |NA |
|Visits |”Unscheduled Visit” Visit Type (H) | | | | |
| |is ticked | | | | |
| Number of 3-Month Review |Add number of records where |I | | |NA |
|Visits |“3-Month Review” Visit Type (I) is | | | | |
| |ticked | | | | |
|Number of 1-Year Follow Up |Add number of records where “1-Year|J | | |NA |
|Visits |Follow Up” Visit Type (J) is ticked| | | | |
|Initial VIAs that were |NUMBER: Add number of records where|F and K | | |NA |
|Positive |both “Initial VIA” (F) and “+” (K) | | | | |
| |are ticked | | | | |
| |PERCENTAGE: Number of positive |[pic] | |NA | |
| |Initial VIAs (F and K)/ Total | | | | |
| |Initial VIAs (F) | | | | |
|1- Year Follow Up VIAs that|NUMBER: Add number of records where|J and K | | |NA |
|were Positive |both “1-Year Follow Up” (J) and “+”| | | | |
| |(K) are ticked | | | | |
| |PERCENTAGE: Number of positive OYFU|[pic] | |NA | |
| |VIAs (J and K)/ Total OYFU VIAs (J)| | | | |
|Initial VIAs that were |NUMBER: Add number of records where|F and L | | |NA |
|Negative |both “Initial VIA” (F) and “-” (L) | | | | |
| |are ticked | | | | |
| |PERCENTAGE: Number of negative |[pic] | |NA | |
| |Initial VIAs (F and L)/ Total | | | | |
| |Initial VIAs (F) | | | | |
|Indicator |Calculation |EQUATION |TALLY/ |Final MONTHLY |
| | | |Calculation |Indicator(s) |
| | | | |# |% |
| |PERCENTAGE: Number of negative OYFU|[pic] | |NA | |
| |VIAs (J and L)/ Total OYFU VIAs (J)| | | | |
|Initial VIA Clients with |NUMBER: Add number of records where|F and M | | |NA |
|Suspect Cancer |both “Initial VIA” (F) and “Suspect| | | | |
| |Cancer” (M) are ticked | | | | |
| |PERCENTAGE: Number Suspect Cancer |[pic] | |NA | |
| |(M) / Total Initial VIA Tests (F) | | | | |
|Initial VIA+ Clients |NUMBER: Add number of records where|F, K, and O | | |NA |
|referred for Large Lesions |“Initial VIA” (F), “+” (K) and | | | | |
| |“Large Lesions” (O) are ticked | | | | |
| |PERCENTAGE: Number Large Lesions / |[pic] | |NA | |
| |Total Initial VIA+ | | | | |
|Initial VIA Clients |NUMBER: Add number of records where|F and P | | |NA |
|referred for Suspect Cancer|both “Initial VIA” (F) and “Suspect| | | | |
| |Cancer” (P) are ticked | | | | |
| |PERCENTAGE: Number Suspect Cancer |[pic] | |NA | |
| |Referrals (P) / Total Initial VIA | | | | |
| |Tests (F) | | | | |
|Initial VIA Clients |NUMBER: Add number of records where|F and Q | | |NA |
|referred for Other |both “Initial VIA” (F) and “Other | | | | |
|Gynaecological Reasons |Gyn” (Q) are ticked | | | | |
| |PERCENTAGE: Number Other |[pic] | |NA | |
| |Gynaecological Reasons (Q) / Total | | | | |
| |Initial VIA Tests (F) | | | | |
|Indicator |Calculation |EQUATION |TALLY/ |Final MONTHLY |
| | | |Calculation |Indicator(s) |
| | | | |# |% |
| |PERCENTAGE: Number of Immediate |[pic] | |NA | |
| |Cryotherapy (F, K and R) / Total | | | | |
| |Initial VIA+ (F and K) | | | | |
|Initial VIA+ Clients with |NUMBER: Add number of records where|F and S | | |NA |
|Postponed Cryotherapy |both “Initial VIA” (F) and | | | | |
| |“Postponed” (S) are ticked | | | | |
| |PERCENTAGE: Number Postponed |[pic] | |NA | |
| |Cryotherapy (S) / Total Initial | | | | |
| |VIA+ (F and K) | | | | |
|Number of Postponed |NUMBER: Add number of records where|S | | |NA |
|Cryotherapy Performed |“Postponed Cryotherapy” (S) is | | | | |
| |ticked | | | | |
|Percentage of Target |Cumulative total of initial VIA |[pic] | |NA | |
|Population Screened |tests performed / Total Target | | | | |
| |Population | | | | |
Appendix F
CERVICAL CANCER PREVENTION PROGRAMME Quarterly/ANNUAL
Report Sample Page
MONTH |# OF INITIAL VIA VISITS |# OF POSTPONED CRYO VISITS |# OF 3-MONTH REVIEW VISITS |# OF UNSCHEDULED VISITS |# OF ONE-YEAR FOLLOW UP VISITS |INITIAL VIAS THAT WERE POSITIVE |OYFU VIAS THAT WERE POSITIVE |INITIAL VIAS THAT WERE NEGATIVE |OYFU VIAS THAT WERE NEGATIVE |INITIAL VIAS THAT WERE SUSPECT CANCER |INITIAL VIA+ CLIENTS REFERRED FOR LARGE LESIONS |INITIAL VIA CLIENTS REFERRED FOR SUSPECT CANCER |INITIAL VIA CLIENTS REFERRED FOR OTHER GYN REASONS |INITIAL VIA+ CLIENTS WITH IMMEDIATE CRYO |INITIAL VIA+ CLIENTS WITH POSTPONED CRYO |# OF POSTPONED CRYO PERFORMED |% OF TARGET POPULATION SCREENED | | | | | | | |# |% |# |% |# |% |# |% |# |% |# |% |% |# |% |# |% |# |% |# | | | |JANUARY | | | | | | | | | | | | | | | | | | | | | | | | | | | | |FEBRUARY | | | | | | | | | | | | | | | | | | | | | | | | | | | | |MARCH | | | | | | | | | | | | | | | | | | | | | | | | | | | | |Q1 TOTAL | | | | | | | | | | | | | | | | | | | | | | | | | | | | |APRIL | | | | | | | | | | | | | | | | | | | | | | | | | | | | |MAY | | | | | | | | | | | | | | | | | | | | | | | | | | | | |JUNE | | | | | | | | | | | | | | | | | | | | | | | | | | | | |Q2 TOTAL | | | | | | | | | | | | | | | | | | | | | | | | | | | | |JULY | | | | | | | | | | | | | | | | | | | | | | | | | | | | |AUGUST | | | | | | | | | | | | | | | | | | | | | | | | | | | | |SEPTEMBER | | | | | | | | | | | | | | | | | | | | | | | | | | | | |Q3 TOTAL | | | | | | | | | | | | | | | | | | | | | | | | | | | | |OCTOBER | | | | | | | | | | | | | | | | | | | | | | | | | | | | |NOVEMBER | | | | | | | | | | | | | | | | | | | | | | | | | | | | |DECEMBER | | | | | | | | | | | | | | | | | | | | | | | | | | | | |Q4 TOTAL | | | | | | | | | | | | | | | | | | | | | | | | | | | | |ANNUAL TOTAL | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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Clinician
• Assess performance of providers (supervision)
• VIA
• Cryotherapy
• Refer large lesions, suspect cancer, and other gynaecological problems to Ob/Gyns
OB/GYNS
• Examine and diagnose referred cases.
• Perform biopsies on suspect cancer
• Perform LLETZ and colposcopy.
• Treat VIA + cases by cryotherapy if appropriate.
• Treat confirmed cancer or the cervix by hysterectomy or refer for chemotherapy and radiotherapy as appropriate
• Identify resources for palliative care i.e. pain relief, Fefo, psychological care and support
• Supervise and support clinical officers.
• Refer cases to other departments as appropriate.
Providers at Service Sites
• VIA
• Cryotherapy
• Refer large lesions, suspect cancer, and other gynaecological problems to Ob/Gyns
Histopathologist
Conduct histopathological tests and communicate the results to the referring practitioner.
Feedback
Feedback
Feedback
Referrals
Referrals
Results
Home Based Care
Clients with terminal cancer of the cervix shall be referred to home-based care services for palliative care.
Feedback
Referrals
Referrals
Feedback
Feedback
Feedback
As seen in the table at the right, 6.74% of the total Malawian population are women aged 30–45 years. Thus, Step 2 is to multiply the total facility catchment area population by 0.0674 to estimate the total number of women in the target age range for screening. This method assumes that each facility’s population has the same age-sex distribution as the national population. See example calculations below for Bangwe Health Center.
KEY
Outline of SCJ
Acetowhite lesion
Cervical Os
Suspect Cancer
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