Annex 3: Review of Standard Operating Procedures specific to focus on decentralization and Districts

This review is based on draft SOPs received by the evaluation team. Our understanding is that finalization of the SOPs is work in progress. Our analysis here indicates further work should be considered specific to the extent to which SOPs address Districts' and Health Facilities' roles and responsibilities in the context of digital data.

1. No number: User Account Management - July 2017

Comments specific to decentralization and the roles and responsibilities of Districts: this seems very much to be a 1st draft. Data custodians include District Health Officers; the list of custodians is led by CMED.

2. SOP 01: Revision of indicators and data collection tools - September 2017

Data custodians are defined as primarily departments/units within the MoH

Comments specific to decentralization and the roles and responsibilities of Districts: this SOP does not mention of disaggregation. There is reference to (but no explanation of) SMART indicators

There is no reference to Districts' roles and responsibilities under the remit of this SOP [unless medical staff at District level are subsumed within MoH staff - but presumably CMED and the Digital Health Division will have different priorities to a DHMT

3. No number: Guidelines to privacy, security and service continuity of HIS in MalawiSeptember 2017

This SOP discusses the shared responsibility for ensuring patients' (digital) data are safeguarded. The list includes Zones, Districts and Health Facilities.

Comments specific to decentralization and the roles and responsibilities of Districts: this SOP does not set out governance structures for ensuring confidentiality; it does not consider how each level of the health system might be supported to ensure best practice in this respect.

4. No number: Guidelines for the Development and Revision of HIS Standard Operating Procedures - May 2018

'While acknowledging that there is a multiplicity of stakeholders engaged in the development of SOPs, the primary focus of this document is the MOH&P, especially those people in the HIS domain. The MOH&P is ultimately the key beneficiary in using information generated from HIS and any efforts to strengthen systems should be targeted at the Ministry.

The secondary audience for these guidelines include other relevant stakeholders supporting HIS such as:

• Development partners, donors and NGOs who provide technical assistance, governance, oversight or financing to health programmes and HIS

• Universities and capacity builders, as HIS capacity building efforts are institutionalized at universities and colleges'

Comments specific to decentralization and the roles and responsibilities of Districts: this is the meta-SOP, i.e. it defines what an HIS SOP should be and why SOPs are relevant

Specified roles and responsibilities do not include Districts, but e.g. development partners are listedperhaps this is a true reflection of where/how power is situated?

Does the MoH entirely subsume and control Districts' health systems, structures, facilities? If not, then those levels are not explicitly mentioned in this meta-SOP.

5. No number: Data Access and Release - July 2018

This SOP is stated as being guided by the E-Transactions and Cyber Security Act (2016)

Comments specific to decentralization and the roles and responsibilities of Districts: Districts are not on the list discussing roles and responsibilities; CMED is to lead. Might Districts be assumed to act as 'data custodians'?

This SOP includes considerable discussion on undergraduate access, while not referring at all to e.g. the DH Office, the DHMT, District Council Planners, etc.

Of the ten reviewed, this SOP most addresses governance, oversight, clear lines of sight for accountability and confidentiality of data use - for all data users. However, the discussion is limited. For instance, there is nothing on client/patient informed consent - their data will apparently be made available to even undergraduates. There is nothing about whether, how, any client has any say in the matter, or indeed what the roles and responsibilities of a DHO or Health Facilities might be in this regard.

6. No number: Guidelines for the Management of the Master Health Facility Registry - July 2018

This SOP has the necessary intention of harmonising the various different lists under the aegis/auspices of...CMED.

Comments specific to decentralization and the roles and responsibilities of Districts: DHMTs are listed as one of the key stakeholders in terms of managing the Master Health Facility Register, as custodians of the District's health data. No roles and responsibilities are specified. The DHO is to be responsible for digitizing and uploading annual updates.

7. No number: User Support - July 2018

This is a 1st/even zero draft.

HMIS Officers play their part in supporting HMIS users at District level, working with the DEHO and responsible for systems maintenance, thereby helping e.g. Data Clerks and Programme Co-ordinators.

Comments specific to decentralization and the roles and responsibilities of Districts: This SOP refers specifically to decentralization, thus: 'HMIS Office or IT Support at district level - Support Level I is the district level support guided by the HMIS Officers in collaboration with the IT Support staff. In the spirit of decentralization, all issues encountered at district level should as much as possible be resolved at that level.'

There is no indication of how e.g. human resources for health (or budgets) are to be mobilized and managed at District level to accommodate such activities.

8. No number: Interoperability of HIS - July 2018

Definitions: Interoperability: Interoperability describes the extent to which systems and devices can share data and information across different platforms using HIS established standards, such as LOINC, HL7, RxNorm, etc.

QMD: This is the Quality Management Directorate of MOHP Malawi. It is the division vested with the design, implementation, management and coordination of digital health solutions of MOHP, Malawi (people, processes and technology), working in close collaboration with the ICT Department and the Central Monitoring and Evaluation Division of MOHP.

CMED: The Central Monitoring and Evaluation Division of MOH Malawi is the division vested with the responsibility to coordinate the collection, consolidation, analysis and dissemination of MOH data in line with section 2 of the HIS Policy.

Comments specific to decentralization and the roles and responsibilities of Districts: this is a SOP written entirely from the central perspective of the MoH. No attention is given to how lower levels of the health system are to engage with interoperability, or how these levels might be supported/encouraged to make optimal use of the health planning and decision-making opportunities that would be afforded by effective use of the interoperable DHIS2.

9. No number: DQA - July 2018

Data collected by many levels; the SOP states these should be entered into DHIS2 and be accessible there.

These are the specified roles and responsibilities of DHMTs: 'The DHMT led by the DHO are primarily responsible for providing the necessary support to HMIS officers and all other staff involved in data management and data quality assurance in their respective districts. Using the DQA Module, Districts should conduct monthly quality checks: On monthly basis perform a district-level desk-based review of all key data sets using the integrated DHIS2 data quality tool. File the relevant reports and identify and document the facilities that need data management supportive supervision and mentorship.'

District Quarterly Data Quality Assessment: the quarterly data quality assessment shall be performed by HMIS Officers and program coordinators. The assessment shall build on the desk review process and focus on measuring data accuracy.

Comments specific to decentralization and the roles and responsibilities of Districts: no indication is given of any support to be provided to DHMTs and DHOs (or indeed Health Facilities) in terms of conducting and reporting on either the monthly DHIS2 audits or the quarterly DQAs.

10. SOP # 11: Introduction of new e-Health in the HIS landscape of MoHP Malawi - February 2019

NB: the e-Health sub-TWG Group includes no representatives from District level - all are from central level, mostly from the MoHP.

'End users: These are persons who will use the intended HIS solution. End users include but are not limited to departments, district health offices, district hospitals, health centers, community settings, health development partners, other institutions and ministries beyond MoHP.'

Comments specific to decentralization and the roles and responsibilities of Districts: End users are right at the bottom of an MoHP heavy governance structure for this SOP on e-Health.

There is reference to a pilot phase: [during this] phase, solution provider disseminates as much information on the pilot as possible to all key stakeholders, including but not limited to QMD, CMED, IT Section, relevant Departments, pertinent TWGs and end users.

The hierarchy appears explicit and fails to specify District and Health Facility levels.

Further comments

There is minimal attention in any of the ten reviewed SOPs to any aspects of decentralized/devolved health systems and structures, in terms of roles and responsibilities or access to resources. There is no consideration of how digital health SOPs might facilitate greater ownership of data for planning and decision-making by relevant District and sub-District health actors.

There is equally minimal attention in any of the SOPs to disaggregation of data collection and analysis and why such focus might be useful.