Early Lessons from Implementing Clinical Safety Checklist (CSC) for

Voluntary Female Sterilization in India

Dr. Geeta Chhibber Advisor MCSP, India

Background

Contraceptive use in India (NFHS-4, 2015-16)

Voluntary female sterilization is the most accepted method of contraception with nearly 4 million procedures performed annually (HMIS; FY2016-17)

While simple and safe, the risk of complications, deaths and failure were unacceptably high due to:

• Camp mode vs Fixed Day Service (FDS) mode

• Limited access to institutional services

• Prescribed standards circumvented during service provision

• Critical steps often omitted

2

Chart1

Condoms

IUCD/PPIUCD

Pills

Non Users

Other/TraditionalMethods

Female Sterilization

Male Sterilization

Method Mix

[][]

[][]

[][]

5.6

1.5

4.1

46.8

5.7

36

0.3

Sheet1

Method Mix

Condoms5.6

IUCD/PPIUCD1.5Other/TraditionalMethods5.7

Pills4.1Non Users46.8

Non Users46.8Condoms5.6Condoms5.6

Other/TraditionalMethods5.7IUCD/PPIUCD1.5IUCD/PPIUCD1.5

Female Sterilization36.0Pills4.1Pills4.1

Male Sterilization0.3Male Sterilization0.3Male Sterilization0.3

Female Sterilization36.0Non Users46.8

Other/TraditionalMethods5.7

Female Sterilization36.0

What is Needed to Improve QOC in Indian Context?

Tools/ technologies/strategies that:• Help service providers know what essential actions are needed

to provide safe care• Help service providers understand and remember to perform

essential actions• Helps them understand and know when they need to be

performed• Help improve resource availability• Help improve supervision• Help improve accountability

3

Checklists have reduced systems failure in complex procedures such as flying multi-engine aircrafts

• What does a Checklist do: strengthens key practices, reduces the chances of errors, omissions and mishaps

• 19-item WHO Surgical Safety Checklist reduced surgical mortality by >40%

• Clinical Safety Checklist was introduced in India to reduce risk of complications, deaths and failures from voluntary female sterilization

3

What is the Clinical Safety Checklist?

On Admission

Pre-operative and Intra-operative

At Discharge

Post-operative

• Simple, easy to understand bilingual tool • Not only what to do but also how to do• Client centred instead of surgeon-centric

approach

• Four pause points corresponding to client flow

• Only spells out critical tasks • Involves nurses in a bigger role and

supports shared team work

• Helps in standardizing and enhancing consistency in surgical team performance

• Reduces reliance on memory

4

Program Intervention: Geographies

CSC implementation in India: 5 States-Assam, Odisha, Chhattisgarh, Telangana & Maharashtra15 Districts186 Facilities1461 nurses and doctors trained

Introduced in Jan 2017 in Chhattisgarh, Odisha, Telangana & June 2017 in Assam and Maharashtra

5

Development and Introduction of the Clinical Safety Checklist in Intervention Facilities

• National data base of complications, failures and deaths in these 5 States reviewed

• Baseline data on current practices in intervention districts and facilities collected

• Development of the tool by MCSP based on evidenced-based best practices and government guidelines

• Review and inputs of State Technical Working Groups

• Pilot and field testing with providers• Final tool developed after incorporating feedback

• Introduced in District Orientation Workshops

• Facility Level Orientation of all facility staff done• Key persons identified who are directly involved

in providing voluntary female sterilization services• Tool use supported on actual FDS days

Maharashtra

Telangana

Chhattisgarh

Odisha

Assam

• A total of 22,409 Clinical Safety Checklists (CSCs) were filled for 38,802 voluntary female sterilization surgeries between January 2017 to June 2018

• 13,083 checklists were digitized and analyzed

Results and Key Findings

6

Chart1

Qtr-12017

Qtr-2

Qtr-3

Qtr-4

Qtr-12018

Qtr-2

% of CSC filled against Case conducted

Percentage of Minilap surgeries for which CSC was filled

Quarter-wise trend of filling the ‘Clinical Safety Checklist’

0.3911152897

0.551701991

0.6845230063

0.6171875

0.5956142871

0.8183881952

Sheet1

Column1Case ConductedCSC FilledCSC Digitized% of CSC filled against Case conducted

2017Qtr-185093328220139%

Qtr-2155785935855%

Qtr-374115073345968%

Qtr-492165688324262%

2018Qtr-1104436220361760%

Qtr-21762144272282%

Quarter-wise Trend of Completeness of Filled Checklists

+ Maximum, - Minimum

7

93% 84%Client re-confirms decision to opt for sterilization

Pelvic Examination done

+ - 86% 74%Sedation and analgesia has been given

Intra-operative vitals monitored

+ 85% 72%Client shifted from OT on trolley or wheelchair

Post-operative vitals monitored

+ 84% 72%Warning signs explained to the client and accompanying adult

Advice on discharge explained

+- - -

Chart1

Qtr-12017Qtr-12017Qtr-12017Qtr-12017

Qtr-2Qtr-2Qtr-2Qtr-2

Qtr-3Qtr-3Qtr-3Qtr-3

Qtr-4Qtr-4Qtr-4Qtr-4

Qtr-12018Qtr-12018Qtr-12018Qtr-12018

Qtr-2Qtr-2Qtr-2Qtr-2

Pause Point 1

Pause Point 2

Pause Point 3

Pause Point 4

% of digitized checklists in which pause points were completely filled

[]

0.282099344

0.3345829428

0.33

0.4868791003

0.2709497207

0.3966480447

0.3631284916

0.3351955307

0.3014101058

0.3622209166

0.4797297297

0.5728554642

0.2167213115

0.2829508197

0.4491803279

0.5154098361

0.2578285045

0.2780216564

0.4123500146

0.4937079309

0.4217877095

0.4525139665

0.5656424581

0.7094972067

Sheet1

Column1Pause Point 1Pause Point 2Pause Point 3Pause Point 4

2017Qtr-128%33%33%49%

Qtr-227%40%36%34%

Qtr-330%36%48%57%

Qtr-422%28%45%52%

2018Qtr-126%28%41%49%

Qtr-242%45%57%71%

Completeness of Select Indicators

8

Chart1

Ensures client has emptied bladderEnsures client has emptied bladder

Confirms client identityConfirms client identity

Ensures consent form is signed by the clientEnsures consent form is signed by the client

Sub-Criteria

Is the client prepared for surgery?

0.54

0.71

0.58

0.71

0.58

0.71

Sheet1

Sub-CriteriaIs the client prepared for surgery?Column1

Ensures client has emptied bladder54%71%

Confirms client identity58%71%

Ensures consent form is signed by the client58%71%

Chart1

Inj. Promethazine (Phenargan)Inj. Promethazine (Phenargan)

Inj. Pentazocine (Fortwin)Inj. Pentazocine (Fortwin)

Any otherAny other

Sub-Criteria

Has sedation and analgesia been given?

0.46

0.64

0.56

0.64

0.17

0.64

Sheet1

Sub-CriteriaHas sedation and analgesia been given?Column1

Inj. Promethazine (Phenargan)46%64%

Inj. Pentazocine (Fortwin)56%64%

Any other17%64%

Chart1

1% Lignocaine used after diluting 2%1% Lignocaine used after diluting 2%

Dose calculated as per body weightDose calculated as per body weight

Plunger withdrawn before infiltrationPlunger withdrawn before infiltration

Skin, rectus sheath & peritoneum infiltratedSkin, rectus sheath & peritoneum infiltrated

Satisfactory anaesthetic effect checkedSatisfactory anaesthetic effect checked

Sub-Criteria

Is surgery done under local anaesthesia (LA)?

0.68

0.7

0.64

0.7

0.7

0.7

0.69

0.7

0.67

0.7

Sheet1

Sub-CriteriaIs surgery done under local anaesthesia (LA)?Column1

1% Lignocaine used after diluting 2%68%70%

Dose calculated as per body weight64%70%

Plunger withdrawn before infiltration70%70%

Skin, rectus sheath & peritoneum infiltrated69%70%

Satisfactory anaesthetic effect checked67%70%

Chart1

Vitals checked and recordedVitals checked and recorded

Surgical dressing checked for soakageSurgical dressing checked for soakage

Sub-Criteria

Client observed for atleast four hours after surgery?

[]

0.38

0.66

0.36

0.66

Sheet1

Sub-CriteriaClient observed for atleast four hours after surgery?Column1

Vitals checked and recorded38%66%

Surgical dressing checked for soakage36%66%

Lack of client assessment & preparation before surgery

Lack of attention to respectful care: poor explanation of the consent form; intra/post-op monitoring; comfort

Implementation Challenges: What are we up against?

Faulty infection prevention practices and technique of surgery

HR challenges04

03

02

01

Faulty perception and behavioral challenges of service providers05

How were the identified gaps addressed?

10

Advocating for a prevent-identify-refer protocol using CSC with policy makers & technical working groups

Advocating for and mobilizing existing government funds for logistics, drugs, pulse oximeters and beds

Developing pause-point wise rosters to meet HR constraints

Capacity building of surgeons & ancillary staff

Periodic supportive supervision visits: Supporting use of job-aids,Hand-holding support in use of CSC on FDS days

Data triangulation and digitization

11

Program Lessons

A rigorous implementation plan is required to ensure routine and correct use of the checklist

Cultivating local champions to drive

the process

Regular data analysis & discussion in facility

based QI meetings

Competency based training

Combined top-down and bottom-up

approach required

Promoting a culture of safety through shared team work

For more information, please visitwww.mcsprogram.org

This presentation was made possible by the generous support of the American people through the United States Agency for International Development (USAID), under the terms of the Cooperative Agreement AID-OAA-A-14-00028. The contents are the responsibility of the authors and do not

necessarily reflect the views of USAID or the United States Government.

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Early Lessons from Implementing Clinical Safety Checklist (CSC) for Voluntary Female Sterilization in India Background What is Needed to Improve QOC in Indian Context?What is the Clinical Safety Checklist?Program Intervention: Geographies�Results and Key FindingsQuarter-wise Trend of Completeness �of Filled Checklists Completeness of Select Indicators Implementation Challenges: What are we up against?How were the identified gaps addressed?Slide Number 11Slide Number 12