This document provides an overview of quality assurance and eligibility for female sterilization procedures. It defines quality assurance as a means to prevent defects and ensure solutions meet standards. It outlines eligibility criteria for different sterilization procedures based on provider training and lists conditions that would make a patient eligible, require caution, necessitate a delay, or require special consideration for the procedure. The timing of sterilization is also discussed in relation to a woman's menstrual cycle or other procedures she may have undergone. Informed consent processes are emphasized.
2. What is quality assurance?
• Quality assurance is a way of preventing mistakes or
defects in manufactured products and services and
avoiding problems when delivering solutions or
services
3. ISO 9000 defines
Quality Assurance as, "part of quality
management focused on providing
confidence that quality requirements
will be fulfilled”.
4. QUALITY ASSURANCE
Quality Assurance is a means by which the institution can
guarantee that standards and quality of its educational
provisions are being maintained and enhanced. Therefore it
relates to a continuous process of evaluating (assessing,
monitoring, guaranteeing, maintaining and improving) the
quality of programmes. It’s a mean to an end and not an end
in itself.
6. FEMALE STERILISATION
TWO METHODS
1. MINI LAPAROTOMY
MAKING A SMALL INCISION IN THE ABDOMEN AND
BRINGING OUT THE TUBES THROUGH THE INCISION TO CLAMP/CUT
2. LAPAROSCOPIC
BOTH CAN BE
PERFORMED BY A TRAINED MBBS DOCTOR OR A SPECIALIST
Both are simple, safe, highly effective, relatively pain free, can be done as an
ambulatory procedure, minimal damage to tube so as to facilitate reversal
7. Eligibility of providers to perform sterilisation
procedures
FEMALE MINILAP
STRERILISATION
DGO/MD,MS OG
SPECIALITIES IN OTHER SURGICAL FIELDS
MBBS TRAINED
SHOULD BE TRAINED
FEMALE
LAPAROSCOPIC
STRERILISATION
DGO/MD,MS OG/ MS SURGERY
SPECIALITIES IN OTHER SURGICAL FIELDS
MBBS TRAINED IN MINILAP
TRAINED IN
LAPAROSCOPY
CONVENTIONAL
VASECTOMY
MBBS AND ABOVE TRAINED
NON SCALPEL
VASECTOMY
MBBS AND ABOVE TRAINED
8. POINTS TO NOTE
THE STATE SHOULD MAINTAIN DISTRICT-WISE LIST OF
DOCTORS EMPANELLED FOR PERFORMING STERILISATIONS
OPERATIONS IN PUBLIC AND ACCREDITED PRIVATE/NGO
FACILITIES
STATE SHOULD MAINTAIN A SEPARATE LIST FOR MINILAP,
LAPAROSCOPIC TUBECTOMY, CONVENTIONAL AND NON-SCALPEL
VASECTOMY PROVIDERS
ONLY THOSE DOCTORS IN THE LIST CAN PERFORM THESE
STERILISATION PROCEDURES
THE LIST SHOULD BE UPDATED EVERY 3MONTHS OR EARLIER IF
WARRANTED AND THE LIST IS FORWARDED TO THE STATE FROM
THE DISTRICT.
A DOCTOR EMPANELLED IN THE LIST OF ONE STATE/DISTRICT
CAN PERFORM IN OTHER STATES/DISTRICTS ALSO.
STATES CAN EMPANEL DOCTORS ALREADY PERFORMING THE
9. FEMALE STERILISATION
IT IS QUIET EASY TO CONVINCE FOR FEMALE
STERILISATION THAN MALE STERILISATION AND HENCE
WIDELY ACCEPTED BY ALL EXCEPT IN FEW CIRCUMSTANCES…
MOST POPULAR HIGHLY EFFECTIVE SAFE PERMANENT
METHOD
TOTAL UNMET NEED FOR CONTRACEPTION IS ONE FIFTH,
MAINLY DUE TO LACK OF SKILLEED SERVICE PROVIDERS AT
PERIPHERAL HEALTH FACILITIES
NHM GOVERNMENT OF INDIA STRENGTHENED HEALTH
FACILITIES FOR PROVIDING ASSURED FIXED DAY FP
SERVICES AT DH,SDH, FRU, CHC AND PHC
10. TIMING OF FEMALE STERILISATION
WOMEN WHEN TO PERFORM
HAS MENSTRUAL CYCLES ANY TIME WITHIN 7 DAYS OF START OF HER
MENSTRUAL CYCLE
ANY TIME OF MENSTRUAL CYCLE IF ITS CERTAIN
THAT SHE IS DEFINETELY NOT PREGNANT
SWITCHES FORM ANOTHER METHOD OCP: CAN CONTINUE PILLS TILL SHE FINISHES
THE PACK SO AS TO RESUME HER NEXT CYCLE.
ST CAN BE DONE ANY TIME
IUCD: CAN BE DONE AT ANY TIME ALONG WITH
REMOVAL OF IUCD
NO MONTHLY MENSTRUAL BLEEDING ANY TIME PROVIDED IT IS CERTAIN THAT SHE IS
NOT PREGNANT
AFTER CHILD BIRTH AFTER 24 HOURS POST-PARTUM AND WITHIN 7
DAYS OF CHILD BIRTH (ONLY MINI LAP)
6 WEEKS OR AFTER – IF IT IS CERTAIN THAT SHE
IS NOT PREGNANT
11. TIMING OF FEMALE STERILISATION
AFTER MTP IMMEDIATELY AFTER SURGICAL MTP OR
WITHIN 7 DAYS OF MTP
IN CASE OF MEDICAL ABORTION TUBECTOMY
SHOULD BE DONE AFTER NEXT MENSTRUAL
CYCLE OR AFTER 15 DAYS WHEN THE PATIENT
COMES FOR FOLLOW-UP AFTER DOING UPT
AND USG
LAPAROSCOPIC TUBAL OCCLUSION CAN BE
PERFORMED ONLY IN MTPs UPTO 12WEEKS OF
GESTATION
AFTER MISCARRIAGE OR ABORTION WITHIN 7 DAYS, IF NO COMPLICATIONS
AFTER USING EMERGENCY CONTRACEPTIVE
PILLS
WITHIN 7 DAYS OF THE START OF HER NEXT
MENSTRUAL BLEEDING OR ANY OTHER TIME IF
IT IS CERTAIN THAT SHE IS NOT PREGNANT
IF THERE IS NO MEDICAL REASON A WOMEN CAN HAVE HER STERILISATION PROCEDURE IF IT IS
REASONABLY CERTAIN THAT SHE IS NOT PREGNANT
12. TIMING OF SURGERY
IN A NUT SHELL
INTERVAL PROCEDURE – WITHIN 7 DAYS OF MENSTRUAL CYCLE
POST-PARTUM STERILISATION – AFTER 24 HOURS TOWITHIN 7 DAYS
OF DELIVERY
FOLLOWING SPONTANEOUS ABORTION – SIMULTANEOUSLY OR WITHIN
7 DAYS AFTER EXCLUDING INFECTION
FOLLOWING MTP – IMMEDIATELY
MEDICAL ABORTION – IN NEXT MENSTRUAL CYCLE OR AFTER 15 DAYS
POST-ABORTAL DURING FOLLOW-UP
CONCURRENTLY WITH OTHER SURGERIES LIKE LSCS, SALPINGECTOMY
OR OVARIAN CYCTECTOMY
13. COUNSELLING AND INFORMED CONSENT
USE SIMPLIFIED DIAGRAMS
IN THE LANGUAGE WHICH CLIENT CAN UNDERSTAND
INFORM ABOUT ALL AVAILABLE , ELIGIBLE AND SUITABLE METHODS OF
FAMILY PLANNING
MAKE HER UNDERSTAND WHAT MAY HAPPEN BEFORE, DURING AND
AFTER THE PROCEDURE, SIDE EFFECTS AND COMPLICATIONS
IT IS A PERMANENT METHOD
CLIENTS SHOULD MAKE AN INFORMED DECISION VOLUNTARILY
CONSENT OF PARTNER IS NOT REQUIRED FOR STERILISATION
BOTH VERBAL AND WRITTEN CONSENT SHOULD BE GOT
14. DOCUMENTATION OF INFORMED CONSENT
CLIENT’S SIGNATURE OR THUMB IMPRESSION ON CONSENT FORM
SIGNATURE OF A WITNESS (ANY PERSON NOT ASSOCIATED WITH
HEALTH FACILITY AND CHOSEN BY THE CLIENT) IN CASE OF THUMB
IMPRESSION
UNFIT CLIENT SHOULD BE COUNSELLED FOR OTHER METHODSAND
REASON FOR DENIAL SHOUILD BE DOCUMENTED
15. ELIGIBILITY CRITERIA FOR FEMALE STERLIZATION
NO ELIGIBLE CLIENT SHOULD BE DENIED FEMALE
STERILISATION SERVICE
CLIENT SHOULD BE EVER - MARRIED
FEMALE CLIENTS SHOULD BE ABOVE 22 YEARS
AND BELOW 49 YEARS
THE COUPLE SHOULD HAVE ATLEAST ONE CHILD,
WHOSE AGE IS ABOVE 1 YEAR, UNLESS THE
STERILIZATION IS MEDICALLY INDICATED
CLIENTS OR THEIR SPOUSE/PARTNERS MUST
16. ELIGIBILTY CRITERIA FOR FEMALE STERILIZATION –
contd..
COUPLE MUST BE IN A SOUND STATE OF MIND,
SO AS TO UNDERSTAND THE FULL IMPLICATIONS
OF STERILIZATION
MENTALLY ILL CLIENTS MUST BE CERTIFIED BY A
PSYCHIATRIST AND A STATEMENT SHOULD BE
GIVEN BY THE LEGAL GUARDIAN/ SPOUSE
REGARDING THE SOUNDNESS OF THE CLIENT’S
STATE OF MIND
A RELEVANT MEDICAL HISTORY , PHYSICAL
17. NO MEDICAL CONDITION PREVENT FEMALE
STERILISATION
CATEGORY EXPLANATION
ACCEPT (A) THERE IS NO MEDICAL REASON TO DENY THE METHOD TO A PERSON WITH THIS
CONDITION OR IN THIS CIRCUMSTANCE.THE PROCEDURE CAN BE PERFORMED IN MOST
CLINICAL CIRCUMSTANCES
CAUTION (C) THE METHOD IS NORMALY PROVIDED IN A ROUTINE SETTING BUT WITH EXTRA
PRECAUTIONS AND PREPARATIONS AS REQUIRED
DELAY (D) PROVISION OF THE METHOD SHOULD BE DELAYED OR POSTPONED. THESE CONDITIONS
SHOULD BE EVALUATED, TREATED AND RESOLVED BEFORE FEMALE STERILISATION CAN
BE PERFORMED. ALTERNATIVELY OPTIONS OF TEMPORARY METHODS OF STERILISATION
OR NSV CAN BE PROVIDED.
SPECIAL (S) CERTAIN WOMEN HAVE CONDITIONS THAT MAKE OPERATION DIFFICULT OR CARRY
INCREASED RISK. THE PROCEDURE SHOULD BE UNDERTAKEN IN A SETTING WITH AN
EXPERIENCED SURGEON AND STAFF, EQUIPMENT NEEDED TO PROVIDE GENERAL
ANAESTHESIA AND OTHER BACK-UP MEDICAL SUPPORT. THE CAPACITY TO DECIDE ON
THE MOST APPROPRIATE PROCEDURE AND ANAESTHESIA SUPPORT IS ALSO NEEDED.
ALTERNATIVELY, TEMPORARY ,METHODS OF CONTRACEPTION SHOULD BE PROVIDED IF
REQUIRED OR THERE IS OTHERWISE ANY DELAY.
18. CATEGORY A
PARITY – NULLIPAROUS AND PAROUS
LACTATING MOTHER
1-7 DAYS POST-PARTUM
≥ 42 DAYS POST-PARTUM
POST-ABORTAL – UNCOMPLICATED
PAST H/O ECTOPIC PREGNANCY
SMOKING
H/O HIGH BLOOD PRESSURE IN PREGNANCY – CURRENT B.P. NORMAL
H/O DVT/PE
FAMILY H/O DVT/PE
MAJOR/ MINOR SURGERY WITHOUT PROLOGED IMMOBILISATION
19. CATEGORY A contd..
KNOWN THROMBOGENIC MUTATIONS
SUPERFICIAL VENOUS THROMBOSIS
KNOWN HYPERLIPIDAEMIAS
HEADACHES – BOTH MIGRAINOUS AND NON-MIGRAINOUS
ANY VAGINAL BLEEDING PATTERNS - REGULAR OR IRREGULAR/ HMB/PROLONGED BLEEDING
BENIGN OVARIAN TUMOURS
SEVERE DYSMENORRHOEA
BENIGN GESTATIONAL TROPHOBLASTIC DISEASE
CERVICAL ECTROPION
CIN
BREAST DISEASE – UNDIAGNOSED MASS/BENIGN/ FAMILY H/O CA, PAST H/O CA WITH NO EVIDENCE OF
CURRENT DISEASE
PAST PID WITH SUBSEQUENT PREGNANCY
VAGINITIS, INCREASED RISK OF STI EXCEPT CURRENT INFECTIONS
HIV – HIGH RISK, INFECTED
20. CATEGORY A contd…
INFECTIONS – TB – NON-PELVIC, MALARIA
H/O GDM
SIMPLE GOITRE
SYMPTOMATIC GALL BLADDER DISEASE TREATED MEDICALLLY OR
SURGICALLY AND ASYMPTOMATIC
H/O CHOLESTASIS
VIRAL HEPATITIS CARRIER
STERILISATION WITH CONCURRENT CAESAREAN SECTION
21. CATEGORY D
PREGNANCY
7-<42 DAYS POST-PARTUM
SEVERE PRE-ECLAMPSIA / ECLAMPSIA (ANAESTHESIA RELATED)
PROLONGED RUPTURE OF MEMBRANES ≥ 24 HOURS
PUERPERAL SEPSIS/ FEVER
SEVERE APH/PPH / POST- ABORTAL HEMORRHAGE
SEVERE TRAUMA TO THE GENITAL TRACT AT THE TIME OF
DELIVERY / ABORTION
POST – ABORTAL SEPSIS / FEVER
ACUTE HEAMATOMETRA
22. CATEGORY D contd…
CURRENT DVT/ PE
MAJOR SURGERY WITH PROLOGED IMMOBILISATION
CURRENT IHD
BEFORE EVALUATION OF UNEXPLAINED VAGINAL BLEEDING
MALIGNANT GTD
CA CERVIX, ENDOMETRIUM
CURRENT PID / PURULENT CERVICITIS OR CHLAMYDIAL INF OR
GONORRHOEA
CURRENT GB DISEASE / ACTIVE VIRAL HEPATITIS
23. CATEGORY D contd…
Hb < 7 G/DL
LOCAL ABDOMINAL SKIN INFECTION
ACUTE RESPIRATORY INFECTIONS LIKE PEUMONIA, BRONCHITIS
SYSTEMIC INFECTION / GASTRO-ENTERITIS
STERILISATION CONCURRENT WITH EMERGENCY (WITHOUT
PRIOR COUNSELLING) ABDOMINAL SURGERY
24. CATEGORY C
Young age – regrets in future
Obesity BMI≥ 30
Hypertension adequately controlled
Elevated b.p. 140-159/90-99
H/O IHD, Stroke
Uncomplicated valvular heart disease
Epilepsy
Depressive disorders
Current CA breast, uterine fibroids, past PID without subsequent
pregnancy
25. Category C contd…
Dm – non - vascular disease
Hypothyroid
Mild cirrhosis – compensated
Liver tumours – benign, malignant
Thalassemia, sickle cell disease
Hb≥ 7g/dl to ,10g/dl
Diaphragmatic hernia, kidney disease, severe nutritional deficiencies,
previous abdominal or pelvis surgery
Sterilisation concurrent with elective abdominal surgery
26. CONDITION S
UTERINE RUPTURE OR PERFORATION – EXPLORE/REPAIR/ST IF NO ADDITIONAL RISK
MULTIPLE RISK FACTORS FOR ARTERIAL DISEASE
B.P. ≥160/≥ 100
VASCULAR DISEASE
COMPLICATED VALVULAR HEART DISEASE
ENDOMETRIOSIS
AIDS
KNOWN PELVIC TUBERCULOSIS
DM WITH NEPHROPATHY/ RETINOPATHY/ NEUROPATHY
HYPERTHYROID, SEVERE DECOMPENSATED CIRRHOSIS
COAGULATION DISORDERS
CHRONIC RESPIRATORY DISEASES
FIXED UTERUS/ HERNIA
27. CONDITION INCLUDED IN CAUTION CATEGORY
i. PREVIOUS ABDOMINAL OR PELVIC SURGERY
ii. OBESITY
iii. CONTROLLED B.P. (140-159, 90-99)
iv. UNCOMPLICATED HEART DISEASE
v. HISTORY OF ISCHEMIC HEART DISEASE
vi. STROKE
vii. HISTORY OF CEREBRO- VASCULAR DISEASE
viii. HISTORY OF DVT OR PULMONARY EMBOLISM
28. CONDITIONS INCLUDED IN DELAY CATEGORY
1. Severe Iron Deficiency Anaemia – Hb 7 gm%
2. Current pregnancy
3. 8-42 days post-partum
4. Pregnancy with severe pre-eclampsia or eclampsia
5. Post-partum or post-abortal complications like infection, trauma,
hemorrhage etc..
6. Current DVT/ PE
7. Major surgery with prolonged immobilisation
8. Abdominal skin infections
29. Conditions included in Special category
Conditions that increase chances of heart disease or stroke like old age,
HTN, DM, smoking
Blood pressure >160/ 100 mmHg
Complicated Heart Disease
Coagulation disorders
Chronic Lung disease – Asthma, Empyema
Endometriosis
Tuberculosis
Fixed uterus due to previous surgery or infection
30. FEMALE STERILISATION IN HIV/AIDS
NO WOMAN SHOULD BE DENIED OF
STERILISATION BASED ON HIV STATUS
WOMAN WITH HIV/AIDS/ON ARV THERAPY
– ANYONE CAN UNDERGO STERILISATION PROCESS
AS LIKE OTHER WOMEN.
COUNSEL WOMEN TO USE CONDOMS EVEN AFTER STERILISATION
NO WOMEN SHOULD BE PRESSURISED TO STERLISATION BASED ON HER HIV
STATUS.
31. ELIGIBILTY BASED ON ASSESSMENT
COMPLETE HISTORY TAKING
COMPLETE EXAMINATION INCLUDING PELVIC
EXAMINATION, SPECULUM EXAMINATION AND
BIMANUAL EXAMINATION
ANY ABNORMALITY IN EXTERNAL GENITALIA,ENLARGED
LYMPH NODES, VAGINAL DISCHARGE, PURULENT
CERVICITIS, CERVICAL MOTION TENDERNESS, UTERUS
SIZE, SHAPE, POSITION AND MOBILITYTO BE NOTED.
ANY ADNEXAL MASS OR TENDERNESS, ACTIVE PID TO BE
RULED OUT
CHECK FOR SIGNS OF PREGNANCY AND ANY UTERINE
ABNORMALITY
32. PREVENTION OF INFECTION
IN SIMPLE WORDS, IT CAN BE PUT AS
PROPER HAND WASHING
SELF PROTECTION OF HEALTH CARE
PROVIDERS
SAFE WORK PRACTICES LIKE HANDLING
OF SHARPS
ENVIRONMENTAL CLEANLINESS
PROPER INSTRUMENT PROCESSING
WASTE MANAGEMENT PLAN
33. POST – OPERATIVE CARE
RECEIVE THE PATIENT FROM OT WITH CARE
REVIEW THE RECORDS
MAKE THE CLIENT AS COMFORTABLE AS POSSIBLE
HANDLE THE PATIENT GENTLY
MAKE SURE THAT THE OVER SEDATED PATIENT IS NEVER LEFT
UNATTENDED
MONITOR THE VITALS EVERY 15 MINUTES FOR ONE HOUR POST-OP OR
TILL THE PATIENT IS STABLE AND AWAKE AND THEN HOURLY FOR 4
HOURS. RECORD ALL THE VITALS AS MONITORED WITH TIME IN THE
CHART AND INFORM THE SURGEON OR DUTY DOCTOR AS NEEDED.
CHECK THE SURGICAL SITE FOR OOZING OR BLEEDING
34. POST- OPERATIVE CARE (contd…)
FOR INTERVAL CASES, check for bleeding pv other than mensturation
(CERVIX INJURY WITH VALSELLUM FOR SAY,.)
FOLLOW TREATMENT ORDERS AS PRESCRIBED BY THE DOCTOR
START WITH ORAL LIQUIDS ONCE THE PATIENT IS FULLY AWAKE AND
COMFORTABLE.
COMPLETE THE CLIENT RECORD FORM
35. Follow-up
FIRST VISIT – AFTER 48 HOURS IF THE PATIENT IS
DISCHARGED ON THE SAME DAY OF PROCEDURE
SECOND VISIT – AFTER 7 DAYS
THIRD VISIT – AFTER NEXT CYCLE
EMERGNCY VISIT – IMMEDIATE ATTENTION
36. Take home points…
Proper case selection after counseling and proper examination according to the
check list
To be done with the client consent
4-6 hours fasting is enough
If only one tube is ligated, it should be explained to the patient and attenders
when they are in a sound state of mind, in their own language which they are
able to understand and documented along with witness signature.
Private hospital should be accredited for procedure by SQAC.
Operating surgeon should be empanelled with state.
Quality Assurance Committee for facility should be framed for self assessment
and improvement.
