From Pre-Implementation to Institutionalization: Lessons From Sustaining a Perinatal Audit Program in South Africa

The authors explored the implementation history of South Africa’s perinatal audit program and identified lessons learned, policy and operational gaps, and issues with an existing measurement tool found while measuring the program’s implementation in 5 districts.


SUPPLEMENT 2. METHODS ADDITIONAL INFORMATION Desk review
To understand the context and history of implementation, MK conducted a desk review of related national guidelines, conference proceedings and literature on implementation of the perinatal death audit program in South Africa.A content analysis was undertaken applying a health policy analysis triangle framework. 1,2For content, national policies, guidelines and reports were mapped chronologically and reviewed and information on perinatal audit extracted.For actors, the names of authors on the perinatal audit related reports were extracted and mapped by year, province and role.For process, activities related to the response of perinatal audit were extracted from the perinatal audit related reports and Conference for Perinatal Priorities proceedings and mapped chronologically.For context, data on the number of facilities implementing PPIP was extracted from the perinatal audit related reports and mapped chronologically.MK conducted all extraction and mapping and verified data with national stakeholders.

Case study research of sustained implementation in the Western Cape
A multiple case study design was applied to understand the "how" or "why" of sustained implementation. 3We used a multiple holistic design whereby the sub-district was considered as a unitary whole allowing for comparison across settings to gain insights on factors influencing sustained implementation of perinatal audit.
We also set out to systematically assess implementation of the perinatal audit program in five sub-districts in the Western Cape, South Africa, applying a standardised scoring methodology.Qualitative and quantitative data collection methods were employed, including observations (e.g., onsite review of facility documents) and semi-structured key informant interviews with subnational and facility managers and staff.

Sampling
The PPIP reporting structure in the Western Cape comprises five PPIP regions, which are aligned to the regional hospitals with a designated regional PPIP coordinator who oversees implementation.The district level-one hospitals manage all of the deliveries in a sub-district, unless referral is required.Antenatal and postnatal care services take place at the primary health care (PHC) level.Perinatal audit considers the full continuum of care and engages both hospital and PHC staff; therefore, each case is defined as a "sub-district" with the district hospital as the host of the process.Criteria for sub-district selection included: 1) currently conducting perinatal review meetings; 2) contributing to PPIP for over 10 years; 3) a district hospital outside of Cape Town Metro, which has a unique system; 4 and 4) demonstrating at least two characteristics from a previous study on perinatal audit in South Africa: team drivers, institutional review, feedback and communication within the system. 5Based on these criteria and stakeholder inputs, two PPIP regions were selected, Cape Winelands East and the Overberg (Region 1) and Garden Route and Central Karoo (Region 2) and then two sub-districts identified within each: case A and B in Region 1; and case C, D and E in Region 2.
Key informants were purposefully sampled based on their involvement with perinatal audit and included two regional PPIP coordinators, sub-district health managers, and clinical staff.Interviews were conducted with at least 10 staff per case or until saturation had been reached, Supplement to: Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.2023;11(1):e2200213. https://doi.org/10.9745/GHSP-D-22-00213 4 with the exception of case D where only five staff were available.In total, 56 key informants were included.Table S1.1 provides details about key informants and meetings observed.

Data collection
Data collection tools included a key informant interview guide and a meeting observation guide.Fieldwork and data collection took place from October 2019 to March 2020 ranging from half of a day to five days per site.MK conducted the fieldwork and sent a summary report of preliminary findings and reflection to the research team within one week of visiting the site.Key informant interviews were in English and ranged from 20 minutes to one hour.All interviews were conducted individually with the exception of case D, which were done in two groups.Non-participant observations occurred at seven meetings: two provincial PPIP meeting, three sub-district perinatal review meetings (M&M meetings), one monitoring and evaluation (M&E) meeting, and one other staff meeting.
For the standard implementation assessments, data collection included: 1) administration of a standardised, semistructured questionnaire to facility health workers supporting MPDSRrelated activities who were present on the day of the visit, and 2) observations of perinatal audit-related documents and activities in the facility (e.g., review of perinatal review meeting notes).The questionnaire was completed with one of the identified PPIP focal points and verified with other stakeholders as needed.A tool developed to measure the stage of MPDSR implementation was applied. 6ta management and analysis Interviews were recorded and transcribed.Transcripts, observation and reflection notes were compiled and analysed using Atlas.ti(v9) by MK with oversight from AG.Thematic analysis was used applying an analysis framework derived from the extended Normalization Process Theory, 7 an implementation theory used to consider broader social systems in which interventions are implemented.Using thematic analysis and an iterative process, the emerging themes were considered in relation to the analysis framework to inform the findings of the research.A report was developed for each case study by MK and received inputs from all authors.
To derive a cumulative implementation progress score for each facility, the quantitative data were analysed using an implementation progress monitoring tool. 6An implementation progress score was calculated for each sub-district across six stages of implementation, with each stage having a weighted score based on specific points.For each stage, MK considered all relevant collected data to assign stage-specific points, contributing to a possible total score of 30.Data from the facility and subnational key informant questionnaires were extracted into a database to tabulate descriptive means and frequencies of explanatory variables and progress markers.Qualitative data were analysed using thematic content analysis.To determine the leading facility-reported barriers and enablers to MPDSR implementation, the team analysed the frequency of qualitative responses from facility interviews based on the thematic content analysis and considered the frequency of relevant progress markers.

Rigour and ethics
Measures were taken to ensure rigour of the case-study approach, 3,8 such as engagement with stakeholders prior to data collection; voluntary participation of participants; seeking peer and expert feedback; audit trail with clear mapping of the research process; and triangulation of data sources.A short report was provided to sub-district representatives to verify results with the stakeholders.Permission to take photographs of documents and training materials was given from sub-district health administrators, with commitment to not to include sensitive information and identifiers.
The ethics approval from the Higher Degrees Committee of the University if the Western Cape was given on 09 November 2018, and approval was received from the Provincial Department of Health in July 2019 (NHRD Number: WC_201906_006).Authorization to conduct the study was granted from the Department of Health of the Western Cape Province.
The 2021 Maternal, Perinatal and Neonatal Health (MPNH) Policy sets an objective to develop a sustainable surveillance system for maternal, perinatal and neonatal morbidity and mortality and argues that "Data governance for MPNH delivery in South Africa is fragmented, with multiple data sources for maternal and neonatal mortality, at times with divergent views." 9The policy does not mention PPIP specifically.Additionally, the section on MPDSR only includes the surveillance component of the cycle, does not specify which system should be used for notification, and does not link to perinatal review meetings.Clinical audits and related review meetings are presented in the section on quality of care.

Figure S3 .
Figure S3.Initiatives to improve neonatal care

Supplement to:SUPPLEMENT 5 .
Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.2023;11(1):e2200213. https://doi.org/10.9745/GHSP-D-22-0021321 PROVINCIAL AND SUBNATIONAL STRUCTURES PPIP, Perinatal Problem Identification Program; Child PIP, Child Problem Identification Program; MCWH, Maternal, Child and Women's Health; QA, Quality Assurance; DHIS, District Health Information Software; O&G, Obstetrics and Gynaecology; Paeds, Paediatrics; PHC, Primary health care; CHC, Community health centre; MOU, Midwife-led obstetric unit Source: Image used with permission from Bergh et al (2011) Completing the audit cycle for quality care in perinatal, newborn and child health 12

Table S2 Distribution of participants and meeting observations
Note: n/a indicates that this position did not exist at this site or was not occupied at the time of the data collection.Key: M&E, monitoring and evaluation; M&M, morbidity and mortality; PPIP, Perinatal Problem Identification Program; PHC, primary health care * Included one academic, one former National Department of Health (DOH) employee, one District Clinical Specialist Paediatrician from another province ** Included one WC DOH employee, one academic, one retired WC DOH Supplement to: Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.2023;11(1):e2200213. https://doi.org/10.9745/GHSP-D-22-002137 SUPPLEMENT 3. DESK REVIEW ADDITIONAL INFORMATION

Table S3 .1 Documents identified in the desk review Type of document Documents
doi: 10.2471/BLT.14.144683Belizan M, Bergh AM, Cilliers C, et al.Stages of change: A qualitative study on the implementation of a perinatal audit program in South Africa.BMC Health Serv Res 2011;11:243.doi: 10.1186/1472-6963-11-243 Swartz A, LeFevre AE, Perera S, et al.Multiple pathways to scaling up and sustainability: an exploration of digital health solutions in South Africa.Globalization and health 2021;17(1):77.doi: 10.1186/s12992-021-00716-1 [published Online First: 2021/07/08] Mukinda FK, George A, Van Belle S, et al.Practice of death surveillance and response for maternal, newborn and child health: a framework and application to a South African health district.BMJ Open 2021;11(5):e043783.doi: 10.1136/bmjopen-2020-043783 Rhoda NR, Greenfield D, Muller M, et al.Experiences with perinatal death reviews in South Africa--the Perinatal Problem Identification Program: scaling up from program to province Woods DL, Pattinson RC, Greenfield D, et al.Saving Mothers and Babies: Assessing and reducing mortality rates in your hospital In: Woods DL, ed.Perinatal Education Program online courses: Bettercare Electronic Book Works 2008.

Table S3 .2 Timeline of the perinatal audit program milestones Year Activity 1982
Priorities in Perinatal Care Association of South Africa established and begins annual conference.1992 The registration of perinatal deaths in South Africa falls under the mandate of the Department of Home Affairs (DHA) and is governed by the Births and Deaths Registration Act 1992 (Act No. 51 of 1992) (Republic of South Africa, 1992).This Act was last amended in 2010 as the Births and Deaths Registration Amendment Act (Act No.18 of 2010), with the regulations of the Act amended in 2014 (Republic of South Africa, 2010; Republic of South Africa, 2014).According to the principal Act, 'A stillborn in relation to a child, means that it has at least 26 weeks of intra-uterine existence but showed no sign of life after complete birth (Republic of South Africa, 1992:5).In terms of the Regulations on the Registration of Births and Deaths, stillbirths and deaths have to be registered within 72 hours of occurrence (Republic of South Africa, 2014).While the certification of the occurrence of a stillbirth and provision of information on causes of death may be done by a professional nurse, all other deaths, including neonatal deaths, have to be certified by a medical practitioner.However, if any death was not due to natural causes, the medical practitioner is obliged to report such a death to a police officer.Subject to the Inquests Act, 1959 (Act No.58 of 1959), the police officer shall investigate the circumstances of the death while a forensic pathologist should perform a medico-legal post mortem to determine the causes of death.Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.
1998-1999 PPIP program change to windows and became operationalized (interview) The national PPIP database administered by the MRC Maternal and Infant Health Care Strategies Research Unit was set up on 1 October 1999 (Saving Babies 2003-5) Supplement to: Supplement to:

POLICY ANALYSIS Phase 1 (1992-2007): The start of the perinatal audit program (pre-implementation)
Supplement to: Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.• Context: District Health Information Software (DHIS) introduced and scaled nationally to collect routine data; multiple maternal and newborn health (MNH) programs initiated; PPIP expands from 27 facilities in 2000 to 244 facilities.• Content: Policy to register perinatal deaths (1992); Convention on the Rights of the Child signed (1993); Millennium Development Goal commitment (2000).• Actors: Bottom up approach from committed champions who initiated PPIP and led the roll out; Saving Babies Technical Task Team established; University of Pretoria established Maternal and Infant Health Care Strategies Research Unit (1997) (an extra-mural unit of the South African Medical Research Council).• Process: User friendly software developed and filled a gap in the routine data systems; annual Perinatal Priorities Conferences with learning shared; multiple PPIP workshops along with regularly published Saving Babies reports; Perinatal Education Program (PEP) in South Africa established (1993) to provide continued learning opportunities for clinical staff.Implementation of MNH programs in response to PPIP findings; PPIP expands from 275 facilities to 588 facilities. 11• Content: The MNCWH&N Strategic Plan 2012-2016 includes indicator making perinatal death reviews mandatory in hospitals; District Clinical Specialist Teams established.• Actors: Formalization of network with ongoing engagement from original champions and expansion of network through establishment of National Perinatal Committee with regular reporting of perinatal mortality to the Minister of Health.• Process: One workshop along with biannual Saving Babies reports; annual Perinatal Priorities Conferences with learning shared; implementation research; 4,5,12 provincial PPIP trainings; PEP develops Saving Mothers and Babies curriculum (2008), which includes perinatal death audit. 10,13Kinney MV, George AS, Rhoda N, Pattinson RC, Bergh AM.From pre-implementation to institutionalization: lessons from sustaining a perinatal audit program in South Africa.Glob Health Sci Pract.Institutionalization of actors and networks to oversee implementation including new posts in National Department of Health (e.g.neonatal care improvement advisor and Deputy Director for Neonatal Care post) and establishment of National Neonatal Coordinating Committee; University of Pretoria Research Centre for Maternal, Fetal, Newborn and Child Health Care Strategies established taking over role of training and technical support (2016).• Process: Reporting and oversight embedded in system demonstrated by biannual Saving Babies report as well as triennial National Perinatal Mortality and Morbidity Committee report; annual Perinatal Priorities Conferences with learning shared.A timeline of activities across the four components of the health policy analysis triangle were adapted from: Kinney, MK. (2019, September 17-19).25 years of the Perinatal Problem Identification Program: Unpacking mortality reduction linked to factors that influenced the development and implementation process.[Conference oral presentation].PHASA 2019 Conference, Athlone, Cape Town.